Epsilogen gets CTA nod for Phase Ib trial of MOv18 IgE in platinum-resistant ovarian cancer

Epsilogen, a prominent company specializing in the development of immunoglobulin E (IgE) antibodies for cancer treatment, has announced the approval of its Clinical Trial Application for a Phase Ib trial of MOv18 IgE by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The Phase Ib study, anticipated to begin in the latter half of 2024, will assess the efficacy of MOv18 IgE in patients suffering from platinum-resistant ovarian cancer (PROC).

Dr. Tim Wilson, Chief Executive Officer of Epsilogen, expressed enthusiasm about this milestone, highlighting its significance for the clinical advancement of MOv18 IgE. He stated that the company looks forward to progressing into the Phase Ib efficacy study later in the year, continuing to showcase the potential of IgE antibodies as a novel and distinct class of cancer treatments.

MOv18 IgE is an IgE antibody aimed at the folate receptor alpha (FR alpha) antigen, which is found in various cancers such as ovarian, endometrial, lung, and triple-negative breast cancer. Epsilogen has previously completed a Phase I safety study of MOv18 IgE in PROC patients. Published results in *Nature Communications* indicated that MOv18 IgE is safe, well-tolerated, and has shown evidence of anti-tumor activity. Additionally, Epsilogen, in collaboration with Lonza, successfully completed large-scale Good Manufacturing Practice (GMP) manufacturing of MOv18 IgE earlier this year.

The upcoming Phase Ib study aims to confirm the safety and tolerability of MOv18 IgE while demonstrating its efficacy in treating PROC. The study will begin with a dose-escalation phase, followed by the recruitment of an expansion cohort to make a preliminary assessment of MOv18 IgE's anti-tumor activity at a determined dose. Parameters such as delay in disease progression and several translational elements will also be evaluated to gain a deeper understanding of MOv18 IgE's impact on the study population.

Epsilogen Ltd, founded in 2017 as a spin-out from King’s College London, has positioned itself as a leader in the development of IgE antibodies to combat cancer. IgE’s natural role is to provide immunological defense against specific parasites, making it a potent candidate for solid tumor treatments due to its strong potency, enhanced tumor access, and prolonged tissue half-life. The company’s primary product, MOv18 IgE, is the first therapeutic IgE antibody to enter clinical trials. Phase I trial data has already shown that MOv18 IgE is safe, well-tolerated, and exhibits early signs of clinical activity. Following the successful large-scale GMP manufacture of MOv18 IgE, Epsilogen is set to commence a Phase Ib trial later this year targeting platinum-resistant ovarian cancer patients.

In addition to MOv18 IgE, Epsilogen is developing a pipeline of IgE therapies in oncology. The company's proprietary platforms include IgE bispecifics and unique IgE/IgG combination antibody molecules (IgEGs) designed to enhance functionality. The company has secured venture capital financing from various investors, including Epidarex Capital, Novartis Venture Fund, 3B Future Health, British Patient Capital, ALSA Ventures, and Schroders Capital.