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 it has inaugurated the first large-scale Phase 1/2 oncology clinical study of its kind in the United Arab Emirates, marking a significant milestone in the region’s healthcare landscape.
Following approval by the UAE regulators and the Ministry and Department of Health, this study will be conducted initially at two major healthcare centres in Abu Dhabi - the Cleveland Clinic and Tawam Hospital. The inclusion of a third study centre is pending. Patient recruitment has commenced.
The trial will focus on Ellipses' next generation selective RET inhibitor (SRI), EP0031/A400, a potential treatment of RET-altered tumours, most prevalent in non-small cell lung cancer and thyroid cancer.
Professor Sir Christopher Evans, OBE, Executive Chairman, Ellipses, said: “Our mission to find outstanding potential cancer treatments and develop them at pace has been made possible in a very large part by the unwavering support we have had from our investors in Abu Dhabi who embraced the Ellipses model and vision from its early stages.
“This tremendous commitment has led us to the point where our achievements can be brought to bear for the potential benefit of patients in UAE. In many ways, we can now bring hope and an innovative therapy to people in the UAE and also enable healthcare professionals to collaborate and share research. This trial is the first of many trials we hope to conduct in the region.”
Sir Chris is one of several global life sciences and healthcare experts on the Advisory Board of M42, the pioneering Abu Dhabi based tech enabled company, which is supporting the Ellipses initiative, and serves on the board of directors of the Emirates Drug Establishment.
The U.S. Food and Drug Administration (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 Tobias Arkenau, Global Head of Drug Development and Chief Medical Officer, Ellipses commented: “The opening of the EP0031/A400 trial in the UAE is a very exciting initiative. Through trials carried out to date, our belief has been reinforced that EP0031/A400 has the potential to be a transformational next generation RET inhibitor - in particular for patients with RET-positive NSCLC and thyroid cancers, which remain a progressive and fatal condition for hundreds of thousands of patients worldwide.”
About EP0031/A400
EP0031/A400 is being developed jointly by Ellipses in a global clinical phase 1/2 trial under the name EP0031 (NCT05443126) and Kelun Biotech (6990.HK) in China under the name A400 (NCT05265091). Modular Phase 1 studies have been conducted in the US, Europe and China and registrational Phase 2 trials in China and US, Europe and UAE are ongoing.
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 certain Asian countries. 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/A400 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, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 1 project has been approved for marketing, 3 projects are in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world’s leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.
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