Coya Therapeutics, Inc. (COYA), a clinical-stage biotechnology company, announced Monday a worldwide agreement with Dr. Reddy's Laboratories Limited. (RDY).
Under the deal, 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 deal terms, 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. The deal is 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 companies said 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 second hald of 2023 with the goal of initiating a phase 1b/2 trial in ALS (Amyotrophic Lateral Sclerosis) soon thereafter.
The deal 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.
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