The first patient in an expansion phase of a trial looking at cancer drug Modi-1 has been enrolled and dosed. Scancell Holdings plc, the developer of immunotherapies for the treatment of cancer and infectious disease made the announcement today (October 31).
The expansion phase is part of the monotherapy arms of the phase 1 clinical trial, ModiFY.
In addition, cohort 3 of ModiFY is now open for recruitment in combination with a checkpoint inhibitor (CPI). Expansion into the monotherapy arms and the start of combination dosing follows review of the safety data from the cohort 2 patients by the Safety Review Board.
First patient enrolled and dosed
The ModiFY study is a first-in-human clinical trial, with Modi-1, which is the first candidate from Scancell’s Moditope platform, being administered alone or in combination with CPIs in patients with head and neck, triple negative breast and renal tumors and as a monotherapy in patients with ovarian cancer, where there are no approved CPI therapies. This open label study will recruit up to 125 patients in up to 20 clinical trial sites across the U.K.
Cohort 1 of the study confirmed the safety profile of a low dose of two citrullinated vimentin peptides. The objective for cohort 2 of the trial was to assess the safety of the two citrullinated vimentin peptides plus an enolase peptide at a higher dose. All three patients in cohort 2 have successfully received two doses and the injections were well tolerated with no safety concerns.
Encouragingly, all three patients showed a delayed type hypersensitivity response to the vaccine, which is indicative of a T cell response, and the first patient to be assessed has shown a partial tumor response at first radiological reassessment. However, this early observation requires further confirmation with subsequent scans, plus analysis of responses in the remainder of the cohort 2 patients.
Tumor types
Based on the safety data from cohort 2, the ModiFY trial will now expand at this dose for Modi-1 monotherapy in all four tumor types and the first patient enrolled in these expansion cohorts has now been dosed. In parallel, patients in cohort 3 will receive Modi-1 plus a CPI to assess if this combination is safe in patients where CPIs are provided as standard of care.
Modi-1 stimulates CD4 T cells which may directly impact tumor growth however, in some patients these T cells may need to be protected by CPIs if the tumor environment is highly immunosuppressive.
Modi-1 peptides are linked to Amplivant, a potent adjuvant which enhanced the immune response 10- to 100-fold and resulted in highly efficient tumor clearance, including protection against tumor recurrence, in preclinical models. Amplivant is the subject of a worldwide licensing and collaboration agreement with ISA Pharmaceuticals for the manufacturing, development, and commercialization of Modi-1.
An encouraging milestone for Scancell
Scancell expects further safety and immunogenicity data to be available in the second half of this year (2022) and early efficacy data in 2023.
Lindy Durrant, chief executive officer, at Scancell, said: “This is an encouraging milestone for the company, showing that the higher dose of Modi-1 is generating immune responses that may be having an impact on tumor growth.
“We are encouraged that there were no safety concerns in cohort 2, allowing us to proceed with the monotherapy expansion and into cohort 3 in combination with checkpoint inhibitors, and look forward to announcing further safety and immunogenicity data in the second half of 2022.”