“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, 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,” says Reagan Jarvis, co-founder and Chief Executive Officer.

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Home-grown production talent 

Biotech talent in production is in high demand and Anocca is taking a creative approach to workforce development: investing in motivated young people through in-house training and education.

VIDAR-1

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 first regulatory authorization in Europe to study a non-viral gene-edited TCR-T therapy in clinical practice.

The CTA approval is the first regulatory authorization 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.