Ocugen Announces FDA Approval for Phase 1 Clinical Trial of OCU500, an Inhaled Mucosal Vaccine for COVID-19

Ocugen’s OCU500, a mucosal COVID-19 vaccine, enters Phase 1 trial; focuses on inhalation and nasal spray administration.

Quiver AI Summary

Ocugen, Inc. announced that the FDA has approved its Investigational New Drug application for OCU500, a mucosal vaccine for COVID-19, which will be delivered via inhalation and as a nasal spray. The Phase 1 clinical trial, sponsored by the NIAID, is set to begin in the second quarter of 2025, aiming to evaluate the vaccine's safety, tolerability, and immune response in 80 adult participants. Despite the pandemic's official end, COVID-19 continues to pose a public health threat, with significant infection and hospitalization rates. OCU500 is based on novel chimpanzee adenovirus-vectored technology, which has shown promise in previous studies for generating a strong immune response. Ocugen is also looking to expand this platform to other respiratory viruses and is collaborating with NIAID through Project NextGen, a government initiative to develop new vaccines and therapeutics against COVID-19.

Potential Positives

• The FDA has activated Ocugen's Investigational New Drug (IND) application, a vital step toward beginning the Phase 1 clinical trial for OCU500.
• The Phase 1 trial will be sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), indicating a strong collaboration and support from a federal agency.
• OCU500 is based on innovative chimpanzee adenovirus-vectored technology with potential advantages demonstrated in earlier studies, including increased antibody response and durability.
• Project NextGen funding will cover all costs associated with the Phase 1 trial, reducing financial burden on Ocugen while providing access to essential clinical data for future development.

Potential Negatives

• The announcement suggests a delayed timeline for the clinical trial, with Phase 1 expected to start in 2Q 2025, which could reflect challenges in the development process or readiness of the product.
• The focus on COVID-19, despite the pandemic being declared over, may indicate limited market interest or relevance for the company's product, raising concerns about the potential demand for OCU500.
• The press release emphasizes various risks associated with forward-looking statements, which could create uncertainty about the success of the clinical trials and the overall viability of the company's pipeline.

FAQ

What is OCU500?

OCU500 is an inhaled mucosal vaccine for COVID-19 developed by Ocugen, utilizing novel adenovirus-vectored technology.

When does the Phase 1 clinical trial for OCU500 begin?

The Phase 1 clinical trial for OCU500 is anticipated to start in the second quarter of 2025.

How will OCU500 be administered in the clinical trial?

OCU500 will be administered via inhalation and as a nasal spray during the clinical trial.

Who is sponsoring the Phase 1 trial for OCU500?

The National Institute of Allergy and Infectious Diseases (NIAID) will sponsor and conduct the Phase 1 clinical trial.

What is Project NextGen?

Project NextGen is a $5 billion initiative aimed at developing the next generation of vaccines and therapeutics for COVID-19.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

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Full Release

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  OCU500 will be administered via inhalation and as a nasal spray
  
  


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  COVID-19 remains a substantial public health threat in the U.S. and around the world
  
  


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  Phase 1 clinical trial is anticipated to start in 2Q 2025
  
  
  
  

MALVERN, Pa., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the U.S. Food and Drug Administration (FDA) has reviewed the Company’s Investigational New Drug (IND) application and it is in effect. This is a critical step toward the initiation of the Phase 1 clinical trial for OCU500—an inhaled mucosal vaccine for COVID-19. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will sponsor and conduct the Phase 1 trial to assess the safety, tolerability, and immunogenicity of OCU500 administered via two different routes, inhalation into the lungs and intranasally as a spray.

“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.”

Even though the pandemic has ended, COVID-19 still presents a significant burden in the U.S. The Centers for Disease Control (CDC)

estimates

that from October 1, 2024 to January 11, 2025, there were 4.4 to 7.9 million COVID infections, resulting in 120,000 to 210,000 hospitalizations and 14,000 to 25,000 deaths.

The Phase 1 trial would enroll 80 adult subjects aged 18 to 64 years. Forty (40) subjects would be assigned to the low-dose group, and 40 subjects would be assigned to the high-dose group. Within each group, 20 subjects would receive the inhalation form of the vaccine, and the other 20 subjects would receive the intranasal form. The primary aim of the study would be to determine safety, while secondary and exploratory endpoints include antibody production and the number of breakthrough COVID-19 infections.

OCU500 is based on a novel chimpanzee adenovirus-vectored (ChAd36) technology. Earlier clinical studies to prevent COVID-19 that employed a similar technology administered via inhalation demonstrated increased mucosal and systemic antibodies and a durable immune response up to one year using one-fifth the dose compared to the same vaccine administered intramuscularly. Ocugen intends to expand this mucosal platform to address other serious respiratory threats including seasonal influenza, bird flu, and respiratory syncytial virus (RSV).

The original ChAd36 vector that makes the Ocugen vaccine unique was licensed from Washington University in St. Louis.

"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. "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," added Dr. David Curiel, Professor of Radiation Oncology, Washington University School of Medicine, co-collaborator on the vector design.

Project NextGen is a $5 billion multi-government agency initiative to develop the next generation of vaccines and therapeutics to combat the spread of COVID-19. NIAID, with funding from Project NextGen, will cover the full cost of the Phase 1 clinical trial, including operations and related analysis. Ocugen is providing clinical trial materials and, upon completion, will have full right of reference to the findings, which Ocugen believes will provide clinical evidence to support the further development of the Company’s lead mucosal vaccine candidate.

"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," said 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."





About Ocugen, Inc.



Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at

www.ocugen.com

and follow us on

X

and

LinkedIn

.

Cautionary Note on Forward-Looking Statements




This


press


release


contains


forward-looking


statements


within


the


meaning


of


The


Private


Securities


Litigation


Reform


Act


of


1995,


including,


but


not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines,


which


are


subject


to


risks


and


uncertainties.


We


may,


in


some


cases,


use


terms


such


as


“predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,”


or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including,


but


not


limited


to,


the


risks


that


preliminary,


interim


and


top-line


clinical


trial


results


may


not


be


indicative


of,


and


may


differ


from,


final


clinical data;


the ability of OCU500 to perform in humans in a manner consistent with nonclinical or preclinical study data;


that


unfavorable


new


clinical


trial


data


may


emerge


in


ongoing


clinical


trials


or


through


further


analyses


of


existing


clinical


trial


data;


that


earlier non-clinical


and


clinical


data


and


testing


of


may


not


be


predictive


of


the


results


or


success


of


later


clinical


trials;


and


that


that


clinical


trial


data


are subject to differing interpretations and assessments, including by regulatory authorities.


These


and


other


risks


and


uncertainties


are


more


fully described


in


our


periodic


filings


with


the


Securities


and


Exchange


Commission


(SEC),


including


the


risk


factors


described


in


the


section


entitled


“Risk Factors”


in


the


quarterly


and


annual


reports


that


we


file


with


the


SEC.


Any


forward-looking


statements


that


we


make


in


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release


speak


only


as of


the


date


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Contact:



Tiffany Hamilton


Head of Communications



Tiffany.Hamilton@ocugen.com

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.