Percheron Therapeutics Ltd (ASX:PER, OTC:PERCF) has completed the manufacture of a new batch of HMBD-002, its VISTA-targeting monoclonal antibody cancer drug candidate, keeping the company on track to prepare clinical trial material for a planned new study in the second half of CY2026.
The Melbourne-based biotechnology company received a Certificate of Analysis for the newly manufactured HMBD-002 batch, with all product quality attributes reported to be within expected limits.
Moving forward, final release and consignment of the drug substance to Percheron remains scheduled for late June.
Agreement summary
Hummingbird Bioscience undertook the manufacturing work under the licence agreement executed between the companies in June 2025.
Under that deal, Hummingbird assumed responsibility for producing one new batch of HMBD-002 drug substance for use in future clinical trials.
Percheron said the arrangement had accelerated and reduced risk around the availability of clinical material.
Fill and finish to follow
Following receipt of the drug substance, Percheron will undertake ‘fill and finish’ activities, which involve placing the material into vials and packaging it for shipment to investigational trial sites.
That work is expected to be completed in the third quarter of CY2026, with final drug product to be released at that time for use in clinical trials.
Percheron chief executive Dr James Garner said the completion of the manufacturing campaign was timely given the company’s clinical development plans.
“We are grateful to the Hummingbird team for overseeing this manufacturing campaign,” Garner said.
“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.”
Biologic manufacturing process
HMBD-002 is a biologic drug and is manufactured using living organisms, specifically a recombinant CHO cell expression system.
Percheron said this type of manufacturing was more complex than production of many small-molecule chemical drugs and required specialist expertise, dedicated facilities and compliance with Good Manufacturing Practice requirements for clinical trial use.
The company’s team observed the manufacturing campaign, gaining experience and insight into the specific requirements of HMBD-002 production. Future batches will be Percheron’s sole responsibility.
VISTA-targeting antibody
HMBD-002 is Percheron’s lead program and is a monoclonal antibody targeting VISTA, an immune checkpoint regulator.
The drug has completed a phase 1 clinical trial in patients with advanced cancer, where it was shown to be generally safe and well tolerated.
Percheron is focused on developing novel therapies for oncology and rare diseases.
What's ahead
Percheron will now progress fill and finish work for HMBD-002, targeting completion in 3Q CY2026.
The company expects to start a new clinical trial of HMBD-002 in the second half of CY2026.
About Percheron
Percheron Therapeutics is 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.