Epsilogen has obtained approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its clinical trial application to commence the Phase Ib study of MOv18 IgE to treat platinum-resistant ovarian cancer (PROC).
The trial is anticipated to commence later this year and will assess the safety, tolerability and efficacy of the asset in patients with PROC.
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It will have dose escalation and expansion cohorts. In the expansion cohort, a preliminary analysis of the anti-tumour activity of MOv18 IgE at a selected dose will be evaluated.
Furthermore, the trial will assess the delay in the progression of the disease along with various translational elements for understanding MOv18 IgE further in the subjects.
An immunoglobulin E (IgE) antibody, MOv18 IgE acts on the folate receptor alpha (FR alpha) antigen.
Many malignancies such as ovarian, endometrial, lung, and triple-negative breast cancer, have FR alpha on them.
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By GlobalDataData from a Phase I safety trial of MOv18 IgE in PROC patients showed that the asset was well tolerated and safe, and had an anti-tumour effect.
Earlier this year, the company along with its partner Lonza completed the large-scale good manufacturing practice (GMP) manufacture of MOv18 IgE.
Epsilogen has a pipeline of IgE therapies for oncology indications, as well as platforms, including IgE bispecifics and IgE/IgG combination antibody molecules (IgEGs).
Epsilogen CEO Dr Tim Wilson said: “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.”
