Partnership to advance novel ALS combination therapy

A pharmaceutical company and a biotechnology firm have announced a development and license agreement for an investigational proprietary biologic combination therapy to treat amyotrophic lateral sclerosis.

According to a release, terms of the agreement between Dr. Reddy’s Laboratories SA and Coya Therapeutics Inc. stipulate that Coya will grant Dr. Reddy’s an exclusive license to commercialize COYA 302, a 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.

Among the terms cited in the release, Coya will retain the right to commercialize COYA 302 for patients with ALS in Japan, Mexico, and each country in South America, as well as to assume responsibility for the clinical development of COYA 302 and to seek regulatory approval in the U.S.

Dr. Reddy will pay Coya $7.5 million up front, per the agreement. Upon the first FDA acceptance of an investigational new drug application for COYA 302, Dr. Reddy’s will pay Coya an additional $4.2 million, and will pay another $4.2 million when dosing of the first patient in the initial phase 2 trial occurs in the United States.

Additionally, Coya can potentially receive $677.25 million in sales-based milestone payments.

Terms of the agreement also include development and regulatory milestones up to $40 million should all such development and regulatory milestones be achieved, the release further stated.

Coya anticipates the IND filing will be made during the first half of 2024.

“The agreement provides the financial resources to execute the phase 2 clinical program for COYA 302,” Coya CEO Howard Berman, PhD, said in the release. “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.”

Editor's note: This article was updated Dec. 27, 2023, to include additional terms of the agreement.