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.

Soligenix Announces Publication Demonstrating Thermostabilization of an Ebola Subunit Vaccine Candidate

Soligenix Announces Publication Demonstrating Thermostabilization of an Ebola Subunit Vaccine Candidate

 

Princeton, NJ – February 7, 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 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 and is available here.

As previously announced, Soligenix has been collaborating with the University of Hawai’i at Mānoa (UH Mānoa) and Hawaii Biotechnology, Inc. (HBI) on the development of a multivalent subunit vaccine for Ebola and Marburg infections.  Axel Lehrer, PhD, Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), UH Mānoa, a co-inventor of the Ebola vaccine with HBI, has shown proof of concept efficacy with subunit Ebola vaccines in non-human primates.  Soligenix evaluated its proprietary vaccine thermostabilization technology, ThermoVax®, to stabilize components of the vaccine with Dr. Carly Chisholm and Dr. Theodore Randolph of the University of Colorado.  These studies identified a formulation that maintained the physical state of the Ebola subunit protein despite incubation at 40 degrees Celsius (104 degrees Fahrenheit) for 12 weeks.  Ultimately, the objective is to produce a thermostable Ebola vaccine for worldwide distribution that does not require cold storage.  In preclinical studies, ThermoVax® has been previously demonstrated to enhance thermostability of ricin (RiVax®) and anthrax subunit vaccines.  Further work optimizing a trivalent Ebola vaccine is ongoing under a National Institute of Allergy and Infectious Diseases (NIAID) grant awarded to the UH Mānoa in collaboration with Soligenix and HBI.

The most advanced Ebola vaccines involve the use of vesicular stomatitis virus (VSV) and adenovirus vectors – live, viral vectors which complicate the manufacturing, stability and storage requirements.  Dr. Lehrer’s vaccine is based on highly purified recombinant protein antigens, circumventing many of these manufacturing difficulties.  Dr. Lehrer and HBI have developed a robust manufacturing process for the required proteins.  Application of ThermoVax® may allow for a product that can avoid the need for cold-chain distribution and storage, yielding a vaccine ideal for use in both the developed and developing world.

“None of the other Ebola vaccines under development have the ability to withstand high temperatures, which is an ongoing concern in areas of the world where Filoviruses are endemic,” stated Dr. Lehrer, Assistant Professor, Department of Tropical Medicine, Medical Microbiology and Pharmacology at JABSOM, UH Mānoa.  “The ability to stabilize our vaccine candidate to retain immunogenicity may not only have an impact on logistics, but also has the potential to reach more persons in need with fewer vaccine doses.  This would be a tremendous advantage, especially in endemic areas, increasing the number of people receiving sufficient doses of the vaccine to protect them from disease.  We are very encouraged by these preliminary results and look forward to our continuing collaboration with Soligenix and HBI to further develop our Ebola and multivalent filovirus vaccines.”

“We continue to demonstrate the potential of the ThermoVax® heat stabilization platform,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  “These results join other successful endeavors with ricin and anthrax vaccines.  We look forward to expanding the use of this proprietary technology, while continuing to develop ThermoVax® using RiVax®, our novel subunit ricin vaccine, under an active NIAID contract award.”

About ThermoVax®

The ThermoVax® technology is 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.  Cold chain requirements add considerable cost to the production and storage of current conventional vaccines.  Elimination of the cold chain would also enhance the utility of these vaccines for emerging markets and for other applications requiring but lacking reliable cold chain capabilities.  For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations, the utilization of ThermoVax® has the potential to facilitate easier storage and distribution of Strategic National Stockpile vaccines in emergency situations.  The underlying ThermoVax® technology has been developed by Drs. John Carpenter and Theodore Randolph at the University of Colorado.

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.  Similar stabilization at temperatures as high as 50 degrees Celsius for up to 3 months (maximum timepoint tested) have also been demonstrated with other antigens (e.g., Ebola and anthrax).

About JABSOM, UH Mānoa

The John A. Burns School of Medicine (JABSOM) at the University of Hawaiʻi Mānoa honors its unique research environment to excel in science-based efforts to eliminate diseases that disproportionately affect people in Hawaiʻi and the Pacific region.  Annually at JABSOM, more than 500 future physicians are learning medicine, JABSOM researchers secure up to $60 million in grants, and overall economic stimulus to Hawaiʻi from the school tops $456 million annually.  JABSOM also confers degrees in Clinical Translational Research, Communication Sciences and Disorders, Tropical Medicine, Cell and Molecular Biology, Medical Technology and Developmental and Reproductive Biology.

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 ThermoVax® or 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 European Patent for Dusquetide and Related Innate Defense Regulator Analogs

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

Princeton, NJ – January 23, 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 European Patent Office has 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 United States (US) and are being pursued in other worldwide jurisdictions.

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, the drug product containing dusquetide, demonstrated positive results in a Phase 2 study in the treatment of oral mucositis in head and neck cancer 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 head and neck 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 head and neck cancer 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.

The new patent corresponds to US patent 9,416,157, granted on August 16, 2016.

“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.  The therapeutic use claims in oral mucositis will follow in the same jurisdictions, including the US where it has already been granted, and will provide extended intellectual property coverage.”

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 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 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.

Director/VP, Global Clinical Operations

POSITION SUMMARY:

This is a full-time or contract position responsible for overseeing all clinical trial activities from start to finish for US and International studies. This includes trials necessitated by R&D, Regulatory and Marketing.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Manage clinical study monitors and interact with investigational sites.
  • Up to 40% travel including international trips.
  • Oversee and Manage Contract Research Organizations (CROs).
  • Track enrollment and subject progress.
  • Review monitoring reports submitted by monitoring personnel.
  • Monitor Case Report Forms in-house for quality assurance.
  • Facilitate and track the generation, transfer, and resolution of all queries leading up to locking clinical databases.
  • Manage the transfer of information and documents between Sponsor and Contract CRAs, and Sponsor and Investigational Sites.
  • Author/review standard operating procedures related to various functional areas.
  • Participation in FDA inspections as it related to sponsor pre-approval inspection and investigational site inspections.
  • Participate in the completion of clinical studies, and subsequent compilation and submission of Marketing Authorization Applications to regulatory health authorities, to be submitted in the electronic common technical document format (eCTD).

ADDITIONAL DUTIES:

  • N/A

EDUCATIONAL REQUIREMENTS (degree, license, certification):

  • Minimum Bachelors Degree in medical field (e.g., nursing); advanced degree in field preferred (i.e., PhD, PharmD, MD).
  • Knowledge of GCP, ICH, GLP and GMP.
  • Proficient computer skills.

YEARS OF EXPERIENCE:

  • Minimum of 6 – 8 years of clinical research management experience.

PHYSICAL REQUIREMENTS / WORKING CONDITIONS of POSITION:

  • N/A

OTHER SKILLS AND ABILITIES:

  • Demonstrated experience managing multiple projects simultaneously with aggressive timelines.
  • Demonstrated experience with management of Phase 3 multicenter/multinational clinical studies, preferably in the oncology or stem cell transplantation.
  • Previous clinical monitoring experience a plus.
  • Demonstrated experience managing CROs and/or clinical monitors simultaneously with aggressive timelines.
  • Experience and demonstrated ability to manage at a high level of productivity with minimum infrastructure.
  • Experience with multinational clinical trials and management of foreign research sites, CRAs, and CROs.
  • Experience in developing and making formal presentations.
  • Experience in budget planning, management and reconciliation.
  • Proficient knowledge of Excel, problem solving and analytical skills required.
  • Ability to function well in a cohesive management team environment, with strong goal and results orientation.
  • 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. No recruiters.

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

Princeton, NJ – December 11, 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 it has received preliminary approval for a tax credit from the New Jersey Economic Development Authority’s (NJEDA) New Jersey Technology Business Tax Certificate Transfer program.  As a result, the Company anticipates being able to transfer this credit and receive approximately $611,000 in net proceeds by year end.

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 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.

“As we are always looking for non-dilutive ways to fund our company, we are once again very pleased with NJEDA’s decision to support advancing biotechnology companies with the approval of our application in this year’s program,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “This is our ninth year receiving NOL funding.  Over this time period we have received approximately $5 million in non-dilutive funding that has allowed us to advance our rare disease pipeline to where we are now actively enrolling patients into two pivotal Phase 3 clinical trials.  The program continues to be a welcomed and important addition to other significant non-dilutive funding we have been awarded from the Biomedical Advanced Research and Development Authority and the National Institutes of Health.  We are, again, very thankful for New Jersey’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, 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 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 RiVaxÒ, that RiVaxÒ will be approved for the PRV program or the amount for which a PRV for  RiVaxÒ can be sold.  Further, Soligenix can offer no assurance that it will be able to use or sell its NOL carryforwards or that there will not be a change in the New Jersey Technology Business Tax Certificate Transfer program that terminates the program or eliminates or reduces Soligenix’s ability to use or sell its NOL carryforwards in the future. 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 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.

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.