MEKanistic Therapeutics has received clearance from the U.S. Food and Drug Administration for its Investigational New Drug (IND) application for MTX-531, allowing the company to begin a Phase 1 clinical trial in advanced solid tumours.

MTX-531 is the company’s lead oncology candidate and is designed as a dual inhibitor of PI3K and EGFR, two signalling pathways linked to tumour growth, survival and treatment resistance. The therapy is being developed as a potential first-in-class small molecule treatment for difficult-to-treat cancers.

Following the IND clearance, the company can move forward with its planned Phase 1 study after completing standard trial start-up activities.

The Phase 1 trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and early anti-tumour activity of MTX-531 in patients with advanced solid tumours associated with abnormal EGFR and PI3K signalling. The study will focus on cancers including head and neck cancer, endometrial cancer and other tumour types linked to these pathways.

The trial will include dose-escalation and expansion cohorts across multiple sites in the United States. The first patient is expected to receive treatment in the third quarter of 2026.

Preclinical research published in Nature Cancer in 2024 showed strong inhibition of EGFR and PI3K, durable tumour regression and a differentiated tolerability profile. Toxicology studies supporting the IND application were backed by the National Cancer Institute through its Experimental Therapeutics (NExT) Programme.

Report Abuse