Epsilogen, a leading immunoglobulin E (IgE) antibodies developer treating cancer, and global biopharma leader Lonza have successfully completed Good Manufacturing Practice (GMP) manufacturing of MOv18 IgE,  Epsilogen’s lead IgE antibody drug candidate.

At Lonza's Slough (UK) site, this complex molecule was developed and cGMP manufactured in less than ten months. Epsilogen intends to use this new material for its upcoming Phase Ib study in platinum-resistant ovarian cancer (PROC) patients, scheduled to start later in 2024.

MOv18 IgE targets the folate receptor alpha (FR alpha) antigen and Epsilogen states that this is the first and only, IgE antibody in clinical development. Epsilogen has successfully completed a Phase I safety study of MOv18 IgE in platinum-resistant ovarian cancer patients, demonstrating safety and effectiveness against tumour growth. 

Dr. Tim Wilson, Chief Executive Officer, Epsilogen, said, “The successful GMP manufacture at scale of MOv18 IgE marks another major milestone in realizing the potential of IgE antibodies as a new and differentiated class of cancer therapies for the treatment of patients with solid tumours. As a part of the IgE antibody class, it is structurally and functionally distinct from IgG. It is very gratifying to see this effort and investment pay off. Having generated encouraging safety and tolerability data in our Phase I safety study for MOv18 IgE in patients with platinum-resistant ovarian cancer, we look forward to exploring further the signals of efficacy observed in that clinical trial and anticipate starting a Phase Ib efficacy study in this setting later in 2024. We remain optimistic about the potential of IgE antibodies as a new treatment modality to improve outcomes for patients with difficult-to-treat cancers.”

Stefan Egli, Global Head of Mammalian Biologics, Lonza, said,  “Having produced the GMP batch of this non-platform complex molecule under record time is also a statement that demonstrates the strategic value of our manufacturing services offering tailored to each molecule’s unique properties, and analytical and purification needs.”