Epsilogen and Lonza achieve manufacturing milestone with ovarian cancer therapy
This news marks the first time that GMP manufacturing of a therapeutic IgE has been achieved a scale.
This included process development and cGMP manufacturing of this complex molecule for clinical supply in less than ten months at Lonza’s Slough site in the UK.
Epsilogen intends to use this new material for its upcoming phase 1b study in platinum-resistant ovarian cancer patients, scheduled to start in 2024.
A previous clinical study found MOv18 IgE to be safe and well-tolerated, with early evidence of anti-tumour activity observed.
Stefan Egli, global head of mammalian biologics at Lonza, said: “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.”
IgE antibodies represent powerful alternatives to more commonly used IgG antibodies, bringing potential opportunities for oncology due to their strong potency, long tissue half-life, and the ability to target tumour cells expressing very low antigen levels.
Dr. Tim Wilson, CEO of Epsilogen, commented: “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.
“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.”
“We remain optimistic about the potential of IgE antibodies as a new treatment modality to improve outcomes for patients with difficult-to-treat cancers.”
MOv18 IgE targets the folate receptor alpha (FR alpha) antigen and Epsilogen believes that it was the first and remains the only, IgE antibody in clinical development.
