TAEST16001 / Guangzhou Xiangxue Pharma, Athenex - LARVOL DELTA

Xiangxue Pharmaceuticals: TAEST16001 injection included in the list of breakthrough therapeutic products does not mean it can be approved for marketing [Google translation] (Shijiazhuang City Network) - "Xiangxue Pharmaceuticals, which has been listed on the 3rd board in 5 days, issued an unusual announcement. The company's subsidiary TAEST16001 injection was included in the list of breakthrough therapeutic products by the Drug Evaluation Center of the National Drug Administration. This does not mean that it can be approved for marketing....The TAEST16001 injection of the company's subsidiary was included in the list of breakthrough therapeutic products by the Drug Review Center of the National Medical Products Administration."

Breakthrough therapy • Soft Tissue Sarcoma

"The first domestically produced" TCR-T therapy is planned to be included in the breakthrough therapy category [Google translation] (Sohu.com) - "On July 22, the CDE official website announced that Xiangxue Life Sciences' TAEST16001 injection is planned to be included in the breakthrough therapy category, and is intended to be used to treat soft tissue sarcomas with tissue genotype of HLA-A*02:01 and positive expression of tumor antigen NY-ESO-1. TAEST16001 is a TCR-T cell immunotherapy product....At the ASCO conference held in June 2024, researchers announced a summary of the interim data of the Phase II clinical trial. This 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)."

Breakthrough therapy • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Xiangxue Pharmaceutical (300147.SZ): The company’s TAEST16001 injection R&D project is advancing Phase II clinical research [Google translation] (Sina Corp) - "On June 27, 2024, Xiangxue Pharmaceutical stated on the interactive platform that the company's main research direction in the field of cutting-edge biotechnology and pharmaceutical research and development is T cell immunotherapy technology, and its main products include TAEST16001, TAEST1901, etc. The TAEST16001 injection research and development project is mainly used to treat synovial sarcoma. It is currently in the clinical trial stage of new drug registration, and the Phase II clinical research is being carried out in an orderly manner; the TAEST1901 injection research and development project is mainly used to treat primary liver cancer, and other preparations for the launch of Phase I clinical research are being carried out."

Trial status • Liver Cancer • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma

Phase IIA study of high-affinity TCR-T (TAEST16001) targeting NY-ESO-1 in soft tissue sarcoma. (ASCO 2024) - P1, P2 | "Patients received 3-day lymphodepleting chemotherapy (cyclophosphamide 15 mg/kg/day and fludarabine 20 mg/m 2 /day). TAEST16001 demonstrated an acceptable safety profile. The encouraging efficacy data (ORR=50%) exceeded our pre-specified target efficacy (ORR=25%). The review committee has recommended TAEST16001 to proceed early to the next stage of clinical development."

P2a data • Hematological Disorders • Neutropenia • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • CTAG1B • HLA-A • IL2

Phase 1 clinical trial to assess safety and efficacy of NY-ESO-1-specific TCR T cells in HLA-A∗02:01 patients with advanced soft tissue sarcoma. (PubMed, Cell Rep Med) - P1 | "Enrolled patients receive TAEST16001 cell infusion after dose-reduced lymphodepletion with cyclophosphamide (15 mg/kg/day × 3 days) combined with fludarabine (20 mg/m/day × 3 days), and the TCR-T cells are maintained with low doses of interleukin-2 injection post-adoptive transfer. The median progression-free survival is 7.2 months, and the median duration of response is 13.1 months. The protocol of TAEST16001 cells delivers a safe and highly effective treatment for patients with advanced soft tissue sarcoma (ClinicalTrials.gov: NCT04318964)."

Journal • Metastases • P1 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Squamous Cell Carcinoma • CTAG1B • HLA-A • IL2

Phase I clinical trial to assess safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of NY-ESO-1–specific TCR T-cells (TAEST16001) in HLA-A*02:01 patients with advanced soft tissue sarcoma. (ASCO 2022) - P1 | "Prior to TAEST16001 cells infusion, patients were to receive lymphodepleting chemotherapy consisting of cyclophosphamide (15 mg/kg/day ´ 3 days) and fludarabine (20 mg/m2/day ´ 3 days). TAEST16001 cells showed an acceptable tolerability profile overall. MTD was not reached. Emerging efficacy data encouraged the continued expansion study of TAEST16001 cells in advanced soft tissue sarcoma."

Clinical • IO biomarker • P1 data • PK/PD data • Anemia • Hematological Disorders • Inflammation • Leukopenia • Neutropenia • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Thrombocytopenia • CTAG1B • HLA-A • IL2

TAEST16001 in the Treatment of Soft Tissue Sarcoma (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Sun Yat-sen University | Trial completion date: Mar 2023 ➔ May 2024

Trial completion date • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • CTAG1B • IL6

NY-ESO-1-specific T Cell Receptor (TCR) T Cell in Sarcoma (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Sun Yat-sen University | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2023 ➔ May 2024 | Trial primary completion date: Feb 2023 ➔ Feb 2024

Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Osteosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • CTAG1B

TAEST16001 in the Treatment of Soft Tissue Sarcoma (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Sun Yat-sen University | Recruiting ➔ Active, not recruiting | Trial primary completion date: Nov 2022 ➔ Apr 2022

Enrollment closed • Trial primary completion date • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • CTAG1B • IL6

Phase II Study of TAEST16001 in Soft Tissue Sarcoma (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • CTAG1B • HLA-A

TAEST16001 in the Treatment of Soft Tissue Sarcoma (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Sun Yat-sen University | Trial primary completion date: Mar 2022 ➔ Sep 2022

Trial primary completion date • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • CTAG1B • IL6

NY-ESO-1-specific T Cell Receptor (TCR) T Cell in Sarcoma (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Sun Yat-sen University | Trial primary completion date: Feb 2022 ➔ Feb 2023

Trial primary completion date • Oncology • Osteosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • CTAG1B

TAEST16001 in the Treatment of Soft Tissue Sarcoma (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Sun Yat-sen University; Trial completion date: Jun 2022 ➔ Mar 2023; Trial primary completion date: Sep 2021 ➔ Mar 2022

Clinical • Trial completion date • Trial primary completion date • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • CTAG1B

To Evaluate the Efficacy of NY-ESO-1-specific T Cell Receptor Affinity Enhancing Specific T Cell in Solid Tumors (clinicaltrials.gov) - P1; N=6; Completed; Sponsor: Zhujiang Hospital; Recruiting ➔ Completed; N=20 ➔ 6; Trial completion date: Dec 2019 ➔ Jun 2019; Trial primary completion date: Dec 2019 ➔ Jun 2019

Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Bladder Cancer • Breast Cancer • Endocrine Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Hepatology • Liver Cancer • Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • Thoracic Cancer • Thyroid Gland Carcinoma • CTAG1B

To Evaluate the Efficacy of NY-ESO-1-specific T Cell Receptor Affinity Enhancing Specific T Cell in Solid Tumors (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Zhujiang Hospital; Trial completion date: May 2019 ➔ Dec 2019; Initiation date: Apr 2018 ➔ Apr 2017; Trial primary completion date: May 2019 ➔ Dec 2019

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Bladder Cancer • Breast Cancer • Endocrine Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Hepatology • Liver Cancer • Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • Thoracic Cancer • Thyroid Gland Carcinoma • CTAG1B

To Evaluate the Efficacy of NY-ESO-1-specific T Cell Receptor Affinity Enhancing Specific T Cell in Solid Tumors (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Zhujiang Hospital; Initiation date: Jun 2017 ➔ Sep 2017

Clinical • Trial initiation date • Bladder Cancer • Breast Cancer • Endocrine Cancer • Esophageal Cancer • Gastric Cancer • Genito-urinary Cancer • Hepatology • Liver Cancer • Lung Cancer • Ovarian Cancer • Prostate Cancer • Thyroid Gland Carcinoma • Urothelial Cancer • CTAG1B

To Evaluate the Efficacy of NY-ESO-1-specific T Cell Receptor Affinity Enhancing Specific T Cell in Solid Tumors (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Zhujiang Hospital

Clinical • New P1 trial • Bladder Cancer • Breast Cancer • Endocrine Cancer • Esophageal Cancer • Gastric Cancer • Genito-urinary Cancer • Hepatology • Liver Cancer • Lung Cancer • Ovarian Cancer • Prostate Cancer • Solid Tumor • Thyroid Gland Carcinoma • Urothelial Cancer • CTAG1B

To Evaluate the Efficacy of NY-ESO-1-specific T Cell Receptor Affinity Enhancing Specific T Cell in Solid Tumors (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Zhujiang Hospital; Initiation date: Sep 2017 ➔ Apr 2018

Clinical • Trial initiation date • Bladder Cancer • Breast Cancer • Endocrine Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Hepatology • Liver Cancer • Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • Thyroid Gland Carcinoma • Urothelial Cancer • CTAG1B

Athenex Provides Fourth Quarter and Full Year 2020 Corporate and Financial Update (GlobeNewswire) - "Key Anticipated Future Milestones: Request a meeting with the FDA to discuss and align on next steps to obtain approval for oral paclitaxel plus encequidar in metastatic breast cancer; Identify and undertake appropriate adjustments for the company pending the outcome of the FDA meeting; Begin expansion portion of the oral paclitaxel plus pembrolizumab Phase I trial; Present the oral paclitaxel plus pembrolizumab Phase I trial data at a medical conference in 2021; TCR-T NY-ESO-1 IRB approval and initiate P1 trial enrollment in 1H 2021; Anticipate results from the I-SPY 2 trial of oral paclitaxel plus anti PD-1 in 2022"

FDA event • P1 data • P2 data • Trial status • Breast Cancer • Oncology

TAEST16001 in the Treatment of Soft Tissue Sarcoma (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Sun Yat-sen University; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Breast Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor

TAEST16001 in the Treatment of Soft Tissue Sarcoma (clinicaltrials.gov) - P1; N=12; Not yet recruiting; Sponsor: Sun Yat-sen University

Clinical • New P1 trial

GenScript ProBio congratulates XlifeSciences on the start of TAEST16001 early phase clinical trial (PRNewswire) - "Guangzhou XlifeSciences...announced that the early phase clinical trial of TAEST16001 project has been started...This clinical trial project is China's first TCR-T project targeted at solid tumor therapy..."

Enrollment open

Athenex Announces Xiangxue Life Sciences Receives IND Allowance from China’s National Medical Products Administration for Cancer Immunotherapy Drug Candidate (GlobeNewswire, Athenex, Inc.) - "Athenex...today announced that its partner in cancer immunotherapy, Xiangxue Life Sciences (XLifeSc), a wholly-owned subsidiary of Xiangxue Pharmaceutical Co., Ltd...has received an allowance by China’s National Medical Products Administration (NMPA, formerly known as the China Food and Drug Administration) of its company-sponsored Investigational New Drug (IND) application to initiate registrational related clinical studies in China of T-cell receptor Affinity Enhanced Specific T-cell (TAEST) therapy in patients with solid tumors that are HLA-A*02:01 positive and NY-ESO-1 positive."

Non-US regulatory

NY-ESO-1 TCR （TAEST16001）for Patients With Advanced NSCLC (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Guangzhou Institute of Respiratory Disease; Trial completion date: Dec 2017 ➔ Mar 2019; Trial primary completion date: Dec 2017 ➔ Mar 2019

Clinical • Trial completion date • Trial primary completion date