Scancell Holdings PLC (AIM:SCLP, FRA:SCP) said the UK's Medicines and Healthcare Products Regulatory Authority has approved the clinical trial application (CTA) for a phase I/II clinical study of Modi-1, the company’s cancer vaccine candidate.
Patient enrolment should take place in the second half of this year with safety and tolerability data potentially available from the initial open-label portion of the study from the first half of 2022.
Modi-1 is to be administered to people with triple-negative breast cancer, ovarian cancer, head and neck cancer, and renal cancer.
It will be given in combination with checkpoint inhibitor drugs with head and neck or renal tumours.
Chief executive, Professor Lindy Durrant, said: "The approval of the Modi-1 CTA is a significant achievement for the company.”
The Modi-1 trial will evaluate the first therapeutic vaccine candidate from the company's Moditope platform, which stimulates immune responses to stress-induced post-translational modifications (siPTMs).
When cells become stressed, they modify their proteins to alert the immune response that there is a problem.
“Targeting siPTMs generated dramatic regression of large tumours in our preclinical models and we hope to see similar results in cancer patients during this trial,” Durrant explained.
“This is the first of several vaccines that we are developing from the Moditope platform and look forward to updating the market on our progress in due course."