FDA completes 30-day safety review of two IND applications for CXCR4-targeted theranostic program in hemato-oncology; proposed clinical study may proceed
“The U.S. INDs provide important regulatory validation of our CXCR4-targeted approach and support its advancement in the stem cell transplant setting, combining PentixaFor imaging with [⁹⁰Y]Y-PentixaTher,” said Dirk Pleimes, CEO of Pentixapharm. “AML and MM are significant hematologic malignancies where transplantation remains central to treatment. We believe that targeted bone marrow conditioning has the potential to offer a differentiated strategy within this established chemotherapy-based paradigm. This regulatory milestone also builds on our ongoing investigator-initiated clinical studies in AML in Europe.”
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“FDA clearance of the IND for ORM-1153 is an important milestone for Orum, bringing another first-in-class DAC into the clinic and extending our approach into CD123-expressing hematologic malignancies,” said Olaf Christensen, M.D., Chief Medical Officer of Orum Therapeutics. “By combining cell-selective delivery with targeted protein degradation in a single molecule,
“We are excited to expand our clinical collaboration with Roche to evaluate a second KRAS combination with potential best-in-class MTA-cooperative PRMT5 inhibitor IDE892 for pancreatic cancer patients, where there remains a high unmet medical need. IDEAYA is advancing multiple rational combination strategies for the IDE892 program, including with MAT2A inhibitor
“These encouraging initial safety observations represent an important first step in the clinical evaluation of ZI-MA4-1 and our TCR-NK platform” said Namir Hassan, Chief Executive Officer of Zelluna. “The first patient received all three planned doses, and the independent committee’s recommendation enables us to continue recruitment at the first dose
“Receiving FTD is an important milestone for ERAS-0015 and reflects the urgent need for new therapies for patients with metastatic pancreatic cancer,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “Together with the encouraging clinical activity and favorable tolerability observed to date, this FTD helps to position us