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Trials & Filings

Syndax Pharma Gets IND Clearance for Leukemia Treatment

Will begin Phase 1/2 trial for targeted Menin inhibitor, SNDX-5613, in patients with relapsed/refractory acute leukemias

By: Cassandra Gervolino

Syndax Pharmaceuticals, Inc. received clearance from the U.S. FDA for its Investigational New Drug (IND) application to begin a Phase 1/2 trial for SNDX-5613, a targeted Menin inhibitor, in patients with relapsed/refractory (R/R) acute leukemias.
 
In preclinical models of MLL-r acute leukemias, SNDX-5613 demonstrated robust, dose-dependent inhibition of tumor growth, resulting in a marked survival benefit. Menin-MLL interaction inhibitors have also demonstrated robust treatment benefit in multiple pre-clinical models of NPM1 mutant AML, which represents the most frequent genetic abnormality in adult AML. 
 
“The FDA’s acceptance of our IND for SNDX-5613 represents an important event in the development of targeted therapies for patients with acute leukemias,” said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. “The advancement of SNDX-5613 builds on three decades of scientific investigation that explored the Menin-MLL-r interaction and its importance in a subset of genetically defined leukemias. Our preclinical results strongly support the therapeutic potential of SNDX-5613 for patients with MLL-r and NPM1 mutant leukemias, many of whom do not derive a durable benefit from existing treatments. We look forward to moving this program into the clinic.” 

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