Ellipses’ next generation selective RET inhibitor EP0031/A400 granted Fast Track designation by US Food and Drug Administration
March 5, 2024 – Drug Discovery – Ellipses Pharma, FDA, RET inhibitor, fast track designation
Compound is currently undergoing clinical trials as a potential treatment option for patients with RET altered tumours
5 March 2024 — London, UK — Ellipses Pharma, a global drug development company focused on accelerating the development of cancer treatments through an innovative drug development model, announced today that it has received Fast Track designation from the US Food and Drug Administration (FDA) for its next generation selective RET inhibitor EP0031/A400 for the potential treatment of RET-fusion positive Non-Small Cell Lung Cancer (NSCLC).
The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.
Data from the ongoing modular interventional phase 1/2 trial, which aims to assess the safety, side effects and effectiveness of EP0031/A400 in patients with advanced RET-altered malignancies, were submitted in support of the application, where for the first time EP0031/A400 showed tumour responses in NSCLC patients who were previously treated with first-generation SRIs. Responses appeared to be durable regardless of tumour type, RET fusion type, previous treatment or presence of brain metastases.
This announcement follows the FDA’s decision in November 2023 to grant Orphan Drug Designation (ODD) to EP0031/A400.
Ellipses will now enter more frequent discussion with the FDA to advance rapidly towards an NDA for EP0031/A400 and earlier access by patients.
EP0031 is being developed jointly by Ellipses Pharma in a global clinical trial under the name EP0031 (NCT05443126) and Sichuan-Kelun Biotech in China under the names KL590586/A400 (NCT05265091).
Dr Rajan Jethwa, CEO, Ellipses, commented: “We are committed to accelerating innovation and addressing the spectrum of unmet patient needs in cancer. With our world class drug development expertise, we are building on our heritage in oncology to bring a potential best-in-class treatment to people living with RET fusion-positive NSCLC”
Professor Sir Christopher Evans, chairman, Ellipses Pharma, said: “We are pleased and encouraged that the FDA has approved our company’s application for Fast Track Designation for EP0031/A400. This is an important step towards bringing this treatment to patients that confirms the potential for EP0031/A400 to address real unmet need in patients with NSCLC. We remain grateful to our partners at Sichuan-Kelun for their continued support.”
Professor Tobias Arkenau, global head of Drug Development and chief medical officer, Ellipses Pharma commented: “Receiving Fast Track designation from the FDA reinforces our belief that EP0031/A400 has the potential to be a transformational treatment for patients with RET fusion-positive NSCLC, which remains a progressive and fatal condition for hundreds of thousands of people worldwide, despite available treatment options. This milestone has been reached rapidly and we look forward to working with the FDA to finalise the requirements for our submission for an NDA in due course.”
About Ellipses Pharma Limited
Ellipses Pharma is a global drug development company based in London, UK, 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. Visit: ellipses.life.
About Kelun-Biotech
Kelun-Biotech is a holding subsidiary of Kelun Pharmaceutical, 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 US. For more information, please visit kelun-biotech.com.
