Completion of HMBD-002 Drug Substance Manufacture
Released
Released
Announcement PDF
ASX Announcement
COMPLETION OF HMBD-002 DRUG SUBSTANCE MANUFACTURE
Melbourne, Australia – 17 June 2026: 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 announce the successful
completion of HMBD-002 drug substance manufacture for forthcoming clinical trials.
Key Points
• As part of the license agreement executed with Hummingbird Bioscience in June
2025, Hummingbird assumed responsibility to manufacture a new batch of HMBD-
002 drug substance for use in clinical trials.
• Percheron has received a Certificate of Analysis for the new batch, which shows all
product quality attributes to be within expected limits. The final release and
consignment to Percheron remains on schedule for late June.
• Percheron will then undertake ‘fill and finish’ to package the HMBD-002 drug
substance in vials for use in clinical trials. That work is expected to be completed in
3Q CY2026, with final drug product released at that time for use in clinical trials.
• Percheron aims to commence a new clinical trial of HMBD-002 in 2H CY2026.
“We are grateful to the Hummingbird team for overseeing this manufacturing campaign,”
commented Percheron CEO, Dr James Garner. “We intend to put the material to use in a
new clinical trial over coming months, and so the successful completion of this project
is very timely. In addition to supporting planned clinical work, this campaign has
provided an opportunity for the Percheron team to follow the process with Hummingbird
closely, leaving us well equipped to manage future manufacturing runs ourselves.”
Background
Manufacture of biologic drugs such as HMBD-002 is often complex. Unlike ‘small
molecule’ chemical drugs, HMBD-002 is manufactured in living organisms, specifically a
recombinant CHO cell expression system. This requires specialist expertise and
dedicated facilities to meet the stringent Good Manufacturing Practice (GMP)
requirements that are necessary for clinical trials.
Under the license agreement between Percheron and Hummingbird, the latter took
responsibility for the manufacture of one batch of drug substance for use in future
clinical trials. This provision both greatly accelerated and substantially de-risked
availability of clinical material. The Percheron team have been intimately involved in the
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campaign as observers, providing the company with invaluable experience and insight
into the specific aspects of HMBD-002 manufacture. Future batches will be the sole
responsibility of Percheron.
Next Steps
The company will now focus on ‘fill and finish’ activities, in which the drug substance is
placed in vials and packaged for shipping to investigational trial sites. This work is
expected to be completed in 3Q CY2026.
Percheron anticipates commencing a new clinical trial of HMBD-002 in 2H CY2026.
~ 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 more information, please contact info@PercheronTx.com.
This announcement has been authorized for release to the Australian Securities Exchange
by the Board of Directors.
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