Sarah Millen, Author at Soligenix

Soligenix Achieves Significant Enrollment Milestone for its Pivotal Phase 3 Clinical Trial of SGX942 in the Treatment of Oral Mucositis in Head and Neck Cancer

Enrollment Sufficient to Support the Interim Efficacy Analysis

Princeton, NJ – April 18, 2019 – Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has reached a significant milestone in the Phase 3 clinical study (the “DOM-INNATE” study) for SGX942 (dusquetide) in the treatment of oral mucositis in patients with head and neck cancer (HNC). Patient enrollment is sufficient to support the planned interim efficacy analysis by the independent Data Monitoring Committee (DMC).

In accordance with the clinical protocol, approximately 90 subjects have been enrolled into the study as required for the planned interim efficacy analysis.  In the coming weeks, subjects that are currently enrolled will have their protocol assessments completed at participating study centers, including the primary endpoint assessment.  The blinded data will be verified for accuracy by the Soligenix clinical team and the data set will be provided to an independent statistical analysis center that interacts directly with the DMC for the interim efficacy analysis.  All participating subjects and study centers, as well as the Company, will remain blinded at all times.

The DMC is a group, independent of the Company, charged with safety oversight of the clinical study as well as the conduct of one, pre-specified interim efficacy analysis.  One DMC member is a statistician, with the remainder consisting of clinicians knowledgeable and experienced in the disease indication being studied. The DMC convenes at pre-determined intervals (in accordance with a pre-defined charter) to review unblinded safety and efficacy data. The DMC has the power to recommend continuation or termination of the study based on the evaluation of these data.  Specific recommendations include stopping the study for overwhelming efficacy, stopping the study for serious safety concern, stopping the study for futility, continuing enrollment in the study at the pre-specified sample size of approximately 190 subjects, or re-estimating sample size up or down to maintain the study’s statistical power.

“Completing the required enrollment to support the DMC interim analysis is a significant milestone for the SGX942 program,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  “We must now wait for the last enrolled subject to reach the study’s primary endpoint measure, which will occur up to 16 weeks after entering the study.  During this time, we will continue enrolling patients from the US and Europe into the trial, while looking forward to receiving the formal DMC recommendation in the September timeframe.”

Soligenix has been working with leading oncology centers internationally, a number of which participated in the Phase 2 study, to advance this Phase 3 clinical trial referred to as the “DOM–INNATE” study (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity).

Based on the positive and previously published Phase 2 results (Study IDR-OM-01), the pivotal Phase 3 clinical trial (Study IDR-OM-02) is designed to be a highly powered, double-blind, randomized, placebo-controlled, multinational trial that seeks to enroll approximately 190 subjects with squamous cell carcinoma of the oral cavity and oropharynx who are scheduled to receive a minimum total cumulative radiation dose of 55 Gy fractionated as 2.0-2.2 Gy per day with concomitant cisplatin chemotherapy given as a dose of 80-100 mg/m2 every third week. Subjects are randomized to receive either 1.5 mg/kg SGX942 or placebo given twice a week during and for two weeks following completion of CRT. The primary endpoint for the study is the median duration of severe oral mucositis, assessed by oral examination at each treatment visit and then through six weeks following completion of CRT. Oral mucositis is evaluated using the WHO (World Health Organisation) Grading system. Severe oral mucositis is defined as a WHO Grade of ≥3. Subjects are followed for an additional 12 months after the completion of treatment.

Patient recruitment is anticipated to be completed 2019 with top-line results available in the first half of 2020, pending the outcome of the interim analysis.

About Oral Mucositis

Mucositis is the clinical term for damage done to the mucosa by anticancer therapies.  It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine.  It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy.  Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia.  The gastrointestinal damage causes severe diarrhea.  These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.

The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system.  Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions.

It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of oral mucositis, that oral mucositis in HNC is a subpopulation of approximately 90,000 patients in the US, with a comparable number in Europe.  Oral mucositis almost always occurs in patients with HNC treated with CRT and is severe, causing inability to eat and/or drink, in >80% of patients. It is common (40-100% incidence) in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of oral mucositis depends greatly on the nature of the conditioning regimen used for myeloablation.

Oral mucositis in HNC remains an area of unmet medical need where there are currently no approved drug therapies.

About Dusquetide

Dusquetide (the active ingredient in SGX942) is an IDR, a new class of short, synthetic peptides.  It has a novel mechanism of action whereby it modulates the body’s reaction to both injury and infection towards an anti-inflammatory, anti-infective and tissue healing response.  IDRs have no direct antibiotic activity but, by modulating the host’s innate immune system responses, increase survival after infections caused by a broad range of bacterial Gram-negative and Gram-positive pathogens.  It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy.  Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, macrophage activation syndrome (MAS) as well as bacterial infections, including melioidosis.

SGX942 has demonstrated safety in a Phase 1 clinical study in 84 healthy human volunteers. Positive efficacy results were demonstrated in an exploratory Phase 2 clinical study in 111 patients with oral mucositis due to CRT for HNC.  Soligenix is working with leading oncology centers in the US and Europe to advance SGX942 in oral mucositis with the conduct of a pivotal Phase 3 clinical trial referred to as the “DOM–INNATE” study (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity).

SGX942 has received Fast Track Designation from the FDA for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in HNC patients, as well as Promising Innovative Medicine designation in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency for the treatment of severe oral mucositis in HNC patients receiving CRT.  In addition, products containing the same active ingredient, dusquetide, have been granted Fast Track Designation as an adjunctive therapy with other antibacterial drugs, for the treatment of melioidosis and Orphan Drug Designations in the treatment of MAS and the treatment of acute radiation syndrome.

Soligenix has a strong intellectual property position in the IDR technology platform, including composition of matter for dusquetide and related analogs.  Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada. Soligenix has received partial funding from NIH for its oral mucositis clinical studies.  The Phase 2 study was supported with a Phase I SBIR grant (#R43DE024032) award, with the Phase 3 study being supported by a Phase II SBIR grant (#R44DE024032) award.

Key nonclinical and clinical findings from the dusquetide program can be found in the following publications:

In addition, a high level review of the dusquetide technology platform is available here.

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201).

Our Vaccines/BioDefense business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).

For further information regarding Soligenix, Inc., please visit the Company’s website at www.soligenix.com.

This press release may contain forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as “anticipates,” “estimates,” “believes,” “hopes,” “intends,” “plans,” “expects,” “goal,” “may,” “suggest,” “will,” “potential,” or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy (including the outcome of the planned interim analysis) or the Phase 3 clinical trial of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma.  There also can be no assurance as to timing or success of the preclinical/clinical trials of RiVax®, that RiVax® will be approved for the PRV program or the amount for which a PRV for  RiVax® can be sold. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

Clinical Research Associate (In House)

POSITION SUMMARY:

Monitor Sponsor clinical studies at sites within the U.S. Responsible for the management of assigned clinical study sites. Ensures the regulatory and scientific integrity of studies. Evaluates, monitors, and documents all study information.  Maintains excellent relationships, and contact with site personnel and uses good judgment based on GCPs, ICH Guidelines.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Responsibilities include, but are not limited to:

  • As a member of the clinical project team, provides CRA oversight for Soligenix managed clinical trials. This includes but is not limited to planning, organizing, and communicating with and managing sites to allow them to meet study objectives for study protocols.
  • Participates in clinical team meetings; leads discussion on assigned protocol(s).
  • Prepares a variety of documents including protocols, CRFs, informed consent forms, operations manuals, and other documentation required for the conduct of a clinical trial.
  • Identifies potential investigators. Conducts and/or reviews pre-study site visits to assure adequacy of site, investigators, and research staff in accordance with SOPs and relevant regulations/guidelines. Recommends acceptable sites to study and management teams.
  • Manages day-to-day clinical operations of assigned protocol(s), including management of vendors (e.g., CRO, central lab, sites, SMOs) and coordination of team member activities.
  • Initiates the development of a template site budget for management review and approval, and negotiates budget with sites.
  • Participates in conducting investigator meetings, including advance preparation, presentations, problem resolution, and follow-up.
  • Performs initiation, interim and close-out site visits in accordance with SOPs when applicable.
  • Takes a lead role, under the supervision of a Clinical Manager, to develop comprehensive subject recruitment strategies and monitors enrollment to assure compliance with clinical milestones.
  • Identifies, analyzes, and reports serious compliance issues, and develops action plans for approval by management. May conduct monitoring or accompanied oversight visits to resolve difficult study conduct issues.
  • Ensures continual availability, at each site, of clinical and non-clinical supplies necessary to meet study requirements.
  • Reviews data tables, listings, and study reports for assigned protocol(s).
  • Reviews data listings, manages processes, and facilitates data review from internal and external sources. Tracks all decisions and items that develop from internal meetings. Coordinates and ensures that all paper and/or electronic study related documents are appropriately filed for submission and inspection purposes.
  • Anticipates study conduct issues and assists in developing contingency plans prior to study initiation and throughout the life of the trial.
  • Conducts oversight visits to CROs throughout the life of the trial and in preparation for inspection.
  • Performs other duties as assigned, including continuing to successfully perform functional responsibilities of CRAs.

EDUCATIONAL REQUIREMENTS (degree, license, certification):

  • Bachelors degree in a health science field or nursing degree.

YEARS OF EXPERIENCE:

  • Minimum of 3 years of experience in the pharmaceutical industry and 3-6 years of clinical trial and monitoring experience.
  • Experience in working on at least 2 multicenter, Phase 2 clinical studies and 1 Phase 3 clinical study.
  • Experience working in the clinical settings of oncology and/or gastroenterology.

PHYSICAL REQUIREMENTS / WORKING CONDITIONS of POSITION:

NA

OTHER SKILLS AND ABILITIES:

  • Requires comprehensive knowledge of the pharmaceutical clinical development process and applicable regulations and guidelines.
  • Thorough knowledge of study SOPs
  • Good working knowledge of medical terminology, physiology, and pharmacology in multiple therapeutic areas.
  • Solid understanding of the roles and responsibilities of all functional areas in the extended project team.
  • Knowledge of GCP/ICH and applicable regulatory requirements.
  • Strong communication, organizational and planning skills.
  • Strong computer skills with demonstrated experience in working with Microsoft Office programs (Word, Excel, PowerPoint, and Outlook).
  • Good understanding of CRA-related software, e.g., eCRF, IVRS.
  • Strong problem solving and analytical skills.
  • Ability to travel up to 50% of the time.

How to Apply

Please provide resume, references, and current location via e-mail to hr@nullsoligenix.com. Compensation will be commensurate with experience. No phone calls, please. No recruiters.

Soligenix Receives $611,000 in Non-Dilutive Funding Through New Jersey Technology Business Tax Certificate Transfer Program

Princeton, NJ – April 15, 2019 – Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has received approximately $611,000, net of transaction costs, in non-dilutive financing via the state of New Jersey’s Technology Business Tax Certificate Transfer Program.

This competitive program enables approved technology and biotechnology businesses to sell their unused Net Operating Loss (NOL) Carryovers and unused Research and Development (R&D) Tax Credits to unaffiliated, profitable corporate taxpayers in the state of New Jersey. This allows businesses with NOLs to turn their tax losses and credits into cash proceeds to fund additional R&D, purchase equipment and/or facilities, or cover other allowable expenditures. The New Jersey Economic Development Authority’s (NJEDA) determines eligibility for the program, the New Jersey Division of Taxation determines the value of the available tax benefits (NOLs and R&D Tax Credits), and the New Jersey Commission on Science and Technology evaluates the technology and its viability. The state of New Jersey was the originator of this Program and the first state to implement and fund it.

“Receipt of this non-dilutive funding is a welcomed addition to our non-dilutive government grant and contract funding,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  “This is our ninth year receiving NOL funding, which now totals approximately $5 million.  We are, again, very thankful for NJEDA’s continued support of its biotechnology industry.”

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201).

Our Vaccines/BioDefense business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).

For further information regarding Soligenix, Inc., please visit the Company’s website at www.soligenix.com.

This press release may contain forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as “anticipates,” “estimates,” “believes,” “hopes,” “intends,” “plans,” “expects,” “goal,” “may,” “suggest,” “will,” “potential,” or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy or the Phase 3 clinical trial of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma.  There also can be no assurance as to timing or success of the preclinical/clinical trials of RiVax®, that RiVax® will be approved for the PRV program or the amount for which a PRV for  RiVax® can be sold. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

Soligenix and the European Medicines Agency Pediatric Committee Reach Agreement on the Pediatric Investigation Plan for SGX942

Acceptance of Pediatric Investigation Plan is important milestone on the path to submission of Marketing Authorization Application in Europe  

 

Princeton, NJ – April 9, 2019 – Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Pediatric Committee (PDCO) of the European Medicines Agency (EMA) agreed to the Company’s Pediatric Investigation Plan (PIP) for SGX942 (dusquetide).  It was also agreed that the Company may defer conducting the PIP until successful completion of its ongoing pivotal Phase 3 clinical study evaluating SGX942 as a treatment for oral mucositis in patients with head and neck cancer (HNC).

As part of the regulatory process for the registration of new medicines in Europe, pharmaceutical companies are required to provide a PIP outlining their strategy for investigation of the new medicinal product in the pediatric population. An approved PIP is a prerequisite for filing a Marketing Authorization Application (MAA) for any new medicinal product in Europe.  Soligenix will be able to file the adult indication MAA prior to completion of the PIP because the PDCO permitted the Company to defer conducting the pediatric program until the benefit/risk of treatment has been established in the adult population.

Following a potential approval of the SGX942 MAA for treatment of oral mucositis in adult patients with HNC, Soligenix will work with PDCO and EMA to include appropriate pediatric data in the approved labeling.

“PDCO’s agreement that we may defer conducting our PIP, allowing us to move forward with a potential submission and approval of an MAA in adults while initiating the pediatric development program, is an important step forward in our efforts to bring SGX942 to market,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  “Likewise, acceptance of our PIP is an important regulatory milestone for the product, which also allows us to potentially expand the label to include appropriate pediatric data.  Oral mucositis remains an extremely debilitating side effect of cancer treatment and is particularly severe and prevalent in HNC patients.  Soligenix looks forward to continuing to work with EMA and PDCO to bring this important therapy to the European market as quickly as possible.”

Soligenix is working with leading oncology centers to advance dusquetide development with the conduct of a Phase 3 clinical trial referred to as the “DOM–INNATE” study (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity).  Patient recruitment is anticipated to be completed in 2019 with top-line results available in the first half of 2020, pending the outcome of the interim analysis in Q3 2019.

About Oral Mucositis

Mucositis is the clinical term for damage done to the mucosa by anticancer therapies.  It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine.  It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy.  Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia.  The gastrointestinal damage causes severe diarrhea.  These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.

The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system.  Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions.

It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of oral mucositis, that oral mucositis in HNC is a subpopulation of approximately 90,000 patients in the US, with a comparable number in Europe.  Oral mucositis almost always occurs in patients with HNC treated with CRT and is severe, causing inability to eat and/or drink, in >80% of patients. It is common (40-100% incidence) in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of oral mucositis depends greatly on the nature of the conditioning regimen used for myeloablation.

Oral mucositis in HNC remains an area of unmet medical need where there are currently no approved drug therapies.

About Dusquetide

Dusquetide (the active ingredient in SGX942) is an IDR, a new class of short, synthetic peptides.  It has a novel mechanism of action whereby it modulates the body’s reaction to both injury and infection towards an anti-inflammatory, anti-infective and tissue healing response.  IDRs have no direct antibiotic activity but, by modulating the host’s innate immune system responses, increase survival after infections caused by a broad range of bacterial Gram-negative and Gram-positive pathogens.  It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy.  Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, macrophage activation syndrome (MAS) as well as bacterial infections, including melioidosis.

SGX942 has demonstrated safety in a Phase 1 clinical study in 84 healthy human volunteers. Positive efficacy results were demonstrated in an exploratory Phase 2 clinical study in 111 patients with oral mucositis due to CRT for HNC.  Soligenix is working with leading oncology centers in the US and Europe to advance SGX942 in oral mucositis with the conduct of a pivotal Phase 3 clinical trial referred to as the “DOM–INNATE” study (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity).

SGX942 has received Fast Track Designation from the FDA for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in HNC patients, as well as Promising Innovative Medicine designation in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency for the treatment of severe oral mucositis in HNC patients receiving CRT.  In addition, products containing the same active ingredient, dusquetide, have been granted Fast Track Designation as an adjunctive therapy with other antibacterial drugs, for the treatment of melioidosis and Orphan Drug Designations in the treatment of MAS and the treatment of acute radiation syndrome.

Soligenix has a strong intellectual property position in the IDR technology platform, including composition of matter for dusquetide and related analogs.  Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada. Soligenix has received partial funding from NIH for its oral mucositis clinical studies.  The Phase 2 study was supported with a Phase I SBIR grant (#R43DE024032) award, with the Phase 3 study being supported by a Phase II SBIR grant (#R44DE024032) award.

Key nonclinical and clinical findings from the dusquetide program can be found in the following publications:

In addition, a high level review of the dusquetide technology platform is available here.

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201).

Our Vaccines/BioDefense business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).

For further information regarding Soligenix, Inc., please visit the Company’s website at www.soligenix.com.

This press release may contain forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as “anticipates,” “estimates,” “believes,” “hopes,” “intends,” “plans,” “expects,” “goal,” “may,” “suggest,” “will,” “potential,” or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy or the Phase 3 clinical trial of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma.  There also can be no assurance as to timing or success of the preclinical/clinical trials of RiVax®, that RiVax® will be approved for the PRV program or the amount for which a PRV for  RiVax® can be sold. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

Soligenix Receives US Patent for Dusquetide Related Analogs

Patent broadens protection in infectious disease and oral mucositis, including composition of matter claims

Princeton, NJ – April 04, 2019 – Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the US Patent Office will issue the patent titled “Novel Peptides for Treating and Preventing Immune-Related Disorders, Including Treating and Preventing Infection by Modulating Innate Immunity” on April 9, 2019.  The new patent (#10,253,068) claims composition of matter for novel innate defense regulator (IDR) analogs, expanding patent protection to more diverse analog structures.  Therapeutic use claims in oral mucositis, colitis, and infectious disease, both alone and in conjunction with antibiotics, will also issue.

Dusquetide (the active ingredient in SGX942) is a novel, first-in-class IDR.  It modulates the response of the innate immune system in response to various stimuli, including infection, tissue damage and inflammation.  Dusquetide has demonstrated efficacy in an extensive array of preclinical models emphasizing all three aspects of its activity.  SGX942 demonstrated positive results in a Phase 2 study in the treatment of oral mucositis in head and neck cancer (HNC) patients.  SGX942 at a dose of 1.5 mg/kg successfully reduced the median duration of severe oral mucositis by 67% in patients receiving the most aggressive chemoradiation therapy for treatment of their cancer.  In addition to the oral mucositis findings, an increased incidence of “complete response” of tumor at the one month and 12-month follow-up visits were observed.  Decreases in infection rate and an increase in the 12-month survival rate were also observed with SGX942 treatment.

SGX942 is currently being evaluated in a pivotal, Phase 3, randomized, double-blind, placebo-controlled, multinational clinical study for the treatment of oral mucositis in HNC patients.  The ongoing Phase 3 trial, referred to as the “DOM–INNATE” study (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity), is actively enrolling patients in the US and Europe.

“Soligenix continues to pursue broad patent coverage for dusquetide and its library of related IDR analogs, first with composition of matter claims followed by therapeutic use claims, such as in oral mucositis,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  “The composition of matter patents are generally valid until 2028.”

About Dusquetide

Dusquetide (the active ingredient in SGX942) is an IDR, a new class of short, synthetic peptides.  It has a novel mechanism of action whereby it modulates the body’s reaction to both injury and infection towards an anti-inflammatory, anti-infective and tissue healing response.  IDRs have no direct antibiotic activity but, by modulating the host’s innate immune system responses, increase survival after infections caused by a broad range of bacterial Gram-negative and Gram-positive pathogens.  It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy.  Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, macrophage activation syndrome (MAS) as well as bacterial infections, including melioidosis.

SGX942 has demonstrated safety in a Phase 1 clinical study in 84 healthy human volunteers. Positive efficacy results were demonstrated in an exploratory Phase 2 clinical study in 111 patients with oral mucositis due to chemoradiation therapy (CRT) for HNC.  Soligenix is working with leading oncology centers in the US and Europe to advance SGX942 in oral mucositis with the conduct of a pivotal Phase 3 clinical trial referred to as the “DOM–INNATE” study (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity).

SGX942 has received Fast Track Designation from the FDA for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in HNC patients, as well as Promising Innovative Medicine designation in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency for the treatment of severe oral mucositis in HNC patients receiving CRT.  In addition, products containing the same active ingredient, dusquetide, have been granted Fast Track Designation as an adjunctive therapy with other antibacterial drugs, for the treatment of melioidosis and Orphan Drug Designations in the treatment of MAS and the treatment of acute radiation syndrome.

Soligenix has a strong intellectual property position in the IDR technology platform, including composition of matter for dusquetide and related analogs.  Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada. Soligenix has received partial funding from NIH for its oral mucositis clinical studies.  The Phase 2 study was supported with a Phase I SBIR grant (#R43DE024032) award, with the Phase 3 study being supported by a Phase II SBIR grant (#R44DE024032) award.

Key nonclinical and clinical findings from the dusquetide program can be found in the following publications:

In addition, a high level review of the dusquetide technology platform is available here.

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201).

Our Vaccines/BioDefense business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).

For further information regarding Soligenix, Inc., please visit the Company’s website at www.soligenix.com.

This press release may contain forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as “anticipates,” “estimates,” “believes,” “hopes,” “intends,” “plans,” “expects,” “goal,” “may,” “suggest,” “will,” “potential,” or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy or the Phase 3 clinical trial of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma.  There also can be no assurance as to timing or success of the preclinical/clinical trials of RiVax®, that RiVax® will be approved for the PRV program or the amount for which a PRV for  RiVax® can be sold. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

Soligenix Announces Recent Accomplishments And Year-End 2018 Financial Results

PRINCETON, NJ – March 26, 2019 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the year ended December 31, 2018.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, “We are actively enrolling patients in our pivotal double-blind, placebo-controlled Phase 3 clinical trial of SGX942 (dusquetide) for the treatment of oral mucositis in patients with head and neck cancer receiving chemoradiation therapy. We anticipate completion of patient enrollment for the planned interim analysis in the first half of 2019, with the results of the interim analysis expected in the third quarter of 2019.”

Dr. Schaber continued, “Following the positive recommendation received from the independent Data Monitoring Committee (DMC), we continue to enroll patients in our double-blind, placebo-controlled Phase 3 study for the treatment of cutaneous T-cell lymphoma (CTCL) with SGX301 (synthetic hypericin), for which we expect final results in the first quarter of 2020.”

Soligenix Recent Accomplishments:

  • On February 11, 2019, the Company announced the allowance of a new United States (US) patent protecting its ricin toxin vaccine, RiVax®.  The patent, titled “Multivalent Stable Vaccine Composition and Methods of making same”, supports combination vaccines protecting against ricin intoxication as well as other toxins, such as those associated with anthrax. To view this press release, please click here.
  • On February 7, 2019, the Company announced publication of a scientific article demonstrating the successful thermostabilization of an Ebola subunit vaccine candidate.  The article titled, “Thermostable Ebola virus vaccine formulations lyophilized in the presence of aluminum hydroxide”, is published in the European Journal of Pharmaceutics and Biopharmaceutics online. To view this press release, please click here.
  • On January 23, 2019, the Company announced that the European Patent Office had granted the patent entitled “Novel Peptides for Treating and Preventing Immune-Related Disorders, Including Treating and Preventing Infection by Modulating Innate Immunity.”  The newly issued patent claims composition of matter of innate defense regulator (IDR) analogs, expanding patent protection around the Company’s lead IDR, dusquetide.  Similar claims have been previously allowed in the US and are being pursued in other worldwide jurisdictions. To view this press release, please click here.
  • On December 5, 2018, the Company announced the publication of a review article discussing the therapeutic applications of its innate immune modulator technology, including dusquetide (the active ingredient in SGX942), its lead clinical IDR.  The article entitled, “Targeting Innate Immunity to Treat Disease: Potential Therapeutic Applications”, was published in the journal Drug Target Review online. To view this press release, please click here.

Financial Results – Year Ended December 31, 2018

Soligenix’s revenues for the year ended December 31, 2018 were $5.2 million as compared to $5.4 million for the prior year. Revenues included payments on a contract in support of RiVax®, in addition to the grants received to support the development of SGX301 for the treatment of CTCL and SGX942 for the treatment of oral mucositis in head and neck cancer, as well as the subaward from the Ebola collaboration with the University of Hawai’i at Mānoa.

Soligenix’s basic net loss was $8.9 million, or ($0.68) per share for the year ended December 31, 2018, as compared to $7.1 million for the prior year, or ($1.16) per share.

Research and development expenses were $6.8 million as compared to $5.5 million for the years ended December 31, 2018 and 2017, respectively. The increase is primarily related to expenditures incurred in the expansion of the Phase 3 clinical trial of SGX942 as well as the ongoing Phase 3 clinical trial of SGX301.

General and administrative expenses were $3.0 million as compared to $3.2 million for the years ended December 31, 2017 and 2016, respectively. This decrease was primarily a result of a decrease in professional fees and employee compensation expenses.

As of December 31, 2018, the Company’s cash position was approximately $9.0 million.

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201).

Our Vaccines/BioDefense business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).

For further information regarding Soligenix, Inc., please visit the Company’s website at https://www.soligenix.com.

This press release may contain forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as “anticipates,” “estimates,” “believes,” “hopes,” “intends,” “plans,” “expects,” “goal,” “may,” “suggest,” “will,” “potential,” or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy or the Phase 3 clinical trial of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma.  There also can be no assurance as to timing or success of the preclinical/clinical trials of RiVax®, that RiVax® will be approved for the PRV program or the amount for which a PRV for  RiVax® can be sold. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

Soligenix to Present at National Institutes of Health – Commercialization Accelerator Program “FeedForward Session” in Washington, DC

Princeton, NJ – March 18, 2019 – Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that they will be presenting at the National Institutes of Health (NIH) – Commercialization Accelerator Program (CAP) “FeedForward Session” in Washington, DC on March 21, 2019. The NIH selected Soligenix’s SGX942 (dusquetide) development program for the treatment of oral mucositis in head and neck cancer (HNC) patients as a Small Business Innovation Research/Small Business Technology Transfer (SBIR/STTR) Commercialization CAP Phase II awardee for 2018-2019.  The SGX942 program was selected by the NIH specifically for the Commercialization Transition Track, which provides technical assistance to awardee companies to advance NIH-funded technologies towards commercialization and market readiness. The “FeedForward Session” represents one of the final activities of this program with a presentation to a select group of NIH representatives, investor groups, and industry advisors.

Soligenix applied for the CAP as part of its $1.5 million Phase II SBIR/STTR NIH grant to develop SGX942 as a treatment for oral mucositis in HNC patients receiving chemoradiation therapy (CRT).  Only a select number of SBIR Phase II awarded companies are accepted into the CAP by the NIH.

“We are appreciative of the NIH for selection into the Commercialization Accelerator Program and for their continued support of Soligenix and the SGX942 development program,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  “Oral mucositis remains an extremely debilitating side effect of cancer treatment and is particularly severe and prevalent in HNC patients.  Soligenix looks forward to continuing work with NIH and to presenting at this invitation only event.”

Dusquetide (the active ingredient in SGX942) is an innate defense regulator (IDR), a new class of short, synthetic peptides with a novel mechanism of action modulating the body’s reaction to both injury and infection towards a simultaneously anti-inflammatory and anti-infective response.  By altering the response of the innate immune system, IDRs increase survival after infections caused by a broad range of bacterial Gram-negative and Gram-positive pathogens.  They also accelerate resolution of tissue damage (including oral mucositis) following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy.

Soligenix is working with leading oncology centers to advance dusquetide with the conduct of a Phase 3 clinical trial referred to as the “DOM–INNATE” study (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity).  Top-line results from this trial are targeted for the second half of 2019.

About Oral Mucositis

Mucositis is the clinical term for damage done to the mucosa by anticancer therapies.  It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine.  It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy.  Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia.  The gastrointestinal damage causes severe diarrhea.  These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.

The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system.  Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions.

It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of oral mucositis, that oral mucositis in HNC is a subpopulation of approximately 90,000 patients in the US, with a comparable number in Europe.  Oral mucositis almost always occurs in patients with HNC treated with CRT and is severe, causing inability to eat and/or drink, in >80% of patients. It is common (40-100% incidence) in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of oral mucositis depends greatly on the nature of the conditioning regimen used for myeloablation.

Oral mucositis in HNC remains an area of unmet medical need where there are currently no approved drug therapies.

About Dusquetide

Dusquetide (the active ingredient in SGX942) is an IDR, a new class of short, synthetic peptides.  It has a novel mechanism of action whereby it modulates the body’s reaction to both injury and infection towards an anti-inflammatory, anti-infective and tissue healing response.  IDRs have no direct antibiotic activity but, by modulating the host’s innate immune system responses, increase survival after infections caused by a broad range of bacterial Gram-negative and Gram-positive pathogens.  It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy.  Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, macrophage activation syndrome (MAS) as well as bacterial infections, including melioidosis.

SGX942 has demonstrated safety in a Phase 1 clinical study in 84 healthy human volunteers. Positive efficacy results were demonstrated in an exploratory Phase 2 clinical study in 111 patients with oral mucositis due to CRT for HNC.  Soligenix is working with leading oncology centers in the US and Europe to advance SGX942 in oral mucositis with the conduct of a pivotal Phase 3 clinical trial referred to as the “DOM–INNATE” study (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity).

SGX942 has received Fast Track Designation from the FDA for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in HNC patients, as well as Promising Innovative Medicine designation in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency for the treatment of severe oral mucositis in HNC patients receiving CRT.  In addition, products containing the same active ingredient, dusquetide, have been granted Fast Track Designation as an adjunctive therapy with other antibacterial drugs, for the treatment of melioidosis and Orphan Drug Designations in the treatment of MAS and the treatment of acute radiation syndrome.

Soligenix has a strong intellectual property position in the IDR technology platform, including composition of matter for dusquetide and related analogs.  Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada. Soligenix has received partial funding from NIH for its oral mucositis clinical studies.  The Phase 2 study was supported with a Phase I SBIR grant (#R43DE024032) award, with the Phase 3 study being supported by a Phase II SBIR grant (#R44DE024032) award.

Key nonclinical and clinical findings from the dusquetide program can be found in the following publications:

In addition, a high level review of the dusquetide technology platform is available here.

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201).

Our Vaccines/BioDefense business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).

For further information regarding Soligenix, Inc., please visit the Company’s website at www.soligenix.com.

This press release may contain forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as “anticipates,” “estimates,” “believes,” “hopes,” “intends,” “plans,” “expects,” “goal,” “may,” “suggest,” “will,” “potential,” or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy or the Phase 3 clinical trial of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma.  There also can be no assurance as to timing or success of the preclinical/clinical trials of RiVax®, that RiVax® will be approved for the PRV program or the amount for which a PRV for  RiVax® can be sold. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

Quality Assurance Associate

POSITION SUMMARY:

The Quality Assurance (QA) Associate will have good manufacturing practices (GMPs), good clinical practices (GCPs) and/or good laboratory practices (GLPs), as well as an awareness of FDA Quality-related standards/guidance.  The QA Associate will coordinate quality assurance programs, policies, processes, procedures and controls to ensure that the performance and quality of products, the conduct of clinical trial materials (CTM) manufacturing, and the pre-clinical GLP testing conform to established quality standards and agency guidelines.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Provide QA support during manufacturing and analytical operation including review of both master and executed manufacturing batch records.
  • Provides input to Research and Development (R&D) entities to ensure that the products under development meet appropriate guidelines and FDA expectations and ensure that vendors are qualified appropriately based on the developmental phase.
  • Assist all departments in the generation of quality system documentation; such as SOPs, deviation/investigation reports and change controls.
  • Provides quality input as part of Soligenix project teams.
  • Coordinates corporate technical change control process to ensure key GMP documents such as product specifications and analytical methods are appropriately controlled.
  • Coordinate process and assist in quality investigations (including OOS investigations) and work with impacted functions in the development of required CAPA items.
  • Provide assistance/support to key supplier/vendor management and oversight, including auditing.
  • Actively participate in the generation and review of key regulatory submissions such as chemistry, manufacturing and controls sections of both INDs and NDAs.
  • Maintains up to date Approved Supplier/Vendor list as well as internal and external auditing schedules.
  • Coordinate deviation process and procedures.
  • Lead quality oversight of stability program inclusive of data analysis.
  • Leads audits/quality control verifications of key clinical/regulatory documents including IND and clinical trial applications submissions (as needed), clinical study reports, Investigator’s Brochure, etc.

EDUCATIONAL REQUIREMENTS (degree, license, certification):

  • Minimum of BA/BS degree in Life Sciences/Chemistry

YEARS OF EXPERIENCE:

  • At least 3 years of experience in a Quality Assurance role in the pharmaceutical industry.

PHYSICAL REQUIREMENTS / WORKING CONDITIONS of POSITION:

N/A

OTHER SKILLS AND ABILITIES:

  • An advanced attention to detail and excellent written communications skills are a must.
  • Strong, professional interpersonal skills including ability to communicate effectively with people individually and in groups.
  • Ability to communicate with technical and non-technical colleagues.
  • Knowledge/awareness of FDA, EU GMP, GLP, ICH regulations and industry best practices.
  • Knowledge/awareness of cGMPs, GCPs and/or GLPs and ICH Guidance.
  • Knowledge of records and data management; best practices, tools and technology support systems.
  • Experience with biologics and vaccines a plus.

How to Apply

Please provide resume, references, and current location via e-mail to hr@nullsoligenix.com. Compensation will be commensurate with experience. No phone calls, please. No recruiters.

Soligenix to Present at the Boston Oncology Investor Conference 2019

Princeton, NJ – March 11, 2019 – Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its Chief Scientific Officer, Oreola Donini, PhD, will deliver a corporate presentation at the Boston Oncology Investor Conference 2019 on Thursday, March 14 at 5:35 PM ET. The event will take place at 28 State Street, Boston, MA.

To access the Soligenix corporate presentation, please visit here.

About Boston Oncology Investor Conference 2019

The Boston Oncology Investor Conference 2019 at Cowen Healthcare Week is organized by OneMed Forum, and sponsored by the National Foundation for Cancer Research, the International Cancer Impact Fund, Klosters Innovation Partners, McDermott Will & Emery, Torreya Partners, and Marcum.  The event sponsor is McDermott Will & Emery. The meeting includes leading life science and oncology venture capitalists, family offices, lawyers, pharma executives, startup public and private cancer companies, and cancer foundations for a discussion of trends, opportunities, and risks in oncology investing, corporate presentations by a select group of public and private oncology companies, and updates on cutting edge science.  For more information about the conference, please refer to the conference website.

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201).

Our Vaccines/BioDefense business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).

For further information regarding Soligenix, Inc., please visit the Company’s website at www.soligenix.com.

This press release may contain forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as “anticipates,” “estimates,” “believes,” “hopes,” “intends,” “plans,” “expects,” “goal,” “may,” “suggest,” “will,” “potential,” or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy or the Phase 3 clinical trial of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma.  There also can be no assurance as to timing or success of the preclinical/clinical trials of RiVax®, that RiVax® will be approved for the PRV program or the amount for which a PRV for  RiVax® can be sold. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

Soligenix Receives US Patent Expanding Protection for its Ricin Toxin Vaccine, RiVax

Princeton, NJ – February 11, 2019 – Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today the allowance of a new United States (US) patent protecting its ricin toxin vaccine, RiVax®.  The patent, titled “Multivalent Stable Vaccine Composition and Methods of making same”, supports combination vaccines protecting against ricin intoxication as well as other toxins, such as those associated with anthrax.

RiVax® is the Company’s vaccine candidate for the prevention of death following exposure to a lethal dose of ricin toxin using a unique antigen that is completely devoid of the toxic activity of ricin.  The RiVax® antigen has demonstrated safety in two Phase 1 clinical studies. When formulated using Soligenix’s proprietary heat stabilization technology (ThermoVax®), RiVax® has demonstrated significantly enhanced thermostability and 100% protection to non-human primates in preclinical aerosol challenge models.  This patent further supports the ability to combine the antigen for the RiVax® vaccine with other antigens to create a multivalent vaccine for potential protection against multiple biothreats, such as a combination with an anthrax vaccine.

The development of RiVax® has been sponsored through a series of grants from both National Institute of Allergy and Infectious Diseases (NIAID) and the Food and Drug Administration (FDA) and ongoing development is sponsored by NIAID contract # HHSN272201400039C.

About Ricin Toxin

Ricin toxin is a lethal plant-derived toxin and potential biological weapon because of its stability and high potency, and the fact it is readily extracted from by-products of castor oil production.  Ricin comes in many forms including powder, mist or pellet.  Ricin can also be dissolved in water and other liquids.  The US Centers for Disease Control and Prevention estimates that the lethal dose in humans is about the size of a grain of salt.  Ricin toxin illness causes tissue necrosis and general organ failure leading to death within several days of exposure.  Ricin is especially toxic when inhaled.  Ricin works by entering cells of the body and preventing the cells from making the proteins it needs.  Without the proteins, cells die, which is eventually harmful to the entire body.

There are currently no effective treatments for ricin poisoning.  The successful development of an effective vaccine against ricin toxin may act as a deterrent against the actual use of ricin as a biological weapon and could be used to vaccinate military personnel and civilian emergency responders at high risk of potential exposure in the event of a biological attack.

About RiVax®

RiVax® is Soligenix’s proprietary heat stable recombinant subunit vaccine developed to protect against exposure to ricin toxin, the recent threat of which has been highlighted in the news with an envelope addressed to President Trump that was thought to contain this potent and potentially lethal toxin.  With RiVax®, Soligenix is a world leader in the area of ricin toxin vaccine research.

RiVax® contains a genetically altered version of a Ricin Toxin A (RTA) chain containing two mutations that inactivate the toxicity of the ricin molecule.  A Phase 1A clinical trial was conducted with a formulation of RiVax® that did not contain an adjuvant.  This trial revealed dose dependent seroconversion as well as lack of toxicity of the molecule when administered intramuscularly to human volunteers.  The adjuvant-free formulation of RiVax® induced toxin neutralizing antibodies that lasted up to 127 days after the third vaccination in several individuals.

To increase the longevity and magnitude of toxin neutralizing antibodies, RiVax® was subsequently formulated with an adjuvant of aluminum salts (known colloquially as alum) for a Phase 1B clinical trial.  Alum is an adjuvant that is used in many human vaccines, including most vaccines used in infants.  The results of the Phase 1B study indicated that alum-adjuvanted RiVax® was safe and well tolerated, and induced greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax®.  In animal studies, the alum formulation of RiVax® also induced higher titers and longer-lasting antibodies than the adjuvant-free vaccine.  Vaccination with the thermostabilized alum-adjuvanted RiVax® formulation in a large animal model provided 100% protection (p<0.0001) against acute exposure to aerosolized ricin, the most lethal route of exposure for ricin.  The protected animals also had no signs of gross lung damage, a serious and enduring ramification with long-term consequences for survivors of ricin exposure.  These results are described in a publication available here.

Heat stabilization of RiVax® is achieved with the Company’s proprietary ThermoVax® technology, designed to eliminate the cold-chain production, distribution and storage logistics required for most vaccines.  The technology utilizes precise lyophilization of protein immunogens with conventional aluminum adjuvants in combination with secondary adjuvants for rapid onset of protective immunity with the fewest number of vaccinations.  By employing ThermoVax® during the final formulation of RiVax®, the vaccine has demonstrated enhanced stability and the ability to withstand temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year. These results are described in a publication available here.

The development of RiVax® has been sponsored through a series of grants from both NIAID, and the FDA and ongoing development is sponsored by NIAID contract #HHSN272201400039C.  The planned Phase 2 clinical trial is contingent upon exercise of the final option by the US government under NIAID contract #HHSN272201400039C and/or through other funding sources.  RiVax® potentially would be added to the Strategic National Stockpile and dispensed in the event of a terrorist attack.  RiVax® has received orphan drug designation in the US and in Europe.

As a new chemical entity, an FDA approved RiVax® vaccine has the potential to qualify for a biodefense Priority Review Voucher (PRV), which allows the holder accelerated review of a drug application.  Approved under the 21st Century Health Cures Act in late 2016, the biodefense PRV is awarded upon approval as a medical countermeasure when the active ingredient(s) have not been otherwise approved for use in any context.  PRVs are transferable and can be sold, with sales in recent years ranging between $125 million to $350 million.  When redeemed, PRVs entitle the user to an accelerated review period of six months, saving a median of seven months’ review time as calculated in 2009.  However, the FDA must be advised 90 days in advance of the use of the PRV and the use of a PRV is associated with an additional user fee ($2.7 million in 2017).

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201).

Our Vaccines/BioDefense business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).

For further information regarding Soligenix, Inc., please visit the Company’s website at www.soligenix.com.

This press release may contain forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as “anticipates,” “estimates,” “believes,” “hopes,” “intends,” “plans,” “expects,” “goal,” “may,” “suggest,” “will,” “potential,” or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to timing or success of the preclinical/clinical trials of RiVax®, that RiVax® will be approved for the PRV program or the amount for which a PRV for  RiVax® can be sold. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

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