Anocca Announces Authorisation of Clinical Trial Application to Start First In-Human Trial in Advanced Pancreatic Cancer

• CTA approval marks Anocca’s transition to a clinical-stage company
• First-in-human VIDAR-1 trial begins with the deployment of ANOC-001 in Advanced Pancreatic Cancer at leading medical centres in Sweden, Denmark, Germany and The Netherlands
• The first TCR-T cell therapy manufactured with non-viral gene-editing approved for trials in Europe
  

/EIN News/ -- SÖDERTÄLJE, Sweden, March 17, 2025 (GLOBE NEWSWIRE) -- Anocca AB, a leading T-cell immunotherapy company, announces the authorisation of its Clinical Trial Application (CTA) from the regulatory authorities in four European countries under the European Union’s (EU) harmonised framework, for VIDAR-1, with Germany acting as the reference state. VIDAR-1 is a Phase I/II multi-product umbrella trial in patients with mutated KRAS-positive advanced pancreatic cancer. VIDAR-1 will test multiple products starting with the company’s lead product ANOC-001 that targets mutant KRAS G12V. ANOC-001 is a novel discovery from Anocca’s platform and will be manufactured in the company’s in-house cGMP facility.

The CTA approval is the first regulatory authorisation in Europe to study a non-viral gene-edited TCR-T therapy in clinical practice, paving the way for the execution of Anocca’s scalable clinical product manufacturing strategy.

Phase I of the multi-centre trial will start in leading university hospitals in four northern European countries: Sweden, Denmark, Germany and The Netherlands. Anocca aims to initiate the study in Q2, 2025.

Reagan Jarvis, co-founder and Chief Executive Officer, commented, “This approval is a significant step in Anocca’s development as we transition to a clinical-stage company. Our highly skilled team is focused on discovering, optimising and manufacturing innovative next generation treatments that harness T-cell immunity and ANOC-001 represents the first of many products that will advance to the clinic in the coming years."

Zahid Bashir, Chief Medical Officer at Anocca, elaborated, "We are excited with the approval of VIDAR-1, as it represents a significant step towards addressing the unmet medical needs in patients with pancreatic cancer.”

About the VIDAR-1 clinical programme
VIDAR-1 is designed as a multi-product umbrella trial targeting oncogenic driver mutations in KRAS within pancreatic ductal adenocarcinoma (PDAC). It will investigate up to 20 patients per product 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. The company plans to initiate first-in-human clinical studies in Q2, 2025. Patients will be eligible to enrol if they have an HLA, and KRAS mutation, matching an available product.

More information about the clinical trial can be found at the EU’s clinical trials website.

About KRAS and PDAC
Mutant KRAS is implicated in pancreatic, lung and colorectal cancers. G12V and G12D mutations in KRAS affect around 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

About Anocca
Anocca is a fully integrated clinical-stage biopharmaceutical company that develops libraries of T-cell receptor-engineered T cell (TCR-T) therapies to redefine the treatment of solid tumours 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 personalised treatments for the broadest patient populations.

Anocca operates an advanced research and development infrastructure, underpinned by a custom software ecosystem, AnoccaOS, and an in-house cGMP manufacturing and process development facility. 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.

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