On December 6, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets in cancer and autoimmune disease, and Cancer Research UK, the world’s leading cancer charity, reported that the first patient has been dosed in a Phase 1 clinical trial of HMBD-001 for the treatment of patients with advanced HER3-expressing solid malignancies (NCT05057013) (Press release, Hummingbird Bioscience, DEC 6, 2021, View Source [SID1234596530]).

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The Phase 1 clinical trial in the United Kingdom is being sponsored and managed by Cancer Research UK’s Centre for Drug Development and led by Chief Investigator, Professor Johann De Bono at the Royal Marsden Hospital and The Institute of Cancer Research, London. The trial intends to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and explore preliminary evidence of HMBD-001 activity in patients with advanced HER3-expressing solid malignancies, including NRG1 fusion-driven cancers.

HMBD-001 is the first of Hummingbird Bioscience’s deep pipeline of antibody drug candidates to enter clinical trials. Rationally developed using Hummingbird Bioscience’s proprietary Rational Antibody Discovery (RAD) platform, HMBD-001 is the only reported anti-HER3 antibody in clinical development that uses a highly differentiated mechanism of action designed to block 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 provide a much-needed and highly differentiated therapy for patients with HER3-driven cancers," said 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, said, "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.

About HMBD-001

HMBD-001 is a clinical-stage IgG1 antibody designed to target HER3. Discovered using our proprietary RAD platform, HMBD-001 is now in development for the treatment of multiple solid tumors. We believe HMBD-001 is the only anti-HER3 antibody in development that has the potential to fully block both ligand-dependent and independent HER3 activation and oncogenic signaling, by targeting a key epitope located at the interface where HER3 forms heterodimers with HER2 or EGFR, independent of the process leading to such dimerization. In preclinical models evaluating HMBD-001, we have observed superior affinity and more potently inhibited tumor growth compared to other existing anti-HER3 antibodies. Our near-term development plan for HMBD-001 focuses on four priority, high-value indications with strong scientific rationale and supporting preclinical data: NRG1 fusion-driven cancers, metastatic castrate resistant prostate cancer (mCRPC), metastatic colorectal cancer (mCRC), and squamous cell carcinoma of the head and neck (SCCHN).