Phase IIA Study of High-Affinity TCR-T (TAEST16001) Targeting NY-ESO-1 in Soft Tissue Sarcoma Presented at 2024 ASCO Annual Meeting

Jun 03, 2024 07:20 CST Updated 07:20

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TAEST16001, independently developed by Xiangxue Life Sciences Technology (Guangdong) Co., Ltd., isChina's First TCR-T Cell Immunotherapy Product to Receive IND ApprovalFollowing the presentation of the Phase I clinical trial data of TAEST16001 at the American Society of Clinical Oncology (ASCO) in 2022 as a thematic oral report, which gained international peer recognition, the interim data summary of TAEST16001's clinical trial has once again been selected for the ASCO Annual Meeting. On June 1, 2024, local time, the interim summary data of the Phase II clinical trial of TAEST16001 for its first clinical indication, advanced soft tissue sarcoma, was published in the form of an academic poster.

The 2024 Annual Meeting of the American Society of Clinical Oncology (2024 ASCO Annual Meeting) was held in Chicago, USA, from May 31 to June 4, 2024.The ASCO Annual Meeting is the largest, most extensive, academically highest-level, and most authoritative event in the global oncology treatment field. It gathers top oncology experts from around the world and the latest global oncology research achievements, providing peers from all over the world with the opportunity to share knowledge and experience. A large number of important research findings and clinical trial results are chosen to be first released at the ASCO Annual Meeting. This year, ASCO received more than 7,000 research abstract submissions.

The Phase II clinical trial of TAEST16001 is jointly led by two clinical institutions: Beijing Tumor Hospital and Sun Yat-sen University Cancer Center. The first author of the selected ASCO research abstract is Professor Liu Jiayong from the Department of Bone and Soft Tissue Tumors at Beijing Tumor Hospital, with corresponding authors being Professor Fan Zhengfu from Beijing Tumor Hospital and Professor Zhang Xing from Sun Yat-sen University Cancer Center.

The interim summary data of the Phase II clinical trial of TAEST16001 was publicly disclosed for the first time this year in the form of an academic poster at ASCO, fully demonstrating that the efficacy and safety of TAEST16001 have been recognized by the top international academic conference.

▲Professor Liu Jiayong (left) from Beijing Cancer Hospital and Dr. Huang Yingjie (right), Chief Medical Officer of Xiangxue Life Sciences Technology (Guangdong) Co., Ltd., at the ASCO conference现场

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Abstract Title:

Phase IIA study of high-affinity TCR-T (TAEST16001) targeting NY-ESO-1 in soft tissue sarcoma.

Sub-venue:

Poster Session – Sarcoma

Display Time:

US Time: 6/1/2024, 1:30 PM-4:30 PM (CDT)

Beijing Time: 6/2/2024, 3:30 AM-6:30AM

The Phase II clinical trial of TAEST16001 is an open-label, single-arm study designed to evaluate the efficacy and safety of TAEST16001 cells in patients with advanced soft tissue sarcoma (NCT05549921).

As of April 2024, 8 subjects were enrolled in the Phase II clinical trial of TAEST16001 [Male:Female 4:4; Median age 37.5 years (28-49 years)]. Early data from the Phase II clinical trial of TAEST16001 demonstrated controllable safety and tolerability consistent with the previous Phase I study. According to RECIST 1.1, the best overall response rate (ORR) assessed by the Independent Radiology Review Committee (IRC) was 50% (4/8). The median progression-free survival (mPFS) evaluated by both the IRC and investigators was 5.9 months. Most subjects are still currently under follow-up.

The current clinical trial data demonstrate good safety and tolerability as well as encouraging efficacy, providing support for TAEST16001 to advance to the next stage of clinical development.

About TAEST16001

TAEST16001 is a TCR-T cell immunotherapy product independently developed by GuangDong XIANGXUE LIFE SCIENCES LTD. It targets NY-ESO-1 cancer-testis antigen. The patient's T cells are transduced with a lentivirus carrying a genetically engineered tumor antigen-specific TCR gene in vitro. These T cells expressing the anti-tumor antigen TCR are then expanded to approximately 1×10^9~2×10^10 cells. After the patient undergoes lymphodepletion with an appropriate dose of medication (lymphocyte depletion), the TCR-T cells are reinfused into the patient.

TAEST16001 is the first TCR-T cell product in China to have obtained an IND approval and initiated clinical research. The first indication is for advanced soft tissue sarcoma that is HLA-A*02:01 positive and expresses the NY-ESO-1 antigen. The clinical trial is being led by the Sun Yat-sen University Cancer Center in Guangzhou and the Peking University Cancer Hospital. Phase I clinical trials have been completed, and multiple clinical institutions in China are currently participating in Phase II clinical trials.

The phase I clinical trial results of TAEST16001 were selected for oral presentation at the 2022 Annual Meeting of the American Society of Clinical Oncology (ASCO). The initial disclosure of the clinical trial data showed that the objective response rate (ORR) reached 41.7%. The safety and efficacy outcomes were comparable to the clinical results of products targeting the same point from well-known foreign pharmaceutical companies, gaining recognition from peers attending the conference and significant attention from the global industry. The phase I clinical trial results of TAEST16001 were published in the prestigious international journal Cell Reports Medicine (IF=16.988) in August 2023. This issue featured a special commentary by a professor from Northwestern University in the United States, who highly praised the article, stating that the phase I clinical study of TAEST16001 marked a crucial step forward in the clinical translation of adoptive T-cell immunotherapy for advanced soft tissue sarcoma.

About Xiangxue Life Sciences

Xiangxue Life Sciences Technology (Guangdong) Co., Ltd. (referred to as "Xiangxue Life Sciences") is a research and development enterprise focusing on cell immunotherapy products and technologies in the TCR field, and is a leading company in TCR-T cell immunotherapy. The company's vision is "to solve difficult points in human health and set a benchmark for cancer treatment," and its mission is "to focus on TCR, empower T cells, and conquer solid tumors."

GuangDong XIANGXUE LIFE SCIENCES LTD owns the independent intellectual property rights of the TCR core technology, and has a complete TCR-T product research and development technology system as well as a production and preparation system. The TCR-T product research and development technology system includes: ① Antigen Peptide Discovery Platform, ② High-affinity TCR Platform, ③ TCR-T Development Platform; the TCR-T production and preparation system includes: ① Automated Cell Production Platform, ② Quality Control Platform. It has formed a full-chain innovative industrial chain for TCR-T cell products.

GuangDong XIANGXUE LIFE SCIENCES LTD's TCR-T products and pipeline reserves are extensively laid out, with a rich array of targets including CT antigens, neoantigens, viral antigens, and nearly all tumor-related specific antigens. They cover multiple HLA genotypes predominant in the Chinese population, such as A0201, A1101, and A2402, with indications spanning various clinically challenging solid tumors, placing them at an internationally leading level.

Currently, GuangDong XIANGXUE LIFE SCIENCES LTD has two products that have obtained IND approval in China. The first product, TAEST16001, is indicated for soft tissue sarcoma and is currently in Phase II clinical trials. The second product, TAEST1901, is indicated for primary liver cancer and is initiating Phase I clinical research.

References:

[1] https://mp.weixin.qq.com/s/sbK9G6hK2Dg8LUeMxo-CCA

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