The FDA lifts its clinical hold on Ocugen’s COVID-19 vaccine, and Ocugen announces a clinical trial for the treatment of inherited retinal diseases.
Ocugen is moving closer to bringing its COVID-19 vaccine, developed by India-based Bharat Biotech, into the United States market after the Food and Drug Administration (FDA) lifted a clinical hold on its Investigational New Drug Application for Covaxin.
Lifting of the hold, which was placed in November, will allow the company to conduct a Phase II/III study in support of a potential Biologics License Application for the vaccine. Ocugen and Bharat Biotech have been working together since 2020 to develop the two-dose vaccine that has already received authorization in India for people ages 12 and above. Covaxin, which is a highly purified and inactivated vaccine developed with a vero cell manufacturing platform, has already been placed on the World Health Organization’s list of authorized vaccines.
Shankar Musunuri, chairman and CEO of Pennsylvania-based Ocugen, expressed excitement about moving forward with its clinical program for Covaxin. Despite the falling number of infections and loosening of mitigation efforts to prevent the spread of COVID-19, Musunuri said they believe the pandemic will require more than one approach to vaccines. The company expects to commence an immuno-bridging and broadening clinical trial as soon as possible.
Additionally, Ocugen said it has shared real-world safety data from 36 million teenagers who have already been treated with Covaxin at the request of the FDA. The company also presented in vitro data that suggests Covaxin provides “robust neutralization” against the Delta and Omicron variants that have been responsible for the most recent surges of infections across the globe. This data was submitted in order to support Ocugen’s pediatric authorization submission, which is currently under review by the FDA.
Ocugen is also planning to seek the potential authorization of Covaxin in Canada. The company submitted data to Health Canada for potential authorization, and the agency is currently reviewing the data.
In addition to the hold lifted on Feb.18, Ocugen announced it has initiated a Phase I/II clinical trial for the treatment of inherited retinal diseases caused by NR2E3 and RHO disease genotypes. That trial will assess OCU400, the company’s lead modifier gene therapy platform candidate.
With the Phase II/III study of Covaxin cleared and the Phase I/II of OCU400, Musunuri said 2022 is poised to be another great year for the company.
Other highlights the company pointed to that will drive its 2022 include its recent letter of intent with Liminal BioSciences for the acquisition of its manufacturing site in Belleville, Ontario. Ocugen said the site will enable the company to develop its internal manufacturing capabilities and expand its research and development capabilities to support its product candidate pipeline. The letter of intent was sent in January.
“We believe establishing a manufacturing and R&D hub for our biotechnology platform is the right investment and next evolution of our business. This site, after transformation into a state-of-the-art hub, with the support of the regional talent pool can help bring our innovative products – from vaccines to our modifier gene therapy assets – to the patients we will serve globally,” Musunuri said.
Financially, Ocugen is secure. Earlier this month, it sold $50 million of common shares to pad its accounts. Its 2021 report showed the company closed out that year with $95.1 million in cash and cash equivalents, and it ended 2020 with $24.2 million in cash and cash equivalents.
