Research programme: coronavirus vaccines - Soligenix/University of Hawaii
Alternative Names: CiVax™; CiVax™ vaccine - Soligenix; COVID-19 Vaccine Programme - Soligenix; COVID-2019 vaccine - Soligenix; SARS-CoV-2 virus vaccine - SoligenixLatest Information Update: 22 Oct 2021
At a glance
- Originator Soligenix; University of Hawaii
- Class Adjuvants; COVID-19 vaccines; Subunit vaccines; Viral vaccines
- Mechanism of Action Immunostimulants
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Preclinical Coronavirus infections; COVID 2019 infections
Most Recent Events
Development Overview
Introduction
Soligenix, in collaboration with the University of Hawaii at Mānoa is developing thermostable alum adjuvanted coronavirus vaccines (CiVax™) for protection against coronavirus infections including COVID-2019 infections. Soligenix will utilise ThermoVax® technology which was in-licensed from the University of Colorado, to stabilise components of the vaccines at high temparature. The vaccines will be based on well-defined surface glycoprotein(s) spike, from one or more coronaviruses, including SARS-CoV-2 virus. Preclinical development is underway in the US.
The vaccines will be made from purified surface glycoproteins from one or more coronaviruses, which will be manufactured with a proprietary insect cell expression system and aluminum salt, (known colloquially as Alum) as an adjuvant to activate cell as well as humoral immunity in heat stable formulation. The alum adjuvanted vaccines, manufactured using ThermoVax® technology eliminate the need for cold chain production and transportation. The vaccines include CoVaccine HT™, an adjuvant, which is being used to enhance both cell mediated and humoral immunity.
Company Agreements
In April 2018, Soligenix, Inc. terminates license agreement with the University of Colorado (UC). The UC failed to achieve one of the development milestones, for initiation of the phase I trial of the heat stabilization technology. Earlier in January 2011, Soligenix, Inc. entered into a definitive license agreement with the University of Colorado (CU) for novel technology for use in the development of subunit vaccines with long-term stability, including stability at elevated temperatures. Soligenix has been developing this stabilization technology under an option-to-license agreement from CU that was initiated to support the technology development efforts funded by a $US9.4 million grant from the National Institute of Allergy and Infectious Diseases (NIAID). The license agreement has an expanded scope for thermostable vaccines for biodefense as well as all potential vaccine indications. The novel technology involves the use of several unique process and formulation steps that fix sensitive vaccine ingredients in native configuration. For biodefense indications, the company is using the stabilization technology to advance RiVax(TM), its subunit vaccine against ricin toxin, as well a subunit vaccine for anthrax prevention. The underlying technology has been developed by Drs. Amber Clausi, John Carpenter and Theodore Randolph at CU-Boulder. The terms of the license were not disclosed. [1] [2]
In October 2022, Soligenix and John A. Burns School of Medicine (JABSOM), University of Hawai'i at Manoa (UH Manoa) expanded the collaboration to develop thermostable vaccines; including filoviruses infection. Earlier, in March 2020, Soligenix and John A. Burns School of Medicine (JABSOM), University of Hawai'i at Manoa (UH Manoa) expanded the collaboration to develop thermostable coronavirus vaccines; including a vaccine for COVID-2019 infections. Earlier in May 2015, Soligenix entered into a collaboration agreement with Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), University of Hawai'i at Manoa (UH Manoa) and Hawaii Biotech, Inc. (HBI) to develop a heat stable subunit Ebola vaccine. Under the terms of the agreement, Soligenix will evaluate its proprietary vaccine thermostabilization technology, ThermoVax™, licensed from the University of Colorado, to stabilize components of the vaccine. Ultimately, the objective is to produce a thermostable Ebola vaccine for worldwide distribution that does not require cold storage. [3] [4] [5]
In April 2020, Soligenix signed an agreement with BTG for the exclusive worldwide license of CoVaccine HT™, a novel vaccine adjuvant. CoVaccine HT is component of Soligenix's vaccine technology platform currently being assessed for use against coronaviruses including SARS-CoV-2, the cause of COVID-19. [6]
Key Development Milestones
In April 2021, Soligenix announced that the proprietary subunit protein antigen of COVID-19 vaccine, locked into its receptor-binding configuration, was immunogenic in both mice and non-human primates (NHPs). Critical immune responses including high total antibody levels, robust neutralising antibody levels and specific cell mediated responses were demonstrated in mice, and strong total and neutralising antibody responses were also demonstrated in NHPs. Use of the CoVaccine HT™ adjuvant enabled dose-sparing in the antigen dose. The CoVaccine HT™ adjuvant was shown to be robust working equally well in both its native and lyophilised formats [7] .
In September 2021, Soligenix released data from a preclinical study of COVID-19 vaccine in non-human primates demonstrating long-lasting and protective immunity against circulating SARS-CoV-2 variants of concern [8] .
In March 2021, Soligenix released preclinical studies data of COVID-19 vaccine [9] .
Preclinical studies data of COVID-19 vaccine against COVID-2019 infections released by Soligenix [10] .
In September 2020, Soligenix released pharmacodynamics data from a preclinical studies with a more complete spike protein in COVID-2019 infections [11] .
Financing information
In December 2020, Soligenix was awarded a direct to phase II Small Business Innovation Research (SBIR) grant of approximately $US1.5 million by the National Institute of Allergy and Infectious Diseases (NIAID) to support manufacture, formulation (including thermostabilisation) and characterisation of COVID-2019 and Ebola virus disease (EVD) vaccine candidates in conjunction with the CoVaccine HT™ adjuvant [12] .
Patent Information
In May 2013, the US Patent and Trademark Office (US PTO) had issued a US patent number 8 444 991 to the University of Colorado at Boulder entitled "Method of Preparing an Immunologically-Active Adjuvant-Bound Dried Vaccine Composition" which cover application of ThermoVax® technology. The patent is expected to expire in February 2030. In May 2012, the University has also filed an additional US patent application number 13/474 661 entitled “Thermostable Vaccine Compositions and Methods of Preparing Same” which also cover application of ThermoVax® technology [13] .
Drug Properties & Chemical Synopsis
- Route of administration Parenteral
- Formulation unspecified
- Class Adjuvants, COVID-19 vaccines, Subunit vaccines, Viral vaccines
- Mechanism of Action Immunostimulants
-
WHO ATC code
J07B-X (Other viral vaccines)
-
EPhMRA code
J7E9 (All other viral vaccines)
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | - | Prevention | Preclinical | USA | Parenteral / unspecified | Soligenix, University of Hawaii | 08 Sep 2020 |
| Coronavirus infections | - | Prevention | Preclinical | USA | Parenteral / unspecified | Soligenix, University of Hawaii | 08 Sep 2020 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| University of Hawaii | Originator | USA |
| Soligenix | Originator | USA |
| University of Hawaii | Owner | USA |
| Soligenix | Owner | USA |
| University of Colorado at Boulder | Technology Provider | USA |
| National Institute of Allergy and Infectious Diseases | Funder | USA |
| Protherics | Collaborator | United-Kingdom |
Scientific Summary
Pharmacodynamics
Summary
Results from preclinical trials showed that, immunity of both broad-spectrum antibody and cell-mediated, rapid onset immunity is possible using the coronavirus vaccines. It showed the ability to rapidly stimulate a balanced antibody response, including an enhanced Th1 response, which includes, raising significant virus neutralizing antibodies and potent cell-mediated immunity which is demonstrated by T-cell activation. It also showed a rapid onset of immunity with antibody responses detected within 14 days after the first vaccination [10] .
Results from the preclinical studies demonstrated strong antibody responses as soon as 7 days after the first coronavirus vaccination, with rapid boosting as soon as 7 days after the second vaccination, when utilising a more complete spike protein antigen. Antibody responses and cell mediated immune responses both demonstrated the desired Th1 bias, at the same time [11] .
In preclinical studies, the heat stable COVID-19 vaccine (CiVax™) demonstrated rapid-onset, broad-spectrum, neutralising antibody and cell-mediated immunity that was confirmed using full-length Spike protein antigens. This recombinant protein subunit SARS-CoV-2 vaccine, in combination with CoVaccine HT adjuvant, induced broad, Th1 biased, humoral and cellular immune responses in mice [9] .
In a preclinical study of non-human primates (NHPs), the heat stable coronavirus vaccine demonstrated durable response elicited by the vaccine even after a Gamma variant virus challenge, 12 weeks post-vaccination. Although the vaccine antigen is developed based on the spike protein of the original SARS-CoV-2 strain, it elicited cross-neutralising antibodies against Beta, Gamma and Delta variants of concerns. Post-vaccination, animals had a lower peak viral load and more rapid resolution of infectious virus, coupled with reduced lung damage. After the challenge with Gamma variant virus, animals that were not vaccinated generated a neutralising antibody response to Beta and Gamma variants but not to the original strain and the Delta variant, demonstrating that natural infection may not yield sufficiently robust immunity. However, CiVax™-vaccinated animals subsequently challenged with Gamma variant had enhanced neutralising antibody responses against the original strain, as well as the Beta, Gamma and Delta variants. The results were obtained from NHPs that were vaccinated twice, three weeks apart, and subsequently challenged with Gamma variant coronavirus, both intranasally and intratracheally, 12 weeks later [8] .
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 28 Sep 2021 | Scientific Update | Pharmacodynamics data from a preclinical study in COVID-2019 infections released by Soligenix [8] Updated 22 Oct 2021 |
| 28 Apr 2021 | Trial Update | Soligenix plans a clinical trial for COVID-2019 infections (Prevention) [7] Updated 04 May 2021 |
| 04 Mar 2021 | Scientific Update | Pharmacodynamics data from preclinical trials in COVID-2019 infections released by Soligenix [9] Updated 03 Aug 2021 |
| 28 Dec 2020 | Company Involvement | Soligenix receives SBIR grant from National Institute of Allergy and Infectious Diseases for COVID-19 vaccine development in COVID-2019 infections [12] Updated 08 May 2021 |
| 11 Sep 2020 | Scientific Update | Pharmacodynamics data from a preclinical study in COVID-2019 infection released by Soligenix [11] Updated 14 Sep 2020 |
| 03 Sep 2020 | Phase Change - Preclinical | Preclinical trials in Coronavirus infections (Prevention) in USA (Parenteral) (Soligenix pipeline, September 2020) Updated 08 Sep 2020 |
| 03 Sep 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections (Prevention) in USA (Parenteral) (Soligenix pipeline, September 2020) Updated 08 Sep 2020 |
| 28 Jul 2020 | Scientific Update | Pharmacodynamics data from a preclinical trial in COVID-2019 infections released by Soligenix [10] Updated 30 Jul 2020 |
| 16 Apr 2020 | Licensing Status | Soligenix signs agreement with Protherics for CoVaccine adjuvant [6] Updated 20 Apr 2020 |
| 23 Mar 2020 | Licensing Status | Soligenix expands collaboration with University of Hawaii at Mānoa to develop thermostable vaccines for Coronavirus infections and COVID-2019 infections [4] Updated 27 Mar 2020 |
| 23 Mar 2020 | Phase Change | Early research in Coronavirus infections (Prevention) in USA (Parenteral) [4] Updated 27 Mar 2020 |
| 23 Mar 2020 | Phase Change | Early research in COVID-2019 infections (Prevention) in USA (Parenteral) [4] Updated 27 Mar 2020 |
| 21 May 2013 | Patent Information | University of Colorado at Boulder has patent protection for ThermoVax® technology in USA [13] Updated 22 Jun 2021 |
| 17 May 2012 | Patent Information | University of Colorado at Boulder has patent pending for ThermoVax® technology in USA [13] Updated 22 Jun 2021 |
| 27 Jan 2011 | Licensing Status | Soligenix in-licenses vaccine thermostabilisation technology from the University of Colorado [1] Updated 27 Mar 2020 |
References
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Soligenix Executes Exclusive License with the University of Colorado for Vaccine Thermostabilization Technology.
Media Release -
Soligenix Announces Collaboration with the University of Hawai'i at Manoa and Hawaii Biotech to Develop Heat Stable Ebola Vaccine.
Media Release -
Soligenix and University of Hawaii at Mnoa Initiate Work on Novel Coronavirus Vaccine for COVID-19.
Media Release -
Soligenix Invited to Submit BARDA Contract Proposal for Development of Thermostabilized Subunit Vaccines for Sudan Ebola and Marburg Viruses.
Media Release -
Soligenix Announces Exclusive Licensing Agreement for Novel Vaccine Adjuvant from BTG Specialty Pharmaceuticals.
Media Release -
Soligenix Presents at the National Foundation for Infectious Diseases Annual Conference on Vaccinology Research.
Media Release -
Soligenix Announces Accelerated Publication Demonstrating Efficacy and Broad Neutralizing Activity of its COVID-19 Vaccine in Non-Human Primates.
Media Release -
Soligenix Announces Positive Progress in the Pre-clinical Development of its COVID-19 Vaccine.
Media Release -
Soligenix Announces Publication of Positive Pre-clinical Results for a Novel COVID-19 Vaccine.
Media Release -
Soligenix Announces Investor Webcast Event and Presentation Today: Advantages of the CiVax(Tm) Program for Development of a Broadly Distributed Heat Stable COVID-19 Vaccine.
Media Release -
Soligenix Announces $1.5 Million NIH Small Business Innovation Research Award Advancing COVID-19 Vaccine Development.
Media Release -
Soligenix - Form 10-K - For the Fiscal Year Ended December 31, 2020. Internet-Doc 2021;.
Available from: URL: https://www.sec.gov/Archives/edgar/data/812796/000121390021018698/f10k2020_soligenix.htm
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