Percheron completes HMBD-002 drug substance manufacture

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Percheron Therapeutics (ASX:PER) has announced the successful completion of manufacturing for a new batch of HMBD-002 drug substance ahead of planned clinical trials.

Under a license agreement with Hummingbird Bioscience, signed in June 2025, Hummingbird took responsibility for producing the batch, and Percheron has now received a Certificate of Analysis confirming that all product quality attributes are within expected limits.

The final release and consignment remain on schedule for late June, after which Percheron will perform fill-and-finish to package the material in vials. That packaging work is expected to be completed in the third quarter of 2026, after which the company aims to commence a new clinical trial.

The company highlighted the technical complexity of biologic manufacturing, noting HMBD-002 is produced in a recombinant CHO cell expression system and requires specialist GMP facilities and expertise.

Percheron said the arrangement with Hummingbird both accelerated the availability of clinical material and reduced risk, while allowing Percheron’s team to observe the campaign closely and gain experience that will support future in‑house manufacturing.

“We are grateful to the Hummingbird team for overseeing this manufacturing campaign,” said 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.”