Vanderbilt Health to conduct clinical trial of HMBD-002
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Released
Announcement PDF
ASX Announcement
VANDERBILT HEALTH TO CONDUCT
CLINICAL TRIAL OF HMBD-002 IN ACUTE MYELOID LEUKAEMIA
Melbourne, Australia – 28 August 2026: Percheron Therapeutics Limited (ASX: PER)
(‘the Company’), an international biotechnology company focused on developing novel
therapies for oncology and rare diseases, is pleased to announce that it has entered into
a clinical research agreement with Vanderbilt Health in Nashville, TN (‘VH’) to conduct
an investigator-sponsored clinical trial of Percheron’s HMBD-002 in acute myeloid
leukaemia (AML) and myelodysplastic syndrome (MDS).
Key Points
• VH will lead a new multi-centre clinical trial of HMBD-002, administered in
combination with standard-of-care treatments for patients with high-risk AML /
MDS. The trial is anticipated to commence start-up activities shortly, with the goal of
initiating recruitment in 4Q CY2026.
• The Principal Investigator is Dr Somedeb Ball, Assistant Professor in the Division of
Hematology and Oncology at VH1
. Dr Ball is an extensively published researcher
with an interest in the development of novel therapies for myeloid malignancies.
• AML / MDS is a malignancy of myeloid cells, which are found in the blood and
function as part of the body’s immune system. AML is the most common form of
acute leukaemia in adults, with approximately 20,000 new cases diagnosed each
year in the United States2
. VISTA is highly expressed in AML and is associated with
recurrence and with resistance to therapy3
.
• VH is one of the leading healthcare institutions in the south-eastern United States
and receives over US$ 1 billion in annual research funding from government,
industry, foundations, and donors. The Vanderbilt Health system comprises more
than 45,000 employees across eight hospitals and more than 200 ambulatory clinic
locations. In 2001, it was designated a National Comprehensive Cancer Center by
the US National Cancer Institute.
• The trial will be an investigator-sponsored trial (IST), which means that VH will lead
design and execution and will be primarily responsible for interactions with the US
FDA. Percheron will provide a financial grant to support the study, as well as study
drug and technical assistance. Percheron will have full access to any trial data,
which the company may use to inform future clinical trials, regulatory interactions,
and partnering discussions.
1
https://medicine.vumc.org/department-directory/Somedeb-Ball
2
T Pan, J Zhang, X Wang, et al. (2025) Experimental Hematology & Oncology 14:98
3
S Pagliuca, C Gurnari, et al. (2022) Int J Mol Sci 23(23):14885
Page 2 of 3
Dr Somedeb Ball, Principal Investigator to the study, commented, “despite significant
advances in the last decade, high-risk AML / MDS remains a challenging diagnosis with
substantial unmet medical need. VISTA is expressed primarily on myeloid cells, and
previous research has indicated that it may be a relevant target in this disease. My
colleagues and I look forward to commencing this clinical trial project and exploring the
potential for HMBD-002 to provide benefit to patients with AML / MDS.”
Dr James Garner, CEO at Percheron Therapeutics, added, “we are delighted to be
supporting Dr Ball and the VUMC team to conduct this interesting and important clinical
trial. AML / MDS is of high strategic interest to the HMBD-002 program, and this study
may provide significant insights to guide further clinical development. We hope to see
recruitment commence in 4Q CY2026.”
Background
HMBD-002 (minperstobart) is a monoclonal antibody against VISTA, a novel immune
checkpoint inhibitor. It has shown preclinical evidence of activity in a wide range of
animal models of cancer. In April 2026, Percheron presented final data from a phase I
clinical trial in 48 patients, which showed the drug to be safe and well-tolerated, and
which provided signals of potential clinical efficacy4
. The Company has previously
indicated its intention to further investigate HMBD-002 in conjunction with existing
therapies across several different cancer types.
There is a persuasive rationale to explore a VISTA inhibitor in myeloid malignancies such
as AML. An experimental VISTA inhibitor has previously shown evidence of preclinical
activity in mouse models of AML5
. Although existing treatment regimes are often initially
efficacious in many patients, most patients will eventually recur, and so the need for
new therapeutic options remains substantial.
The VUMC study proposes to investigate HMBD-002 in combination with azacitidine and
venetoclax, two standard-of-care therapies, in up to 38 patients with recurrent or newly
diagnosed AML / MDS. Percheron expects to share additional information regarding the
study design around the time of its commencement.
The Company continues to advance discussions with other clinical research institutions
and with clinicians to identify additional patient populations in which HMBD-002 may be
investigated and expects to provide updates to investors as those discussions progress.
~ ENDS ~
4
PER announcement to ASX of 21 April 2026
5
TK Kim, X Han, et al. (2024) J Clin Invest 134(3):e164325
Page 3 of 3
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 more information, please contact info@PercheronTx.com.
This announcement has been authorised for release to the Australian Securities Exchange
by the Board of Directors.
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