Coya Therapeutics inks deal with Dr. Reddy’s to license proposed biosimilar Abatacept

Coya Therapeutics, a clinical-stage biotechnology company developing multiple therapeutic platforms intended to enhance Treg function, including biologics and cell therapies, has reached a worldwide agreement with Dr. Reddy’s.

Coya will in-license the proposed Abatacept biosimilar of Dr. Reddy’s for the development of Coya’s combination product for neurodegenerative diseases, Coya 302. It is a dual biologic intended to suppress neuroinflammation via multiple immunomodulatory pathways for the treatment of neurodegenerative conditions.

Coya 302 is comprised of two components—Coya 301 and CTLA4-Ig. Coya will develop Coya 301. Under the terms of the agreement, Coya has been granted an exclusive, royalty-bearing license to Dr. Reddy’s proposed biosimilar Abatacept for the development and commercialization of Coya 302 for the treatment of certain neurological diseases for sale in multiple territories including North and South America, the EU, United Kingdom and Japan.

[Read more: Dr. Reddy’s to acquire Mayne Pharma’s U.S. generic portfolio]

As consideration for the license, Coya will pay a one-time non-refundable upfront fee to Dr. Reddy’s. In addition, Coya will owe tiered payments to Dr. Reddy’s based upon Coya’s achievement of certain developmental milestones. Coya also will owe royalties to Dr. Reddy’s on net sales of Coya 302 within its licensed territory on a tiered basis. The agreement does not preclude Dr. Reddy’s from launching its proposed biosimilar Abatacept globally for approved indications post regulatory approval.

Coya anticipates that it will file an IND for Coya 302 in the 2H of 2023 with the goal of initiating a phase 1b/2 trial in ALS (Amyotrophic Lateral Sclerosis) soon thereafter.

The agreement also provides for the license of Coya 301, Coya’s low dose IL-2 to Dr. Reddy’s to permit the commercialization by Dr. Reddy’s of Coya 302 in territories not otherwise granted to Coya. Coya will receive royalties on net sales by Dr. Reddy’s in their territories based on the same tiered structure as Coya owes Dr. Reddy’s. The agreement also allows Dr. Reddy’s and Coya to enter into a mutually satisfactory commercial supply agreement at an appropriate time.

“This is a landmark agreement for Coya in our efforts to develop Coya 302. To partner with such a high-caliber pharmaceutical company like Dr. Reddy’s is what every emerging biotechnology company strives for, and we believe that the combined resources of both organizations strengthens our chances to bring this therapeutic modality to patients with neurodegenerative diseases if approved by regulatory authorities,” said Howard Berman, CEO of Coya.

[Read more: Challenges continue, but generics companies see a bright future with biosimilars]

Adrian Hepne, chief medical officer of Coya added, “We believe that the Coya 302 proof-of-concept clinical data in ALS patients is encouraging and sets the foundation to advance our development program. Our combination therapy approach has been designed to address the multiple pathophysiological pathways leading to chronic and sustained inflammation that drives the progression of serious neurodegenerative diseases. We plan to file an IND in the second half of this year and work closely with the regulatory authorities to initiate our clinical studies soon thereafter.”

Jayanth Sridhar, global head of biologics at Dr. Reddy’s, said, “We are very happy to collaborate with Coya in this effort to advance therapies that address critical unmet needs for a variety of neuro-degenerative diseases. As a global biosimilars developer, we believe our proposed Abatacept biosimilar will be valuable in the development of this innovative combination therapy. We continue to look for ways to use our scientific capabilities and product portfolio to serve patients around the world."