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- Part of the license agreement executed with Hummingbird Bioscience in June 2025
- Percheron has received certificate of analysis for new batch
- Final release and consignment to Percheron remains on schedule for late June
- Preparing to package drug substance in vials
Biotechnology company Percheron Therapeutics (ASX:PER) has welcomed a major milestone in the commercial development of HMBD-002, a novel checkpoint involved in the body’s immune response to cancer.
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The company says HMBD-002’s drug substance manufacture for forthcoming clinical trials has now been completed.
Percheron signed an exclusive worldwide license to develop, manufacture, and commercialise HMBD-002 with Hummingbird Bioscience in June 2025.
“We are grateful to the Hummingbird team for overseeing this manufacturing campaign,” Percheron CEO, Dr James 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.”
Dr Garner said 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 campaign as observers, providing the company with invaluable experience and insight into the specific aspects of HMBD-002 manufacture,” Dr Garner said.
Future batches will be the sole responsibility of Percheron.
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.
PER is steady at 0.5¢. Mkt cap $6.850M.
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