Ocugen Mucosal Vaccine Candidate OCU500 Selected by NIH/NIAID Project NextGen for Inclusion in Clinical Trials
October 10 2023 - 6:30AM
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 National Institute of Allergy
and Infectious Diseases (NIAID), a part of the National Institutes
of Health, will conduct a trial comparing the administration of
Ocugen’s mucosal vaccine candidate, OCU500, via two different
mucosal routes, inhalation into the lungs and as a nasal spray.
Ocugen is developing a novel anti-viral mucosal vaccine platform
initially targeting COVID-19 and influenza (flu). The intent is to
provide protection against severe disease, increase durability and
prevent transmission of viral threats. OCU500 is based on a novel
chimpanzee adenovirus-vectored (ChAd) technology. Earlier clinical
studies to prevent COVID-19 employing a similar vector administered
via inhalation demonstrated increased mucosal antibodies, systemic
antibodies, and durable immune response up to one year using one
fifth (1/5) of the dose compared to the same vaccine given via
intramuscular administration. Additionally, Ocugen believes that
this vaccine can be rapidly scaled-up as new variants emerge.
“We believe our novel mucosal vaccine platform technology has
the potential to prevent infection and spread of COVID-19, and
improve durability for an annualized vaccine similar to flu,” said
Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and
Co-Founder of Ocugen. “This is the first vaccine candidate using
our inhaled platform technology, which we hope to expand in order
to address multiple respiratory threats, including flu. We have
benefited from a strong collaborative relationship with NIAID and
BARDA since the start of Project NextGen and we look forward to
participating in this initiative.”
NIAID will be conducting clinical trials to evaluate several
early stage vaccine candidates. The study involving Ocugen’s
vaccine will be administered via both intranasal and inhaled routes
and is designed to help answer an important question – does an
inhaled COVID-19 vaccine provide greater immune response than the
same vaccine administered through a nasal spray. Upon completion of
the trial NIAID and Ocugen will assess the results and determine
next steps for OCU500.
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 clinical
trials, including operations and related analysis. Ocugen will be
responsible for 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.
The announced collaboration comes at a time when COVID-19
infection rates are rising with the emergence of new variants.
Durability of existing vaccines continues to be of concern with
antibody protection waning several months following vaccination
while vaccine compliance rates have declined since the initial
wave. According to a recent Harris poll, 66% of Americans would
prefer to have more vaccine options. The poll also found that 52%
of Americans would be more open to getting an intranasal or
inhaled, versus injectable COVID-19 vaccine.
Ocugen looks forward to this important next step in the
development of its novel mucosal vaccine platform and further
supporting the Company’s commitment to advancing public health.
About Ocugen, Inc.Ocugen, Inc. is a
biotechnology company focused on discovering, developing, and
commercializing novel gene and cell therapies 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 Twitter and LinkedIn.
Cautionary Note on Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995, 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. 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 this press release speak
only as of the date of this press release. Except as required by
law, we assume no obligation to update forward-looking statements
contained in this press release whether as a result of new
information, future events, or otherwise, after the date of this
press release.
Contact:Tiffany HamiltonHead of
CommunicationsTiffany.Hamilton@ocugen.com
Ocugen (NASDAQ:OCGN)
Historical Stock Chart
From Sep 2024 to Oct 2024
Ocugen (NASDAQ:OCGN)
Historical Stock Chart
From Oct 2023 to Oct 2024