Candidates: Vaccine for prevention/control of COVID-19
Category: VAX
Type: Multi-antigenic, synthetic, attenuated modified vaccinia Ankara (sMVA) vector expressing spike (S) and nucleocapsid (N) antigens of the SARS-CoV-2 virus. The vaccine is based on GeoVax’s Modified Vaccinia Ankara Virus-Virus Like Particle (MVA-VLP™) platform, designed to prime and/or boosts the immune system against COVID-19. COH04S1 was initially developed at City of Hope for immunocompromised and other patients.
2021 Status: Phase II Dosing Begins–GeoVax said December 15 that it had launched vaccine dosing in the Phase II portion of its Phase I/II clinical trial of COH04S1, designed to evaluate its use as a universal booster to current FDA-approved vaccines. The clinical trial is being conducted at City of Hope.
The Phase II booster study will include 60 healthy individuals, 18 years of age and older, who were previously vaccinated with one of the FDA-approved SARS-CoV-2 mRNA vaccines. The study is designed as a dose-escalation trial to specifically evaluate the safety profile and immunogenicity of COH04S1 as a booster shot. Immunological responses to be measured throughout the study will include both the level of SARS-CoV-2 neutralizing antibodies against SARS-CoV-2 variants of concern (VOC), including the newly identified Omicron VOC, and specific T-cell responses, GeoVax said.
The Phase I portion of the trial was designed as a dose-escalation safety study in healthy individuals between the ages of 18 to 55, who had not been previously infected with SARS-CoV-2. The primary objectives were to evaluate the safety, tolerability and immunogenicity of the COH04S1 vaccine in healthy volunteers who were administered the vaccine at three different dose levels by intramuscular (IM) injection. According to GeoVax, follow-up studies of the volunteers are continuing in order to better assess duration of immune responses and scientific presentations, and publications of results are planned for early 2022.
2020 Status: City of Hope Agreement–GeoVax entered into an exclusive license agreement November 9 with City of Hope, granting GeoVax world-wide rights to the patents covering COH04S1 and to further develop and commercialize COH04S1. Also granted were rights to expertise and clinical materials related to COH04S1. The value of the agreement and other financial information were not disclosed.
Status: GeoVax said October 26 that it signed a Patent and Biological Materials License Agreement with the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), toward developing a vaccine against SARS-CoV-2.
The agreement provides GeoVax with nonexclusive rights to develop, manufacture, and commercialize its COVID-19 vaccine by combining its proprietary technology with NIAID’s patent rights to the stabilized Spike protein. The agreement includes commercialization rights to the NIH MVA backbone for the vaccine, arising from the laboratory of Bernard Moss, MD, PhD, Chief of the Genetic Engineering Section at NIAID’s Laboratory of Viral Diseases (LVD). Financial terms of the license agreement were not disclosed.
GeoVax said that as of October 26, the company had designed and constructed four COVID-19 vaccine candidates, one of which is expected to provide a single-dose, universal vaccine effective against multiple coronavirus strains. Preclinical small animal studies for the first candidate are currently being conducted in collaboration with researchers at the University of Texas Medical Branch at Galveston (UTMB), with the company intending to accelerate small animal testing in order to generate initial results “soon.”
On August 10, GeoVax said its four vaccine candidates for COVID-19 had entered animal challenge testing. Once a single candidate is selected, GeoVax plans to proceed directly to manufacturing and initial human clinical testing for safety and immunogenicity, subject to additional fundraising and/or support from U.S. funding agencies. GeoVax added that its vaccine platform’s track record of safety in humans through its HIV vaccine program—and preclinical testing results seen with vaccine programs for HIV, Ebola, Sudan, Marburg and Zika—provided the scientific rationale to move forward “confidently” with its COVID-19 program.
In March, GeoVax and BravoVax said they completed three vaccine candidates after making rapid progress with design, construction and in vitro characterizations. The companies will narrow down the candidates to the one that shows the best safety, immunogenicity and protective efficacy in upcoming animal studies. GeoVax and BravoVax aim to advance a vaccine candidate to human clinical trials before year’s end, GeoVax President and CEO David Dodd stated.
GeoVax said it was in talks with, and submitted applications to, the Biomedical Advanced Research and Development Authority (BARDA) and other U.S. and international funding agencies. The company noted that BARDA has $3.5 billion available toward supporting the manufacturing, production and purchase of vaccines, therapeutics, and diagnostics under the $2 trillion Coronavirus Aid, Relief, and Economic Security Act (CARES ACT), signed into law by President Donald Trump on March 27.
GeoVax disclosed its intent to collaborate with BravoVax, a vaccine developer in Wuhan, China, to develop a COVID-19 vaccine in January.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types:
● ANTIVIRAL
● VAX
● ANTIBODY
● RNA
