NT-112 / AstraZeneca - LARVOL DELTA

Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Apr 2044 ➔ Nov 2043

Trial completion date • Colorectal Cancer • Endometrial Adenocarcinoma • Endometrial Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: AstraZeneca | Active, not recruiting ➔ Recruiting | Trial completion date: Aug 2042 ➔ Apr 2044

Enrollment open • Trial completion date • Colorectal Cancer • Endometrial Adenocarcinoma • Endometrial Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

A Study of NT-112 in HLA-C*08:02-Positive Adult Subjects With Unresectable, Advanced, and/ or Metastatic Solid Tumors Positive for the KRAS G12D Mutation (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: AstraZeneca | Trial completion date: Aug 2040 ➔ Aug 2042 | Recruiting ➔ Active, not recruiting

Enrollment closed • IO biomarker • Trial completion date • Colorectal Cancer • Endometrial Adenocarcinoma • Endometrial Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

A Study of NT-112 in HLA-C*08:02-Positive Adult Subjects With Unresectable, Advanced, and/ or Metastatic Solid Tumors Positive for the KRAS G12D Mutation (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Jan 2040 ➔ Aug 2040 | Trial primary completion date: Aug 2025 ➔ Aug 2027

IO biomarker • Trial completion date • Trial primary completion date • Colorectal Cancer • Endometrial Adenocarcinoma • Endometrial Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

Non-clinical evaluation of NT-112, an autologous T cell product engineered to express an HLA-C*08:02-restricted TCR targeting KRAS G12D and resistant to TGF-b inhibition. (ASCO 2024) - "Non-clinical studies revealed a favorable safety and efficacy profile for NT-112 and supported further clinical development of a TGF-β-resistant TCR-edited T-cell product for mutant KRAS-targeted cancer immunotherapy."

Clinical • IO biomarker • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CD4 • CD8 • HLA-C • KRAS • TGFB1 • TGFBR2

An open-label, phase 1, multicenter study to evaluate the safety and preliminary anti-tumor activity of NT‑112 in human leukocyte antigen-C*08:02–positive adult patients with unresectable, advanced, and/or metastatic solid tumors that are positive for the KRAS G12D mutation. (ASCO 2024) - P1 | "NT-112 is an autologous TCR-T cell therapy targeting the KRAS G12D mutation presented by HLA-C*08:02, armored by disruption of the gene encoding the transforming growth factor beta receptor type 2 (TGFBR2) in order to reduce the immunosuppressive effect of TGF-β in the tumor microenvironment...Comprehensive translational analysis will be conducted to gain insights into the mechanism of action, biomarkers associated with treatment response, and potential mechanisms of resistance. All subjects will be followed for up to 15 years."

Clinical • IO biomarker • Metastases • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CD4 • CD8 • HLA-C • IL2 • KRAS • TGFB1 • TGFBR2

A Study of NT-112 in HLA-C*08:02-Positive Adult Subjects With Unresectable, Advanced, and/ or Metastatic Solid Tumors Positive for the KRAS G12D Mutation (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Neogene Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Endometrial Adenocarcinoma • Endometrial Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

A Study of NT-112 in HLA-C*08:02-Positive Adult Subjects With Unresectable, Advanced, and/ or Metastatic Solid Tumors Positive for the KRAS G12D Mutation (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Neogene Therapeutics, Inc.

IO biomarker • Metastases • New P1 trial • Colorectal Cancer • Endometrial Adenocarcinoma • Endometrial Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS