SRN-101 announced as Lead Asset for High-Grade Gliomas with Both Orphan Drug and Rare Pediatric Disease Designations from the FDA
“We are excited to announce SRN-101 as the lead universal AAV immuno-gene therapy asset in our platform’s pipeline,” said Dr. Nicole K. Paulk, PhD, Siren Biotechnology’s CEO and Founder. “Our team has worked tirelessly to develop an approach that demonstrates remarkable promise for the treatment of high-grade gliomas but also has transformative potential for use in additional indications.”
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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.