Anocca AB has secured regulatory authorization from authorities in four European countries to commence VIDAR-1, a Phase I/II clinical trial evaluating novel T-cell receptor-engineered T cell (TCR-T) therapies in patients with advanced pancreatic cancer. The approval marks a significant milestone as the company transitions to a clinical-stage organization.
The multi-product umbrella trial will focus on patients with KRAS-positive advanced pancreatic cancer, beginning with the company's lead product ANOC-001, which specifically targets the KRAS G12V mutation. The trial is scheduled to begin in Q2 2025 at leading university hospitals across Sweden, Denmark, Germany, and The Netherlands.
"This approval is a significant step in Anocca's development as we transition to a clinical-stage company," said Reagan Jarvis, co-founder and Chief Executive Officer of Anocca. "Our highly skilled team is focused on discovering, optimizing 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."
Pioneering Non-Viral Gene Editing in Europe
The Clinical Trial Application (CTA) approval represents the first regulatory authorization in Europe to study a non-viral gene-edited TCR-T therapy in clinical practice. This pioneering approach could establish a new paradigm for the development and manufacturing of cell therapies.
ANOC-001 is manufactured at Anocca's state-of-the-art cGMP facility in Sweden, showcasing the company's end-to-end capabilities from discovery to clinical product manufacturing. The non-viral gene editing technology employed by Anocca potentially offers advantages in terms of scalability and safety compared to viral vector-based approaches.
VIDAR-1 Trial Design and Patient Population
The VIDAR-1 program is designed as a multi-product umbrella trial targeting oncogenic driver mutations in KRAS within pancreatic ductal adenocarcinoma (PDAC). Phase I will initially enroll up to 20 patients per product across eight sites in four countries, with plans to expand to additional countries and sites in Phase II.
"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," said Zahid Bashir, Chief Medical Officer at Anocca.
Patients will be eligible to participate if they have an HLA type and KRAS mutation that matches an available product. This precision medicine approach aims to deliver targeted therapy to patients most likely to benefit.
Addressing a Critical Unmet Need
Pancreatic cancer represents one of the most challenging malignancies, with a five-year survival rate of less than 10%. Mutations in KRAS, particularly G12V and G12D, are implicated in approximately 90% of pancreatic cancer cases, making it a critical therapeutic target.
Despite recent advances in cancer treatment, there are currently no definitive treatments for advanced pancreatic cancer patients. The VIDAR-1 trial aims to address this significant unmet need by leveraging Anocca's proprietary technology platform to develop targeted immunotherapies.
Anocca's Integrated Approach
Anocca operates as a fully integrated biopharmaceutical company with a unique discovery engine that uses programmable human cells to recreate and manipulate T cell immunity. This proprietary technology enables the systematic generation of personalized treatments for broad patient populations.
The company's advanced research and development infrastructure is supported by a custom software ecosystem called AnoccaOS and an in-house cGMP manufacturing facility. All of Anocca's therapeutic TCRs are novel discoveries from its platform and manufactured using non-viral gene editing technology at the company's facilities in Sweden.
By combining innovative science with robust clinical methods, Anocca aims to redefine the treatment landscape for solid tumors and other difficult-to-treat diseases, including infectious and autoimmune conditions.
