In February 2023 Scancell announced completion of a monotherapy dose finding arm of the Phase I/II ModiFY clinical trial. Data demonstrated that the Modi-1 cancer vaccine was “safe and well tolerated” with “encouraging early efficacy” in a head and neck cancer patient.
Modi-1 in trial
Modi-1 is the first candidate from Scancell’s Moditope platform and targets four different types of cancer: HGSOC, TNBC, head and neck squamous cell carcinoma (SCCHN) and renal cell carcinoma (RCC). The Modi-1 peptides are linked to AMPLIVANT, an adjuvant from ISA Pharmaceuticals.
Modi-1 is intended to stimulate CD4 T cells, which may “directly impact tumour growth”. For some patients, however, these T cells “may need to be protected by CPIs if the tumour environment is highly immunosuppressive”.
The ModiFY trial is an “open-label, multicohort, multicentre, adaptive” trial of Modi-1 in patients with “unresectable HGSOC, SCCHN, TNBC, or RCC”. Patients are treated with Modi-1 or Modi-1 and a CPI. Scancell reports that a total of 23 patients have been vaccinated, with 55 doses administered. All had “skin reactions” at the site of injection “consistent with a delayed-type hypersensitivity (DTH) reaction”. This indicates a T cell response.
The first study cohort confirmed the safety profile and the objective for Cohort 2 was to “assess the safety of the two citrullinated vimentin peptides plus an enolase peptide at a higher dose”. Following safety data from the second cohort, the trial was expanded for Modi-1 monotherapy in all four tumour types.
Dr David Pinato, Principal Investigator at Imperial College, described advanced ovarian cancer as “aggressive” and “hard to treat”.
“The early efficacy data showing that the Modi-1 vaccine is stabilising this advanced disease is very encouraging.”
Professor Christian Ottensmeier, Chief Investigator at the University of Liverpool, believes that “this therapeutic cancer vaccine could have significant potential”.
“Further studies with Modi-1 monotherapy and in combination with CPIs should tell us in which settings it will have maximum benefit to patients.”
Professor Lindy Durrant, CEO at Scancell, is “highly encouraged with the early efficacy data”.
“These results allow us to proceed with the monotherapy expansion cohorts and into the cohorts in combination with checkpoint inhibitors as planned.”