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MHRA has approved Scancell’s clinical trial application for the initiation of the first-in-human Phase I/II study of Modi-1—a therapeutic vaccine candidate from the company's Moditope platform.
The UK’s Medicines and Healthcare products Regulatory Authority (MHRA) has approved Scancell’s clinical trial application (CTA) for the initiation of the first-in-human Phase I/II study of Modi-1, which is the first therapeutic vaccine candidate from Scancell’s Moditope platform.
Patients with triple negative breast cancer, ovarian cancer, head and neck cancer, and renal cancer will be enrolled in the Modi-1 clinical trial during the second half of 2021 following the ethics committee sign-off, the company reported in an Aug. 26, 2021 press release. In the trial, Modi-1 will initially be administered in combination with checkpoint inhibitors in patients with head and neck or renal tumors. Trial investigators will focus on the safety of two citrullinated vimentin peptides to begin with, and if there are no significant side effects, will then add a citrullinated enolase peptide.
“The approval of the Modi-1 CTA is a significant achievement for the Company. Targeting [stress induced post-translational modifications] siPTMs generated dramatic regression of large tumors in our preclinical models and we hope to see similar results in cancer patients during this trial,” said Lindy Durrant, CEO, Scancell, in the press release. “[Modi-1] is the first of several vaccines that we are developing from the Moditope platform and look forward to updating the market on our progress in due course.”
Christian Ottensmeier at The Clatterbridge Cancer Centre and University of Liverpool, added in the press release, “I am very excited to be the principal investigator for this first-in-human clinical trial to determine if siPTMs and, in particular, citrullination will be able to transform the prognosis for these patients with hard-to-treat tumors.”
The company expects that initial safety and tolerability data from the initial open label portion of the trial may be available in the first half of 2022.