June 11, 2026 —
Anocca announced that the first patients have been dosed across multiple clinical sites with ANOC-001, a novel T cell receptor-modified T cell therapy, or TCR-T, targeting KRAS G12V mutations in pancreatic cancer.
ANOC-001 is the first product candidate to enter Anocca’s VIDAR-1 clinical program, which focuses on pancreatic ductal adenocarcinoma, or PDAC. The therapy is designed for patients whose tumors carry a specific KRAS mutation and aims to engineer T cells to recognize and attack cancer cells presenting mutant KRAS-derived targets.
The product was discovered, developed, and manufactured by Anocca at its in-house facilities in Sweden. According to the company, ANOC-001 is the first non-viral gene-edited T cell therapy to be evaluated in Europe, highlighting a differentiated manufacturing and engineering approach for precision TCR-T therapies.
Pancreatic cancer remains one of the most difficult-to-treat solid tumors, with a five-year survival rate below 10%. Treatment options are particularly limited for patients with advanced or progressed disease. KRAS mutations are among the most common cancer-associated mutations and are frequently found in pancreatic, lung, and colorectal cancers. In pancreatic cancer, KRAS G12V and G12D mutations are especially prevalent.
The VIDAR-1 program is designed to evaluate multiple TCR-T product candidates targeting different KRAS mutations and HLA combinations. ANOC-001 is the first candidate in this series, with additional products targeting other mutant KRAS forms expected to be introduced into the clinical program.
Unlike viral-vector-based cell therapy manufacturing approaches, Anocca is using non-viral gene editing technology to engineer patient T cells. This strategy is intended to support scalable development, precise TCR insertion, and future commercial manufacturing across multiple mutation- and HLA-defined patient populations.
The Phase 1 portion of the multi-center VIDAR-1 trial is ongoing, with recruitment and manufacturing underway. The study is being conducted at eight leading university hospitals across Sweden, Denmark, Germany, and the Netherlands.
The first patient dosing marks an important milestone for Anocca’s TCR-T platform and for the broader development of engineered T cell therapies in solid tumors. While clinical validation is still needed, ANOC-001 represents a precision cell therapy approach targeting one of the most clinically important oncogenic drivers in pancreatic cancer.
