FineImmune Biotech's TAL-T Cell Therapy Receives IND Approval for Advanced Solid Tumors

On July 23, 2024, according to the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), Guangzhou FanEn Biotechnology Co., Ltd. (hereinafter referred to as "FanEn Biotech" or "the company") applied for"TAL-T Cell Injection" has obtained clinical trial implied permission., Indication for advanced malignant solid tumors (Acceptance No. CXSL2400285).

The cell injection approved for IND this time is the world's first TAL-T cell therapy. It is a high-quality autologous anti-tumor T-cell preparation developed from tumor-associated lymph nodes using Pan-E Bio's proprietary core technology. This therapy successfully addresses the challenges faced by other autologous anti-tumor T-cell therapies, such as TIL, including low production success rates and suitability for only a small number of patients, enabling the successful application of autologous anti-tumor T-cell therapy to the majority of solid tumor patients. The TAL-T cell therapy boasts advantages such as broad indications, no genetic modification, short preparation cycles, and excellent treatment outcomes. Ongoing IIT clinical studies have demonstrated its excellent safety and significant efficacy.

Tumor-Associated Lymph Node T Cell (TAL-T) TherapyTumor-associated lymph node T cell (TAL-T: Tumor Associated Lymphnode T cell) therapy involves the extraction of anti-tumor T cells from tumor-associated lymph nodes, which are then cultured and expanded in vitro to obtain a high quantity of quality anti-tumor T cells for reinfusion into the patient for treatment. Tumor-associated lymph nodes are key immune organs in forming anti-tumor immune responses. Compared with the harsh microenvironment of tumor tissues, tumor-associated lymph nodes have a favorable immune microenvironment, providing better stimulation signals and cytokines for immune cells. Therefore, the anti-tumor T cells within tumor-associated lymph nodes exhibit better functional status, strong proliferation ability, and memory phenotypes. Under specific conditions, these T cells can be massively expanded and demonstrate efficient tumor cell killing capabilities.

Pan-E Bio is an innovative biopharmaceutical company co-founded by several returned doctors, including Harvard University returnees and recipients of the "National Key Talent Project." The company primarily focuses on the development of immunotherapy drugs for solid tumors and related businesses. The team has been deeply engaged in the field of cell therapy for solid tumors for many years, establishing several world-leading cutting-edge core technologies, such as accurate identification and separation of autologous anti-tumor T cells, multi-gene combinations to reverse the solid tumor microenvironment, and memory T cell induction culture, breaking through multiple key technical bottlenecks in solid tumor immunotherapy. Independently developed original product pipelines include "Personalized TCR-T Cell Therapy," "Super TCR-T Cell Therapy Reversing the Solid Tumor Microenvironment," and "TAL-T Cell Therapy," which have shown significant efficacy in clinical trials. The company owns a 2,000-square-meter immune cell therapy R&D laboratory and GMP production workshop for cell therapy products in Guangzhou Science City, and is constructing a 5,000-square-meter GMP cell preparation platform at the Zhongshan Health Base. The company’s new cell therapy drugs, such as "Personalized TCR-T Cell Therapy" and "TAL-T Cell Therapy," are currently undergoing IIT clinical studies at Sun Yat-sen University Cancer Center, Hainan Tumor Hospital, and the Second Affiliated Hospital of Hainan Medical University, with over 20 immune cell therapy products and technologies under development.