MALVERN, PA — Biopharmaceutical company Ocugen, Inc. (NASDAQ: OCGN) has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for OCU500, a novel inhaled and intranasal mucosal vaccine for COVID-19. This approval enables the commencement of a Phase 1 clinical trial, a highly anticipated step toward addressing unmet needs in COVID-19 prevention.
The trial, sponsored and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will evaluate the vaccine’s safety, tolerability, and immune response. NIAID’s sponsorship is part of Project NextGen, a multi-agency initiative aimed at advancing next-generation vaccines and therapeutics against COVID-19.
“We are grateful for our ongoing collaboration with NIAID and pleased to bring our novel vaccine technology into the clinic through Project NextGen,” said Mike Shine, Senior Vice President, Commercial at Ocugen. “COVID-19 remains a real public health concern, and an increasing number of studies are showing the benefit of mucosal vaccines that attack the virus where it enters the body—through the nose and mouth—to give better and longer protection. We look forward to this important next step in potentially providing a more durable and safer option to help prevent infection and transmission of COVID-19 regarding various variants of concern.”
The Phase 1 trial is expected to start in the second quarter of 2025 and will enroll 80 adults aged 18 to 64. Participants will be divided into low-dose and high-dose groups, with half receiving an inhaled vaccine and the other half receiving a nasal spray. Safety is the trial’s primary focus, while secondary endpoints include antibody production and breakthrough infection rates.
OCU500 is based on a chimpanzee adenovirus-vectored (ChAd36) platform licensed from Washington University in St. Louis. Earlier studies of similar technology demonstrated robust mucosal and systemic immune responses and long-lasting protection using smaller doses compared to intramuscular administration. Ocugen intends to leverage this platform to address other respiratory illnesses like influenza and RSV.
“We are delighted to see the progress of the ChAd36 vector encoding a SARS-CoV-2 spike antigen that was originally designed and tested at Washington University in St. Louis,” said Dr. Michael Diamond, Professor of Medicine and Co-Director of the Center for Vaccines and Immunity to Microbial Pathogens at Washington University School of Medicine.
Dr. David Curiel, co-collaborator on the vector design and Professor of Radiation Oncology at Washington University School of Medicine, added, “We believe this vector is ideal for mucosal administration and can be designed to carry COVID-19 strains as well as influenza and antigens from other respiratory viruses.”
Ocugen has advanced this vector technology to allow the inclusion of multiple antigens, offering rapid adaptability against emerging variants. “Ocugen further advanced the vector technology, enabling the incorporation of single/multiple antigens into a single vector. This innovation offers significant manufacturing flexibility in responding to emerging variants within one hundred days of identifying a circulating variant of concern,” explained Dr. Arun Upadhyay, Chief Scientific Officer at Ocugen. “This vector technology, combined with mucosal delivery, has the potential to enable rapid development of respiratory vaccines in response to future outbreaks including bird flu.”
With the backing of NIAID and Project NextGen, the results of this Phase 1 trial could mark a major advancement in respiratory vaccine development and global COVID-19 prevention strategies.
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