George Clinical, a global CRO, initiated preparations in Australia for two Phase 1b oncology trials that will examine a Hummingbird Bioscience precision therapy program targeting HER3, a potent driver of tumor growth and resistance against cancer drugs, in biomarker-selected patient populations, including lung cancer.

George Clinical is providing its full-service clinical research services for the Hummingbird Bioscience-sponsored trials.

Hummingbird Bioscience, a data-driven precision biotherapeutics company discovering and developing biologic medicines for hard-to-treat diseases, is bringing its clinical-stage anti-HER3 drug known as HMBD-001 into molecular-matched patient trials in Australia for the first time. According to the company, molecular-matched therapies have revolutionized cancer treatment with the capability to inhibit specific molecular targets leading to better therapeutic responses and less system toxicity.
 
Developed with Hummingbird Bioscience’s Rational Antibody Discovery platform, HMBD-001 is a unique antibody engineered to bind strongly and specifically to the dimerization interface of HER3. This gives HMBD-001 a novel mechanism of action via preventing HER3 dimerization and activation regardless of NRG1 binding. Preclinical models have shown that HMBD-001 potently inhibits the activation of the MAPK/PI3K signaling pathway and consequently, prevents tumor growth and drug resistance.

“We are thrilled to be able to partner with Hummingbird Bioscience and several well regarded Australian clinical trial sites to avail Australian cancer patients with this precision therapy where hopefully ‘cancer meets its match,” said, George Clinical Early Phase Global Head, Gillian Ryan. “George Clinical’s expertise enables our clients to move through the regulation process to quick start-up and helps them think through their early phase trial strategies, site selections and operational models.”
 
Jerome Boyd-Kirkup, chief scientific officer, Hummingbird Bioscience, said, “By providing access to some of the world’s most experienced medical, scientific, and operational teams in oncology research, George Clinical is uniquely placed to partner with us to meet the complex and specialized demands of these early phase trials in Australia.”