Percheron Therapeutics has reported the completion of manufacturing of the first batch of HMBD-002 under Good Manufacturing Practice (GMP) standards, removing a key clinical supply hurdle ahead of Vanderbilt’s investigator-sponsored study in acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS). Recruitment is expected in H1 CY27, subject to FDA clearance. The study will assess the anti-VISTA antibody with azacitidine/venetoclax in up to 38 patients. Percheron will provide the study drug, a financial grant and advisory support, with the A$2.3m institutional placement announced in September fully funding these commitments and providing working capital flexibility.
We view this as a cost-efficient route to proof of concept, with manufacturing completion reducing execution risk. High VISTA expression in AML supports the rationale, but demonstrating deeper or more durable responses without materially increasing toxicity remains key to clinical differentiation. Percheron assumes responsibility for future batches following Hummingbird’s initial drug substance contribution, making clinical validation important to financing broader development.
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