CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU,
China, Sept. 14,
2024 /PRNewswire/ -- Harbour BioMed (the
"Company"; HKEX: 02142), a global biopharmaceutical company
committed to the discovery, development, and commercialization of
novel antibody therapeutics focusing on oncology and immunology,
announced the latest clinical data on HBM1020, a first-in-class,
fully human anti-B7H7/HHLA2 monoclonal antibody, in patients with
advanced solid tumors as a poster presentation (Presentation
Number: 1010P) at the ESMO Congress 2024. The data has also been
published online as an abstract on the ESMO website.
The results are derived from the dose-escalation, multi-center,
open-label phase I trial (NCT05824663) that evaluates the safety
and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD)
profiles of HBM1020 in patients with advanced solid tumors.
Highlights of the abstract include:
- Demonstrated favorable safety and tolerability of HBM1020
across all tested doses.
- HBM1020 was administered intravenously at dose levels ranging
from 0.3 mg/kg to 30 mg/kg every three weeks (Q3W). All 17 patients
completed the dose-limiting toxicity (DLT) observation period (21
days), and no DLT events were observed. The maximum tolerated dose
(MTD) has not been reached yet.
- Most treatment-related adverse events (TRAEs) were grade 1 or
grade 2. No TRAEs led to permanent discontinuation of the study
treatment.
- No treatment-related deaths occurred.
- Promising PK profiles.
- PK analysis of HBM1020 demonstrated typical IgG behavior,
with an elimination half-life of approximately two weeks in the
dose range of 3 mg/kg to 20 mg/kg.
- Drug exposure increased in a nearly dose-proportional
manner.
- Preliminary efficacy signals with disease control and tumor
size reduction.
- Efficacy was assessed using the Response Evaluation Criteria in
Solid Tumors Version 1.1 (RECIST 1.1).
- Of the 15 patients who received post-treatment tumor
assessments, 7 patients (46.7%) achieved stable disease (SD), with
two patients showing tumor shrinkage of 11% and 25%.
The data demonstrated excellent safety and tolerability profiles
of HBM1020 in patients with advanced solid tumors. Further studies
are warranted to explore the therapeutic potential of HBM1020 in
selected solid tumors.
"B7H7/HHLA2 is a promising immune checkpoint target in solid
tumors. We are pleased to share the latest clinical data of our
first-in-class B7H7/HHLA2 antibody," said Dr. Jingsong Wang, Founder, Chairman and CEO of
Harbour BioMed. "These findings highlight the potential of HBM1020
to address the unmet medical needs of patients with advanced solid
tumors. With its innovative biology mechanisms, we believe HBM1020
will emerge as a novel anti-tumor therapy, complementing PD-(L)1
therapies, particularly for patients who are PD-L1 negative or
refractory."
About HBM1020
HBM1020 is a first-in-class fully human monoclonal antibody
generated from Harbour Mice® H2L2 transgenic mice
platform, targeting B7H7/HHLA2.
B7H7, also known as HHLA2, is a novel immune modulatory molecule
belonging to the B7 family. The B7 family is of central importance
in regulating the T-cell response, making these pathways very
attractive in cancer immunotherapy. Most of the validated targets
in immune-oncology so far are related to B7 family, including
PD-(L)1, and CTLA-4. The therapies against B7 family targets have
already shifted the paradigm for cancer therapy with outstanding
clinical benefits. As a newly discovered member of the B7 family,
B7H7 expression is found non-overlapping with PD-L1 expression in
multiple tumor types, which indicates an alternative immune evasion
pathway besides PD-(L)1. In PD-L1 negative/ refractory patients,
B7H7 potentially plays a critical role for tumor cells to escape
immune surveillance. HBM1020 can enhance anti-tumor immunity by
blocking the novel immune checkpoint target. Preclinical data
demonstrated its immune activation and anti-tumor functional
activities.
With its innovative biology mechanisms, HBM1020 presents a novel
anti-tumor therapeutics complementary to PD-(L)1 therapeutics to
patients, especially for PD-L1 negative/refractory patients.
About Harbour BioMed
Harbour BioMed (HKEX: 02142) is a global biopharmaceutical
company committed to the discovery, development, and
commercialization of novel antibody therapeutics focusing on
immunology and oncology. The Company is building its robust
portfolio and differentiated pipeline through internal R&D
capability, collaborations with co-discovery and co-development
partners, and select acquisitions.
The proprietary antibody technology platforms Harbour
Mice® generates fully human monoclonal antibodies
in two heavy and two light chains (H2L2) format, as well as heavy
chain only (HCAb) format. Building upon the HCAb antibodies, the
HCAb-based immune cell engagers (HBICE®) bispecific
antibody technology is capable of delivering tumor-killing effects
unachievable by traditional combination therapies. Integrating
Harbour Mice®, and HBICE® with a single
B cell cloning platform, our antibody discovery engine is highly
unique and efficient for the development of next-generation
therapeutic antibodies. For further information, please refer
to www.harbourbiomed.com.
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