08:45 AM EDT, 06/26/2024 (MT Newswires) -- Medicenna Therapeutics ( MDNAF ) on Wednesday said the European Medicines Agency (EMA) approved its clinical trial application to conduct the Phase 1/2 ABILITY-1 Study with lead candidate MDNA11 either alone or in combination with pembrolizumab.

The ABILITY-1 trial is currently enrolling patients at clinical trial sites in the U.S., Canada, Australia, and Korea.

"Expanding the clinical trial to various centers in the EU is an important milestone and adds to the positive momentum behind our MDNA11 program," said Medicenna President and CEO Fahar Merchant. "We anticipate that the expansion to Europe will expedite enrolment in the trial and advance the study towards key updates in the monotherapy expansion and combination escalation portions of the ABILITY-1 study which will be presented at medical conferences during H2 2024."

The ABILITY-1 study is designed to assess the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of various doses of intravenously administered MDNA11 in patients with advanced, relapsed, or refractory solid tumors. It includes an MDNA11 monotherapy arm, and a combination arm designed to evaluate MDNA11 in combination with the cancer immunotherapy drug pembrolizumab.