Ellipses Announces FDA Clearance of IND Application for EP0031 for Patients With Advanced RET-altered Malignancies
A phase 1/2 trial to initiate across a range of patient populations with RET-altered cancers
LONDON--(BUSINESS WIRE)-- Ellipses Pharma (“Ellipses”), a global drug development company focused on accelerating the development of cancer medicines and treatments through an innovative drug development model, today 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.”
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 overcome resistance mechanisms to first generation SRIs. In preclinical studies, EP0031 (A400) demonstrated favourable inhibitory activity against key RET kinases in-vitro and in-vivo. EP0031 (A400) also demonstrated good penetration of the blood brain barrier in animal models. 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.
About Ellipses Pharma Limited
Ellipses Pharma is a global drug development company based in London, focused on accelerating the development of cancer treatments through an innovative drug development model that combines unbiased vetting to de-risk initial asset selection with an uninterrupted funding flow to minimise the time it takes to advance lead products through clinical trials and reach patients.
For more information, please visit ellipses.life
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. is a subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd., founded in 2016. Kelun-Biotech is committed to developing and commercializing innovative drugs for the treatment of cancer, autoimmune and other diseases with unmet medical needs.
Kelun-Biotech has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls) and clinical development capabilities. Leveraging the platform, the company has built a robust pipeline, one I/O molecule in NMPA NDA stage, three molecules (including one monoclonal antibody and 2 ADCs) in Phase 3 or pivotal clinical trials and an additional 10 molecules in early Phase 1 or 2 clinical studies.
Source: Ellipses Pharma