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ThermoVax®: Thermostabilized Vaccines for Global Use

Proof-of-ConceptINDPhase 1Phase 2/3Market
Proof-of-Concept
IND
Phase 1
Phase 2/3
Market
Denotes funding by NIH, BARDA, DTRA and/or FDA.

ThermoVax®: Thermostabilized Vaccines for Global Use

ThermoVax® is a proprietary method of preparing vaccines composed of protein and adjuvant such that they can be lyophilized (freeze-dried) while maintaining optimal potency. Once lyophilized, the vaccines are generally stable even at elevated temperatures (e.g., 40°C or 104°F) for extended periods of time. ThermoVax® has the potential to eliminate the need for cold-chain production, transportation and storage – relieving the health care system of the high costs of producing and maintaining vaccines under refrigerated or frozen conditions.

For anti-viral vaccines, it is important to produce a vaccine which can stimulate both humoral (antibody) and cell mediated (eg., T-cell immunity). By combining representative viral surface glycoproteins with a different adjuvant, we have extended our platform to other protein subunit vaccines.

Our most advanced candidates include a FILOVIRUS vaccine for which we are exploring monovalent (covering a single viral disease), bivalent and trivalent formulations covering filovirus infections caused by Zaire ebolavirus (EBOV), Sudan ebolavirus (SUDV) and Marburg Marburgvirus (MARV).

We have also recently initiated a COVID-19 vaccine effort for which preliminary data in mice looks very promising.

Current Treatments

There are NO post-exposure therapies for filovirus infections. There is one vaccine approved for Zaire ebolavirus only, and the vaccines requires storage and distribution at temperatures below -60°C (-76 °F). There are no approved vaccines for the other filovirus infections

There are NO vaccines for coronavirus infections. There are a number of vaccine efforts underway, many of which use vaccine technology with no approved precedent for human vaccines.

Our Approach: GlyoProtein Vaccine Platform

The use of protein antigens in vaccines is considered the gold standard from a safety perspective. It is a well-established and well-understood vaccination approach, which is utilized in many childhood vaccines.

The role of the protein antigen is to induce the body to form antibodies that will ultimately recognize that protein on a virus, and therefore target the virus for destruction.

Protein-based vaccines need to be coupled with an adjuvant to generate a sufficiently strong immune response.

The resulting combination of adjuvant and antigen can then be thermostabilized with our proprietary ThermoVax® technology.

Interested in testing out your antigen and/or adjuvant with our process? Please contact us.

What adjuvants can be stabilized with ThermoVax®?

An adjuvant is a molecule that stimulates an immune response and each adjuvant can stimulate different aspects of the immune system.

ThermoVax has been demonstrated to stabilize a number of adjuvants, including those which have been previously considered difficult to lyophilize. These include:

  • Alum (such as used in RiVax®), which is known to stimulate antibody responses.
  • CoVaccine HTTM, which is known to stimulate both humoral (antibody) and cell mediated (eg., T-cell) immunity. CoVaccine is a nano-emulsion based on squalene and sucrose fatty acid esters.

Anti-Viral Vaccines using Glyocprotein Antigens

Vaccines for viral infections commonly target proteins on the viral surface for binding and recognition. Many viruses have surface glycoproteins that are used to facilitate cellular entry and infection. We are collaborating with the University of Hawaiʻi at Mānoa to develop vaccines utilizing a glyocoprotein vaccine platform which includes:

  1. A glycoprotein antigen, which is manufactured using recombinant cell expression with an S2 insect cell expression system that has been demonstrated to produce stable glycosylation patterns

    Spike Protein Diagram
  2. The CoVaccine adjuvant, which has been shown to stimulate both humoral and cell-mediated immunity, necessary for combatting many viral infections
  3. A formulation combining antigen, adjuvant and Generally Regarded As Safe (“GRAS”) excipients for lyophilization (freeze-drying).

The end result is individual vials of solid product which is stable to temperatures as high as 40 °C or 104 °F, can be shipped and stored at room temperature. The product is used by adding sterile water at point of use, mixing to reconstitute, and then injecting the resulting mixture. The clinical format of these vaccines is compatible with shipment and utilization worldwide with limited need for supportive infrastructure.

Filovirus Vaccines

Filoviruses are the family of viruses that cause highly lethal hemorrhagic infections like Ebola. There are a number of related viruses in this family with similar disease characteristics. The diseases are often transmitted from animal hosts and are endemic in Africa.

The filovirus vaccine platform uses the “GP” (glycoprotein) from the viral surface of each virus, either alone or in combination with each other, to product monovalent or multivalent vaccines.

The resulting vaccines have demonstrated up to 100% protection in animal models of infection, despite the very high mortality rate associated with these infections.

Coronavirus Vaccines (CiVaxTM)

Coronaviruses are a family of viruses that are known to cause a variety of respiratory infections, with varying symptoms and severity. SARS-CoV-2, the cause of COVID-19, is the most recent example of this family of viruses. These viruses are particularly problematic because of their high transmissibility, resulting in high absolute mortality even with relatively low overall mortality rates.

The key antigen for targeting coronaviruses is believed to be a Spike protein on the viral surface. This protein is also a multimeric (specifically trimeric) glycoprotein. It is therefore very compatible with our existing collaborative program

CiVax™ is a vaccine candidate that combines the Spike protein antigen with the CoVaccine adjuvant. Results to date have indicated strong immunogenicity in mouse models and nonclinical studies are continuing.

Clinical Studies & Commercialization

Filovirus Vaccines

Soligenix is developing thermostabilized vaccine candidates in conjunction with the University of Hawaiʻi at Mānoa and Hawaii Biotech Inc. under an R01 grant granted to Dr. Axel Lehrer at the University of Hawaii.

Further information on the Filovirus program can be found in this presentation by Dr. Donini.

Coronavirus Vaccines (CiVax™)

Soligenix is developing thermostabilized vaccine candidates in conjunction with the University of Hawaiʻi at Mānoa.

Further information on the Filovirus program can be found in this presentation by Dr. Donini.

Regulatory Status

Filovirus Vaccines

The program is in the non-clinical stage of development with a pre-IND meeting anticipated in the next 12-18 months.

Coronavirus Vaccines (CiVax™)

This program is in the non-clinical stage of development pending identification of funding sources.

Intellectual Property

Soligenix has a strong worldwide intellectual property position on the use of the CoVaccine adjuvant and the unique thermostabilized formulation.

Our pipelines focuses on orphan and unmet medical need across a range of indications

Interested in exploring whether ThermoVax® will work for a different vaccine? Soligenix is interested in collaborating.