Kaiti Medicine Receives IND Approval for MSLN-Targeted CAR-T Therapy KT032 in Advanced Ovarian Cancer

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On September 26, 2023, the clinical trial application for the cell therapy product (KT032 Cell Injection) of Nanjing CART Medical Technologies, Ltd. (CART Medical) received tacit approval from the National Medical Products Administration (NMPA), with the indication being: advanced ovarian cancer positive for mesothelin (Acceptance No.: CXSL2300444).

The product adopts a parallel signal design, guiding the flexible activation of T cells. The flexibly activated CAR-T cells have distinct characteristics in resisting the tumor microenvironment and differentiation-driven persistence, achieving unique anti-cancer efficacy.

KT032 Cell Injection is a novel multi-chain CAR-T independently developed by Nanjing CART Medical Technologies, Ltd, based on the DAP-CAR platform technology. The DAP-CAR technology platform provides T cells with natural immune receptor signals. This receptor design separates the recognition domain from the activation domain, enabling T cells to naturally transition between coupled activation and decoupled resting states. It maintains CAR expression levels in T cells within the solid tumor microenvironment, preventing CAR-T cell exhaustion and dysfunction, thereby enhancing the anti-solid tumor efficacy of CAR-T. This is the first-in-China rationally designed CAR-T, optimized from structure to components, specifically targeting the tumor microenvironment. KT032 demonstrated excellent clinical outcomes in IIT clinical trials, and its recent IND approval will undoubtedly accelerate the product’s translation, benefiting more patients.

CART MedicalR&D Pipeline

Dr. Enxiu Wang, Founder of CART Medical"This marks an important milestone for the company in terms of innovative product transformation, as well as team development, as KT032 cell injection enters the registration clinical trial phase. Currently, the first core product of Nanjing CART Medical Technologies, Ltd is about to enter Phase I clinical trials. The company has gradually completed the construction of key capabilities across the entire chain from research and development to commercialization, forming a highly cohesive and efficient professional business and management team. This lays a 'highway' for the rapid commercialization of subsequent pipeline products." Nanjing CART Medical Technologies, Ltd currently has more than 10 product pipelines under development across three major technology platforms, covering various solid tumors, establishing a fundamental position with multiple disease types and multi-product tiered output. This strengthens the company's innovative status in the field of CAR-T new drug R&D for solid tumors. The company will continue to be guided by clinical value, accelerating the progress of pipeline product R&D and expediting the entry of more high-quality cell therapy products into the clinical stage for earlier market launch to benefit more patients!"

Nanjing CART Medical Technologies, Ltd is a clinical-stage new drug development company. The company is committed to the research and development of novel CAR-T cell therapies for the treatment of malignant solid tumors. Relying on its advanced immune receptor library technology platform, CART Medical has successfully developed multiple pipelines for first-in-class CAR-T drugs targeting malignant solid tumors, including parallel multi-chain CAR-T resistant to the tumor microenvironment, exhaustion-resistant full-activation CAR-T, multi-target recognition CAR-T, and a new rapid production process for CAR-T. A patent layout protecting core intellectual property has been completed.

Nanjing CART Medical Technologies, Ltd was founded by Dr. Enxiu Wang, a core member of Carl June's team, the pioneer of CAR-T immunotherapy, upon his return to China. The University of Pennsylvania is the cradle of CAR-T drug development and growth. Upholding its pioneering and pragmatic style, Nanjing CART is committed to the development and application of innovative proprietary drugs. Since its establishment in 2017, the company has developed a new product matrix consisting of four major categories and dozens of product pipelines focused on the "recognition, activation, vector, and process" aspects of solid tumor cell therapy. The most advanced product pipeline has now fully entered the rapid industrialization phase.

Reference: CART Medical