Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a
biotechnology company focused on discovering, developing, and
commercializing novel gene and cell therapies and vaccines, today
announced that Arun Upadhyay, PhD, Chief Scientific Officer, Head
of Research & Development, Ocugen will speak at the
International Society for Cell & Gene Therapy (ISCT) Annual
Meeting being held May 29-June 1, 2024 in Vancouver, Canada.
“I’m very pleased to present OCU400 data among an organization
dedicated to translating cell and gene therapies into safe and
effective treatments to improve patients’ lives,” said Dr.
Upadhyay. “OCU400 modifier gene therapy represents a breakthrough
approach for the potential treatment of broader retinitis
pigmentosa (RP) and Leber congenital amaurosis (LCA) diseases where
more than 100 mutations are involved.”
ISCT provides cutting-edge translational content and an
opportunity to connect with global experts from academic
institutions, regulatory agencies, and the healthcare industry.
Attendees can participate in robust debates, collaborate on
developing solutions to sector challenges, and join conversations
advancing the field of cell and gene therapy.
Details on Dr. Upadhyay’s presentation are as follows:
Late-Breaking Oral Abstract Session: Safety and
Efficacy Results from a Phase 1/2 Clinical Trial of OCU400 Modifier
Gene Therapy for Treatment of Retinitis Pigmentosa
Date: Thursday, May 30,
2024Time: 5-6 p.m. PDT Location:
Room 202-204, Vancouver Convention Centre, West Building
Dr. Upadhyay’s poster will also be available during Poster
Networking Session #1 on Wednesday, May 29, 2024 from 7-8:30 p.m.
PDT.
The OCU400 Phase 3 liMeliGhT clinical trial is currently
underway and on track to meet the Company’s 2026 BLA and MAA
approval targets. OCU400 is the first gene therapy program to enter
Phase 3 with a broad RP indication.
About OCU400OCU400 is the Company’s
gene-agnostic modifier gene therapy product based on nuclear
hormone receptor (NHR) gene, NR2E3. NR2E3 regulates
diverse physiological functions within the retina—such as
photoreceptor development and maintenance, metabolism,
phototransduction, inflammation and cell survival networks. Through
its drive functionality, OCU400 resets altered/affected cellular
gene networks and establishes homeostasis—a state of balance, which
has the potential to improve retinal health and function in
patients with RP. Nearly 300,000 people are affected by RP in the
U.S. and EU combined.
About Modifier Gene TherapyModifier
gene therapy is designed to fulfill unmet medical needs related to
retinal diseases, including IRDs, such as RP, LCA and Stargardt
disease, as well as multifactorial diseases like dry age-related
macular degeneration (dAMD). Our modifier gene therapy platform is
based on the use of NHRs, master gene regulators, which have the
potential to restore homeostasis — the basic biological processes
in the retina. Unlike single-gene replacement therapies, which only
target one genetic mutation, we believe that our modifier gene
therapy platform, through its use of NHRs, represents a novel
approach that has the potential to address multiple retinal
diseases caused by mutations in multiple genes with one product,
and to address complex diseases that are potentially caused by
imbalances in multiple gene networks. Currently, Ocugen has three
modifier gene therapy programs in the clinic: OCU400, OCU410, and
OCU410ST. In addition to the OCU400 Phase 3 liMeliGhT clinical
trial, the OCU410 Phase 1/2 ArMaDa clinical trial for geographic
atrophy (GA) secondary to dAMD and the OCU410ST Phase 1/2 GARDian
clinical trial for Stargardt disease are currently underway. GA
affects approximately two to three million people in the U.S. and
EU combined and Stargardt disease affects nearly 100,000 people in
the U.S. and EU combined.
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 X 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, 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;
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 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)
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