XLifeSc's TCR-T Therapy TAEST16001 Granted Breakthrough Therapy Designation in China for Advanced Solid Tumors
XLifeSc
New Drug Developer for Oncology, Autoimmune Diseases, and Viral Infections
Xiangxue
Developer, Producer, and Seller of Traditional Chinese Medicine and Chinese Herbal Pieces
On July 30, 2024, the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) approved XLifeSc's TAEST16001 injection for inclusion in the Breakthrough Therapy Designation list. This marks a significant breakthrough for the product as the first TCR-T cell therapy new drug in China to receive IND approval for clinical trials, accelerating the process of pivotal clinical trials and conditional approval for marketing. It is expected to become the first TCR-T cell therapy drug to be marketed in China, representing a milestone for the development of innovative immunotherapy drugs in the country.
GuangDong XIANGXUE LIFE SCIENCES LTD has built an independently developed innovation platform, breaking through the key technologies of TCR-T cell immunotherapy. It is in a leading position in China's tumor cell immunotherapy field and has reached international standards. The products under development can represent Guangzhou and China in global competition, benefiting patients and society, and becoming a new benchmark for promoting the high-quality development of the Greater Bay Area's biopharmaceutical industry.
Regarding Breakthrough Therapy
With the advancement of basic medical science and the deepening understanding of diseases, new drug development has become increasingly purposeful and directional. Driven by the joint development of multiple disciplines, many innovative products with breakthrough mechanisms and efficacy have emerged, bringing disruptive changes. In July 2020, the CDE released and implemented the "Pilot Review Procedure for Breakthrough Therapy Drugs." This procedure targets drugs used to prevent or treat diseases that seriously endanger life or significantly impact quality of life, particularly when there are no effective treatments available. These drugs offer either a new effective prevention or treatment method or demonstrate significant clinical advantages over existing treatments. By analyzing early clinical research data, innovative drugs with outstanding clinical benefits are included in the list of breakthrough therapies. Through optimized allocation of clinical development resources and shortening the clinical development cycle, this process accelerates product approval and market entry, allowing patients suffering from life-threatening or quality-of-life-impacting diseases to access better treatments sooner.
The breakthrough therapeutic drugs recognized by the CDE represent the highest starting point for exploring valuable new drug projects, focusing on superior clinical data, more differentiated clinical targets, and more definitive therapies. At the same time, the CDE incorporates the breakthrough therapy designation process into the expedited drug marketing registration process, which has drawn widespread attention from the pharmaceutical research and development industry. The recognition criteria for breakthrough therapies have also become one of the key focal points for both the industry and academia.
Soft tissue sarcoma is a group of solid malignant tumors derived from mesenchymal tissue, with a high degree of malignancy and poor response to conventional treatments, representing significant unmet clinical needs. TAEST16001 Injection, a novel TCR-T cell therapy developed by Xiangxue Life Sciences, has demonstrated clinically significant therapeutic effects in the clinical trial targeting NY-ESO-1 positive and HLA-A02:01 positive advanced soft tissue sarcoma patients with no other treatment options. As a breakthrough and disruptive innovative drug, it has been designated as a breakthrough therapy by the CDE. Under the guidance of the Center for Drug Evaluation, this designation helps accelerate the process of conducting pivotal clinical trials and obtaining conditional approval for marketing. It has become the first TCRT cell therapy innovative drug approved for marketing in China.
About TAEST16001
TAEST16001 Injection is the first TCR-T cell therapy product developed based on the TCR-T cell product technology development platform and production preparation system of Xiangxue Life Sciences. It involves genetically engineering the patient’s T cells in vitro, transducing them with a lentivirus carrying the TCR gene specific to the NY-ESO-1 tumor antigen, expanding these TCR-T cells in vitro, and then infusing them back into the patient to effectively treat tumors.
TAEST16001 is the first TCRT cell product in China to receive an IND approval and initiate clinical research. Its first indication targets advanced soft tissue sarcoma that is HLA-A*02:01 positive and expresses the NY-ESO-1 antigen. Clinical trials are being led by the Sun Yat-sen University Cancer Center in Guangzhou and the Peking University Cancer Hospital. Currently, the Phase I clinical trial and the first phase of the Phase II clinical trial have been completed. Significant clinical efficacy and controllable safety were observed in patients with advanced soft tissue sarcoma who had failed standard systemic treatments and lacked effective therapeutic options. The results of TAEST16001's Phase I clinical trial were recognized at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, where they were orally presented in the sarcoma session. This was the first public disclosure of the clinical trial data, showing an objective response rate (ORR) of 41.7%. The safety and efficacy outcomes were comparable to clinical results from similar targeted therapies developed by renowned international pharmaceutical companies, gaining recognition and significant attention from global peers. The Phase I clinical trial results of TAEST16001 were published in the prestigious journal Cell Reports Medicine (IF=16.988) in August 2023. The journal featured a special commentary by a professor from Northwestern University, who highly praised the study, stating that TAEST16001's Phase I clinical research marked a crucial step in the clinical translation of adoptive T-cell immunotherapy for advanced soft tissue sarcoma. In June 2024, interim summary data from TAEST16001’s Phase II clinical trial were again selected for presentation at the ASCO Annual Meeting. The poster presentation revealed that, according to RECIST 1.1, the best overall response rate assessed by the Independent Review Committee (IRC) was 50%, and the median progression-free survival (mPFS) evaluated by both the IRC and investigators was 5.9 months. These clinically significant efficacy data of TAEST16001 were once again acknowledged by top-tier international academic conferences.
About Xiangxue Life Sciences
GuangDong XIANGXUE LIFE SCIENCES LTD ("Xiangxue Life Sciences"), a subsidiary controlled by Xiangxue Pharmaceutical, is a leading company in the field of TCR-T cell immunotherapy, focusing on the research and development of cell immunotherapy products and technologies in the TCR area. With the vision of "addressing the challenges of human health and setting a benchmark for cancer treatment," the company's mission is to "focus on TCR, empower T cells, and conquer solid tumors."
GuangDong XIANGXUE LIFE SCIENCES LTD owns the core TCR technology with independent intellectual property rights and has a complete TCR-T cell therapy product technology R&D platform and production system. The TCR-T cell therapy product technology R&D platform includes: ① Antigen peptide discovery platform, ② High-affinity TCR platform, ③ TCR-T development platform; the TCR-T cell therapy product production system includes: ① Automated cell production platform, ② Quality control platform, forming an innovative industrial chain covering the entire process of TCR-T cell products.
Xiangxue Life Sciences' TCR-T products and pipeline reserves are extensively laid out, with a rich array of targets including CT antigens, neoantigens, and viral antigens, covering almost all tumor-related specific antigens. They encompass multiple HLA genotypes predominant in the Chinese population, such as A0201, A1101, and A2402, with indications covering various clinically difficult-to-treat solid tumors, placing them at an internationally leading level.
Currently, Xiangxue Life Sciences has two products that have obtained IND approval in China. The first product is TAEST16001, indicated for soft tissue sarcoma, which has completed the Phase I clinical trial and the first stage of the Phase II clinical trial in China. It has been included in the list of breakthrough therapies and has obtained IND approval in the United States. The second product is TAEST1901, indicated for primary liver cancer, which is initiating Phase I clinical research. The third product, XLS103, indicated for advanced pancreatic cancer, non-small cell lung cancer, and colorectal cancer, is undergoing IND submission.
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