FDA Clears IND Application for ATX-559 Ph 1 study in solid tumor patients with a focus on BRCA1/2-deficient breast cancer and MSI-H and dMMR solid tumors
“We are honored to have such distinguished experts join our Clinical Advisory Board as we advance our programs into the clinic,” said Shakti Narayan, Ph.D., J.D., Chief Executive Officer of Accent Therapeutics. “Their experience will be invaluable as we work to bring transformative therapies to patients.”
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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.