Ellipses Announces FDA Clearance of IND Application for EP0031 for Patients With Advanced RET-altered Malignancies

Ellipses Pharma (“Ellipses”), a global drug development company focused on accelerating the development of cancer medicines and treatments through an innovative drug development model, announces that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for EP0031, a next generation selective RET inhibitor (SRI).

Developed in partnership with Sichuan Kelun-Biotech Pharmaceutical Co., Ltd (Kelun-Biotech), EP0031 (known as A400 when in conjunction with Kelun-Biotech’s ongoing regional development) is a next generation SRI under development for the treatment of RET-altered cancers, with the first trials to focus on thyroid and non-small cell lung cancer. Kelun-Biotech has already commenced a clinical trial of EP0031 (A400) in China, which is progressing rapidly towards the dose expansion stage.

Approval of the IND is a significant step in the initiation of a global, modular Phase 1/2 trial to evaluate the safety, tolerability and efficacy of EP0031 in patients with advanced RET-altered cancers including patients who have not received prior treatment with first generation SRIs. The trial will include sites across the US and Europe and the first patient is anticipated to enter the dose escalation part of the trial in Q3 2022. Further regulatory submissions in the UK and EU are anticipated shortly to support the initiation of the trial in countries outside of the US.

Dr Rajan Jethwa, Chief Executive Officer & Founder of Ellipses, commented:
“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.”