Soligenix Announces $1.5 Million NIH Compact Business Innovation Investigation Award Advancing COVID-19 Vaccine Growth

PRINCETON, N.J., Dec. 28, 2020 /PRNewswire/ — Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Corporation), a late-stage biopharmaceutical corporation concentrated on producing and commercializing products to take care of uncommon ailments the place there is an unmet medical will need, announced today that the Nationwide Institute of Allergy and Infectious Diseases (NIAID), component of the National Institutes of Overall health (NIH), has awarded Soligenix a Direct to Stage II Compact Business enterprise Innovation Analysis (SBIR) grant of close to $1.5 million to support manufacture, formulation (which include thermostabilization) and characterization of COVID-19 (Coronavirus Ailment 2019) and EVD (Ebola Virus Disorder) vaccine candidates in conjunction with the CoVaccine HT™ (CoVaccine) adjuvant.  This award also will support immune characterization of this novel, emulsified adjuvant that has distinctive efficiency and compatibility with lyophilization techniques to allow thermostabilization of subunit vaccines.

CiVax™ is the Company’s heat secure subunit vaccine candidate for the prevention of COVID-19, the infection brought about by SARS-CoV-2.  Ongoing collaborations with Axel Lehrer, PhD, Associate Professor (Vaccinology) in the Office of Tropical Drugs, Healthcare Microbiology and Pharmacology, John A. Burns University of Medication (JABSOM), University of Hawaiʻi at Mānoa (UHM) have shown the feasibility of acquiring a extremely immunogenic vaccine for COVID-19.  With important exploration dedicated all over the world to the generation of COVID-19 vaccines, it is noteworthy that the crucial attributes of a vaccine thriving in managing the ongoing pandemic are believed to involve the means to swiftly stimulate a Th1/Th2 well balanced antibody response, raising major virus neutralizing antibodies, as nicely as induce strong cell-mediated immunity.  Prior do the job with the CoVaccine adjuvant, which Soligenix accredited from BTG Specialty Prescription drugs, a division of Boston Scientific Company, has indicated that CoVaccine has these crucial attributes.  In addition, contrary to other vaccine candidates that have logistical troubles because of to chilly chain prerequisites (in some circumstances demanding servicing of temperatures significantly less than -70 levels Celsius), the underlying know-how system has demonstrated the capacity to generate one vial vaccines which are secure up to temperatures at minimum as substantial as +40 degrees Celsius.

The awarded grant allows thorough immunogenicity analysis of CoVaccine in the existence of possibly the SARS-CoV-2 Spike protein antigen or the Zaire ebolavirus glycoprotein antigen in each mice and non-human primates, and will drastically increase both of those vaccine plans.  It also will help re-initiation of key CoVaccine production procedures.

Several plans are targeted on the growth of vaccines for COVID-19 and two vaccines have not long ago gained Crisis Use Approval by the Fda.  However, the around the world extent of the dilemma implies that a full resolution to the pandemic will demand parallel methods.  Moreover, there is the potential want for annual vaccinations.  The full variety of vaccine doses expected to command the ongoing pandemic also indicates that numerous vaccines, centered on diverse production platforms, will be needed to proficiently vaccinate the throughout the world populace.  Subunit vaccines are regarded as the gold normal for vaccine protection, but are somewhat less than-represented in fast-tracked COVID-19 vaccine candidates to date.  Compared with virally vectored vaccines, there is no limit to the amount of situations the adjuvant and antigen can be employed and the normal security profile of a subunit vaccine outcomes in a vaccine that is appropriate for immune compromised or elderly populations as well.  Further more, while RNA vaccines are fast to manufacture, the specifications for chilly chain distribution continue being a real constraint.

“We are appreciative of the continued assist presented by NIAID for our thermostabilization program,” stated Christopher J. Schaber, PhD, President and Main Government Officer of Soligenix. “This SBIR grant award will more advance our reports with the CoVaccine adjuvant, as very well as our CiVax™ and filovirus vaccine applications.  We keep on being devoted to progressing our Community Health and fitness Alternatives business enterprise section and appear ahead to accelerating our CiVax™ system in specific with this funding.”

NIAID assistance is getting presented by SBIR grant number 1 R44 AI157593-01.

About CiVax™

CiVax™ is the Company’s warmth steady subunit vaccine applicant for the avoidance of COVID-19, the infection induced by SARS-CoV-2.  Less than the Company’s Community Overall health Answers business enterprise segment, ongoing collaborations with Axel Lehrer, PhD of the Division of Tropical Drugs, Clinical Microbiology and Pharmacology, JABSOM, UHM have shown the feasibility of acquiring warmth secure subunit filovirus vaccines, which includes hemorrhagic illness prompted by Zaire ebolavirus, Sudan ebolavirus as properly as Marburg marburgvirus, with the two monovalent and bivalent vaccine combos.  Formulation problems have been determined to help warmth stabilization of each individual antigen, by itself or in combination, for at the very least 12 weeks at 40 degrees Celsius (104 degrees Fahrenheit).  In March 2020, Soligenix and its collaborators expanded the know-how platform to assess compatibility with vaccine candidates focusing on SARS-CoV-2, the induce of COVID-19.

The vaccine platform includes a few critical components:

  1. a protein antigen, particularly a viral floor glycoprotein, which mediates entry and fusion of the virus with host cells and is made with a proprietary insect mobile expression technique coupled with protein-unique affinity purification
  2. an adjuvant which has been revealed to enrich both mobile mediated and humoral immunity and
  3. a formulation which permits thermostabilization of the ensuing combination, staying away from the will need for cold chain storage and transport.

The ensuing vaccine is broadly relevant, like to people often excluded from popular viral vector vaccine ways this kind of as small children, the aged and the immunocompromised.  The security of aged and immunocompromised populations are particularly essential in the context of COVID-19. The skill to supply a thermostabilized, solitary vial vaccine, is particularly significant in the context of speedy and wide vaccine distribution.

These very same parts are now remaining utilized to coronavirus vaccine, applying the effectively-described surface glycoprotein, acknowledged as the Spike protein, as the antigen. Nonclinical get the job done in mice with a prototype vaccine not too long ago have been posted, demonstrating the skill of the CoVaccine adjuvant in blend with a prototype antigen, to:

  • encourage immunity inside 14 days soon after the to start with vaccination
  • induce a balanced Th1 response, believed to be vital to inducing immunity with no aggravating ailment pathology
  • induce a neutralizing antibody reaction and
  • induce a cell mediated immune response.

About Coronavirus An infection

Coronavirus infections can lead to a large spectrum of sickness in individuals, ranging from a widespread chilly to a additional intense respiratory infection, this sort of as Serious Acute Respiratory Syndrome (SARS) and Center East Respiratory Syndrome (MERS), which have a situation mortality price of approximately 10% and 30%, respectively.  Comparable to filoviruses, coronaviruses also are endemic in wildlife populations and can be transmitted to people with near call.  The COVID-19 outbreak, induced by SARS-CoV-2, is the most modern illustration of a suspected species crossover noticed with this virus family.  While the circumstance fatality rate of COVID-19 is still beneath investigation, COVID-19 has been declared a global pandemic by the Entire world Well being Organization.  The international impression of this rising infection demonstrates the urgent need for sturdy technological know-how platforms to quickly produce new vaccines for novel conditions.  The only Fda sanctioned solutions for COVID-19 are accessible below Crisis Use Authorization.   There are at present two vaccines obtainable beneath Food and drug administration Unexpected emergency Use Authorization.

About Soligenix, Inc.

Soligenix is a late-phase biopharmaceutical firm focused on building and commercializing merchandise to take care of unusual disorders where by there is an unmet professional medical will need. Our Specialised BioTherapeutics organization segment is establishing SGX301 as a novel photodynamic treatment using risk-free noticeable light for the remedy of cutaneous T-cell lymphoma our first-in-course innate protection regulator (IDR) technology, dusquetide (SGX942), for the procedure of oral mucositis in head and neck cancer and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the avoidance/procedure of gastrointestinal (GI) ailments characterized by serious irritation together with pediatric Crohn’s ailment (SGX203) and acute radiation enteritis (SGX201).

Our General public Overall health Answers organization phase incorporates active progress programs for RiVax®, our ricin toxin vaccine candidate SGX943, our therapeutic applicant for antibiotic resistant and emerging infectious disease and our study systems to identify and establish novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The advancement of our vaccine courses incorporates the use of our proprietary warmth stabilization system technological know-how, acknowledged as ThermoVax®.  To day, this company section has been supported with govt grant and contract funding from the National Institute of Allergy and Infectious Illnesses (NIAID), the Defense Risk Reduction Brokers (DTRA) and the Biomedical State-of-the-art Study and Advancement Authority (BARDA).

For further facts with regards to Soligenix, Inc., make sure you visit the Firm’s web-site at www.soligenix.com.

This push launch may well contain forward-wanting statements that reflect Soligenix, Inc.’s present-day anticipations about its long term success, general performance, prospective customers and alternatives, which include but not constrained to, potential current market measurements, patient populations and medical trial enrollment.  Statements that are not historic details, these kinds of as “anticipates,” “estimates,” “thinks,” “hopes,” “intends,” “designs,” “expects,” “intention,” “could,” “counsel,” “will,” “probable,” or similar expressions, are forward-on the lookout statements.  These statements are subject to a quantity of dangers, uncertainties and other aspects that could lead to true activities or results in potential durations to vary materially from what is expressed in, or implied by, these statements, this kind of as skilled with the COVID-19 outbreak.  Soligenix can not guarantee you that it will be able to correctly acquire, achieve regulatory acceptance for or commercialize merchandise centered on its technologies, specially in light-weight of the substantial uncertainty inherent in developing therapeutics and vaccines versus bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, getting regulatory approvals and producing therapeutics and vaccines, that product growth and commercialization efforts will not be diminished or discontinued due to issues or delays in medical trials or owing to absence of progress or positive outcomes from research and enhancement efforts, that it will be equipped to successfully receive any further funding to guidance solution advancement and commercialization efforts, including grants and awards, retain its current grants which are subject to efficiency specifications, enter into any biodefense procurement contracts with the US Government or other nations around the world, that it will be capable to contend with bigger and much better financed opponents in the biotechnology field, that adjustments in wellbeing care follow, 3rd get together reimbursement limitations and Federal and/or point out health care reform initiatives will not negatively have an affect on its business enterprise, or that the US Congress may not go any laws that would supply more funding for the Job BioShield software. Despite the statistically considerable result realized in the SGX301 Phase 3 clinical demo for the therapy of cutaneous T-cell lymphoma, there can be no assurance that a marketing and advertising authorization from the Food and drug administration or EMA will be effective.  Even further, there can be no assurance that RiVax® will qualify for a biodefense Priority Evaluation Voucher (PRV) or that the prior revenue of PRVs will be indicative of any opportunity product sales price tag for a PRV for RiVax®. Also, no assurance can be supplied that the Corporation will obtain or keep on to obtain non-dilutive govt funding from grants and contracts that have been or may possibly be awarded or for which the Corporation will utilize in the potential. These and other risk things are described from time to time in filings with the Securities and Exchange Fee, which include, but not minimal to, Soligenix’s stories on Forms 10-Q and 10-K.  Except required by legislation, Soligenix assumes no obligation to update or revise any forward-searching statements as a final result of new data or long run events.

Source Soligenix, Inc.

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