Epsilogen Receives CTA Approval for Phase Ib Trial of MOv18 IgE in Platinum-Resistant Ovarian Cancer

Epsilogen Receives CTA Approval for Phase Ib Trial of MOv18 IgE in Platinum-Resistant Ovarian Cancer

Epsilogen has announced that it has received Clinical Trial Authorization (CTA) approval for a Phase Ib study to evaluate the efficacy of MOv18 IgE in patients with platinum-resistant ovarian cancer (PROC). The trial is expected to commence later in 2024.

Dr. Tim Wilson, Chief Executive Officer of Epsilogen, remarked, “This CTA marks another significant milestone for Epsilogen and the development of MOv18 IgE. We are excited to advance MOv18 IgE into a Phase Ib efficacy study later this year, continuing to showcase the potential of IgE antibodies as a novel class of cancer treatments.”

MOv18 IgE

MOv18 IgE is an immunoglobulin E (IgE) antibody targeting the folate receptor alpha (FR alpha) antigen, which is present on various cancers, including ovarian, endometrial, lung, and triple-negative breast cancer. Epsilogen has completed a Phase I safety study of MOv18 IgE in PROC patients, with results published in Nature Communications. The study found MOv18 IgE to be safe, well tolerated, and showed evidence of anti-tumor activity. Additionally, Epsilogen and its partner Lonza have successfully completed the large-scale Good Manufacturing Practice (GMP) manufacturing of MOv18 IgE earlier this year.

the Phase Ib Study

The Phase Ib study aims to confirm the safety and tolerability of MOv18 IgE and demonstrate its efficacy in PROC patients. Following dose escalation, an expansion cohort will be recruited to make a preliminary assessment of MOv18 IgE’s anti-tumor activity at a selected dose. The study will also evaluate the delay in disease progression and include several translational elements to enhance understanding of MOv18 IgE in the study population.

Epsilogen is a global leader in developing immunoglobulin E (IgE) antibodies for cancer treatment. IgE’s natural function is to provide immunological defense against certain parasites, making it ideal for treating solid tumors due to its strong potency, enhanced tumor access, and long tissue half-life.

Epsilogen’s lead product candidate, MOv18 IgE, is the first therapeutic IgE antibody to enter clinical trials. Data from a completed Phase I trial demonstrated that MOv18 IgE is safe, well tolerated, and shows early signs of clinical activity. Epsilogen has recently completed the large-scale GMP manufacture of MOv18 IgE 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,

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