Ocugen and Bharat Biotech announced that the companies have signed a binding letter of intent (LOI) to co-develop Bharat Biotech’s COVID-19 vaccine  candidate, COVAXIN, an advanced stage whole-viron inactivated vaccine candidate, for the United States market.

COVAXIN has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials in India, with promising safety and immunogenicity data. The vaccine candidate is currently part of a Phase III clinical trial in India involving 26,000 volunteers.

As per the LOI, Ocugen will have US rights to the vaccine candidate and, in collaboration with Bharat Biotech, will be responsible for clinical development, registration, and commercialisation for the US market. The companies have begun collaborating and will finalise details of the definitive agreement in the next few weeks. This collaboration leverages Ocugen’s vaccine expertise, and its R&D and regulatory capabilities in the US.

In preparation for the development of COVAXIN in the US, Ocugen has assembled a Vaccine Scientific Advisory Board featuring leading academic and industry experts to evaluate the clinical and regulatory path to approval in the US market.
“COVAXIN utilises a historically proven approach to vaccine design. The adjuvanted inactivated virus vaccine candidate elicited strong IgG responses against spike (S1) protein, receptor-binding domain (RBD) and the nucleocapsid (N) protein of SARS-CoV-2 along with strong cellular responses in Phase I and II clinical trials. COVAXIN offers a vaccine candidate that is different from other options currently available in the US market with potentially broader coverage against multiple protein antigens of the virus” said Harvey Rubin, M.D. Ph.D. of the University of Pennsylvania, a member of Ocugen’s Vaccine Scientific Advisory Board.

David Fajgenbaum, M.D. of University of Pennsylvania’s Division of Translational Medicine and Human Genetics, Director of the Center for Cytokine Storm Treatment and Laboratory, and member of Ocugen’s Vaccine Scientific Advisory Board said, “The COVID-19 pandemic has caused unmatched devastation to individual patients and to the world. It is going to take the kind of unmatched collaboration and innovation that is occurring right now to effectively fight back. Vaccines such as COVAXIN that can potentially elicit a broad immune response and may limit future COVID-19 severity could be important to have in our arsenal.”

“We are delighted to collaborate with Bharat Biotech to potentially bring COVAXIN to the US market. In the face of the coronavirus pandemic, it is incumbent upon all of us to find solutions that have the potential to save lives and restore normalcy to our day-to-day activities. We have been very pleased with the safety and immunogenicity demonstrated by the Phase I and Phase II trials of COVAXIN and are encouraged with the progress of the Phase III trials in India. We believe this unique yet traditional approach to vaccination holds great potential to appeal to a broad range of the population,” said Dr Shankar Musunuri, Chairman, CEO, and Co-Founder, Ocugen.

“The development and clinical evaluation of COVAXIN marks a significant milestone for vaccinology in India. COVAXIN has garnered interest from several countries worldwide for supplies and introduction and we are excited to collaborate with Ocugen to bring it to the US market,” said Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech.