The US Food and Drug Administration (FDA) has approved Ellipses Pharma’s investigational new drug (IND) application for EP0031 (A400) to treat advanced RET-altered cancers.
EP0031 is a potent next generation selective RET inhibitor (SRI) with broad activity against common RET fusions and mutations, like solvent front resistance mutations.
It is jointly developed by Ellipses Pharma and Sichuan Kelun-Biotech Pharmaceutical.
The therapy showed favourable inhibitory activity against key RET kinases in- vitro and in-vivo in preclinical studies.
Ellipses Pharma stated that the initial trials of EP0031 will focus on thyroid and non-small cell lung cancer.
The IND approval is a significant step to begin a modular, global Phase I/II trial which is designed to assess EP0031’s tolerability, efficacy, and safety in advanced RET-altered cancers patients including people without prior treatment with first generation SRIs.
The study will include sites across Europe and the US. The first participant is expected to enter the trial’s dose escalation part in the third quarter of this year.
Ellipses CEO and founder Dr Rajan Jethwa said: “EP0031 offers the potential for a promising new treatment option that seeks to address some of the issues with first generation SRIs.
“Next generation SRIs offer the potential to expand the armamentarium against RET-driven cancers and further improve patient outcomes.
“This IND marks another important step for Ellipses. Our strategy is to advance the most promising cancer treatments to the clinic as soon as possible, and the clearance of this IND will allow us to rapidly move forward with our planned clinical trial of EP0031.”
Furthermore, the company plans to submit applications for regulatory approvals in the UK and EU shortly that will support the initiation of the trials on the EP0031 in countries outside of the US.