New Preclinical Data Reported for HMBD-002 in Breast Cancer
Released
Released
Announcement PDF
ASX Announcement
RESEARCHERS AT UNIVERSITY OF TEXAS PUBLISH
NEW PRECLINICAL DATA SHOWING ACTIVITY OF HMBD-002
IN TRIPLE-NEGATIVE BREAST CANCER
Melbourne, Australia – 6 August 2025: Percheron Therapeutics Limited (ASX: PER) (‘the
Company’), an international biotechnology company focused on the development of
novel therapies for oncology and rare diseases, is pleased to share new preclinical data
for its investigational cancer drug, HMBD-002.
The data was recently published in the peer-reviewed scientific journal, Cancer
Research, and describes a detailed exploration of the role of VISTA in triple-negative
breast cancer (TNBC) 1. The work was performed by collaborators at the University of
Texas Southwestern Medical Center (UTSW), and was led by Professor Josh Gruber, who
is an extensively published authority on this condition.
Key Points
•
TNBC is the most aggressive form of breast cancer and is estimated to represent
approximately 10-15% of newly diagnosed cases, or about 30,000 patients per
annum in the United States. The disease is notoriously resistant to existing therapies
and represents a substantial unmet clinical need. Approximately one quarter to one
third of TNBC tumours express high levels of VISTA 2.
•
The UTSW data suggests potent activity of HMBD-002 in TNBC. In the EO771 mouse
model of TNBC, administration of HMBD-002 substantially blocked tumour growth
entirely in VISTA+ animals (p < 0.0001).
•
The UTSW team have also made important new findings regarding the role of VISTA
in TNBC, including the identification of a specific amino acid signature that could in
future provide a patient selection biomarker.
•
Moreover, the data indicates that the activity of HMBD-002 is not purely immunedriven but may also derive from modulation of growth signals such as EGFR 3. This
may be an important point of differentiation with existing immunotherapies such as
Keytruda® (pembrolizumab) which are though to act only via the immune system.
•
The UTSW data in TNBC adds to very promising data for HMBD-002 in combination
with radiotherapy in the treatment of squamous cell cancer of the head and neck
(SCCHN) which was recently published by researchers at Stanford University 4.
Y Zhao et al. (2025) Cancer Research (doi: 10.1158/0008-5472.CAN-24-4774)
VISTA (v-linked immunoglobulin suppressor of T-cell activation) is the molecular target of HMBD-002
3
EGFR = epidermal growth factor receptor, a common target for cancer therapies
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PER announcement to ASX of 23 July 2025
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2
“This work provides important new insights into the relevance of VISTA in this very
challenging and all-too-common cancer,” commented Percheron CEO, Dr James
Garner. “There are few effective treatments for TNBC, and the disease represents one of
the most significant areas of unmet need in cancer therapy. The data from Professor
Gruber and colleagues gives us a persuasive indication that a VISTA inhibitor such as
HMBD-002 may have a role to play in the future management of this condition.”
He added, “we continue to evaluate a range of potential avenues via which HMBD-002
may progress into phase II, and we expect to share further detail with investors in Q4
CY2025. Our consideration will undoubtedly be influenced and encouraged by some of
the very high-quality preclinical data that has recently been published with the drug.”
Phase I Data Expected in 4Q CY2025
In collaboration with its licensor, Percheron expects to receive final data from the
completed phase I study of HMBD-002 in patients with advanced cancer
(NCT05082610) in 4Q CY2025. The Company anticipates sharing that data with investors
as soon as it is available and will provide discussion at that time as to its implications for
future development of HMBD-002.
Background to This Research
Investigation of new cancer drugs is typically performed initially in animal models of the
disease. Doing so is faster and more economical than moving directly into human trials
and reduces the ethical challenges associated with exposing patients to drugs with
uncertain effects.
Typically, standardised samples of human tumours are surgically grafted onto mice,
resulting in a ‘PDX model’ (patient-derived xenograft). The treatment in question is then
administered to the mice, sometimes in comparison to other treatments, and usually in
comparison to a ‘control group’ which receives only inert treatment. Researchers will
typically measure parameters such as the size of the tumour and the survival of the
mice, as well as safety parameters and potential biomarkers of activity.
Mouse models are never entirely predictive of efficacy in human patients, but they do
provide very useful insights in the development of new medicines, and are particularly
useful in eliminating ineffective therapeutic strategies.
In this experiment, an EO771 model of TNBC was primarily used to explore the activity of
HMBD-002 in both wildtype and VISTA-expressing animals. The background work on
VISTA expression and mechanism also utilised other common model systems, such as
the 4T1 and MDA-MB-231models.
Implications for Future Development
The UTSW data suggests TNBC as a potential indication for the future development of
HMBD-002, especially if it is focused on patients with high VISTA expression. The
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Company expects to further discuss these implications with researchers, clinicians, and
advisors over coming months.
Percheron anticipates releasing full data from the completed phase I study of HMBD002 in patients with advanced cancer in 4Q CY2025, and to provide an overview of its
proposed phase II clinical trial design shortly thereafter.
~ ENDS ~
About Percheron Therapeutics Limited
Percheron Therapeutics Limited [ASX: PER | US OTC: PERCF] is a publicly listed biotechnology
company focused on the development and commercialisation of novel therapies for oncology
and rare diseases. The company’s lead program is HMBD-002, a monoclonal antibody targeting
the immune checkpoint regulator, VISTA. HMBD-002 has completed a phase I clinical trial in
patients with advanced cancer, which has shown the drug to be generally safe and well
tolerated, and Percheron aims to commence further clinical trials in CY2026. For further
information, please see our website at www.PercheronTx.com, or email
info@PercheronTx.com.
This announcement has been authorized for release to the Australian Securities Exchange
by the Board of Directors.
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