Benzinga | Dec 15, 2021 06:50AM EST

Ocugen Highlights Data Analyzing Immune Response From Two Doses Of COVAXIN; Says Study Found COVAXIN 'generated a robust immune memory against spike and nucleoprotein that was comparable to that following natural COVID-19 Infection...'

* Level of vaccine-induced spike and nucleoprotein antibodies titers demonstrated to be comparable to that following natural infection

* Immune memory against conserved nucleoprotein may provide an added advantage over spike-only responses

* Memory T and B cells persisted for at least 6 months post vaccination

* Data suggest COVAXIN(tm) (BBV152) may provide protection against current and future variants

* Effectiveness of COVAXIN(tm) (BBV152) against the Omicron variant is currently being studied

MALVERN, Pa., Dec. 15, 2021 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ:OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that data analyzing immune response following two doses of the vaccine candidate, COVAXIN(tm) (BBV152), from a third-party study were published on the preprint server, medRxiv. The data compared the immune memory response of 71 vaccinated and 73 naturally infected subjects with SARS-CoV-2, including variants of concern, for up to six months. The study found that COVAXIN(tm) (BBV152) generated a robust immune memory against spike and nucleoprotein that was comparable to that following natural COVID-19 infection for the levels of antibodies, memory B cells and memory CD4+ T cells.

In addition to controlling infections, the adaptive immune system creates immunological memory, such as memory B and T cells, to enable long-term protection against a virus. In the analysis, COVAXIN(tm) (BBV1542) generated T-cells against both spike and nucleocapsid proteins in nearly 85 percent of subjects that persisted for at least 6 months. This data supports previous findings that COVAXIN(tm) (BBV152) is able to induce long-term memory.

"As a whole-virion inactivated vaccine, we anticipated COVAXIN(tm) would produce an immune response against multiple antigens present in the SARS-CoV-2 virus, such as spike and nucleoprotein antibodies," said Shankar Musunuri, PhD, MBA, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen.

"The results of this analysis are extremely important findings as we continue to learn about how the virus is mutating and how we can address variants of concern with vaccines, especially with the emergence of Omicron," said David Fajgenbaum, MD, MBA, MSc, FCPP, Assistant Professor of Medicine in Translational Medicine & Human Genetics at the University of Pennsylvania and member of Ocugen's Vaccine Scientific Advisory Board. "Given that current variants of concern exhibit mutations concentrated in the spike protein of the virus, vaccines like COVAXIN(tm) that can generate broad immune memory beyond the spike protein are a promising tool to protect us from emerging variants of concern."



Ocugen is currently evaluating COVAXIN(tm) (BBV152) against the Omicron variant and plans to share the data as soon as they are available.

Earlier this year, Ocugen's co-development partner, Bharat Biotech, announced data from a Phase 3 trial that included nearly 25,800 participants. In the study, published in The Lancet, COVAXIN(tm) (BBV152) demonstrated 77.8% overall efficacy, 93.4% efficacy against severe illness (which requires hospitalization, intensive care and/or a ventilator) and 65.2% efficacy against the Delta variant. Adverse events reported in the trial were low, with 12.4% of subjects experiencing commonly known side effects and less than 0.5% of subjects experiencing serious adverse events, which is consistent with data from other vaccines that apply whole-virion technology. Both adverse events and serious adverse events reported in the vaccine group were reported at similar rates to the placebo group.

About COVAXIN(tm) (BBV152)

COVAXIN(tm) (BBV152) is an investigational vaccine candidate product in the U.S. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). COVAXIN(tm) is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

With more than 125 million doses having been administered to adults outside the U.S., COVAXIN(tm) is currently authorized under emergency use in 17 countries, and applications for emergency use authorization are pending in more than 60 other countries. The World Health Organization (WHO) recently added COVAXIN(tm) to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of Covid-19 vaccination certificates with India that includes vaccination using COVAXIN(tm). The trade name COVAXIN(tm) has not been evaluated by the FDA.