Movers and SHAKERS
Small Caps in the COVID-19 Vaccine and Treatment Space
In the United States, there are three covid vaccines currently authorized by the FDA and recommended by the CDC (BioNTech/Pfizer, Johnson & Johnson, and Moderna). While larger companies in the U.S. dominate this space, there are still several opportunities both here and in other countries, with billions of people still awaiting vaccinations and various other covid-related treatments.
There are a number of small-cap companies working in the covid space, on their own candidates both in the U.S. and abroad on improved drug delivery or production methods or various medications for Covid-related illnesses. Below is a list of small cap companies operating (at least in part) in the covid landscape.
Cocrystal Pharma (COCP)
Pre-clinical Antiviral Treatment
In February of 2020, Cocrystal Pharma entered into a license agreement with Kansas State University Research Foundation to develop proprietary antiviral compounds for the treatment of coronavirus infections. Pre-clinical studies of COVID-19 inhibitors were initiated in Q2 2020. A lead pre-clinical module was announced in Q4 2020.
In a March 2021 press release, Cocrystal provided 2 updates on their COVID-19 programs: (1) Advancement of pre-clinical studies with CDI-45205, which demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS and has potential for injection or inhalation delivery; and (2) Application of their proprietary structure-based platform technology to discover novel covid inhibitors with the potential for oral administration.
Ceapro, Inc. (CRPOF)
In Q3 2020, Ceapro announced that they had achieved the first milestones in the successful development of a PGX-processed yeast beta-glucan product, which could be a potential inhalable therapeutic for COVID-19. They also made significant technical upgrades to a demo plant to allow for sufficient production of the yeast beta-glucan for human trials.
electroCore has been exploring the potential use of their existing product, gammaCore Sapphire CV, for use on hospitalized COVID-19 patients experiencing respiratory symptoms. In a March 2021 press release, the company announced the completion of enrollment in the investigator-initiated SAVIOR-1 clinical trial to evaluate gammaCore Sapphire CV for COVID-related respiratory conditions.
gammaCore Sapphire CV has received Emergency Use Authorization from the FDA for acute use at home or in a healthcare setting to treat adult patients (both known and suspected COVID-19 cases) who are experiencing an exacerbation of asthma-related dyspnea and reduced airflow.
Ocugen partnered with Bharat Biotech to develop COVAXIN, a whole-virion inactivated COVID-19 vaccine, for the U.S. market. COVAXIN was approved for clinical trials in India in June 2020, with Phase 1 & 2 clinical trials beginning the next month. A phase 3 trial with up to 25,800 patients commenced in October of 2020. In December, Bharat announced their partnership with Ocugen to develop the vaccine for the United States market. The vaccine was authorized for emergency use in India on January 3, 2021, despite a lack of published Phase 3 data.
The execution of the co-development agreement for the U.S. market occurred on February 2, 2021. Under the agreement, profits from the sale of COVAXIN in the U.S. will be shared, with Ocugen retaining 45%. Ocugen has established a vaccine scientific advisory board and feels they are making steady progress towards developing an Emergency Use Authorization pathway in the United States, according to a March 2021 press release.
COVAXIN demonstrates efficacy of 81%, according to interim Phase 3 results.
PDS Biotechnology (PDSB)
In June 2020, PDS Biotechnology and Farmacore Biotechnology announced the co-development of a potential COVID-19 Vaccine based on the Versamune platform. This partnership allowed them to quickly accelerate towards Phase 1 trials in Brazil. The vaccine candidate (Versamune-CoV-2FC) was designed to provide rapid induction of neutralizing antibodies, as well as killer T-cells and memory T-cells against COVID-19, and to prevent the spread of infection.
In a March 2021 press release, PDS announced that their vaccine consortium had received a commitment from the Ministry of Science, Technology and Innovation of Brazil to fund clinical development and commercialization. This award (~$60MM) was based on pre-clinical studies which showed strong potential to induce immune responses against the virus. Phase 1 and 2 trials to assess safety and efficacy will run together in Brazil, and are expected to enroll 360 pateints.
“PDS Biotech and Farmacore Biotechnology have taken the important step of advancing our Versamune®-based COVID-19 vaccine into the clinic,” said Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech.“ The pre-clinical results demonstrate the vaccine’s potential to induce a broad range of robust anti SARS-CoV-2 immune responses. The rapidly increasing number of SARS-CoV-2 mutations highlights the need for novel, second generation vaccines capable of generating both killer and helper T-cells that can recognize and attack conserved and non-mutating regions of the virus. We applaud Farmacore Biotechnology and Blanver Farmoquímica for reaching this important milestone and look forward to the results of the planned human clinical trials and hopefully a rapid advancement towards commercialization of the product. These clinical trials will also advance our understanding of the potential for novel Versamune®-based vaccines to provide long-term protection against infection with viruses with pandemic potential such as SARS-CoV-2.”