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Anocca submits Clinical Trial Application
Anocca has announced 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.
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.
“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 tumor-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 tumors,” says Reagan Jarvis, co-founder and CEO, Anocca.
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.
“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,” says Hugh Salter, Chief Scientific Officer, Anocca.
Published: November 26, 2024