Sanofi has signed an exclusive global licence agreement with Kali Therapeutics for KT501, a new tri-specific antibody for B cell-mediated autoimmune diseases.
The agreement grants Sanofi worldwide rights to KT501, which is under evaluation in a first-in-human clinical trial for rheumatoid arthritis, focusing on tolerability, safety, pharmacodynamics, and pharmacokinetics.
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Under the agreement, Kali Therapeutics is set to receive $180m in upfront and near-term payments.
The company also stands to gain up to $1.05bn in potential development and commercial milestone payments. Tiered royalties on product sales, ranging from high single to double digits, are also part of the deal.
KT501 is an immunoglobulin G (IgG)-like tri-specific T-cell engager targeting cluster of differentiation 3 (CD3), CD19, and B-cell maturation antigen (BCMA) with high affinity. Its molecular design aims to maximise potency while reducing cytokine release through a unique CD3 masking platform.
Kali Therapeutics CEO Weihao Xu said: “We are thrilled to collaborate with Sanofi, a global leader in immunology, to advance the development of KT501, our lead tri-specific programme. Our platform leverages state-of-the-art protein engineering to solve complex therapeutic challenges.
“This collaboration highlights the potential of our unique CD3 masking technology to decouple potency from toxicity, aiming to provide safer, more effective options for patients.
“Autoimmune diseases require treatments that are not only highly potent but also exhibit a superior safety profile. KT501 represents a significant leap forward in this regard.”
Earlier this month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the approval of Sanofi and Regeneron’s Dupixent (dupilumab) in the European Union for paediatric patients with chronic spontaneous urticaria.
