First time GMP manufacturing of a therapeutic IgE antibody has been achieved at scale
GMP material to be used in Phase Ib study in platinum-resistant ovarian cancer (PROC) patients scheduled to start this year. Previously reported Phase I safety study results in PROC patients showed MOv18 IgE to be safe and well-tolerated, with early evidence of anti-tumour activity observed
Lonza supported the expression and manufacturing of the MOv18 IgE antibody in less than ten months
Epsilogen, a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, and Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, today announced successful completion of Good Manufacturing Practice ("GMP") manufacturing of MOv18 IgE, Epsilogen's lead IgE antibody drug 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.
IgE antibodies represent powerful alternatives to more commonly used IgG antibodies. They bring exciting opportunities for oncology thanks to their strong potency, long tissue half-life, and the ability to target tumour cells expressing very low antigen levels. Current research and monitoring indicate that this is the first time GMP manufacturing of a therapeutic IgE antibody has been completed at scale. 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 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.
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."
MOv18 IgE targets the folate receptor alpha (FR alpha) antigen and Epsilogen believes that this was the first, and remains the only, IgE antibody in clinical development. Epsilogen has successfully completed a Phase I safety study of MOv18 IgE in platinum-resistant ovarian cancer patients where it was found to be safe and well-tolerated, with evidence of anti-tumour activity observed. This study and its results were reported in Nature Communications
About Epsilogen Ltd
Epsilogen is a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer. IgE's natural function is to provide immunological defence against certain parasites. This functionality makes it an ideal treatment of solid tumours due to its strong potency, enhanced tumour access and long tissue half-life.
Epsilogen's lead product candidate, MOv18 IgE, is the first therapeutic IgE antibody to enter the clinic and encouraging data from a completed Phase I trial demonstrated MOv18 IgE to be safe and well tolerated with early signs of clinical activity. The company is also developing a proprietary IgEG antibody platform combining elements from both IgE and IgG antibodies into novel and proprietary antibody molecules with enhanced functionality.
Epsilogen began operations in 2017 as a spin-out of King's College London and has attracted venture capital financing from Epidarex Capital, Novartis Venture Fund, 3B Future Health, British Patient Capital, ALSA Ventures and Schroders Capital amongst others. Find out more at epsilogen.com.
Disclaimer
Certain matters discussed in this media advisory may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this media advisory.
All trademarks belong to Lonza and are registered in CH, US and/or EU, or belong to their respective third party owners and are used only for informational purposes.
Privacy Policy link
View source version on businesswire.com: https://www.businesswire.com/news/home/20240305297151/en/
Contacts:
Epsilogen Contact Details
Simon Conway
Senior Managing Director
FTI Consulting
epsilogen@fticonsulting.com
+44 (0)20 3727 1000
Lonza Contact Details
media@lonza.com
