Kemwell Biopharma and RevOpsis Enter into Strategic Manufacturing Partnership to Expedite Development of Novel Multispecific Biologics

• 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.

BANGALORE, INDIA and SAN CARLOS, CA, USA – June 17, 2024 – 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.

Kemwell is a contract biologics development and CDMO company providing services to global biologics organizations. Kemwell facilities, located in Bengaluru, are designed and developed with technological support from a leading German pharma company. Established in 1980, it has had long term associations with pharma majors such as Bayer, GlaxoSmithKline, Merck KGaA, Novartis, Pfizer and others for small molecule contract manufacturing and R&D.

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 visitwww.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.