Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets, today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the clinical trial application (CTA) to initiate first-in-human phase 1 trial of HMBD-001 in patients with advanced cancers.

HMBD-001 is a novel antibody with a unique, differentiated mechanism of action that fully inhibits HER3 activation of the MAPK/PI3K tumor growth signaling pathway. By binding to the HER3 dimerization interface, HMBD-001 blocks the formation of all HER3 dimers, regardless of NRG1 ligand-binding or HER2/EGFR overexpression. Pre-clinical studies in multiple HER3 cancer models, including those with NRG1-fusions, have shown that these differentiated properties of HMBD-001 result in robust and sustained tumor growth inhibition.

The phase 1 trial will be a multi-center, open-label, dose-escalation and -expansion study, to be conducted in two parts. First, the safety and tolerability profile and recommended phase 2 dose of HMBD-001 will be determined in patients with advanced tumors known to overexpress HER3. This will be followed by further evaluation of safety and preliminary anti-tumor activity of HMBD-001 as a monotherapy in biomarker-selected patients, including those with NRG1 fusions, as well as in combination with other selected targeted therapies. Under a clinical development partnership agreement, Cancer Research UK will be funding and conducting the phase 1 trial in the UK.

"This marks an exciting next step in our journey to deliver a potentially transformative therapy for hard-to-treat cancers that express HER3 and are resistant to standard of care treatments," said Jerome Boyd-Kirkup, Chief Scientific Officer and co-founder of Hummingbird Bioscience. "Our platform technology was developed specifically to tackle biologically relevant yet extremely challenging targets for which research efforts to-date have yet to generate effective treatments. HMBD-001 is the first of our growing pipeline of rationally designed antibodies to obtain clinical trial approval, demonstrating the power of the platform to develop highly differentiated, precision therapies."

About HMBD-001

HMBD-001 is a anti-HER3 neutralizing antibody, with a novel mechanism of action that offers significant potential for clinical benefit. Previous attempts to block the HER3 receptor, a key player in the PI3K/MAPK signaling pathways that promotes cell division and tumor growth in cancer, have not proven to be effective. HER3 is activated by the binding of NRG1, which stabilizes a transient open conformation to allow it to form heterodimers with HER2/EGFR. In the presence of abundant HER2/EGFR, heterodimers can form without NRG1.

Pre-clinical studies have shown that HMBD-001 potently inhibits the formation of these heterodimers, blocking activation of the signalling pathway – and consequently, prevents tumor growth. Cancer Research UK has partnered with Hummingbird Bioscience to advance this novel drug candidate into clinical trials for the treatment of HER3-driven cancers.

About Hummingbird Bioscience

Hummingbird Bioscience is an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets to improve treatment outcomes. We harness the latest advances in systems biology and data science to better understand and solve the underlying causes of disease and guide development of our therapeutics.

Enabled by our proprietary Rational Antibody Discovery platform, we discover and engineer precision therapies against optimal yet elusive epitopes that have not been successfully drugged, unlocking novel mechanisms of action. We are advancing a rich pipeline of first- and best-in-class precision therapies in oncology and autoimmunity, in collaboration with global partners in academia and industry.

Our highly experienced, multidisciplinary teams in US and Singapore span antibody discovery, pharmacology, production, data science and clinical development. Together we aim to accelerate the journey of new drugs from concept to clinical care.