By Kenneth Adams, Benzinga
Coya Therapeutics, Inc. (NASDAQ: COYA) recently announced a worldwide agreement with Dr. Reddy’s Laboratories Limited. (BSE: 500124, NSE: DRREDDY) (NYSE: RDY) (NSEIFSC: DRREDDY), a global pharmaceutical company.
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 (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 article was originally published on Benzinga here.
About Coya Therapeutics, Inc.Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to a sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system. Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. Coya’s 300 Series product candidates, COYA 301 and COYA 302, are biologic therapies intended to enhance Treg function and expand Treg numbers. COYA 301 is a cytokine biologic for subcutaneous administration intended to enhance Treg function and expand Treg numbers in vivo, and COYA 302 is a biologic combination for subcutaneous and/or intravenous administration intended to enhance Treg function while depleting T effector function and activated macrophages. These two mechanisms may be additive or synergistic in suppressing inflammation.
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David S. Snyder