Epsilogen announces CTA approval for Phase Ib trial of MOv18 IgE in platinum-resistant ovarian cancer

2024-07-08

临床1期免疫疗法临床申请

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

LONDON, UK I July 08, 2024 I 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.

SOURCE: Epsilogen

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