MOv18 IgE is the first therapeutic IgE antibody to enter clinical trials
Results support, for the first time, the safety and potential efficacy of an IgE antibody as a treatment for advanced cancer
London, 27 April 2020 – Epsilogen (formerly IGEM Therapeutics), a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, today announces that encouraging interim data from the ongoing phase 1 clinical study of MOv18 IgE was presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting I. Epsilogen recently in-licensed exclusive global rights to MOv18 IgE from Kings College London (KCL), UK.
Lead investigator, Professor James Spicer of KCL, presented results from the study, which is being funded, sponsored and conducted by Cancer Research UK’s Centre for Drug Development. The trial is evaluating MOv18 IgE, a first-in-class IgE antibody, specific for anti-folate receptor alpha (FR alpha), in patients with advanced cancer. The primary objectives of the study are safety and tolerability of the study drug, which is administered by intravenous (IV) infusion. Secondary objectives include anti-tumour activity, as measured by computed tomography (CT) scans and tumour markers.
Results were presented on the first 24 patients enrolled in the study. Most of these patients had ovarian cancer, the most common cancer in which FR alpha is overexpressed. MOv18 IgE, at the doses administered, was found to be well tolerated in almost all patients, with urticaria1 being the most frequently observed adverse event. Importantly, given the role of IgE in mediating allergic reactions, only one patient exhibited any symptoms of anaphylaxis (500 μg dose). The episode was quickly resolved using standard management. This patient was the only one out of the 24 treated to date with a positive baseline basophil2 activation test (BAT). BAT is a flow cytometry-based in vitro assay, in which expression of activation markers is measured on the surface of basophils in whole patient blood following stimulation with IgE antibody. A positive baseline BAT assay has been used as an exclusion criterion for patients enrolled subsequent to the single anaphylaxis event. The investigators believe that the BAT could be employed as a risk mitigator for anaphylaxis in further studies with the drug.
The phase 1 study was not designed to assess efficacy as the primary endpoint. However, the investigators believe that there was a transient signal of anti-tumour activity in CT scans and in a temporary CA125 biomarker decrease for one patient with ovarian cancer, where their ascites3 were also reduced.
Professor James Spicer, of KCL and lead investigator of the phase 1 study said: “This phase 1 study, evaluating MOv18 IgE in advanced cancer patients, is the first time in which an IgE antibody has been tested in humans as a potential therapeutic. I believe that the encouraging data generated in this trial support the safety and potential efficacy of IgE as new class of antibody treatment for cancer.”
Dr Tim Wilson, Chief Executive Officer of Epsilogen commented: “This data, presented at the prestigious AACR conference, builds on compelling preclinical data and provides the strongest suggestion to date that IgE antibodies can viably form the basis of an efficacious new class of biologic. We believe that IgE antibody therapeutics potentially offer significant advantages over those based on IgG, which currently account for over $120bn in worldwide drug sales – especially in the treatment of solid tumours. These include greater potency, better tumour access and longer tissue half-life.
“Following Epsilogen’s recent in-licensing of MOv18 IgE, the Company look forward to progressing the further clinical development of this promising new treatment for ovarian cancer.
The presentation abstract can be found at https://www.abstractsonline.com /pp8/#!/9045/presentation/10640. The slides and video presentation by Prof Spicer will also be available on the Company’s website, www.epsilogen.com, following the conclusion of the AACR meeting.
Outline of the Phase 1 study (NCT number: NCT02546921)
This multi-centre, dose escalation, phase 1 study, enrols patients with histologically, or cytologically-proven, advanced, unresectable solid tumours where FR alpha on their tumour was detected in a previous biopsy. Eligible patients must also have adequate organ function and no history of severe allergy. Additionally, patients must not require concomitant medication, or have comorbidities, that increase the risk of anaphylaxis. Patients are being administered their allocated dose of MOv18 IgE by IV infusion. Per protocol, following baseline assessment, patients initially receive drug once weekly for six weeks. Following an interim CT assessment, patients may then go on to receive three additional maintenance drug dose, every two weeks. The primary objectives of the study are safety and tolerability of the study drug. Secondary objectives are anti-tumour activity, as measured by CT scanning and/or tumour markers. To date, patients have been assigned to six different dose cohorts ranging from 70μg to 3mg.
1 – hives
2 – a type of white blood cell
3 – a build up of fluid in the lining of the abdomen and a common issue in patients with advanced ovarian cancer
About Epsilogen Ltd (formerly IGEM Therapeutics)
Epsilogen is a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer. IgE has several key features that make it ideal for the treatment of solid tumours including greater potency, enhanced tumour access and a long tissue half-life.
The company has raised Series A finance from Epidarex Capital, ALSA Ventures and the UCL Technology Fund.
For more information, visit www.epsilogen.com
About King’s College London
King’s College London is one of the top 10 UK universities in the world (QS World University Rankings, 2018/19) and among the oldest in England. King’s has more than 31,000 students (including more than 12,800 postgraduates) from some 150 countries worldwide, and some 8,500 staff.
King’s has an outstanding reputation for world-class teaching and cutting-edge research. In the 2014 Research Excellence Framework (REF), eighty-four per cent of research at King’s was deemed ‘world-leading’ or ‘internationally excellent’ (3* and 4*).
World-changing ideas. Life-changing impact: https://www.kcl.ac.uk/news/headlines.aspx
About Cancer Research UK’s Centre for Drug Development
Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for more than 25 years, taking over 160 potential new anti-cancer agents into clinical trials in patients. It currently has a portfolio of around 20 new anti-cancer agents in preclinical development, Phase I or early Phase II clinical trials. Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase III trials.
About Cancer Research UK
For more information please contact:
Chief Executive Officer
+44 (0)20 3657 7612
Communications advisor to Epsilogen:
+44 (0)20 3727 1000
March 8, 2021