ADEL Inc., a biopharmaceutical company dedicated to developing therapies for neurodegenerative diseases, has entered into an exclusive worldwide license agreement with Sanofi, a multinational healthcare company, for the development and commercialization of ADEL-Y01, a potential first-in-class antibody therapy for Alzheimer’s disease, and related backup compounds.

ADEL-Y01 is a humanized monoclonal antibody that selectively targets tau protein acetylated at Lysine-280 (acK280). It specifically inhibits the aggregation and propagation of toxic tau species—a key driver of Alzheimer’s pathology—while preserving the function of normal microtubule-associated tau.

ADEL spearheaded the entire discovery and preclinical development of ADEL-Y01 using its proprietary neural disease research and development platform. Since 2020, ADEL has been co-developing the asset through a joint research and development agreement with Oscotec Inc. Currently, ADEL-Y01 is undergoing a global Phase 1 clinical trial (First-in-human study) under an Investigational New Drug (IND) application approved by the U.S. FDA.

“This strategic partnership with Sanofi, a global leader in healthcare, underscores ADEL’s technological strength and highlights the therapeutic promise of ADEL-Y01,” said Seung-Yong Yoon, CEO of ADEL. “By combining our scientific expertise with the proven development and commercialization capabilities of Sanofi, we hope to accelerate the delivery of this disease-modifying therapy to people living with Alzheimer’s around the world.”

Erik Wallstroem, Global Head of Multiple Sclerosis, Neurology and Gene Therapy Development, Sanofi, commented, “ADEL’s innovative approach to targeting tau acetylation offers a promising and differentiated mechanism for addressing the underlying causes of Alzheimer’s disease. We look forward to advancing ADEL-Y01 through clinical development to provide new hope for patients living with this devastating condition.”

The total potential value of the agreement is up to $1.04 billion. ADEL will receive a non-refundable upfront payment of $80 million and is eligible to receive additional payments contingent upon the achievement of specified development and commercial milestones. Additionally, ADEL is entitled to receive tiered royalties on net sales ranging up to double-digit percentages.