Coya Therapeutics enters worldwide COYA 302 agreement with Dr. Reddy’s

Coya Therapeutics (COYA) announced a worldwide agreement with Dr. Reddy’s (RDY). Under this agreement, 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. 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 will also 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 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.