FDA Grants Orphan Drug Designation to SNB-101 for SCLC
US FDA had granted an orphan drug designation for small cell lung cancer for SNB-101, a new polymer nanoparticle drug under development. SNB-101 is the world’s first nanoparticle anticancer drug that has developed extremely insoluble SN-38 into polymer nanoparticles. It has been approved for phase 1 clinical trials in the US (NCT04640480) and Korea, and the IND for phase 2 has been filed after phase 1 clinical trial in Korea.
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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.