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/.
www.ellipses.life
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