Safety and anti-tumour activity of the IgE antibody MOv18 in patients with advanced solid tumours expressing folate receptor-alpha: a phase I trial

James Spicer (), Bristi Basu, Ana Montes, Udai Banerji, Rebecca Kristeleit, Rowan Miller, Gareth J. Veal, Christopher J. Corrigan, Stephen J. Till, Mariangela Figini, Silvana Canevari, Claire Barton, Paul Jones, Sarah Mellor, Simon Carroll, Chris Selkirk, George Nintos, Vineet Kwatra, Ionut-Gabriel Funingana, Gary Doherty, Hannah J. Gould, Giulia Pellizzari, Mano Nakamura, Kristina M. Ilieva, Atousa Khiabany, Chara Stavraka, Jitesh Chauhan, Cheryl Gillett, Sarah Pinder, Heather J. Bax, Debra H. Josephs and Sophia N. Karagiannis
Additional contact information
James Spicer: King’s College London
Bristi Basu: University of Cambridge
Ana Montes: Cancer Centre, Guy’s and St Thomas’ NHS Foundation Trust
Udai Banerji: Institute of Cancer Research and Royal Marsden Hospital NHS Foundation Trust
Rebecca Kristeleit: Cancer Centre, Guy’s and St Thomas’ NHS Foundation Trust
Rowan Miller: University College London
Gareth J. Veal: Newcastle University Centre for Cancer
Christopher J. Corrigan: King’s College London
Stephen J. Till: King’s College London
Mariangela Figini: Fondazione IRCCS, Istituto Nazionale dei Tumori
Silvana Canevari: Fondazione IRCCS, Istituto Nazionale dei Tumori
Claire Barton: Cancer Research UK
Paul Jones: Cancer Research UK
Sarah Mellor: Cancer Research UK
Simon Carroll: Cancer Research UK
Chris Selkirk: Cancer Research UK
George Nintos: Cancer Centre, Guy’s and St Thomas’ NHS Foundation Trust
Vineet Kwatra: Cancer Centre, Guy’s and St Thomas’ NHS Foundation Trust
Ionut-Gabriel Funingana: University of Cambridge
Gary Doherty: University of Cambridge
Hannah J. Gould: King’s College London
Giulia Pellizzari: King’s College London
Mano Nakamura: King’s College London
Kristina M. Ilieva: King’s College London
Atousa Khiabany: King’s College London
Chara Stavraka: King’s College London
Jitesh Chauhan: King’s College London
Cheryl Gillett: King’s College London
Sarah Pinder: King’s College London
Heather J. Bax: King’s College London
Debra H. Josephs: King’s College London
Sophia N. Karagiannis: King’s College London

Nature Communications, 2023, vol. 14, issue 1, 1-11

Abstract: Abstract All antibodies approved for cancer therapy are monoclonal IgGs but the biology of IgE, supported by comparative preclinical data, offers the potential for enhanced effector cell potency. Here we report a Phase I dose escalation trial (NCT02546921) with the primary objective of exploring the safety and tolerability of MOv18 IgE, a chimeric first-in-class IgE antibody, in patients with tumours expressing the relevant antigen, folate receptor-alpha. The trial incorporated skin prick and basophil activation tests (BAT) to select patients at lowest risk of allergic toxicity. Secondary objectives were exploration of anti-tumour activity, recommended Phase II dose, and pharmacokinetics. Dose escalation ranged from 70 μg–12 mg. The most common toxicity of MOv18 IgE is transient urticaria. A single patient experienced anaphylaxis, likely explained by detection of circulating basophils at baseline that could be activated by MOv18 IgE. The BAT assay was used to avoid enrolling further patients with reactive basophils. The safety profile is tolerable and maximum tolerated dose has not been reached, with evidence of anti-tumour activity observed in a patient with ovarian cancer. These results demonstrate the potential of IgE therapy for cancer.

Date: 2023
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DOI: 10.1038/s41467-023-39679-9

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