Medicenna Therapeutics is approaching other regulatory agencies outside the US to expand its upcoming Phase III trial in recurrent glioblastoma investigating MDNA55, CEO Dr Fahar Merchant told Clinical Trials Arena.
The Canada-headquartered immunotherapy company first received positive feedback from the US Food and Drug Administration (FDA) in 2020. Now, Medicenna is seeking trial design approval from regulators in Canada, Europe, and potentially parts of Asia.
Medicenna also seeks partnering opportunities for the MDNA55 programme or to secure funding over the upcoming months to conduct the registrational trial. Merchant said that the trial initiation will most likely happen next year.
The Phase III trial will enrol 300 recurrent glioblastoma patients without 1DH1/1DH2 gene mutation. The trial will measure overall survival (OS) as the primary endpoint.
Half of the participants will be recruited into the MDNA55 treatment arm, 50 will be assigned to a standard of care (SOC) arm while another 100 patients who received SOC in a hospital setting will act as an external control arm. MDNA55 is an IL-4 receptor-targeting toxin.
Merchant said: “That is a real major breakthrough. In the past, there has never been a registrational Phase III trial conducted and [a drug] approval based on an external control arm. It allows the drug to advance into commercialisation much faster and encourages patients to enrol in a clinical trial because they have less likelihood of being allocated to the control arm.”
MDNA11 in solid tumours
Medicenna is also conducting a Phase I/II trial in advanced solid tumours investigating its IL-2 super-agonist MDNA11 as a single agent and in combination with Merck’s Keytruda (pembrolizumab).
In August, Medicenna completed the dose escalation portion of the trial and moved to the dose expansion part. The company plans to enrol around 40 patients, with enrolment completion expected by the end of Q1 or early Q2 2024, Merchant said.
In the monotherapy arm, Medicenna is recruiting patients who have failed treatment with checkpoint inhibitors and had disease progression. This part of the trial focuses on melanoma, non-melanoma skin cancer and tumours that are biomarker-driven, such as MSI-high tumours.
The combination part of the trial will commence in Q4 2023, and the enrolment of 40 patients will be completed by the middle of 2024. Medicenna plans to release interim data in Q1 2024.
Currently, Medicenna has opened trial sites in Canada, the US, and Australia, but plans to start enrolling patients in South Korea and Europe.
Data from the dose expansion part will inform Medicenna which indications to pursue in a potential registrational trial.
Merchant added: “We won't be waiting for the full data set to be released before we plan ahead. We will be making decisions based on any interim data we generate over the next six to nine months.”
