Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets, today announced the presentation of pre-clinical data on novel biomarkers for HER3-driven cancers at the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics 2021. The conference will take place from October 7 to 10, 2021.

To date, despite extensive clinical testing of several HER3-targeting antibodies, there have been few reports of predictive biomarkers of response to HER3 inhibition. Through genomic and transcriptomic analysis of HER3 signaling pathways in pre-clinical models of cancer, Hummingbird has identified a novel gene signature that has the potential to predict response to HER3 inhibition in patients. Hummingbird has also generated additional supporting data for functional NRG1 gene fusions as important predictive biomarkers of response to HER3 inhibition.

In pre-clinical models that carried these biomarkers, Hummingbird's differentiated and highly potent anti-HER3 antibody, HMBD-001, showed potent activity compared to previous generations of anti-HER3 antibodies. These findings build on previous published data, which demonstrated how HMBD-001, with its novel mechanism of action, prevents all types of HER3 activation by blocking the critical heterodimerization interface. Published last year in Molecular Cancer Therapeutics,^[1] the data showed higher potency of HMBD-001 in inhibiting HER3-driven pre-clinical cancer models compared to other classes of HER3-targeting antibodies.

"The traditional approach for understanding which patients will respond to a new therapy often involves a trial-and-error process that not only risks missing the patients that will benefit the most, but also incurs an emotional toll on patients and their families," said Dr. Jerome Boyd-Kirkup, Chief Scientific Officer, Hummingbird. "Through deeper analyses of the underlying disease processes, we aim to make the patient identification process more efficient for our therapies. New biomarkers such as these will allow us to accelerate the precision development of HMBD-001, and get this important new drug to the right patients as quickly as possible."

Hummingbird will further evaluate these biomarkers for identifying patients with a higher probability of response during the upcoming clinical trials of HMBD-001. In Q4 2021, a Phase 1 clinical study is anticipated to begin in the UK in partnership with Cancer Research UK's Centre for Drug Development, following the approval of Clinical Trial Authorization by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in August 2021.

Presentation title: An anti-HER3 antibody, HMBD-001, that uniquely binds to and blocks the HER3 heterodimerization interface, shows superior tumor growth inhibition in biomarker-defined preclinical cancer models including NRG1 fusion driven cancers

Presentation will be available on demand throughout the conference. On-demand materials will be available for 90 days, starting approximately 5-7 business days after the live program ends.