FDA Clears IND Application for SYNC-T SV-102 for metastatic CRPC
“Receiving clearance of our IND is a significant milestone for Syncromune and will allow us to rapidly advance the clinical development of SYNC-T SV-102,” said Syncromune’s President and CEO, Eamonn Hobbs. “This clearance, following our recent presentation at AACR of data demonstrating unprecedented response rates, underscores the potential of SYNC-T SV-102 to change the landscape of prostate cancer treatment.”
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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.