Episologen, Lonza manufacture first IgE to treat ovarian cancer

According to the firm, immunoglobulin G (IgG)-based products take at least 12 months to achieve manufacturing, a feat they achieved in less than ten months. The process development and production for clinical supply was carried out at the contract development and manufacturing organization’s (CDMO’s) Slough, UK site.

“Together, we have achieved the first GMP manufacturing of an immunoglobulin E (IgE) antibody at scale for clinical supply in less than ten months at Lonza’s site in Slough, UK,” a spokesperson for Lonza told BioProcess Insider.

"Epsilogen and Lonza have worked together to manufacture Epsilogen’s therapeutic IgE antibody, MOv18 IgE. This is the first time an IgE antibody has been GMP manufactured at scale. The prior Phase I trial was smaller than the forthcoming Phase Ib study and required less material.”

MOv18 IgE is Epsilogen’s lead candidate, which has successfully completed a Phase I trial in platinum-resistant ovarian cancer patients. It is an IgE antibody targeting folate receptor alpha (FR alpha) and has evolved to treat parasitic infections.

To do this it drives a potent immune response against cells expressing the target antigen. The approach relies upon the targeting of this immunological power against tumor-specific antigen.

Epsilogen intends to use this new material for its upcoming Phase Ib study in PROC patients, scheduled to start later in 2024.

“MOv18 IgE is the world’s first IgE antibody to enter the clinic and has successfully completed a Phase I trial in PROC patients,” the spokesperson confirmed.

In 2022, Lonza partnered with Epsilogen’s investment firm ALSA to leverage its development and manufacturing services and network, along with its regulatory competence expertise.

European biotech investment firm ALSA, which includes Promatix, Montis Biosciences, Epsilogen, and Oxford BioTherapeutics, contracted Lonza to help develop and manufacture molecules within its biologics and small molecule portfolio.