KSH01 HD-TCR T-cell Therapy Receives IND Approval in China and Orphan Drug Designation from FDA for Advanced Solid Tumors

Keshihua (Nanjing) Biotechnology Co., Ltd. team proposed, based on TCR therapy,HD-TCR (human-derived TCR): The core concept is to obtain potent TCRs from natural sequences as candidate molecules for drug development, rather than potent TCR molecules obtained through in vitro affinity optimization.The advantage of this strategy lies in the use of TCR sequences that have undergone negative selection in the human thymus, ensuring high affinity for antigen binding while avoiding the issues brought by artificial sequence optimization.SevereOff-target toxicity`, thereby achieving TCR with both good safety and efficacy after completing POC and establishing PCC.`

In March 2023, the FDA granted Keshihua (Nanjing) Biotechnology Co., Ltd.'s KSH01 HD-TCR T orphan drug designation, which was primarily based on the positive results of KSH01 HD-TCR T cells in pharmacodynamic studies for end-stage tumors.In addition, Keshihua (Nanjing) Biotechnology Co., Ltd. has currently developed multiple cutting-edge TCR-T cell products targeting end-stage major cancer types for the international market. The product pipeline is aimed at the global market, and several multi-center clinical trial studies have been initiated.

Currently, Keshihua (Nanjing) Biotechnology Co., Ltd. is focusing on the development of HD-TCR T-cell drugs for the treatment of solid tumors. The company has built the TCR-XFinder™ sequence discovery platform and established TCR-XPlanet™, a large database of tumor-specific T-cells based on accumulated data. The TCR-XFinder™ sequence discovery platform, by integrating artificial intelligence algorithms, can simultaneously support the discovery of both fixed-target TCR sequences and patient-specific personalized TCR sequences. Combined with the company’s pharmaceutical team and clinical transformation platform, it enables rapid clinical translation from the patient end to the formulation of TCR-T cell therapy products.

KSH01 HD-TCR T's core sequence, relying on Keshihua (Nanjing) Biotechnology Co., Ltd.'s core technology platforms TCR-XFinder™ and TCR-XPlanet™ T cell database, is a naturally sourced TCR sequence with potent anti-tumor activity rapidly screened from patients. The drug's indications include various advanced solid tumors such as esophageal cancer, gastric cancer, melanoma, sarcoma, bladder cancer, and laryngeal cancer.

It is understood that,Currently, the KSH01 HD-TCR T pipeline has launched clinical research at multiple clinical centers, including Beijing 301 Hospital and the First Affiliated Hospital of Guangxi Medical University, and is continuing to expand recruitment of patients with advanced solid tumors.After obtaining orphan drug designation, the pipeline can receive numerous policy supports from the FDA to shorten the product's clinical development cycle, benefiting patients more quickly.

Keshihua (Nanjing) Biotechnology Co., Ltd. was founded in 2020 by a team of returned overseas talents from the 2018 Nobel Prize-winning group at the MD Anderson Cancer Center in the United States. The company focuses on the development of HD-TCR T-cell drugs for treating solid tumors, and has built the TCR-XFinder™ sequence discovery platform. Based on accumulated data, it has also established TCR-XPlanet™, a large database of tumor-specific T-cells. TCR-XFinder™Sequence DiscoveryPlatform IntegrationArtificialIntelligent algorithms can simultaneously support the discovery of fixed-target TCR sequences and patient-specific TCR sequences. Combined with the company's pharmaceutical team and clinical transformation platform, rapid clinical translation from the patient end to the TCR-T cell therapy product formulation can be achieved.

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