EMA Approves MDNA11 CTA to Expand Ph 1/2 ABILITY-1 Study to Europe

“We are excited to build on the early success and promising efficacy and safety of our ongoing ABILITY-1 study that is demonstrating MDNA11’s best-in-class potential,” said Fahar Merchant, PhD, President & CEO of Medicenna. “Expanding the clinical trial to various centers in the EU is an important milestone and adds to the positive momentum behind our MDNA11 program. 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.”

Share:

More News

“The designation reinforces the significant unmet need for effective treatment options for patients with advanced breast cancer,” said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto Biosciences. “We are committed to advancing highly selective therapies designed to expand treatment options for patients with difficult to treat cancers.”

“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two

Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.