On December 14, 2022 Ellipses Pharma ("Ellipses"), a global drug development company focused on accelerating the development of new oncology treatments, reported the first dosing of a patient in EP0031-101, a trial investigating Ellipses’ next generation selective RET inhibitor (SRI) EP0031 (Press release, Ellipses Pharma, DEC 14, 2022, View Source [SID1234625287]).

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EP0031 is an SRI which aims to address the unmet need for patients with RET-altered tumours (Non-Small Cell Lung Cancer (NSCLC), medullary thyroid and other RET-altered tumours) who have progressed on first generation SRIs. This global, modular, Phase 1/2 trial will evaluate the safety, tolerability and efficacy of EP0031 in patients with advanced RET-altered tumours and is now open to enrolment at multiple US sites. Ellipses plans to open further trial sites in the UK and EU in 2023.

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 already under clinical investigation in China for NSCLC and thyroid cancers. Kelun-Biotech continues to rapidly progress their clinical trial which is now in the dose expansion stage. Kelun will present clinical data for the first time at an international conference in 2023.

Prof Tobi Arkenau, Global Head of Drug Development & CMO, commented:

"Enrolment has started at UCLA, Portland Providence, MD Anderson and University of Kentucky and these will be joined by more sites in the next few months. There is an increasing number of patients whose cancers progress despite treatment with first generation SRIs, and as such EP0031 provides an exciting opportunity to address this unmet need."

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

"EP0031 is a promising next generation SRI that seeks to address some of the issues with first generation SRIs. Dosing the first patient in this trial is an important first step for EP0031. Next generation SRIs offer the potential to expand the armamentarium against RET-driven cancers and further improve patient outcomes."

Dr Junyou Ge, Chief Executive Officer of Kelun-Biotech, commented:

"A400 (EP0031) offers a significant therapeutic potential for tumours with RET oncogene mutation/fusion and is hoped to bring new treatment options for patients. We are pleased that the EP0031-101 trial has dosed the first patient in the United States and congratulate our partner Ellipses on this important milestone. Kelun-Biotech will continue to collaborate with Ellipses to promote the global development and subsequent potential commercialisation of A400 to benefit more cancer patients around the world."

About EP0031 (A400)

EP0031 is a potent next generation SRI with broad activity against common RET fusions and mutations, including solvent front resistance mutations. Therefore, EP0031 (A400) may have the potential to overcome resistance to first generation SRIs. An IND application for EP0031 (A400) was approved by China’s National Medicinal Products Administration (NMPA) in June 2021 and a Phase 1/2 trial is ongoing in China. In March 2021, Kelun-Biotech granted Ellipses an exclusive license for EP0031 (A400) in certain territories including the US and Europe, with Kelun-Biotech retaining certain rights in Greater China and part of the Asia-Pacific region. In June 2022, the US FDA approved the EP0031 IND application, and the Ellipses Phase 1/2 trial is ongoing in the US.

About RET-altered cancers

It is estimated that RET fusions & mutations may be responsible for ≃2% of all cancers, this includes 2% of NSCLC, 60-80% of medullary thyroid cancers (MTC) and <1-20% across a range of other cancers.1 When patients progress on currently approved first generation SRIs there are limited treatment options and prognosis is poor.