Phase Ib study expected to initiate in H2 2024
Previously reported Phase I results showedMOv18 IgE to be safe and well tolerated, with evidence of anti-tumour activity
LONDON, 8 July 2024 – 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 ofMOv18 IgE earlier this year.
About the Phase Ibstudy
The Phase Ib study isdesigned to confirm the safety and tolerability of MOv18 IgE and demonstrateefficacy in PROC. Following the dose escalation, an expansion cohort will berecruited to make a preliminary assessment of the anti-tumour activity of MOv18IgE at a selected dose. In addition, delay to disease progression will beassessed along with a number of translational elements to generate furtherunderstanding of MOv18 IgE in the study population.
ENDS
About Epsilogen Ltd
Epsilogen is a globalleader in the development of immunoglobulin E (IgE) antibodies to treat cancer.IgE’s natural function is to provide immunological defence against certainparasites. This functionality makes it an ideal treatment of solid tumours dueto its strong potency, enhanced tumour access and long tissue half-life.
Epsilogen’s leadproduct candidate, MOv18 IgE, is the first therapeutic IgE antibody to enterthe clinic and encouraging data from a completed Phase I trial demonstratedMOv18 IgE to be safe and well tolerated with early signs of clinical activity. Epsilogenhas recently successfully completed large scale GMP manufacture of MOv18 IgE(the first time this has been achieved for an IgE antibody) and will initiate aPhase Ib trial in platinum-resistant ovarian cancer patients later this year. Thecompany is also developing a pipeline of IgE therapies in oncology as well as proprietaryplatforms including IgE bispecifics and unique IgE/IgG combination antibodymolecules (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, 3BFuture Health, British Patient Capital, ALSA Ventures and Schroders Capital amongst others. Find out more at epsilogen.com.
For more information please contact:
Communications advisor to Epsilogen Ltd:
Simon Conway
Senior Managing Director
FTI Consulting
epsilogen@fticonsulting.com
+44 (0)20 3727 1000
