Updates on DCR in the Part A safety lead-in of THIO-101 phase 2 trial of THIO + cemiplimab in patients with advanced NSCLC announced
“The 82% disease control rate observed so far with this combination is highly encouraging, especially in the heavily pre-treated population with previous immune CPI resistance, where typically the Disease Control Rates are in the 25-35% range. This preliminary data aligns with our pre-clinical data which showed that THIO, followed by an immune checkpoint inhibitor, greatly slowed and reduced tumor progression when compared to treatment with CPI alone. We look forward to continue the monitoring of these patients and evaluate disease control rates on a longer time frame with the next response assessment phases,” said Vlad Vitoc, MAIA’s Chief Executive Officer.
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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.