Coya retains the right to commercialise COYA 302 for patients with amyotrophic lateral sclerosis (ALS) in Japan, Mexico, and each country in South America

Dr Reddy’s Laboratories and Coya Therapeutics have entered into a development and license agreement for the development and commercialisation 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 commercialise COYA 302, a proprietary co-pack kit containing a combination of low dose IL-2 and CTLA-4 Ig (abatacept) in the US, Canada, the European Union and the UK for ALS. This agreement is in addition to the in-licensing agreement with Dr Reddy’s signed in early 2023.

According to a press statement, Coya retains the right to commercialise COYA 302 for patients with amyotrophic lateral sclerosis (ALS) in Japan, Mexico, and each country in South America. Coya will be responsible for the clinical development of COYA 302 and for seeking regulatory approval for COYA 302 for patients with ALS in the US.

“Dr Reddy’s will make a $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 $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 US, Dr Reddy’s will pay Coya an additional $4.2 million. Coya anticipates that the IND filing will be made in the first half of 2024,” the company said in a statement.

The agreement also includes development and regulatory milestones up to $40 million should all such development and regulatory milestones be achieved. Additionally, Coya is eligible to receive sales-based milestone payments of up to $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), it added.

Additionally, Dr Reddy’s will pay Coya royalties based on a percentage net sales of COYA 302 ranging from low to middle teens. Coya is not a related party to Dr Reddy’s or its promoters/promoter group, it stated.

“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,” Marc Kikuchi, CEO, Dr Reddy’s North America, said in a statement.

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.