US-based Coya Therapeutics, Inc. has announced a worldwide agreement with Hyderabad-based Dr. Reddy’s Laboratories. 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 commercialisation 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 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 commercialisation by Dr. Reddy’s of Coya 302 in territories not otherwise granted to Coya.