Subjects: TRI, FDA
Ellipses' next generation selective RET inhibitor EP0031/A400 cleared to start Phase 2
Drug has successfully completed US Food and Drug Administration's End of Phase 1 data review
LONDON, May 1, 2024 /PRNewswire/ -- Ellipses Pharma Limited ("Ellipses"), a global drug development company focused on accelerating the development of cancer treatments through an innovative drug development model, announced today the U.S. Food and Drug Administration (FDA) has confirmed the company's next generation selective RET inhibitor (SRI), EP0031/A400, is clear to progress into Phase 2 clinical development.
EP0031/A400 is a potential treatment of RET-altered tumours and clinical data in studies to date has shown promising efficacy in patients with NSCLC, thyroid and other solid tumours. Durable responses have been seen in patients who were naive to, or who had been pre-treated with, 1st generation SRIs including in patients with brain metastases1. The latest clinical data from the Ellipses Phase 1 study will be presented at ASCO in Chicago on June 3rd 2024.
EP0031 is being developed jointly by Ellipses in a global clinical phase 1/2 trial under the name EP0031 (NCT05443126) and Sichuan-Kelun Biotech in China under the names KL590586/A400 (NCT05265091). Modular Phase 1 studies have been conducted in the US, Europe and China and a registrational Phase 2 trial in China is ongoing.
The FDA granted Orphan Drug Designation to EP0031/A400 in November 2023 and in March of this year granted it Fast Track Designation, which facilitates the expedited development and review of new drugs intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.
Professor Sir Christopher Evans, Chairman, Ellipses, said: "We are greatly encouraged with the progress to date of EP0031/A400 and look forward to rapidly generating Phase 2 data, which will be another key step towards bringing this treatment to patients."
Dr Rajan Jethwa, Chief Executive Officer, Ellipses, commented: "We are excited to announce another important clinical milestone as we continue to drive the development of EP0031 towards an NDA as a potential next-generation treatment for people living with RET-altered NSCLC and other cancers."
Professor Tobias Arkenau, Global Head of Drug Development and Chief Medical Officer, Ellipses commented: "At every stage our belief has been reinforced that EP0031/A400 can be a transformational treatment for patients with RET fusion-positive NSCLC, which remains a progressive and fatal condition for hundreds of thousands of patients worldwide, despite available treatment options."
About EP0031
In March 2021, Kelun-Biotech granted Ellipses an exclusive licence for EP0031 (A400) in certain territories including the US and Europe, with Kelun-Biotech retaining certain rights in Greater China. An Investigational New Drug Application (IND) application for EP0031 (A400) was approved by China's National Medicinal Products Administration in June 2021 and a registrational Phase 2 trial is ongoing in China. In June 2022, the U.S. Food and Drug Administration approved the EP0031 Phase 1/2 study IND application in the US.
About RET altered malignancies
Activating RET mutations and rearrangements have been identified as actionable drivers of oncogenesis in numerous tumour types and are most prevalent in non-small cell lung and thyroid cancer. It is estimated that RET mutations and rearrangements may be responsible for ~2% of all solid tumours. After the successful development of first generation SRIs and an increasing understanding of escape mechanisms to these agents, there is an unmet need to develop new treatments that can address acquired resistance, including the development of next-generation SRIs.
About Ellipses Pharma Limited
Ellipses 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.
About Kelun-Biotech
Kelun-Biotech?6990.HK?is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialisation and global collaboration of innovative drugs. The company focuses on major disease areas such as solid tumours, autoimmune, inflammatory and metabolic diseases.
At present, the company has 33 on-going innovative projects for medical needs in selected major disease areas such as solid tumours, autoimmune, inflammatory, and metabolic diseases, including 14 projects in the clinical stage and multiple global trials conducted in several regions such as China, Europe, and the United States. For more information, please visit https://kelun-biotech.com/.
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