Scancell Holdings plc 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 showedthat 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.