TCRT-ESO-A2 / Axis Therap, Guangzhou Xiangxue Pharma, PharmaEssentia - LARVOL DELTA

[Announcement] Yaohua: Update on the progress of the Phase I clinical trial application (IND) of T cell receptor immunotherapy TCRT-ESO-A2-TW for the treatment of patients with end-stage solid tumors [Google translation] (stock.yahoo) - "The company cooperates with Axis Therapeutics Limited (hereinafter referred to as Axis) for T cell receptor immunotherapy Phase I Clinical Trial Application (IND) for TCRT-ESO-A2-TW for the Treatment of Patients with End-Stage Solid Tumors, was informed by a letter from the Ministry of Health and Welfare that it was unable to agree to the implementation, the company will supplement relevant information based on the recommendations in the letter from the Ministry of Health and Welfare....If f there is significant significance or other major events affecting new drug research and development occur, the risks faced by the company and its responses measure: Our company will supplement the relevant information based on the recommendations in the letter from the Ministry of Health and Welfare, and will provide the documents as soon as possible within the deadline."

New P1 trial • Non-US regulatory • Solid Tumor

Yaohua Pharmaceutical's T-cell receptor immunotherapy applies for Phase I clinical trial [Google translation] (stock.yahoo) - "Yaohua Pharmaceutical...announced that it has applied to Taiwan’s TFDA to conduct the first phase clinical trial of T cell receptor (TCR-T) immunotherapy TCRT-ESO-A2-TW for the treatment of patients with terminal solid tumors, officially announcing its entry into cell therapy. field."

New P1 trial • Oncology • Solid Tumor

Evaluate TCRT-ESO-A2 Autologous T Cells Expressing TCR Specific for NY-ESO-1 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Athenex, Inc. | N=48 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Breast Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • CTAG1B

Evaluate TCRT-ESO-A2 Autologous T Cells Expressing TCR Specific for NY-ESO-1 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Athenex, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • Breast Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • CTAG1B

Evaluate TCRT-ESO-A2 Autologous T Cells Expressing TCR Specific for NY-ESO-1 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=48; Not yet recruiting; Sponsor: Athenex, Inc.

Clinical • New P1 trial • Alzheimer's Disease • Breast Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • CTAG1B

Axis Therapeutics Announces Research Collaboration with PharmaEssentia for Development of TCR-T Cell Therapy in Taiwan (GlobeNewswire) - "Axis Therapeutics Limited...that it has entered into a research collaboration with PharmaEssentia Corporation (Taipei Exchange: 6446). The collaboration involves the development of T Cell Receptor (TCR)-T therapy (based on the proprietary TAEST (T cell receptor Affinity Enhancing Specific T cell therapy) technology platform) in Taiwan. Under the terms of the agreement, Axis Therapeutics and PharmaEssentia will collaborate to conduct an initial clinical study of Axis Therapeutics’ TCRT-ESO-A2 therapy, targeting solid tumors that are NY-ESO-1 positive in HLA-A*02:01 positive patients, and to manufacture the investigational products, in Taiwan." "

Licensing / partnership • Oncology • Solid Tumor

Athenex Announces FDA Allowance of IND Application for TCRT-ESO-A2, a TCR-T Cell Therapy (GlobeNewswire) - "Athenex...announced that the U.S. Food and Drug Administration (FDA) has allowed its Investigational New Drug (IND) application for TCRT-ESO-A2, an autologous T cell receptor (TCR)-T cell therapy targeting solid tumors that are NY-ESO-1 positive in HLA-A*02:01 positive patients."

IND • Oncology • Solid Tumor