Soligenix Announces Publication of Scientific Review Discussing Clinical Applications of Innate Defense Regulator Technology

Highlights Potential for Treating Multiple Diseases with Dusquetide and Related IDR Analogs

 

Princeton, NJ – December 5, 2018 – 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 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 Innate Defense Regulator (IDR).  The article entitled, “Targeting Innate Immunity to Treat Disease: Potential Therapeutic Applications”, is published in the journal Drug Target Review online and is available here.

Innate immune modulation as a therapeutic intervention reflects our enhanced understanding of an ancient aspect of the immune system.  With our increasingly sophisticated exploration of innate immunity, it has become possible to manipulate this system in a beneficial manner, potentially benefiting a wide range of patient populations, including oncology, oncology supportive care, infectious disease and acute and chronic inflammatory conditions.  These applications have been made possible by recent studies identifying the intricacies of the signaling pathways, and the ability to differentially impact these pathways.  Dusquetide is one of the first therapeutic approaches in this field, and is initially being developed in the context of oncology supportive care.  Preclinical data with dusquetide has demonstrated a wide range of potential application, including in gastrointestinal inflammation, infectious disease and oncology, discussed in the presentation here.  This brief review explores some of these concepts and proposes that innate immune modulation may become as important as other adaptive immune approaches (e.g., checkpoint inhibitors, CAR-T therapies) in the future.

About Dusquetide

Dusquetide (the active ingredient in SGX942) is an Innate Defense Regulator (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 head and neck cancer (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, OrbeShield®, our GI acute radiation syndrome therapeutic 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 RiVaxÒ, that RiVaxÒ will be approved for the PRV program or the amount for which a PRV for  RiVaxÒ 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.

Administrative Assistant

POSITION SUMMARY:

The Administrative Assistant will perform administrative and office support activities for multiple departments within a 20-person biotech firm.        

The position requires superior attention to detail, a commitment to accuracy, and excellent organizational skills. The candidate must have demonstrated proficiency in MS Office programs, including Word, Excel, PowerPoint and Outlook

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Provide exceptional administrative support by managing the schedule/calendar, making travel arrangements, preparing expense reports, directing calls as required, greeting and directing visitors, maintaining company files, printing materials as needed.
  • Coordinates and oversees the day-to-day management of supplies, equipment, and facilities for the organization, as appropriate, to include maintenance, inventory management, logistics, security, and related activities.
  • Plan meetings and coordinate travel arrangements including air, hotel, and car service for employees and Board of Directors
  • Attend staff meetings and record minutes
  • Maintain Company files as well as Company calendar
  • Receive courier and other deliveries, sort and distribute mail; ship FedEx, U.S. Postal Service and other packages
  • Monitor Company social media accounts, research and post articles and company announcements, update company contacts, participate in Investor Relations mailings
  • Perform offsite errands (as needed)
  • Corporate credit card reconciliation
  • Evaluate vendors for cost-savings opportunities
  • Assisting with special projects as needed

ADDITIONAL DUTIES/QUALIFICATIONS:

  • Strong initiative and ability to work effectively with minimal supervision
  • Ability to juggle multiple projects and handle challenges of working for a small company
  • Team player, efficient and able to problem solve
  • Trustworthy, able to handle confidential data
  • Good judgment, flexibility, self-confidence, maturity, refinement and high energy.
  • Good verbal and written communications skills.
  • Excellent interpersonal skills with the ability to effectively interact with people of all skill levels and diverse backgrounds.

EDUCATIONAL REQUIREMENTS (degree, license, certification):

  • Associates or Bachelors Degree
  • Valid driver’s license

YEARS OF EXPERIENCE:

  • Minimum 1 year of related experience preferred

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.

Soligenix Selected to Present RiVax® Data at the Fourth International Conference on Vaccines Research & Development in Baltimore, Maryland

Princeton, NJ – November 12, 2018 – 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 Dr. Oreola Donini, Chief Scientific Officer, will be presenting data from the ricin toxin vaccine (RiVax®) program describing development of the vaccine under the Food and Drug Administration (FDA) Animal Rule.  The presentation will be given at the upcoming Fourth International Conference on Vaccines Research & Development on November 13-15, 2018 to be held at the Radisson Hotel Baltimore Downtown-Inner Harbor, MD.

Oral Presentation:

Thermostabilized vaccine development under the animal rule: ricin toxin vaccine presented by Dr. Oreola Donini, Chief Scientific Officer, Soligenix, Inc., on November 14, 2018 from 8:50 – 9:15 AM EDT.

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.  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.  Moreover, potential correlates of immune protection have been identified in collaboration with the laboratory of Dr. Nicholas Mantis, Research Scientist, Division of Infectious Diseases, Wadsworth Center, New York State Department of Health. The presented results will discuss a species-independent assay for immune correlates of protection, an important requirement of the FDA “Animal Rule” to pursue approval of RiVax®.

The development of RiVax® has been sponsored through a series of grants from both National Institute of Allergy and Infectious Diseases (NIAID) and the FDA and ongoing development is sponsored by NIAID contract # HHSN272201400039C. Ricin epitope mapping has been sponsored by NIAID contract # HHSN272201400021C and grant # R01 AI125190.

About the Fourth International Conference on Vaccines Research & Development

This annual conference focuses on international and interdisciplinary exchange at the forefront of vaccine research. Over the course of three days, internationally-renowned speakers from both industry and academics describe how their research journeys have developed in response to contemporary challenges.

For more information about the conference, please refer to website here.

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 may have contained 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 National Institute of Allergy and Infectious Diseases (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 U.S. 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 U.S. 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, OrbeShield®, our GI acute radiation syndrome therapeutic 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.

Soligenix Announces Recent Accomplishments And Third Quarter 2018 Financial Results

PRINCETON, NJ – November 9, 2018 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 third quarter ended September 30, 2018.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, “Our primary focus remains the quality execution of our two pivotal Phase 3 clinical programs.  Following the positive recommendation recently 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). With this new level of clarity from the DMC’s analysis of the interim Phase 3 study data, we expect to complete the study before the end of 2019 with topline results coming no later than the first quarter of 2020. Additionally, we are actively enrolling patients in our double-blind, placebo-controlled, multinational Phase 3 clinical trial of SGX942 (dusquetide) for the treatment of oral mucositis in patients with head and neck cancer (HNC) receiving chemoradiation therapy. We currently anticipate final results for this pivotal study in the second half of 2019.”

Dr. Schaber continued, “We have been fortunate to secure non-dilutive funding from various government sources, allowing us to advance multiple development programs across our biodefense and biotherapeutics pipelines. For the third quarter of 2018, our combined revenues from both our business segments were $1.4 million, and we expect this non-dilutive government funding to continue throughout the remainder of 2018 and beyond.”

Soligenix Recent Accomplishments:

  • On October 15, 2018, the Company announced it had received a positive recommendation from the independent DMC to continue enrolling into the Company’s Phase 3 “Fluorescent Light Activated Synthetic Hypericin” (FLASH) study for SGX301 (synthetic hypericin) in the treatment of CTCL. No safety concerns were reported by the DMC based on the interim analysis. To view this press release, please click here.
  • On September 13, 2018, the Company announced that the National Institutes of Health (NIH) selected Soligenix’s SGX942 (dusquetide) development program for the treatment of oral mucositis in HNC patients as a Small Business Innovation Research/Small Business Technology Transfer Commercialization Accelerator Program Phase II awardee for 2018-2019. To view this press release, please click here.
  • On September 4, 2018, the Company announced publication of extended stability studies for RiVax® showing up to 100% protection in mice even after 12 months storage at 40 degrees Celsius (104 degrees Fahrenheit), as well as the identification of a potential in vitro stability indicating assay, critical to adequately confirming long-term shelf-life of the vaccine.  The article, entitled “Thermal Stability and Epitope Integrity of a Lyophilized Ricin Toxin Subunit Vaccine”, is published in the journal Vaccine online and is available here. To view this press release, please click here.
  • On August 22, 2018, the Company announced that the United States Patent Office had granted the patent titled “Systems and Methods for Producing Synthetic Hypericin”.  The newly issued patent’s claims are directed to a novel, highly purified form of synthetic hypericin manufactured through a unique proprietary process. Synthetic hypericin is the active pharmaceutical ingredient in SGX301, the Company’s photodynamic therapy currently in a Phase 3 clinical trial for the treatment of CTCL. To view this press release, please click here.

Financial Results – Third Quarter Ended September 30, 2018

Soligenix’s revenues for the quarter ended September 30, 2018 were $1.4 million as compared to $1.8 million for the quarter ended September 30, 2017. 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 HNC, as well as the subaward from the Ebola collaboration with the University of Hawaii.

Soligenix’s basic net loss was $1.9 million, or ($0.11) per share, for the quarter ended September 30, 2018 as compared to $1.0 million, or ($0.17) per share, for the quarter ended September 30, 2017.

Research and development expenses were $1.4 million as compared to $0.6 million for the quarters ended September 30, 2018 and 2017, respectively. The increase is primarily due to the expenditures incurred in the Phase 3 clinical trial of SGX942, including the expansion of the trial to select countries in Europe, as well as the ongoing Phase 3 clinical trial of SGX301.

General and administrative expenses were $0.7 million for the quarters ended September 30, 2018 and 2017.

As of September 30, 2018, the Company’s cash position was $11.7 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, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine program 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 US 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 US 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.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. 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.

European Medical Director

POSITION SUMMARY:

The European Medical Director will provide medical support in Europe for Soligenix-sponsored clinical programs initially focusing on the company’s ongoing Phase 3 clinical program. This will included supporting Soligenix’s CRAs, European clinical study centers, and Soligenix partners as well as providing the initial European pharmacovigilance oversight and regulatory compliance. They will help ensure the regulatory and scientific integrity of all studies performed in Europe, the UK, and other non-American countries. This position will help evaluate, monitor and audit, and document all study information arise in Europe including fostering excellent relationships, and contact with site personnel, clinical operation personnel, and the Soligenix management team based in the United States.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Responsibilities include, but are not limited to:

  • Provides detailed medical support for all aspects of the clinical trials conducted by Soligenix including protocol design, site selection, study site training, adverse event review, safety reviews of clinical data, and initial serious adverse event reporting,
  • Participates in clinical team meetings; co-leads discussions regarding medical issues with US counterpart.
  • Prepares and reviews 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 and will work with the European clinical operation and USA management teams to assess and select sites that are assessed to be capable of adequate recruitment and generating high quality study data. This will be accomplished by telephone, site visits, and discussions with the CRA(s) assigned to the site.
  • Will review the initial budget and clinical trial contracts from all European sites approved to participate in Soligenix clinical trials.
  • Will monitor the quality of the European clinical trial data by telephone, site visits, discussions with the CRA(s) assigned to the site, and review of ongoing and final data in the electronic case report forms.
  • Will provide medical support for clinical sites, regulatory agencies, and clinical operation personnel in Europe on a 24/7 basis.
  • Will monitor during and at the conclusion of each clinical trial all safety information- including adverse event reports, serious adverse event reports, and health authority fillings for all patients enrolled in Europe.
  • Will monitor the critical primary outcome data, real time, for all clinical trial data from Europe for accuracy and consistency.
  • Participates in conducting investigator meetings, including advance preparation, presentations, problem resolution, and follow-up.
  • 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.
  • Reviews data tables, listings, and study reports for assigned protocol(s).
  • Conducts oversight visits to CROs throughout the life of the trial and in preparation for inspection.
  • Review and revise all clinical study related SOPs, procedures, and policies to assure compliance of these documents to all appropriate European rules, guideline, and regulations.
  • Support operations to ensure that the study is being conducted in compliance with the GDPR for Europe.
  • Performs other duties as assigned, including continuing to successfully perform functional responsibilities of medical director.

EDUCATIONAL REQUIREMENTS (degree, license, certification):

  • Bachelors degree in a health science field or nursing degree, doctorate preferred.

YEARS OF EXPERIENCE:

  • Minimum of 7.5 years of experience in the pharmaceutical industry and 5 years of clinical trial monitoring experience.
  • Experience in working on at least 2 multicenter, international, Phase 2 clinical studies and 1 Phase 3 clinical study.
  • Experience working in the clinical settings of oncology.
  • Experience in submitting Clinical Trial Authorizations in multiple European countries, successful Ethical Committee submissions in multiple European countries, presentations to EMA and local Health Authorities, and preferably, submission of at least 1 MAA.
  • Working knowledge of local and regional requirements for initiating clinical studies in the critical countries in West, Central and Eastern Europe.

PHYSICAL REQUIREMENTS / WORKING CONDITIONS of POSITION:

  • Must be able to travel up to 40% of the time, when needed, including 2-4 trips to the USA per year.

OTHER SKILLS AND ABILITIES:

  • Requires comprehensive knowledge of the pharmaceutical clinical development process and applicable regulations and guidelines.
  • 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).
  • Strong problem solving and analytical skills.
  • Excellent English and preferable fluency in several European languages.

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.

Senior Clinical Research Associate (Midwest or Central U.S.)

Reports To: Senior Department Manager
Location: Midwest or Central U.S.

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 5 years of experience in the pharmaceutical industry and 4 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.

Accounting Manager

POSITION SUMMARY:

This position is responsible for the timely and accurate completion of all internal and external financial reporting. Responsible for the preparation and reporting of consolidated financial results and the establishment of timelines and accountability for all accounting activities. The individual will interface with the external auditors and prepare quarterly financial statements, annual audited financial statements and footnotes and the information required for the filing of periodic SEC documents and Registration Statements as they arise.  Candidate will have a working knowledge of current SEC filings, GAAP, FASB and SOX standards/compliance. The individual will participate in the periodic budgeting and planning process through the preparation of consolidated balance sheet, income statement, cash flow forecasts, and departmental and program activity to be reviewed by management and Board approval. Specific functions within the Accounting Manager’s scope of direct or indirect responsibility include:

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Custodian of the Company’s finance and accounting records including related contracts, agreements, leases and other documents to support both internal and external financial reporting and accountability.
  • Primary interface with external auditors and responsible for preparing all required financial reports and supporting schedules required for quarterly reviews and annual audit(s). Responsible for the timely filing of all required SEC filings, including XBRL and registration statements as needed.
  • Support the development and preparation of business operating plan and budget.
  • Develop, implement and guide the cash flow process across the business including daily cash monitoring and capital expenditure plans.
  • Assist in the creation, structuring and implementation of transactions with specific focus on accounting issues. Interpret results and make recommendations.
  • Treasury and Accounts Payable maintenance and supervision.
  • Sarbanes Oxley / Internal Control Compliance.
  • Establish and maintain relationships with key vendors and business partners related to accounting and financial services.
  • Performs other duties as assigned.

 

ADDITIONAL DUTIES:

  • Periodic Regulatory Government Filings
  • Taxes (Income, Franchise, GST/VAT)
  • Purchasing administration

 

EDUCATIONAL REQUIREMENTS (degree, license, certification):

  • Certified Public Accountant (current license)
  • Undergraduate Degree in Accounting or Finance

 

YEARS OF EXPERIENCE:

  • 3 to 5 years of progressive accounting and financial  experience required, including:
    • Experience in internal/external financial reporting and analysis
    • Experience with reporting requirements and software packages, such as Microsoft Dynamics, are a significant plus.
    • Knowledge of GAAP, FASB and SOX required
  • Experience in all required SEC filings
  • Exposure to implementing process and system(s) improvements
  • Life Sciences experience preferred

 

OTHER SKILLS AND ABILITIES:

  • Demonstrated experience managing multiple projects simultaneously with aggressive timelines.
  • Knowledge of automated financial/accounting systems, experience with Microsoft Dynamics (formerly Great Plains) accounting system a plus.
  • Ability to operate independently and at a high level of productivity.
  • Proficient knowledge of Excel, problem solving and analytical skills required.
  • Ability to interact with non-financial staff members.
  • Strong goal and results orientation.
  • Open and honest communication required.
  • Proven verbal and written communication skills.

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.

Soligenix Announces Positive Recommendation by Independent Data Monitoring Committee on its Phase 3 Clinical Trial of SGX301 for the Treatment of Cutaneous T-cell Lymphoma

Princeton, NJ – October 15, 2018 – 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 it has received a positive recommendation from the independent Data Monitoring Committee (DMC) to continue enrolling into the Company’s Phase 3 “Fluorescent Light Activated Synthetic Hypericin” (FLASH) study for SGX301 (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL).  Following its unblinded interim analysis with data from approximately 100 subjects, including assessment of the study’s primary efficacy endpoint, the DMC recommended that approximately 40 additional subjects be randomized into the trial to maintain the rigorous assumption of 90% statistical power for the primary efficacy endpoint.  No safety concerns were reported by the DMC based on the interim analysis.

“We are pleased to have received the DMC’s recommendation to continue enrolling to the adjusted target of 160 evaluable subjects in order to maintain our conservative power calculation,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  “We have invested a significant amount of the Company’s resources over the last three years into the CTCL development program and it is gratifying to have received this feedback from the DMC indicating sufficient potential efficacy to warrant enrolling additional subjects into the trial.  With this new level of clarity from the DMC’s analysis of the interim Phase 3 study data and given our current enrollment status of approximately 120 subjects, we anticipate completing the study before the end of 2019 with topline results coming no later than the first quarter of 2020.  Given our current cash resources, we anticipate that the available funds are sufficient to cover the additional study patients needed.  We believe SGX301 has the potential to be a valuable therapy in the treatment of early stage CTCL, which is an orphan disease and area of unmet medical need.”

“The DMC’s recommendation is very encouraging and will allow us to aggressively pursue completing the trial, demonstrating SGX301’s potential to successfully treat the CTCL index lesions using a combination therapy (SGX301 and the proprietary fluorescent light panel) that minimizes the long-term risks of treatment-associated secondary cancers,” stated Richard Straube, MD, Senior Vice President and Chief Medical Officer of Soligenix.  “SGX301 truly has the potential to have a significant impact on the lives of CTCL patients.  We would like to thank the DMC members for their assistance, as well as our esteemed medical advisory board and our dedicated clinical investigators for their ongoing efforts in the design and conduct of this important clinical trial.”

Based on the positive results demonstrated in the Phase 2 study of SGX301, the pivotal Phase 3 protocol is a highly powered, double-blind, randomized, placebo-controlled, multicenter trial originally targeted to enroll 120 evaluable subjects.  The trial consists of three treatment cycles, each of 8 weeks duration.  Treatments are administered twice weekly for the first 6 weeks and treatment response is determined at the end of Week 8.  In the first treatment cycle, approximately two-thirds of the subjects receive SGX301 (0.25% synthetic hypericin) and one-third of the subjects receive placebo treatment of their index lesions.  In the second cycle, all subjects receive SGX301 treatment of their index lesions and in the optional third cycle all subjects receive SGX301 treatment of all their lesions.  Subjects are followed for an additional 6 months after the completion of treatment.  The primary efficacy endpoint is assessed on the percent of patients in each of the two treatment groups (i.e., SGX301 and placebo) achieving a successful response of the treated lesions, defined as an overall ≥50% reduction as assessed by the Composite Assessment of Index Lesion Severity (CAILS) scoring system across the three index lesions at the Cycle 1 evaluation visit (week 8) compared to the total CAILS score at baseline.  Other secondary measures assessed are treatment response (including duration), degree of improvement, time to relapse and safety.

About Cutaneous T-Cell Lymphoma (CTCL)

CTCL is a class of non-Hodgkin’s lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system.  Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin.  These malignant cells migrate to the skin where they form various lesions, typically beginning as a rash and eventually forming raised plaques and tumors as the disease progresses.  Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL.  Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 500,000 individuals living with the disease.  It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 20,000 individuals in the US, with approximately 2,800 new cases seen annually.

About SGX301

SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation.  The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions, is taken up by the malignant T-cells, and then activated by fluorescent light 16 to 24 hours later.  This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on ultraviolet exposure.  Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p ≤ 0.04) improvement with topical hypericin treatment whereas the placebo was ineffective:  58.3% compared to 8.3%, respectively.   SGX301 has received orphan drug and fast track designations from the US Food and Drug Administration, as well as orphan designation from the European Medicines Agency.

The Phase 3 CTCL clinical study is partially funded with a National Cancer Institute Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc.

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, OrbeShield®, our GI acute radiation syndrome therapeutic 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 US 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 US 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.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. 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.