- Scancell’s phase I ModiFY trial assessing its cancer vaccine Modi-1 in various difficult-to-treat cancer types makes progress following a positive safety review which included no safety concerns and has been well tolerated in patients so far.
- The trial is now open for its expansion cohorts in combination with checkpoint inhibitors (CPI).
- The first patient to be assessed has shown a tumour regression at their 8 week radiological assessment.
Scancell Holdings plc, Calculus portfolio company, the developer of novel immunotherapies for the treatment of cancer and infectious disease, announces that the ModiFY trial is now open for expansion in combination with checkpoint inhibitors (CPI) and in the neoadjuvant setting.
Following the successful completion of Cohort 4, where three patients received at least two doses of Modi-1 combined with CPI, the safety review committee has approved expansion into two cohorts of patients with renal or head and neck cancer who receive CPI as standard of care. 21 patients will be recruited into each cohort. Patients with triple negative breast cancer will not be included in this part of the study as these patients receive checkpoints in combination with chemotherapy which may induce citrullination in normal cells and induce toxicity.
Additionally, recruitment into the neoadjuvant arm of the Modi-1 trial in combination with CPI was also approved. This study will recruit 30 patients who will be randomised at diagnosis to receive either two doses of Modi-1 three weeks apart or two doses of Modi-1 plus one dose of CPI. Tumour biopsies will be taken prior to immunisation and from the tumour resection 6 weeks following the initial vaccination. The two tumour samples will allow the extent of T cell infiltration and activation pre- and post-Modi-1 vaccination to be assessed with and without a checkpoint inhibitor.
Modi-1 treatment were well tolerated in Cohort 4 with no safety concerns. Encouragingly, the first patient to be assessed has shown a tumour regression at their first radiological assessment at 8 weeks. The remaining patients have not yet been assessed radiologically.
Prof Lindy Durrant, Chief Executive Officer, Scancell, commented: “This is an important milestone for the Company as we now have approval to treat patients with Modi-1 monotherapy or in combination with a CPI in four different tumour types either pre- or post-tumour resection. The information extracted from this study will be invaluable in defining the patient population that will benefit the most from our cancer vaccine, Modi-1.”