Anocca AB, a biopharmaceutical company specializing in T-cell receptor-engineered T-cell (TCR-T) therapies, has announced the submission of its first Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for the Phase I/II VIDAR-1 trial. The trial will evaluate ANOC-001, a TCR-T cell therapy targeting the Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12V mutation, in patients with advanced pancreatic cancer.
Targeting KRAS Mutations in Pancreatic Cancer
The VIDAR-1 trial is designed as a multi-asset umbrella study focusing on oncogenic driver mutations in KRAS within pancreatic ductal adenocarcinoma (PDAC). KRAS mutations, particularly G12V and G12D, are present in approximately 90% of pancreatic cancer patients. The trial will enroll up to 20 subjects per product, with each product tailored to a unique combination of human leukocyte antigen (HLA) and mutation. The Phase I portion of the trial is planned to take place across eight sites in four countries, with expansion to additional countries and sites planned for Phase II.
ANOC-001: A Novel TCR-T Cell Therapy
ANOC-001 represents the first product from Anocca's TCR-T pipeline to enter human trials. The therapy is designed to address the unmet medical need in PDAC, a cancer with a five-year survival rate of less than 10%. Reagan Jarvis, co-founder and CEO of Anocca, stated that this submission affirms the value of their unique cell biology R&D engine, which integrates the systematic generation of validated TCR-T target maps from tumor-selective genetic sequences.
Trial Design and Patient Eligibility
The VIDAR-1 trial will investigate multiple assets, each specific to a different combination of HLA and KRAS mutation. Patient eligibility requires a matching HLA and KRAS mutation for the available product. The trial aims to initiate first-in-human clinical studies in Q2 2025, pending CTA approval. Hugh Salter, Chief Scientific Officer at Anocca, emphasized that KRAS mutations are a hallmark of PDAC, and TCR-T cell therapies like ANOC-001 could provide a new solution for this difficult-to-treat cancer.
Anocca's Strategy and Manufacturing Capabilities
Anocca operates in-house cGMP facilities and gene-edited autologous TCR-T manufacturing capability, allowing for efficient and cost-effective development of new investigational products at scale. The company's ambition is to rapidly grow its pipeline across the untapped target space for TCR-T cell therapies in solid tumors. In March, Anocca entered a non-exclusive licensing agreement with EmendoBio for the use of the latter’s OMNI-A4 nuclease to expedite the manufacture and development of its TCR-T cell therapies.
