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MEKanistic Therapeutics is developing MTX-531, a single tablet designed to block two cancer growth signals, EGFR and PI3K, at the same time, to get around the resistance that develops when only one is blocked. Its first human trial in advanced solid tumours started in October 2026.
MEKanistic Therapeutics, Inc., at 1015 Glenwood Avenue, Minneapolis, Minnesota, was founded in 2015, according to the company, by Judith Sebolt-Leopold, who led the Parke-Davis team behind the first oral MEK inhibitor to enter clinical trials, and the computational chemist Christopher Whitehead; it was launched publicly by the venture studio Invenshure in June 2022. Its lead candidate MTX-531 is an oral, computationally designed dual EGFR and PI3K inhibitor, which the company says also has PPAR-gamma agonist activity intended to limit hyperglycaemia; preclinical data were published in Nature Cancer in July 2024, and IND-enabling work was supported by the NCI Experimental Therapeutics (NExT) programme from August 2023. The FDA cleared the IND in May 2026. A phase 1 study in advanced solid tumours, with planned cohorts in head and neck squamous cell carcinoma, endometrial cancer, HER2-negative metastatic breast cancer and RAS- and BRAF-wild-type colorectal cancer (NCT07874880), was posted in October 2026. Founded in 2015, according to the company. Its first registered cancer trial, NCT07874880, was posted on ClinicalTrials.gov in October 2026.
Shares PI3K, AKT and mTOR inhibitors, Endometrial cancer, Breast cancer (all types), Colorectal cancer.
Shares PI3K, AKT and mTOR inhibitors, PIK3CA / PI3K-alpha, Small-molecule kinase inhibitors.
Shares PI3K, AKT and mTOR inhibitors, Small-molecule kinase inhibitors.
Shares PI3K, AKT and mTOR inhibitors, PIK3CA / PI3K-alpha, Breast cancer (all types).
Shares PI3K, AKT and mTOR inhibitors, Small-molecule kinase inhibitors.
Shares PI3K, AKT and mTOR inhibitors, Small-molecule kinase inhibitors.
Shares PI3K, AKT and mTOR inhibitors, Small-molecule kinase inhibitors.
Shares PI3K, AKT and mTOR inhibitors, Small-molecule kinase inhibitors.
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