Therapeutic IgE antibody manufactured at scale

In a partnership to produce a therapeutic antibody targeting ovarian cancer, immunoglobulin (IgE) antibodies developer Epsilogen and manufacturing partner Lonza have announced successful completion of Epsilogen’s MOv18 Iead candidate. This included process development and cGMP manufacturing of this complex molecule for clinical supply in less than ten months at Lonza’s Slough (UK) site.

Current research and monitoring indicates that this could be the first time GMP manufacturing of a therapeutic IgE antibody has been completed at scale. As a powerful alternative to more commonly used IgG antibodies, IgE’s offer strong potency, long tissue half-life and the ability to target tumour cells expressing very low antigen levels. 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.

Dr. Tim Wilson, Chief Executive Officer, Epsilogen, commented: “The successful GMP manufacture at scale of MOv18 IgE marks another major milestone in realising the potential of IgE antibodies as a new and differentiated class of cancer therapies for the treatment of patients with solid tumours. Decades of technical achievement and financial investment have made GMP manufacture of the IgG class of therapeutic antibodies a routine process. Lonza and Epsilogen have worked together to apply Lonza’s knowledge and experience to MOv18 IgE. 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, added: “This marks a significant milestone for Epsilogen, bringing its promising IgE-based product closer to the clinic. 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.”

The study and results were published in Nature Communications

More information online