In the early-stage trial, the Modi-1 vaccine candidate demonstrated a partial response and stable disease in patients having head and neck, high-grade serous ovarian or triple negative breast cancers
Modi-1 is the first candidate from the Moditope platform of Scancell. (Credit: MasterTux from Pixabay)
Scancell has reported promising early efficacy data for its Modi-1 cancer vaccine candidate from the monotherapy part of the ModiFY phase 1/2 clinical trial.
The UK-based biopharmaceutical company has completed the monotherapy dose finding part of the multicentre early-stage trial.
Modi-1 is the first candidate from Scancell’s Moditope platform. It is being developed to treat high grade serous ovarian carcinoma (HGSOC), triple negative breast cancer (TNBC), head and neck squamous cell carcinoma (SCCHN), and renal cell carcinoma (RCC).
As per the findings of the phase 1/2 trial, the vaccine candidate was demonstrated to be safe and well tolerated in patients receiving it as a monotherapy.
The vaccine trial also showed promising early efficacy in a head and neck cancer patient and in other hard-to-treat cancers, said Scancell.
ModiFY is an open-label, multicohort, adaptive basket trial to study the use of Modi-1.
Scancell said that up to 138 cancer patients will be enrolled in the clinical trial of the vaccine candidate. They will be randomly assigned to receive either monotherapy or monotherapy plus standard-of-care checkpoint inhibitor (CPI) therapy.
If the patients are surgical candidates with SCCHN, then the company plans to randomise them to receive either Modi-1 alone or the investigational vaccine with Merck’s pembrolizumab (Keytruda).
Scancell CEO Lindy Durrant said: “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.”
As of now, 14 patients had their initial clinical responses evaluated, with the first imaging examination time point occurring at week eight, Scancell added.
Seven of the patients have stable disease in spite of having progressing disease prior to enrolment in the trial, while one of the 14 patients had a confirmed partial response.
According to the biopharmaceutical firm, no dose-limiting toxicities were observed in the monotherapy dose escalation cohorts.