Asana BioSciences Announces Acceptance of IND Application for Its Oral ERK1/2 Inhibitor

On January 3, 2018 Asana BioSciences, an oncology-focused, clinical stage biopharmaceutical company, reported that the U.S. FDA has accepted the IND application for ASN007, a potent and selective ERK1/2 inhibitor (Press release, Asana BioSciences, JAN 3, 2018, View Source [SID1234522875]).

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"We are extremely pleased with the acceptance of this IND for evaluation of our potential Best-in-Class, oral ERK1/2 inhibitor that shows potent anti-proliferative activity in cancer models driven by MAP Kinase pathway mutations, as well as those resistant to BRAF and MEK inhibitors," said Sandeep Gupta, PhD, Founder, President and Chief Executive Officer at Asana BioSciences. "We continue to execute on our strategy of developing novel drugs that work on clinically validated targets, are clearly differentiated from the competition, and expected to offer significant benefit over the existing standards of care. This represents the 5th successful IND of our proprietary portfolio in the past 3 years, and is a testament to the capabilities, dedication and high efficiency of Asana’s R&D team," said Dr. Gupta.

The RAS/RAF/MEK/ERK (MAP Kinase) signaling pathway is frequently hyperactivated in a wide range of cancers through mutations in upstream targets such as BRAF, RAS and receptor tyrosine kinases. Inhibition of ERK1/2 offers a promising therapeutic strategy for these cancers, particularly those driven by RAS mutations. Enrollment in this Phase 1, open-label, dose-finding study of ASN007 in patients with advanced solid tumors is expected to start soon. The study will evaluate the safety, tolerability and preliminary efficacy of ASN007 in patients with BRAFV600, KRAS, HRAS or NRAS mutations.