FDA Clearance of IND for Telomir-Zn in TNBC
“The clearance of our IND, including the Phase 1/2 clinical protocol, marks an important step as we advance Telomir-Zn into clinical evaluation,” said Erez Aminov, CEO of Telomir. “Triple-negative breast cancer remains one of the most difficult cancers to treat in the advanced or metastatic setting, with limited options and consistently poor outcomes. There is a clear need for new therapeutic approaches, and we look forward to evaluating Telomir-Zn in this patient population.”
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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.