Immunocore Holdings has dosed the first subject in a multicentre Phase I/II trial of IMC-R117C, a PIWIL1-targeted immunotherapy, for treating colorectal and other gastrointestinal cancers.
The therapy is the fifth Immune mobilising monoclonal TCRs Against Cancer (ImmTAC) molecule from the company to enter clinical trials.
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The open-label, first-in-human trial aims to evaluate its clinical activity and safety in HLA-A*02:01-positive subjects with select advanced solid tumours.
It is also designed to assess various aspects of the therapy, including tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamics.
IMC-R117C will be assessed as both a single agent and in conjunction with other therapies.
Immunocore Clinical Development senior vice-president, and chief medical officer Mohammed Dar said: “We are proud to bring forward the first immunotherapy program to target PIWIL1, through our novel ImmTAC candidate, IMC-R117C.
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By GlobalData“PIWIL1 is expressed across all major subsets of colorectal cancer, including microsatellite-stable CRC, which has historically been insensitive to immunotherapy.”
The company’s T-cell receptor (TCR) technology has led to the development of ImmTAC molecules, a new class of bispecific biologics, with the potential to treat a wide range of cancers.
The molecules are soluble TCRs that are specifically engineered to identify intracellular cancer antigens and kill malignant cells through an anti-CD3 immune-activating effector function.
ImmTAC’s mechanism of action, which includes T-cell infiltration into human tumours, offers the potential to treat haematologic and solid tumours, including those with low mutation rates or immune ‘cold’ tumours.
Overexpressed in various malignancies, PIWIL1 is associated with aggressive tumour growth. The company continues to advance its ImmTAC platform, with nine active clinical and pre-clinical programmes covering infectious and autoimmune diseases, as well as oncology.
KIMMTRAK is the company’s lead TCR therapeutic and has gained approval in several regions, including Australia, Canada, the UK, the European Union, and the US, for the treatment of a specific type of melanoma.
