Scancell Holdings PLC (AIM:SCLP, OTC:SCNLF), a developer of immunotherapies for cancer, has announced the expansion of its Modi-1 trial in combination with checkpoint inhibitors (CPI) for patients with renal or head and neck cancer.
This decision follows the successful completion of Cohort 4, where the higher dose Modi-1 in combination with CPI was found to be well-tolerated with no safety concerns.
The safety review committee has approved the inclusion of two new cohorts, with 21 patients to be recruited into each group.
The expansion will not include patients with triple-negative breast cancer, as these individuals typically receive checkpoints in combination with chemotherapy, potentially causing toxicity.
In addition to the cohort expansion, recruitment into the neoadjuvant arm of the Modi-1 trial, again in combination with CPI, has been approved.
This study will enrol 30 patients who will be randomly selected 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 before and after vaccination, allowing for the evaluation of T cell infiltration and activation in both pre- and post-Modi-1 vaccination with or without a checkpoint inhibitor.
The first assessment in Cohort 4 has shown tumour regression at the initial 8-week radiological check, though the remaining patients have not yet been evaluated radiologically.
"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," said Scancell chief executive, Professor Lindy Durrant. "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."