FDA clears IND for Novel Bispecific CAR IMPT-314 to Treat Aggressive B-cell Lymphoma
“This IND clearance is a significant milestone for our company,” said Sumant Ramachandra, M.D., Ph.D., president and chief executive officer of ImmPACT Bio. “Results from an investigator-led study evaluating this CAR T-cell therapy demonstrated that 70 percent of patients achieved a complete response with significant durability of remission. These initial efficacy results combined with the favorable safety profile show that IMPT-314 could potentially be a best-in-class treatment for patients with B-cell lymphomas. We look forward to initiating this Phase 1/2 trial to help cancer patients who need new therapies.”
Share:
More News
“Giredestrant represents the first major endocrine therapy advance in early-stage ER-positive breast cancer in decades, where the chance for cure is highest,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “The FDA’s filing acceptance brings us closer to delivering a new standard-of-care with the
“Orphan Drug Designation for SOT106 underscores both the urgent need for new treatment options in osteosarcoma and the strength of our ADC platform,” said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO. “Osteosarcoma is a devastating disease that has seen little therapeutic innovation over the past four decades. Treatment
“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