Second DSMB Issues Positive Recommendation to Continue Bria-IMT Ph 3 Study in Metastatic Breast Cancer
“We are very pleased with the safety and tolerability profile of Bria-IMT plus immune checkpoint inhibitor (CPI) combination in metastatic breast cancer to date,” stated Dr. William V. Williams, BriaCell’s President & CEO. “The DSMB’s second positive data review and recommendation to continue with patient enrollment in BriaCell’s pivotal Phase 3 study clinical trial is highly encouraging and further highlights the potential of our groundbreaking novel immunotherapy to treat this urgent medical need.”
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“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.