In an exclusive interview with The Fly, Ocugen (OCGN) CEO Shankar Musunuri talked about the company, COVID vaccine COVAXIN, ongoing clinical trials, upcoming milestones, pandemic-related impacts on the company and much more.
COVID VACCINE: COVAXIN, which is developed and manufactured by Ocugen's partner Bharat Biotech International, is currently under clinical investigation by Ocugen in the United States. The COVID-19 vaccine candidate BBV152, known as COVAXIN outside the U.S., is a whole-virion inactivated COVID-19 vaccine candidate that applies the same vero cell manufacturing platform used in the production of polio vaccines for decades. It has been granted Emergency Use Listing by the World Health Organization, based on a submission by Bharat Biotech.
"We started a Phase 2/3 clinical trial in the U.S. It's an immuno-bridging study. Our partner Bharat from India did a large-scale Phase 3 clinical trial. And as part of the FDA approval process, they want data from U.S. demographic. Since it's difficult repeat the efficacy trial, we do an immune-bridging trial. In a few hundred patients, you collect the data in U.S. population and you look for immune responses that are comparable to the immune responses of the patients who run through the large-scale clinical trial," Musunuri explained to The Fly.
"The second part relates to safety in the U.S. population. We’re planning on doing the safety trial later this year in order to meet BLA [Biologics License Application] requirements. The market is shifting to booster doses. So, we also need to be prepared to give COVAXIN as booster dose to people in the U.S. Having a booster specific study would be essential to us and that’s the other study we're planning to do in the U.S. We have a plan for the BLA as we believe COVID is going to be here for four to five years. Our goal is to file for BLA and get that approval by the second half of next year," he added.
CELL, GENE THERAPIES: Among the company’s ongoing clinical trials is the Phase 3 study for Ocugen’s program called NeoCart, which was acquired as a part of its reverge merger with the original developer of the therapy, Histogenics, in 2019. NeoCart is a three-dimensional tissue-engineered disc of new cartilage that is manufactured by growing chondrocytes – the cells responsible for maintaining cartilage health – derived from the patient on a unique scaffold. NeoCart has the potential to accelerate healing and reduce pain by rebuilding a patient's damaged knee cartilage. Ultimately, the goal is to prevent a patient's progression to osteoarthritis. "Everything is going as expected with the trial. We’re working the FDA to finalize confirmation Phase 3 protocol," the executive told The Fly.
Discussing the company's Phase 1/2 study for OCU400, a novel gene therapy product candidate with the potential to be broadly effective in restoring retinal integrity and function across a range of genetically diverse inherited retinal diseases, Musunuri said it is also "going well and as expected." After concluding Phase 1/2, Ocugen is expecting to "initiate Phase 3 trials in the later part of next year, and might combine U.S. and the EU."
UPCOMING MILESTONES: Looking out over the remainder of the year, Ocugen's CEO sees COVAXIN interim data as an important milestone. "If we can release some interim data from the COVAXIN study by the end of the year, that would be good. For the gene therapy program, the target is to complete enrollment this year and get to Phase 3 by the end of next year," the executive added.
COVID-RELATED IMPACT: Discussing COVID-related impacts with The Fly, CEO Musunuri acknowledged that, "just as with any other company, there are a lot of supply challenges. We’re dealing with any issues. There was some impact on some programs. But we’re still on target."
NOT JUST A COVAXIN COMPANY: Ocugen, which focuses on gene therapies, biologicals and vaccines, has recently attracted a lot of social media interest, being dubbed by some as a "meme stock." "We think they’re missing the entire concept. We’re committed to patients. Our goal is to really focus on our gene and cell therapies. We’re willing to take risks. We want patients to look at Ocugen with hope because we really care about them. When we jumped into COVAXIN it was because we couldn’t sit on the sidelines. A pandemic is like a war. We’re soldiers and we jumped in to contribute. We’re not just a COVAXIN company. We’re a true biotech company focused on vaccines, gene therapies and cell therapies trying to contribute to unmet medical needs of patients globally," Musunuri explained.
"Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company.
