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Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against difficult-to-treat targets in cancer and autoimmune diseases, and Cancer Research UK, the world’s leading cancer charity, today announced that the first patient has been treated in Phase 1 clinical trial of HMBD-001 for the treatment of patients with advanced HER3-expressing solid malignancies (NCT05057013).

The Phase 1 UK clinical trial is sponsored and managed by Cancer Research UK’s Centre for Drug Development and led by principal investigator Professor Johann De Bono at the Royal Marsden Hospital and Institute of Cancer Research, London. The trial is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HMBD-001 in patients with advanced HER3-expressing solid malignancies, including NRG1-fused cancers, and to provide initial evidence of the drug’s efficacy.

HMBD-001 is the first antibody from Hummingbird Bioscience’s extensive pipeline to enter clinical trials. HMBD-001 is the only anti-HER3 antibody in clinical development that has been rationally developed using Hummingbird Bioscience’s Rational Antibody Discovery (RAD) platform. It has a highly differentiated mechanism of action that blocks the formation of all active HER3 dimers, regardless of NRG1 ligand binding or HER2/EGFR overexpression.

“Dosing of the first patient in the clinical trial of HMBD-001, Hummingbird’s most advanced program, marks the beginning of a potentially transformative approach to treating HER3-driven cancers,” said Dr. Jerome Boyd-Kirkup, Chief Scientific Officer, Hummingbird Bioscience. “I am immensely proud of the teamwork that has brought our differentiated program to this point. Hummingbird Bioscience is dedicated to discovering and developing important medicines for cancer and autoimmune disease with our unique Rational Antibody Discovery platform.” 

“This significant milestone brings us a step closer to providing a much-needed and highly differentiated therapy for patients with HER3-driven cancers,” added Dr. Eric Rowinsky, Chief Medical Officer, Hummingbird Bioscience. “We are pleased to partner with Cancer Research UK for this trial, and we look forward to advancing the clinical development of HMBD-001 for cancer patients.”

Dr. Nigel Blackburn, Director of Cancer Research UK’s Centre for Drug Development, stated, “We are thrilled to be working with Hummingbird Bioscience to advance its novel drug candidate into clinical trials. 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.”

Initial data from the Phase 1 dose-escalation is expected in the second half of 2022.