CuraCell Holding’s clinical trial application (CTA) has received approval from Germany’s federal authority for vaccines and biomedicines, Paul-Ehrlich-Institut (PEI), to begin a Phase I/IIa trial of CC-38.
The trial will assess the autologous tumour-infiltrating lymphocyte (TIL) therapy in patients with metastatic colorectal and prostate cancers. It is set to start in the latter half of this year.
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CC-38 is based on the company’s CytoPLY platform, which aims to intensify the cytotoxic response against tumours by improving the diversity and functionality of tumour-specific T-cells.
The therapy leverages the immune system of the patient with the expansion of lymphocytes, which are tumour-reactive and directly taken from the tumour.
The planned open-label study is set to enrol up to 16 subjects with advanced solid tumours, specifically targeting prostate and colorectal cancers.
It will be carried out at Krankenhaus Nordwest in Frankfurt, focusing on the feasibility of repeated CC-38 administration, with the primary goal being the therapy’s tolerability and safety.
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By GlobalDataThe trial will also look into the immune responses and initial anti-tumour activity.
CuraCell CEO Jonas Båtelson said: “This CTA approval marks a major milestone for CuraCell and affirms the strength of our science and clinical strategy.
“Our dedicated team, together with our expert collaborators, has worked tirelessly to advance our first TIL therapy from bench to bedside. This is a big step forward in our mission to provide curative treatments for the toughest and most deadly solid tumours.”
According to the company, the CytoPLY platform allows for a quicker expansion of tumour-killing T cells compared to conventional interleukin-2 (IL-2)-based approaches.
It also seeks to expand the TCR repertoire to recognise a wider array of neoantigens and to boost cytokine production, thereby prolonging the survival and anti-tumour activity of T-cells.
