• Modi-1 cancer vaccine showed partial response and stable disease in patients with hard-to-treat head and neck, high grade serous ovarian or triple negative breast cancers
  • First clinical candidate from Moditope® platform well tolerated with no dose limiting toxicities

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, today announces completion of the monotherapy dose finding arm of the multicentre Phase 1/2 ModiFY clinical trial. Data from patients receiving the Modi-1 cancer vaccine as a monotherapy showed that it was safe and well tolerated and demonstrated encouraging early efficacy in a head and neck cancer patient and in other hard-to-treat cancers such as high grade serous ovarian carcinoma (HGSOC) and triple negative breast cancer (TNBC).

ModiFY is a first-in-human Phase 1/2 basket trial investigating the use of Modi-1, the first candidate from Scancell’s Moditope® platform, to treat four different types of cancer: HGSOC, TNBC, head and neck squamous cell carcinoma (SCCHN) and renal cell carcinoma (RCC). A total of up to 138 cancer patients will be recruited into either the monotherapy groups of the trial, or treated in combination with standard of care checkpoint inhibitor (CPI) therapy, or if surgical candidates with SCCHN, they will be randomised to receive either Modi-1 alone or Modi-1 with pembrolizumab (Keytruda®).

To date, 23 patients have been vaccinated with Modi-1 and all have had skin reactions at the injection sites consistent with a delayed-type hypersensitivity (DTH) reaction indicative of a T cell response. So far, initial clinical responses have been assessed in 14 patients reaching the first imaging evaluation timepoint at week 8. Of these patients, one has had a confirmed partial response and seven patients have stable disease, despite having progressive disease prior to enrolment in the study. As no dose limiting toxicities were observed in the monotherapy dose escalation cohorts, patients continue to be enrolled into both the ongoing monotherapy expansion cohorts and the CPI combination dose escalation cohorts during H1 2023.

Dr David Pinato, Principal Investigator at Imperial College, commented: “Advanced ovarian cancer is an aggressive cancer which is hard to treat. The early efficacy data showing that the Modi-1 vaccine is stabilising this advanced disease is very encouraging”.

Prof Christian Ottensmeier, Chief Investigator, University of Liverpool commented: “The strong DTH responses in all patients and the early clinical results, particularly in the patient with advanced SCCHN, suggests 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.”

Prof Lindy Durrant, Chief Executive Officer, Scancell, commented: “We are highly encouraged with the early efficacy data we have achieved in the ModiFY clinical trial, and safety profile to date with patients receiving Modi-1. These results allow us to proceed with the monotherapy expansion cohorts and into the cohorts in combination with checkpoint inhibitors as planned.”

Read the full press release here