LONDON - Monday, 23. December 2024 AETOSWire
(BUSINESS
WIRE) -- 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.
www.ellipses.life
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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Contacts
media@ellipses.life
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