IND filed with FDA for Ph 2 study of TBS-2025 for the treatment of R/R mutNPM1 AML in combination with a menin inhibitor
“There is a broad body of scientific evidence showing that leukemogenic mutations common in AML, such as mutNPM1, may drive the expression of VISTA on the surface of leukemic cells, which contribute to low response rates to therapy and markedly reduced overall survival,” said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences.
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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.