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

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

• Application to the European Medicines Agency (EMA) covers ANOC-001 as the initial product in the company’s VIDAR-1 Phase I/II multi-asset programme targeting mutated KRAS in advanced pancreatic cancer
• ANOC-001 is the first product to enter human trials from Anocca’s robust T-cell receptor T-cell therapy (TCR-T) pipeline and, subject to approval, the trial will start during Q2, 2025
• Anocca is focused on developing innovative precision TCR-T cell therapies as potential new solutions in cancers with high unmet medical need

SÖDERTÄLJE, SWEDEN, 26 November 2024 – Anocca AB, a leading T-cell receptor-engineered T-cell (TCR-T) cellular therapeutics company, announces the submission of its first Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for a Phase I/II multi-asset umbrella trial, VIDAR-1. The VIDAR-1 programme 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 tumour-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 tumours."

Hugh Salter, Chief Scientific Officer at Anocca, elaborated, "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”.

About the VIDAR-1 clinical programme

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 I/II studies. Phase I is planned for eight sites in four countries with additional countries and sites in phase II. 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.

About KRAS and PDAC

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% (1). Despite recent advances there are no definitive treatments for advanced patients at present (2).

References

1. Rawla et al (2019). Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 10(1):10–27. doi: 10.14740/wjon1166

2. Hu & O’Reilly (2023). Therapeutic developments in pancreatic cancer. Nat Rev Gastroenterol Hepatol 21, 7–24 . doi: 10.1038/s41575-023-00840-w