Sanofi and IGM Biosciences have entered into an exclusive worldwide collaboration agreement to create, develop, manufacture, and commercialize a new class of potential therapeutics, IgM antibody agonists against three oncology targets and three immunology/inflammation targets. Engineered IgM antibodies represent a new class of potential therapeutics that combine the multi-valency of IgM antibodies possessing 10 binding sites, compared to conventional IgG antibodies having only 2 target binding sites.
Under the terms of the agreement, IGM will receive a $150 million upfront payment. Sanofi has also expressed an interest in purchasing up to $100 million of IGM non-voting common stock in a public financing.
For each oncology target collaboration program, IGM will lead research and development activities, and assume related costs, through approval of the first biologics license application (BLA) for a product directed to that oncology target by the FDA or EMA in exchange for up to $940 million in development and regulatory milestones per oncology target. After receipt of the first marketing approval for a product directed to an oncology target, Sanofi will lead all subsequent development and commercialization activities for that oncology target. For each oncology target, the companies will share profits 50/50 in certain major markets, and IGM will be eligible to receive tiered royalties on net sales in the rest of world.
For each immunology/inflammation target collaboration program, IGM will lead research and development activities, and assume related costs, through the completion of Phase 1 clinical trial for up to two constructs directed to each immunology/inflammation target, after which Sanofi will be responsible for all future development and related costs, in exchange for up to $1,065 million in aggregate development and regulatory and commercial milestones per immunology/inflammation target. Following the completion of Phase 1 clinical trial for each immunology/inflammation target, Sanofi will be responsible for subsequent development activities, commercialization efforts, and related costs. IGM is eligible to receive tiered high single-digit to low-teen royalties on global net sales.
Closing of the collaboration is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S., and customary closing conditions.