Hummingbird Bioscience and Cancer Research UK have dosed the first subject in a Phase I trial of the company’s monoclonal antibody drug candidate, HMBD-001, to treat individuals with advanced HER3-expressing solid malignancies in the UK.

An anti-HER3 antibody, HMBD-001 leverages a differentiated mechanism of action to potentially hinder the development of all active HER3 dimers, irrespective of NRG1 ligand binding or overexpression of HER2/EGFR.

The trial is sponsored and run by the Centre for Drug Development of the Cancer Research UK and The Institute of Cancer Research, London.

It will analyse the safety, tolerability, pharmacodynamics, pharmacokinetics and detect initial evidence of the antibody’s activity in subjects with advanced HER3-expressing solid malignancies, comprising NRG1 fusion-driven tumours.

Hummingbird Bioscience chief scientific officer Dr Jerome Boyd-Kirkup said: “Dosing of the first patient in the clinical trial of HMBD-001, Hummingbird’s most advanced programme, marks the beginning of a potentially transformative approach to treating HER3-driven cancers.

“Hummingbird Bioscience is dedicated to discovering and developing important medicines for cancer and autoimmune disease with our unique Rational Antibody Discovery platform.”

Preliminary results from the Phase I dose-escalation trial are anticipated in the second half of next year.

In preclinical models, HMBD-001 showed greater affinity and potently hindered tumour growth versus other current anti-HER3 antibodies.

Cancer Research UK Centre for Drug Development director Dr Nigel Blackburn said: “Although HER3 was discovered over 30 years ago, no therapies able to block its cancer-promoting action have been approved.

“Hummingbird Bioscience has taken fresh aim at a difficult drug target and has come up with a novel, potentially transformative antibody for cancer patients who desperately need new treatments.”

In August 2019, Hummingbird and Cancer Research UK partnered to develop HMBD-001 for the treatment of HER3-driven cancer patients.