Epsilogen announces CTA approval for Phase Ib trial of MOv18 IgE in platinum-resistant ovarian cancer
08 Julio 2024 - 1:00AM
Business Wire
Phase Ib study expected to initiate in H2
2024
Previously reported Phase I results showed
MOv18 IgE to be safe and well tolerated, with evidence of
anti-tumour activity
Epsilogen, a global leader in the development of immunoglobulin
E (IgE) antibodies to treat cancer, today announces that the
Clinical Trial Application for the Phase Ib trial of MOv18 IgE has
been approved by the UK Medicines and Healthcare products
Regulatory Agency (MHRA).
The Phase Ib study is expected to initiate later in 2024 and
will evaluate the efficacy of MOv18 IgE in patients with
platinum-resistant ovarian cancer (PROC).
Dr Tim Wilson, Chief Executive Officer of Epsilogen,
said: “This CTA is another significant milestone for Epsilogen
and the clinical development of MOv18 IgE. We look forward to
progressing MOv18 IgE into a Phase Ib efficacy study later this
year as we continue to demonstrate the potential of IgE antibodies
as a new, differentiated class of cancer treatments.”
About MOv18 IgE
MOv18 IgE is an immunoglobulin E (IgE) antibody targeting the
folate receptor alpha (FR alpha) antigen. FR alpha is present on a
variety of cancers including ovarian, endometrial, lung and triple
negative breast cancer. Epsilogen has successfully completed a
Phase I safety study of MOv18 IgE in PROC patients. The results of
the study, published in Nature Communications, found MOv18 IgE to
be safe and well tolerated, with evidence of anti-tumour activity
observed. Epsilogen, alongside its partner Lonza, also announced
the successful completion of large-scale Good Manufacturing
Practice (GMP) manufacturing of MOv18 IgE earlier this year.
About the Phase Ib study
The Phase Ib study is designed to confirm the safety and
tolerability of MOv18 IgE and demonstrate efficacy in PROC.
Following the dose escalation, an expansion cohort will be
recruited to make a preliminary assessment of the anti-tumour
activity of MOv18 IgE at a selected dose. In addition, delay to
disease progression will be assessed along with a number of
translational elements to generate further understanding of MOv18
IgE in the study population.
About Epsilogen Ltd
Epsilogen is a global leader in the development of
immunoglobulin E (IgE) antibodies to treat cancer. IgE’s natural
function is to provide immunological defence against certain
parasites. This functionality makes it an ideal treatment of solid
tumours due to its strong potency, enhanced tumour access and long
tissue half-life.
Epsilogen’s lead product candidate, MOv18 IgE, is the first
therapeutic IgE antibody to enter the clinic and encouraging data
from a completed Phase I trial demonstrated MOv18 IgE to be safe
and well tolerated with early signs of clinical activity. Epsilogen
has recently successfully completed large scale GMP manufacture of
MOv18 IgE (the first time this has been achieved for an IgE
antibody) and will initiate a Phase Ib trial in platinum-resistant
ovarian cancer patients later this year. The company is also
developing a pipeline of IgE therapies in oncology as well as
proprietary platforms including IgE bispecifics and unique IgE/IgG
combination antibody molecules (IgEGs) with enhanced
functionality.
Epsilogen began operations in 2017 as a spin-out of King’s
College London and has attracted venture capital financing from
Epidarex Capital, Novartis Venture Fund, 3B Future Health, British
Patient Capital, ALSA Ventures and Schroders Capital amongst
others. Find out more at epsilogen.com.
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Communications advisor to Epsilogen Ltd: Simon Conway Senior
Managing Director FTI Consulting epsilogen@fticonsulting.com +44
(0)20 3727 1000