Anocca Announces Submission of Clinical Trial Application for Multi-Asset Trial VIDAR-1 in Advanced Pancreatic Cancer

Anocca AB recently announced the submission of its first Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for a Phase 1/2 multi-asset umbrella trial, VIDAR-1. The VIDAR-1 program will begin with ANOC-001, which targets mutant KRAS G12V, in patients with advanced pancreatic cancer. Subject to approval of the CTA, Anocca aims to initiate the study in Q2, 2025. ANOC-001 is the lead product from Anocca’s robust preclinical pipeline of TCR-T cell therapies.

Reagan Jarvis, co-founder and Chief Executive Officer, commented “This is an important milestone for Anocca, affirming the value of our unique cell biology R&D engine. Our approach integrates the systematic generation of validated TCR-T target maps from tumor-selective genetic sequences and supports the delivery of libraries of potent and highly specific therapeutic TCRs to leverage the diverse cancer target space. With our in-house cGMP facilities and gene-edited autologous TCR-T manufacturing capability we can efficiently and cost effectively develop new investigational products at scale. Our ambition is to grow our pipeline rapidly across the immense untapped target space for TCR-T cell therapies in solid tumors.”

Hugh Salter, Chief Scientific Officer at Anocca, added “KRAS is an immensely important target in many cancer types, but has to date been challenging to address. KRAS mutations are a hallmark of PDAC, which is among the most difficult to treat cancers, and we believe TCR-T cell therapies and, in particular, our VIDAR-1 assets can be effective in addressing this target and providing a new solution in an indication with high unmet medical need.”

VIDAR-1 is designed as a multi-asset umbrella trial targeting oncogenic driver mutations in KRAS within pancreatic ductal adenocarcinoma (PDAC). It will investigate up to 20 patients per product, where each product is specific for a different combination of HLA and mutation, in a set of Phase 1/2 studies. Phase 1 is planned for eight sites in four countries with additional countries and sites in Phase 2. Subject to approval of the CTA, the company plans to initiate first-in-human clinical studies in Q2, 2025. Patients will be eligible to enroll if they have a HLA and KRAS mutation matching an available product.

Mutant KRAS is implicated in pancreatic, lung and colorectal cancers. G12V and G12D mutations in KRAS affect ~90% of pancreatic cancer patients. The five-year survival rate of patients with PDAC is less than 10%. Despite recent advances there are no definitive treatments for advanced patients at present.

Anocca is a fully integrated biopharmaceutical company that develops libraries of T-cell receptor-engineered T cell (TCR-T) therapies to redefine the treatment of solid tumors and other difficult to treat diseases, including infectious and autoimmune diseases. Its unique discovery engine uses programmable human cells to recreate and manipulate T cell immunity. This proprietary technology scales TCR-T cell therapy development, allowing the systematic generation of personalized treatments for the broadest patient populations. Anocca operates an advanced research and development infrastructure, underpinned by a custom software ecosystem, AnoccaOS, and in-house cGMP manufacturing and process development facilities. All Anocca’s therapeutic TCRs are novel discoveries from its platform and manufactured using non-viral gene editing technology at Anocca’s facilities in Sweden.