By David Willey, Benzinga
Houston-based Coya Therapeutics (NASDAQ: COYA) has entered into a partnership with Dr. Reddy’s Laboratories Ltd. (NYSE: RDY), a world-leading pharmaceutical company based in India. Through this partnership, Coya will license Dr. Reddy’s biosimilar product, Abatacept, allowing Coya to develop its combination product, COYA 302. This drug will combat various neurodegenerative diseases, including Amyotrophic Lateral Sclerosis (ALS).
Through its one-time, non-refundable fee, Coya has an exclusive and royalty-bearing license to Abatacept for the development and commercialization of COYA 302. This license also gives Coya the right to sell the drug in the Americas, the EU, the United Kingdom, Japan and elsewhere, and Coya will owe royalties to Dr. Reddy for the sale of the product. In addition, Dr. Reddy’s will develop COYA 302 in its own territories and will owe royalties back to Coya upon the commercialization of COYA 302.
COYA 302 is a dual biologic product that will provide a novel treatment for various neurodegenerative diseases. Using the components COYA 301 and CTLA4-Ig, the drug suppresses inflammation in the brain or spinal cord via the body’s immunomodulatory pathways. Coya expects to file an investigational new drug (IND) application with the Food and Drug Administration (FDA) in the second half of 2023, with a phase 1b/2 trial to follow.
Why This Deal Matters For Future Drug Development
This partnership, between a multi-billion generic drug company and a small biotech, is amongst the first of its kind. It could indicate a shift in how major drug companies are positioning their development pipeline, as they explore a biologic biosimilar’s ability to treat new indications, or symptoms, for major diseases.
The global biosimilar market has seen recent growth, with North America making up the largest portion of the market. The market was worth $28.61 billion in 2021 and is predicted to reach $103 billion by 2028, growing by a compound annual growth rate (CAGR) of 25.6% during the forecast period of 2022-2028. There are already 33 FDA-approved biosimilars that are used in various treatments including for cancer and autoimmune diseases. As well as improving treatments, biosimilars have already helped bring the cost of medication down.
Dr. Reddy is a leading player in the biosimilar market. The partnership it entered with Coya signals that Dr. Reddy is adopting a new and possibly transformative approach to biosimilars. By combining a biologic biosimilar with another drug product, it is adapting the potential of biosimilars so they can treat new symptoms of serious diseases.
Coya is already developing a Treg-based therapy to deal with neurodegenerative diseases with its Coya-101 product. Now, through its partnership with Dr. Reddy, Coya is showcasing the exciting potential of collaborations between smaller biotech companies and billion-dollar pharmaceutical corporations. Coya already has compelling early data from its clinical trials for COYA 302, and it will be revealing the data at the Muscular Dystrophy Association (MDA) conference on March 21st.
Other biologics companies include Eli Lilly and Company (NYSE: LLY), bluebird bio (NASDAQ: BLUE) and GeoVax, Inc. (NASDAQ: GOVX).
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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