Oricell Therapeutics Receives China NMPA IND Clearance for MSLN/Claudin 18.2 Dual CAR-T Therapy for Solid Tumors

Shanghai, China & New Jersey, USA (October 17th, 2024) — Oricell?Therapeutics, a clinical-stage biotechnology?company aiming to lead in oncology immunotherapy innovation and focusing on developing advanced cell therapies,?announced the clearance of its investigational new drug (IND)?application?from China's National Medical Products Administration?(NMPA)?for its proprietary Dual AND Logic Claudin 18.2/Mesothelin (MSLN)?autologous chimeric antigen receptor (CAR-T)?therapy, OriC613. This approval grants Oricell?the authority to initiate a Phase I clinical trial for advanced solid tumors, including gastric cancer, in China.

Ms. Helen Yang, Co-founder and CEO of Oricell, stated, “Oricell has consistently pushed the boundaries of cell therapy drug development with a diverse portfolio targeting hematological and solid tumors. To date, we've secured four clinical trial approvals in both China and the US. The IND approval for OriC613 marks a pivotal moment in Oricell's drug development journey, further validating our R&D capabilities and offering new hope to patients battling advanced solid tumors.???We're excited to explore the potential of this groundbreaking product in treating solid tumors,?such as gastric cancer and ovarian cancer. ”

Dr. Peter He, Co-founder and CSO at Oricell Therapeutics, added, “OriC613 features an advanced dual-receptor logic gate design that ensures T-cells are activated only when they recognize two specific tumor antigens simultaneously. Our preclinical data has shown promising results, giving us the confidence to proceed with clinical studies for OriC613. This innovative approach addresses one of the key challenges in solid tumor treatment and holds great promise for improving patient outcomes.”

About OriC613

On-Target/Off-Tumor (OTOT) toxicity is a key challenge in CAR-T therapy. To enhance specificity, antitumor activity, and safety, Oricell developed the dual-target CLDN18.2/MSLN CAR-T cell OriC613?using its OriAb, OriCAR, and logic gate platforms. OriC613 employs an "AND" logic gate design, expressing receptors targeting CLDN18.2?and MSLN. It selectively kills tumor cells expressing both antigens, reducing OTOT and enhancing safety. This innovative design holds promise for addressing solid tumor cancer drug challenges.

About CLDN18.2 & MSLN

CLDN18.2, a tetra-transmembrane protein in tight junctions, is limited in normal tissues but significantly increased in various malignant tumors, enhancing CAR-T cell killing effects. Mesothelin is highly expressed in multiple solid tumors such as mesothelioma, ovarian epithelial cancer, and pancreatic cancer, and is associated with lower patient survival.

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About Oricell Therapeutics

Oricell is a clinical-stage biotechnology company?dedicated to developing innovative cell therapies to address unmet medical needs in oncology and immunology around the world. With?Ori?Ab, Ori?CAR technology platforms,?and unique CMC know-how, Oricell has developed a broad portfolio of pipeline?programs?for the treatment of hematologic malignancies and solid tumors. These therapies have demonstrated good safety and efficacy in exploratory clinical studies. The related clinical results were presented at international conferences and published in international academic journals, including the 2021 ASCO, 2022 ASCO, 2022 EHA, 2024 ASCO,?and The Lancet Haematology.

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