NT-175 / AstraZeneca - LARVOL DELTA

NT-175-201: A Study of NT-175 in Adult Subjects With Unresectable, Advanced, and/or Metastatic Solid Tumors That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation (clinicaltrials.gov) - P1 | N=46 | Recruiting | Sponsor: AstraZeneca | N=162 ➔ 46 | Trial completion date: Aug 2039 ➔ Jul 2029

Enrollment change • Trial completion date • Breast Cancer • Colorectal Cancer • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • TP53

NT-175-201: A Study of NT-175 in Adult Subjects With Unresectable, Advanced, and/or Metastatic Solid Tumors That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation (clinicaltrials.gov) - P1 | N=162 | Recruiting | Sponsor: AstraZeneca | Trial primary completion date: Aug 2026 ➔ Sep 2028

Trial primary completion date • Breast Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • HLA-A • TP53

A Study of NT-175 in Adult Subjects With Unresectable, Advanced, and/or Metastatic Solid Tumors That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation (clinicaltrials.gov) - P1 | N=162 | Recruiting | Sponsor: Neogene Therapeutics, Inc. | N=24 ➔ 162

Enrollment change • Metastases • Breast Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • HLA-A • TP53

Open-label, phase 1, multicenter study to evaluate the safety and preliminary anti-tumor activity of NT-175 in human leukocyte antigen-a*02:01-positive adult subjects with unresectable, advanced and/or metastatic solid tumors that are positive for the TP53 R175H mutation. (ASCO 2024) - "Subjects will undergo lymphodepletion chemotherapy with fludarabine and cyclophosphamide followed by a single infusion of NT-175 and subcutaneous recombinant IL-2 administration for up to 8 days. Translational analysis will evaluate potential biomarkers for insights into mechanism of action, response prediction, or resistance mechanisms. The study was activated in March 2023 and is open to accrual; 5 patients have been enrolled as of 4 Jan 2024."

Clinical • Metastases • P1 data • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CD4 • CD8 • HLA-A • IL2 • TGFB1 • TGFBR2 • TP53

Non-clinical evaluation of NT-175, an autologous T cell product engineered to express an HLA-A*02:01-restricted TCR targeting TP53 R175H and resistant to TGF-b inhibition. (ASCO 2024) - "Non-clinical studies revealed a favorable safety and efficacy profile for NT-175 and supported further clinical development of a TGF-β-resistant TCR-edited T-cell product for mutant TP53-targeted cancer immunotherapy."

Clinical • IO biomarker • Oncology • CD4 • CD8 • HLA-A • TGFB1 • TGFBR2 • TP53

A Study of NT-175 in Adult Subjects With Unresectable, Advanced, and/or Metastatic Solid Tumors That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Neogene Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Breast Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • HLA-A • TP53

A Study of NT-175 in Adult Subjects With Unresectable, Advanced, and/or Metastatic Solid Tumors That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Neogene Therapeutics, Inc.

Metastases • New P1 trial • Breast Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • HLA-A • TP53