Therapy Areas: Respiratory
Ellipses Receives FDA Clearance of IND Application for EP0031 for Patients with Advanced RET-altered Malignancies
22 June 2022 - - The US Food and Drug Administration has cleared UK-based drug development company Ellipses Pharma's Investigational New Drug application for EP0031, a next generation selective RET inhibitor, the company said.

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 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 3Q22.

Further regulatory submissions in the UK and EU are anticipated shortly to support the initiation of the trial in countries outside of the US.

EP0031 is a potent next generation SRI with broad activity against common RET fusions and mutations, including solvent front resistance mutations.

Therefore, EP0031 may overcome resistance mechanisms to first generation SRIs. In preclinical studies, EP0031 demonstrated favourable inhibitory activity against key RET kinases in-vitro and in-vivo.

EP0031 also demonstrated good penetration of the blood brain barrier in animal models.

An IND application for EP0031 was approved by China's National Medicinal Products Administration 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 in certain territories including the US and Europe, with Kelun-Biotech retaining certain rights in Greater China and part of the Asia-Pacific region.

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.

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 and 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.


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