ADEL, Inc has entered into a licence agreement with Sanofi for the development and commercialisation of ADEL-Y01, a potential first-in-class antibody therapy for Alzheimer's disease and related backup compounds.

The total potential value of the agreement is up to USD 1.04 billion. ADEL will receive a non-refundable upfront payment of USD 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.

ADEL-Y01 is a humanised monoclonal antibody that selectively targets tau protein acetylated at Lysine-280 (acK280). Unlike therapies targeting total tau, ADEL-Y01 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.

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

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 I clinical trial (first-in-human study) under an Investigational New Drug (IND) application approved by the US FDA.

"Erik Wallstroem, Global Head—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."