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(Sharecast News) - Immunotherapy developer Scancell announced on Thursday that the UK Medicines and Healthcare products Regulatory Authority (MHRA) has approved the clinical trial application to initiate the first-in-human phase 1 and 2 clinical study of 'Modi-1'.
The AIM-traded company said it was expecting to enrol patients into the study in the second half, following ethics committee sign-off.
Initial safety and tolerability data from the initial open-label portion of the trial could be available from the first half of 2022, the board said.
The Modi-1 clinical trial would be a first-in-human clinical trial in patients with triple negative breast cancer, ovarian cancer, head and neck cancer, and renal cancer.
Modi-1 would be administered in combination with checkpoint inhibitors in patients with head and neck or renal tumours.
The firm said the trial would initially focus on the safety of two citrullinated vimentin peptides and, if there were no significant side effects, a citrullinated enolase peptide would be added.
Scancell said the Modi-1 peptides were linked to 'Amplivant', which it described as a potent adjuvant which enhanced the immune response 10 to 100-fold, and resulted in highly efficient tumour clearance, including protection against tumour recurrence, in preclinical models.
Applicant is the subject of a worldwide licensing and collaboration agreement with ISA Pharmaceuticals for the manufacturing, development and commercialisation of Modi-1.
The Modi-1 clinical trial would evaluate the first therapeutic vaccine candidate from the company's novel '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, and one of those modifications is citrullination, which is the target for the Modi-1 vaccine.
Fast-growing cancer cells need a lot of oxygen and nutrients, Scancell explained, and were always highly stressed.
Included in the Modi-1 vaccine were specific T-cell epitopes derived from citrullinated vimentin, which is involved in tumour spread, and citrullinated enolase, which is an enzyme that generates nutrients to drive tumour growth.
Removal of cells expressing those proteins by vaccine-specific T-cells should eradicate the tumour, and prevent further spread.
"The approval of the Modi-1 clinical trial application is a significant achievement for the company," said chief executive officer Lindy Durrant.
"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.
"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."
At 1218 BST, shares in Scancell Holdings were up 4.88% at 21.5p.
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