The trial is specifically structured to target oncogenic driver mutations in KRAS within pancreatic ductal adenocarcinoma. Credit: Jo Panuwat D/Shutterstock.

Anocca has submitted its first clinical trial application (CTA) to the European Medicines Agency (EMA) for conducting the Phase I/II VIDAR-1 trial.

The trial’s commencement depends on the EMA’s approval, with the company aiming to initiate the study in the second quarter of next year.

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The multi-asset umbrella trial is set to commence with the company’s lead T-cell receptor (TCR-T) cell therapy, ANOC-001, targeting the Kirsten Rat Sarcoma Viral Oncogene Homolog glycine 12 mutated to valine (KRAS G12V) mutation in individuals with advanced pancreatic cancer.

VIDAR-1 is specifically structured to target oncogenic driver mutations in KRAS within pancreatic ductal adenocarcinoma (PDAC).

The trial plans to include up to 20 subjects per product, with each product tailored to a unique combination of human leukocyte antigen (HLA) and mutation across a series of Phase I/II studies.

The Phase I segment of the trial is set to take place across eight sites in four countries, with an expansion to additional countries and sites planned for Phase II.

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Eligibility for enrolment in the trial requires subjects to have a matching HLA and KRAS mutation for the available product.

Anocca co-founder and CEO Reagan Jarvis said: “This is an important milestone for Anocca, affirming the value of our unique cell biology research and development 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.”

In March this year, the company entered into a non-exclusive licensing agreement with EmendoBio for the use of the latter’s OMNI-A4 nuclease.

This agreement aims to expedite the manufacture and development of Anocca’s deep pipeline of TCR-T cell therapies for solid cancers that are challenging to treat.

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