Ocugen Engages Kemwell Biopharma for cGMP Manufacture of OCU200
October 06 2020 - 7:30AM
Ocugen, Inc., (NASDAQ: OCGN), a biopharmaceutical company focused
on discovering, developing, and commercializing transformative
therapies to cure blindness diseases, today announced it has
entered into an agreement with Kemwell Biopharma Pvt. Ltd.
(Kemwell) to manufacture OCU200, Ocugen’s novel biologic product
candidate in preclinical development for treating severely
sight-threatening diseases like Diabetic Macular Edema (DME),
Diabetic Retinopathy (DR), and Wet Age-Related Macular Degeneration
(Wet-AMD).
Under this agreement, Kemwell will manage all CMC and clinical
manufacturing activities as well as provide OCU200 supplies for
IND-enabling toxicology studies and Phase 1/2a clinical trials.
Kemwell offers proven expertise in supporting companies with
process development, clinical and commercial manufacturing of
biologicals at their state-of-the-art facilities located in
Bangalore, India.
“Biological manufacturing is critical and rate-limiting for
Phase 1/2 clinical trials, and this partnership paves the way for
us to potentially enter the clinic by 1H2022 as planned. We are
picking a CMO with commercial capabilities with a goal of ensuring
product consistency throughout development and minimizing
regulatory issues as we drive the development of OCU200,” said Dr.
Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen.”
“We are delighted to partner with Ocugen as they advance their
portfolio of transformative therapies to cure blindness diseases.
We believe our expertise in process development and manufacturing
solutions will play a critical role to advance OCU200 into the
clinic and could deliver hope to patients with severely
sight-threatening diseases who do not respond to currently
available therapies,” said Anurag Bagaria, Chairman and CEO of
Kemwell. Ocugen is planning to initiate IND-enabling studies,
including GLP toxicology studies next year. DME is the first
targeted indication for OCU200, and the Company plans to advance
into Phase 1/2a trials in 1H2022. Based on early clinical success
in DME, the Company will undertake evaluation of broader
indications such as DR and Wet-AMD. In the US alone, over 9.5
million patients struggle with these retinal diseases.
Approximately 50% of patients do not respond to current therapies
including anti-VEGF treatments. This patient population represents
a significant underserved population who are looking for new
therapies. OCU200 has a distinct method of action compared to
current anti-VEGF therapies and has potential to be a
disease-modifying drug based on in vivo and in vitro preclinical
studies to date.
About
OCU200OCU200 is a
biologic product candidate in preclinical development for treating
severely sight-threatening diseases like Diabetic Macular Edema
(DME), Diabetic Retinopathy (DR), and Wet Age-Related Macular
Degeneration (Wet-AMD). Patients affected by these diseases share
common symptoms, such as blurriness in vision and progressive
vision loss as the disease progresses. The formation of fragile and
leaky new blood vessels leads to fluid accumulation in and around
the retina, causing damage to vision.
OCU200 is a novel fusion protein consisting of two human
proteins, tumstatin and transferrin, that are already present
normally in retinal tissues. OCU200 possesses unique features which
enable it to (a) efficiently target leaky blood vessels, (b)
regress the existing abnormal blood vessels, and (c) inhibit the
growth of new blood vessels in the retina and choroid. Tumstatin,
which acts as an anti-VEGF, anti-inflammatory and anti-oxidative
agent, is the active component of OCU200. It binds to integrin
receptors, which play a crucial role in disease pathogenesis.
Transferrin facilitates the targeted delivery of tumstatin into the
retina and choroid and potentially helps increase the interaction
between tumstatin and integrin receptors.
About Ocugen, Inc.Ocugen, Inc. is a
biopharmaceutical company focused on discovering, developing, and
commercializing transformative therapies to cure blindness
diseases. Our breakthrough modifier gene therapy platform has the
potential to treat multiple retinal diseases with one drug – “one
to many” and our novel biologic product candidate aims to offer
better therapy to patients with underserved diseases such as wet
age-related macular degeneration, diabetic macular edema, and
diabetic retinopathy. For more information, please visit
www.ocugen.com.
About Kemwell Biopharma Pvt. Ltd. Kemwell is a
leading biologics CDMO in Asia which provides services to global
biopharmaceutical organizations for both clinical and commercial
needs. Kemwell, located in Bangalore, India provides customers with
high quality and cost-effective access to state-of-the-art
technology for development and manufacturing of all mammalian cell
culture-based products. Kemwell’s facilities consists of cGMP drug
substance manufacturing suites with over 4500L bioreactor capacity,
sterile fill and finish line for cGMP drug product manufacturing
and development laboratories to support process and analytical
development and production of protein therapeutics such as
monoclonal antibodies, bi-specific antibodies and fusion proteins.
For more information, please visit www.kemwellbiopharma.com.
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 (the “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.
Corporate Contact:Ocugen, Inc.Sanjay
SubramanianChief Financial Officerir@ocugen.com
Media Contact:LaVoieHealthScienceKatie
Gallagherkgallagher@lavoiehealthscience.com+1 617-792-3937
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