Scancell has received approval from the UK’s Medicines and Healthcare Products Regulatory Authority (MHRA) to conduct a Phase I/II clinical trial of its cancer vaccine, Modi-1.

Modi-1 is the first vaccine based on the company’s Moditope platform. It combines three peptides from two target antigens that are usually altered in cancer cells.

The first-in-human Phase I/II trial will assess the safety, immunological activity and preliminary efficacy of the vaccine in triple-negative breast cancer, ovarian cancer, head and neck cancer and renal cancer patients.

Scancell anticipates recruiting participants into the trial in the second half of this year, after receiving approval from the ethics committee.

Modi-1 will be given along with checkpoint inhibitors for head and neck or renal tumour patients.

Initially, the trial will focus on two citrullinated vimentin peptides’ safety and, in case of no substantial side effects, a citrullinated enolase peptide will then be added.

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In preclinical models, the peptides in the vaccine are linked to AMPLIVANT, an adjuvant that improved the immune response ten to 100 times and led to an effective tumour clearance, including protection against recurrence.

Scancell entered a global licensing and collaboration agreement with ISA Pharmaceuticals to use the AMPLIVANT adjuvant technology for the Modi-1 cancer vaccine.

Preliminary safety or tolerability results from the initial open-label part of the Phase I/II trial are expected in the first half of next year.

Scancell’s Moditope platform triggers immune responses to stress-induced post-translational modifications (siPTMs).

Upon stress, cells alter their proteins to notify the immune response about the problem. Citrullination is one of these alterations and is the target for Modi-1.

Certain T-cell epitopes obtained from citrullinated vimentin, which is associated with tumour spread, and citrullinated enolase, an enzyme that produces nutrients to promote tumour growth, are part of the vaccine.

When vaccine-specific T-cells remove cells that express these proteins, the tumour should be removed and further spread should be prevented, Scancell noted.

Scancell CEO professor Lindy Durrant said: “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.”

Last month, Scancell received approval from the South African Health Products Regulatory Authority to conduct a Phase I trial of its Covid-19 vaccine candidates.