SELLAS Announces Positive Data from Preclinical Studies Indicating ASXL1 Mutations as Predictor of Response to SLS009 in Solid Cancers

Core Insights - SELLAS Life Sciences Group, Inc. announced high efficacy of SLS009, a selective CDK9 inhibitor, in solid cancers with ASXL1 mutations, showing a response rate of 67% compared to 0% in non-mutated cancers [1][5] - ASXL1 mutations were identified as a predictive biomarker for SLS009 efficacy in colorectal cancer (CRC MSI-H) and non-small cell lung cancer (NSCLC) [1][2] - The company has filed for provisional patent protection for the use of ASXL1 mutations as a predictive diagnostic tool for selecting cancer patients likely to benefit from SLS009 [5] Summary by Sections Efficacy of SLS009 - In preclinical studies, SLS009 demonstrated high efficacy (IC50 < 100 nM) in 67% of ASXL1 mutated solid cancer cell lines, while no efficacy was observed in non-ASXL1 mutated lines [4][5] - In CRC MSI-H, 57% of ASXL1 mutated cell lines showed high efficacy, while none of the non-mutated lines responded [4] - In NSCLC, 100% of ASXL1 mutated cell lines exhibited high efficacy, with no response in non-mutated lines [4] ASXL1 Mutations in Solid Cancers - ASXL1 mutations were found in 58% of CRC MSI-H patient-derived cell lines and 33% of NSCLC cell lines, exceeding predicted frequencies [4] - Overall, ASXL1 mutations were recorded in 9 out of 18 studied solid cancer cell lines [4] Clinical Development and Future Prospects - The findings support the development of targeted therapies for solid tumors based on ASXL1 mutation status [5] - The company aims to leverage existing clinical data demonstrating SLS009's efficacy in acute myeloid leukemia (AML) to strengthen its position in solid cancers [5][6]