Author：XLIFESC
Release date：2022-07-10
On July 8, 2022, XlifeSc Technology (Guangdong) Co., Ltd. and the Sun Yat-sen University Cancer Center held a kick-off meeting for the multicenter, open-label, single-arm Phase II clinical study of the cell therapy asset TAEST16001 for treating advanced soft tissue sarcoma patients who are NY-ESO-1 positive and HLA-A*02:01 genotype. This marks a new phase in clinical research for China’s first TCR-T cell therapy asset.
The first initiated research center is the Sun Yat-sen University Cancer Center, with Professor Zhang Xing, Director of the Department of Melanoma and Sarcoma, serving as the principal investigator (PI). XlifeSc Technology (Guangdong) Co., Ltd. is the sponsor, and the collaborating CRO company is Kunling Enterprise Management (Shanghai) Co., Ltd.
TCR-T therapy is a form of adoptive cell transfer therapy (ACT), which involves isolating immune-active cells from a tumor patient, expanding and functionally identifying them in vitro, and then reinfusing them back into the patient to directly kill the tumor or stimulate an immune response to attack tumor cells.
In this study, TAEST16001 is developed by XlifeSc Technology (Guangdong) Co., Ltd. It involves using gene-engineered lentiviruses to transfect patients’ T cells with TCR genes specific to the NY-ESO-1 cancer-testis antigen. These T cells expressing anti-tumor antigen TCRs are then expanded to approximately 1×10^9 to 2×10^10 cells. After the patient undergoes lymphodepletion with appropriate drugs, the TCR-T cells are reinfused back into the patient.
During the Phase I clinical study, the safety and efficacy of TAEST16001 were preliminarily validated, supporting the continuation of Phase II clinical research in advanced soft tissue sarcoma.
At the meeting, the sponsor staffs provided a detailed explanation of the study background, study protocol, inclusion criteria, and exclusion criteria for the TAEST16001 project. All parties involved fully discussed key issues regarding the study protocol and implementation, reaching a consensus and making thorough preparations for the subsequent project phases.
About TAEST16001
TAEST16001 is independently developed by XlifeSc Technology (Guangdong) Co., Ltd. It is China’s first TCR-T cell immunotherapy asset to receive an IND approval. At the 2022 Annual Meeting of the American Society of Clinical Oncology (ASCO), Professor Zhang Xing was invited to present the Phase I clinical study data of TAEST16001 at the sarcoma session. The results showed an objective response rate (ORR) of 41.7%, with safety and efficacy comparable to assets from renowned international pharmaceutical companies targeting the same antigen, gaining recognition from attendees and significant global industry attention.
About XlifeSc
XlifeSc Technology (Guangdong) Co., Ltd. (referred to as “XlifeSc”) is a leading enterprise focused on the research and development of cell immunotherapy assets and technologies in the TCR field. The company’s vision is to "solve human health challenges and set a benchmark for cancer treatment," with the mission to "focus on TCR, empower T cells, and conquer solid tumors."
XlifeSc possesses proprietary TCR core technology and has established a comprehensive TCR-T asset research and development technology system as well as a assetion and preparation system. The TCR-T asset R&D technology system includes: 1) an antigen peptide discovery platform, 2) a high-affinity TCR platform, and 3) a TCR-T development platform. The TCR-T assetion and preparation system includes: 1) an automated cell assetion platform, and 2) a quality control platform. This has resulted in a complete innovation industry chain for TCR-T cell assets. XlifeSc’ R&D technology system has generated a rich pipeline of ongoing and reserve projects, covering proprietary targets related to solid tumors and assets that cover the HLA typing of the Chinese population, reaching an international leading level.
Currently, XlifeSc has two investigational assets that have received IND approvals in China. The first asset, TAEST16001, is indicated for soft tissue sarcoma and is currently in Phase II clinical trials. The second asset, TAEST1901, is indicated for primary liver cancer and is about to initiate Phase I clinical trials.
