Swedish immunotherapy company Anocca has secured authorisation from regulatory authorities in four European nations for its Phase I/II VIDAR-1 clinical trial.
The trial will focus on subjects with Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) positive advanced pancreatic cancer.
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It will begin the evaluation with ANOC-001, Anocca’s lead product, which targets mutant KRAS glycine 12 mutated to valine (G12V).
Germany is serving as the reference state for the first-in-human, multi-product umbrella trial, which falls under the European Union’s harmonised framework.
The authorisation is the first instance in Europe of a non-viral gene-edited T cell receptor (TCR) T therapy being studied in clinical practice.
Anocca originally applied for authorisation to carry out the trial to the European Medicines Agency (EMA) in November last year.
Anocca CEO and co-founder Reagan Jarvis said: “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.”
Phase I of the trial is due to begin later this year in university hospitals across the Netherlands, Denmark, Germany and Sweden.
Anocca said the trial is structured to target oncogenic driver mutations in KRAS in the pancreatic ductal adenocarcinoma (PDAC).
It will explore several products, with up to 20 subjects for each product in a series of Phase I/II trials.
Phase I will be conducted across eight sites in four nations, with more countries and sites to be included in Phase II.
Anocca plans to begin first-in-human clinical studies as part of VIDAR-1 in the second quarter of this year.
Enrolment eligibility criteria for these trials will include human leukocyte antigens (HLA) and KRAS mutations matching the available product.
