Ocugen, a fully integrated, patient-centric biotech company, is committed to developing gene and cell therapies to address unmet medical needs, and vaccines to positively impact public health. While the Company was founded on cutting-edge science for inherited retinal diseases, Co-Founder, CEO and Chair, Dr. Shankar Musunuri has spent over 30 years in biotech and half of that time in vaccines operations for one of the world’s leading pneumococcal vaccines. As such, he remains passionate about preventing life-threating diseases. When the world changed forever in 2020, there was no way Dr. Musunuri and his experienced leadership team were going to sit on the sidelines and wait for someone else to address the COVID-19 pandemic.
With Ocugen’s R&D team and technical capabilities in place, the Company leveraged its network, and in 2021 licensed COVAXIN™ from Bharat Biotech for North American Markets. COVAXIN, a whole-virion inactivated COVID-19 vaccine candidate, applies the same vero cell manufacturing platform used in the production of polio vaccines for decades. COVAXIN is designed for a broad immune response with adult and pediatric Phase 2/3 data suggesting both humoral and cellular responses generated against multiple viral proteins. Data also support that the vaccine induces a Th1 response (cell-mediated immunity), which can be vital for durable protection.
COVAXIN may provide an important additional vaccine option as a primary series or booster and to broaden the immune response among individuals who have been previously vaccinated with other U.S.- licensed vaccines. This vaccine is currently in late-stage trials in the U.S.
While COVAXIN offers a new option using a traditional platform, the fight against COVID-19 is entering a new phase as sequential mutations of the virus feature ever more transmissibility and immune-evading properties. For this reason, there is also a desperate need for next generation vaccines that provide protective immunity at the source of the infection and reduce the rate of transmission from one person to another. Mucosal vaccines have the potential to offer that type of protection.
Leaders in the fields of epidemiology, public health, and vaccine development believe that a mucosal vaccine that provides immunity at the point of transmission and where COVID-19 is most lethal — the lungs — may be the most effective way to directly combat new variants. That’s why Ocugen obtained licensing rights from Washington University in St. Louis to develop a novel inhaled booster vaccine to be sold in the United States, Europe, Japan, and other major markets.
OCU500, Ocugen’s inhaled COVID-19 vaccine candidate, has the potential to generate rapid local immunity in the upper airways, and lungs—where both SARS-CoV-2 and seasonal flu enter and infect the body. This technology has been shown to generate neutralizing IgG, mucosal IgA, and T cell responses to help reduce transmission rate. Mucosal immunity has been demonstrated as a potential way to prevent infection and spread, which contributes to the evolution of new variants. Furthermore, OCU500 represents a potential universal booster, regardless of previous COVID-19 vaccination.
As COVID-19 vaccines will ultimately move to an annual booster, Ocugen is also exploring options to deliver OCU500 in a quadrivalent flu formulation intended to cover multiple seasonal flu strains.
Ocugen is pursuing development of both COVAXIN and OCU500 to provide new, safe and effective alternatives in the fight against COVID-19. While billions of doses of vaccines have been delivered globally, vaccines that produce a more sustained response, suppress variants, and reduce transmission are still needed. As a recent editorial in the New England Journal of Medicine said, “Currently available vaccines have only modest effectiveness against mild infection and transmission, which is further reduced in the context of the newly emerging omicron subvariants. Hence, to slow down the circulation of the virus and to limit the speed at which further variants emerge, new vaccines that have a substantial effect on reducing mild infection and transmission are needed, even as the world attempts to learn how to live with SARS-CoV-2.”i
The Company is engaging with government agencies to align on funding, which has been a hallmark of expediting vaccine development in the U.S., to bring both vaccine candidates through the required clinical trials to benefit public health in America and ultimately the world.
i Nohynek, Hanna and Annelies Wilder-Smith, “Does the World Still Need New Covid-19 Vaccines,” The New England Journal of Medicine, June 2, 2022, 386:2140-2142. https://www.nejm.org/doi/full/10.1056/NEJMe2204695