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PharmaCircleMonitoring shows:On March 23, Kali Therapeutics from the United States and Sanofi reached a licensing agreement for a trispecific T-cell engager, which is expected to be used in the treatment of various B-cell mediated autoimmune diseases.

According to the terms of the agreement, Sanofi will receiveKT501The global exclusive rights. KT501 is a novel tri-specific antibody developed based on Kali Therapeutics' self-developed drug discovery and research platform. Currently, KT501 is undergoing its first-in-human clinical trial to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in subjects with rheumatoid arthritis.

This BD deal: Kali Therapeutics will receive an upfront and near-term payment totaling $180 million, with eligibility to obtain up to $1.05 billion in development and commercialization milestone payments, as well as tiered royalties based on product sales ranging from high single-digit to double-digit percentages.

Kali Therapeutics CEO Dr. Weihao Xu stated, "We are deeply honored to collaborate with Sanofi, a global leader in immunology, to advance the development of our core trispecific program, KT501. Our platform leverages cutting-edge protein engineering technology to address complex therapeutic challenges. This collaboration fully demonstrates the potential of our proprietary CD3 shielding technology in balancing drug efficacy and toxicity, aiming to provide patients with safer and more effective treatment options."

Weihao Xu added, "The treatment for autoimmune diseases needs to not only be highly effective but also possess excellent safety. KT501 represents a significant breakthrough in this area. The drug can effectively deplete multiple B-cell subsets while minimizing cytokine release. We believe it can meet the significant unmet clinical needs of patients with autoimmune diseases. Leveraging Sanofi's deep expertise, there is potential to accelerate the development of this promising therapy."

Kali Therapeutics is a clinical-stage biotechnology company dedicated to redefining the innovation model in the biopharmaceutical field. The company integrates advanced protein engineering technology with high-throughput experimental techniques to streamline the drug discovery and research process. Its self-developed immune cell engager platform enables precise optimization of the functionality, manufacturability, and developability of biologics with first-in-class or best-in-class potential. Kali Therapeutics achieves the remodeling and regeneration of the immune system through T-cell engagers with precise targeting and controllable cytotoxicity, delivering transformative therapeutic effects. Founded inJune 2024The company was founded by Dr. Wei-Hao Xu, former CBO/CFO of Harbour BioMed.

KT501 is a novel IgG-like tri-specific T cell engager that binds with high affinity to CD3, CD19, and BCMA targets, thereby targeting multiple B cell subsets. The drug leverages innovative molecular design and a proprietary CD3 shielding technology platform to enhance efficacy while reducing cytokine release. Non-human primate studies have shown that KT501 can efficiently deplete B cells in both peripheral blood and tissues, significantly reducing cytokine production. These features make KT501 a highly promising candidate drug with the potential for treating a wide range of B cell-mediated autoimmune diseases.

The antibody format in the image is for illustration purposes only. KT501 is of a different format. 

PharmaCircle closely monitors the progress of product safety and efficacy information.

Other candidate new drugs include KT209- CD19xCD20xCD3; KT502 - CD19xCD3, etc.

References:

PharmaCircle Data;

Moxie Pharma pharma.bcpmdata.com (formerly Pharma Data);

http://www.marketscreener.com；

https://www.businesswire.com；

www1.hkexnews.hk/；

https://www.kalitherapeutics.com/post/kali-therapeutics-announces-worldwide-exclusive-license-agreement-withsanofi-for-next-generation-tri；

info@kalitherapeutics.com；

; etc.