SYDNEY, May 4, 2023 – George Clinical announces that the company has initiated preparations in Australia for two oncology Phase 1b 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 organization (CRO) expertise for the Hummingbird Bioscience-sponsored trials.
Molecular-matched therapies have revolutionized cancer treatment with the capability to inhibit specific molecular targets leading to better therapeutic responses and less system toxicity. 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.
Early phase clinical trials are primarily designed to evaluate the safety and tolerability of a new therapy as well as to identify a suitable dose for further evaluation. However, historically any preliminary efficacy data generated has been considered only as suggestive and requires further exploration in larger later phase trials. As molecular-based therapies have evolved, it is common to see significant antitumor activity when targeted agents are tested on molecularly selected populations in early drug development. Signaling pathways and molecular networks are known for their critical roles in driving and controlling cellular processes and are therefore linked to the onset of cancer, as well as its potential treatment. The development of agents targeting these pathways and networks is a key piece in the ongoing advancement of molecular-matched therapy and its advancement to provide better patient outcomes.
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.’ 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,” said George Clinical Early Phase Global Head, Gillian Ryan.
Coupled with its experience in conducting more than 300 oncology studies across the globe, as well as its established robust network of practicing medical oncologists with expertise across a range of tumor types and the latest immunotherapies, George Clinical has a deep and well-regarded history in the conduct of early phase studies. The organization’s success with trials of this type has been driven by scientific expertise and operational excellence. Using the combination of scientific leadership and local knowledge, the oncology trials conducted by George Clinical maintain their focus on the trials’ scientific objective while maximizing trial conduct expertise to enable the best result possible.
“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,” said Jerome Boyd-Kirkup, Ph.D., Chief Scientific Officer, Hummingbird Bioscience.
About George Clinical
George Clinical is a leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence. With over 20 years of experience and more than 450 people managing over 39 geographical locations throughout the Asia-Pacific region, USA, and Europe, George Clinical provides the full range of clinical trial services to biopharmaceutical, medical device, and diagnostic customers, for all trial phases, registration and post-marketing trials.