Gravel Biotech Announces IND Approval in China for Innovative TIL Therapy GT101 and Files IPO Prospectus

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GT101 Injection is a novel autologous tumor-infiltrating lymphocyte (TIL) therapy in pivotal clinical development for the second-line treatment of cervical cancer. The indication for which investigational new drug approval was recently granted is its use in combination with Toripalimab Injection for the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma.

At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, Grail Bio presented therapeutic data on GT101 injection in 11 patients with recurrent or metastatic cervical cancer: GT101 injection achieved an objective response rate (ORR) of 45.5% and a disease control rate (DCR) of 90.9%, with one patient maintaining a complete response for over 14 months, and the overall safety profile was favorable.

Grail Bio, founded in 2019, is an innovation-driven, late-stage clinical biopharmaceutical company dedicated to pioneering next-generation immunotherapies for patients with cancer and autoimmune diseases worldwide. Leveraging deep insights into immunotherapy, cutting-edge R&D and technology platforms, and world-class manufacturing capabilities, Grail Bio has established multiple independently developed technology platforms in China and the United States, along with a diversified R&D pipeline comprising seven candidate products to address significant unmet clinical needs. Grail Bio’s innovative product pipeline includes GT101, a novel autologous tumor-infiltrating lymphocyte (TIL) therapy independently developed by the company and currently in pivotal clinical trials for the second-line treatment of cervical cancer, as well as six other candidate products, including GT719, an innovative off-the-shelf allogeneicChimeric AntigenChimeric Antigen Receptor-Invariant Natural Killer T (CAR-iNKT) Cell Therapy, and GT801, a Next-Generation In Vivo Chimeric Antigen Receptor T (CAR-T) Cell Therapy.

References: Compiled from public sources