Harbour BioMed Presents New Clinical Data on HBM1020 at ESMO 2024

On September 14, 2024, Harbour BioMed, a global biopharmaceutical company based in Cambridge, Mass., Rotterdam, Netherlands, and Suzhou, China, disclosed the latest clinical data on HBM1020, a groundbreaking fully human anti-B7H7/HHLA2 monoclonal antibody. This announcement was made in the form of a poster presentation at the ESMO Congress 2024, detailing the findings from a Phase I clinical trial involving patients with advanced solid tumors.

HBM1020 is designed to target B7H7/HHLA2, a novel immune checkpoint molecule. The Phase I trial, identified as NCT05824663, is a dose-escalation, multi-center, open-label study aimed at assessing the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HBM1020.

The clinical trial results indicate that HBM1020 has a favorable safety and tolerability profile. The participants received varying intravenous doses of HBM1020, ranging from 0.3 mg/kg to 30 mg/kg every three weeks. Throughout the study, all 17 patients successfully completed the 21-day dose-limiting toxicity (DLT) observation period without experiencing any DLT events. Consequently, the maximum tolerated dose (MTD) has not yet been reached. Most treatment-related adverse events (TRAEs) observed were of mild to moderate severity (grade 1 or grade 2), and none led to the permanent discontinuation of the treatment. Importantly, there were no treatment-related deaths.

From a pharmacokinetic perspective, HBM1020 exhibited typical IgG behavior, with an elimination half-life of approximately two weeks within the dosage range of 3 mg/kg to 20 mg/kg. Drug exposure increased almost proportionally with the dose administered.

Preliminary efficacy assessments using the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) showed promising results. Of the 15 patients who underwent post-treatment tumor evaluations, 46.7% (7 patients) achieved stable disease (SD). Notably, two patients experienced tumor shrinkage of 11% and 25%, respectively.

These findings underscore the potential of HBM1020 as a new therapeutic option for advanced solid tumors. Further studies are warranted to explore its full therapeutic potential, especially in specific solid tumor types.

Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, expressed optimism about the clinical data, highlighting the promise of HBM1020 in meeting the unmet medical needs of patients with advanced solid tumors. Dr. Wang emphasized that HBM1020, with its innovative biological mechanisms, could become a novel anti-tumor therapy, especially for patients who are PD-L1 negative or refractory, complementing existing PD-(L)1 therapies.

HBM1020 is derived from Harbour Mice® H2L2 transgenic mice platform and targets B7H7, also known as HHLA2, an immune modulatory molecule in the B7 family. The B7 family plays a crucial role in regulating T-cell responses and has been a major focus in cancer immunotherapy. B7H7's expression is independent of PD-L1, providing an alternative pathway for immune evasion in tumors. This makes HBM1020 a promising candidate for enhancing anti-tumor immunity by blocking this novel immune checkpoint target.

Harbour BioMed focuses on discovering, developing, and commercializing innovative antibody therapeutics in immunology and oncology. The company leverages its proprietary antibody technology platforms, including Harbour Mice® and HBICE®, to develop next-generation therapeutic antibodies.