- Partnership to accelerate development of lead product
candidate, RO-104; a first-in-class tri-specific biologic for
treating neovascular age-related macular degeneration.
- Broader collaboration to streamline and expedite therapeutic
discovery to IND submission timelines of the proprietary
multispecific Rev-Mod Platform.
SAN
CARLOS, Calif. and BANGALORE,
India, June 17, 2024 /PRNewswire/ -- RevOpsis
Therapeutics, a next-generation biopharmaceutical company
spearheading innovation of multispecific ophthalmic therapies, and
Kemwell Biopharma, a leading biologics contract development and
manufacturing organization (CDMO), announced today a broad
strategic manufacturing partnership. This collaboration aims to
accelerate the development of RevOpsis' lead candidate, RO-104, a
first-in-class tri-specific biologic for the treatment of
neovascular age-related macular degeneration (nAMD).
Under this partnership, Kemwell will manufacture RO-104, a novel
tri-specific biologic designed to target the three dominant
angiogenic pathways (VEGF-A, VEGF-C, Ang-2) for treating nAMD, a
leading cause of blindness worldwide. The unique ability of RO-104
to bind these three validated targets simultaneously positions it
as a first-in-class fully human monotherapy biologic, poised to
redefine the treatment landscape for retinal vascular diseases.
As India's first commercial
current Good Manufacturing Practices (cGMP) manufacturing facility,
Kemwell is a trusted and respected partner with extensive
experience in complex protein manufacturing. This collaboration
leverages Kemwell's well-established manufacturing excellence and
RevOpsis' innovative Rev-Mod platform to expedite the development
of novel multispecific biologics.
"Partnering with Kemwell is a pivotal step in accelerating the
development of our lead candidate, RO-104, and advancing our
pipeline of innovative multispecific biologics," said Ram Bhandari,
MD, Co-founder and Interim CEO of RevOpsis. "Kemwell's
exemplary track record in high-quality biologics manufacturing and
their efficiency in reducing timelines, combined with our
proprietary Rev-Mod platform, ensures we can deliver transformative
therapies to patients efficiently. This collaboration aligns with
our mission to develop groundbreaking treatments expeditiously, and
bring our innovation to patients worldwide."
Anurag Bagaria, CEO of Kemwell
Biopharma, added, "We are excited to collaborate with RevOpsis to
manufacture and commercialize RO-104. Our expertise in complex
protein manufacturing, coupled with RevOpsis' innovative
therapeutic approaches, holds great promise for advancing the
treatment of retinal vascular diseases. This strategic partnership
underscores our commitment to delivering high-quality biologics for
patients in need."
This new alliance provides RevOpsis a critical biologics
development solution to rapidly transition from pre-clinical
activities to first-in-human clinical trials, expediting the
development of RO-104 and the broader platform. By integrating
RevOpsis' next generation plug-and-play multispecific biologics
platform with Kemwell's deep biologics development and
manufacturing knowledge, the collaboration aims to accelerate
therapeutic discovery to IND submission timelines. This new
alliance efficiently connects preclinical efforts, process
development, and clinical manufacturing allowing significantly
reducing the complexity and timelines of managing early GMP
manufacturing process.
About RO-104
Leveraging the proprietary Rev-Mod
platform, RO-104 is RevOpsis' current lead candidate. Engineered as
a first-in-class fully human modular tri-specific
biologic designed to address all three clinically validated
dominant angiogenic pathways (VEGF-A, VEGF-C, Ang-2) implicated in
retinal vascular disease progression, including neovascular
age-related macular degeneration (nAMD). RO-104 represents a
significant innovative advancement in the treatment landscape for
retinal vascular diseases. Backed by a significant body of
preclinical evidence demonstrating intended efficacy and safety in
established animal models, RO-104 heralds a transformative approach
positioned to redefine the current standard of care for patients
with nAMD.
About Rev-Mod Platform
The proprietary Rev-Mod
Platform employs a modular 'plug-and-play' approach to streamline
and expedite the efficient discovery and development of
multispecific biologics targeting a wide spectrum of chronic,
prevalent, large diseases, that are the leading causes of death and
disability worldwide. Our proprietary platform boasts a vast
library of nearly 30 billion fully human antibody components in a
structured phage display system, facilitating rapid identification
and assembly of multispecific product candidates. With seamless
compatibility, the Rev-Mod platform enables swift and efficient
design of multispecific biologics to address unmet needs in major
therapeutic areas including ophthalmology, oncology, and
immune-mediated diseases.
About RevOpsis Therapeutics
Founded in 2018, RevOpsis
Therapeutics is a privately held, next-generation biopharmaceutical
company spearheading innovation in ophthalmic therapies. Guided by
a team of leading physicians, scientists, and business leaders, we
are dedicated to leveraging our proprietary Rev-Mod Platform to
develop and commercialize groundbreaking treatments for chronic
multifactorial diseases. With a steadfast commitment to responsibly
advancing patient care, we aim to usher in a new era of
improved disease management and extended disease remission. For
more information, please visit www.revopsis.com.
About Kemwell Biopharma
Kemwell Biopharma is a leading biologics CDMO 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 end-to-end services in
development and manufacturing of mammalian cell culture-based
therapeutic proteins. Kemwell's facilities consist of cGMP drug
substance manufacturing suites with over 5000L bioreactor capacity,
sterile fill and finish for cGMP drug product manufacturing, and
development laboratories to support process and analytical
development for protein therapeutics such as monoclonal antibodies,
multispecific proteins, cell therapies, etc. Kemwell is currently
manufacturing commercial drug substances and drug products and has
worked on numerous R&D projects to support its customers during
the development and clinical phase for both novel biologics and
biosimilars. For more information, please visit
www.kemwellbiopharma.com.
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