Dr. Reddy's Laboratories SA, wholly-owned subsidiary of Dr. Reddy's Laboratories Ltd. and Coya Therapeutics announced that they have entered into a development and license agreement for the development and commercialization of COYA 302, an investigational combination therapy for the treatment of Amyotrophic Lateral Sclerosis (ALS).

Under the terms of the Agreement, Coya has granted Dr. Reddy's an exclusive license to commercialize COYA 302, a proprietary co-pack kit containing combination of low dose IL-2 and CTLA-4 Ig (abatacept) in the United States, Canada, the European Union and the United Kingdom for ALS. This Agreement is in addition to the in-licensing agreement with Dr. Reddy's signed in early 20231. Coya retains the right to commercialize COYA 302 for patients with amyotrophic lateral sclerosis (ALS) in Japan, Mexico, and each country in South America. Coya will have responsibility for the clinical development of COYA 302 and for seeking regulatory approval for COYA 302 for patients with ALS in the United States.

Dr. Reddy's will make a US$ 7.5 million upfront payment to Coya. Upon the first FDA acceptance of an investigational new drug (IND) application for COYA 302 for the treatment of ALS, Dr. Reddy's will pay Coya an additional US$ 4.2 million. Upon dosing of the first patient in the first Phase 2 trial of COYA 302 for the treatment of ALS in the United States, Dr. Reddy's will pay Coya an additional US$ 4.2 million.

Coya anticipates that the IND filing will be made in the first half of 2024. The Agreement also includes development and regulatory milestones up to USD 40 million should all such development and regulatory milestones be achieved.

Additionally, Coya is eligible to receive sales-based milestone payments of up to USD 677.25 million linked to tiers of cumulative net sales being achieved over several years (over the term of the agreement subject to product commercial exclusivity). In addition, Dr. Reddy's will pay Coya royalties based on a percentage net sale of COYA 302 ranging from low to middle teens. Coya is not a related party to Dr. Reddy's or its promoters/promoter group.

Marc Kikuchi, Chief Executive Officer of Dr. Reddy's North America, said: "Patients with ALS, commonly known as Lou Gehrig's disease, have very few treatment options. We are pleased to partner with Coya Therapeutics on this investigational therapy which may have a unique place in treating patients with this progressive neurodegenerative disease. With this promising biologic product, we hope to reach many more patients around the world in keeping with our aim of serving over 1.5 billion patients by 2030. Dr. Reddy's biosimilars/biologics business is part of our key strategic initiatives expected to drive both near-term and long-term growth."

Dr. Howard Berman, Chief Executive Officer of Coya, observed: "The Coya team is delighted to enter this exciting partnership with Dr. Reddy's, a world class organization that defines excellence in innovation and commercialization. While the agreement provides the financial resources to execute on the Phase 2 clinical program for COYA 302 in ALS, the strategic value of the partnership contributes much more than capital. We will benefit from and leverage Dr. Reddy's manufacturing expertise and growing commercial infrastructure both in the USA and worldwide as we plan together for the future of COYA 302 in ALS, a devastating disease with a high unmet need." 

COYA 302 was developed out of the multi-year translational research collaboration between Coya and Houston Methodist in the laboratory of Dr. Stanley Appel, an internationally renowned researcher and clinician. Houston Methodist is one of the leading hospital and academic research facilities.