Sparks - Percheron Therapeutics

Percheron Therapeutics as secured US FDA clearance for Vanderbilt Health-led investigator-sponsored trial of HMBD-002 in relapsed/refractory acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS). The study will evaluate HMBD-002 alongside standard-of-care azacitidine and venetoclax in up to 20 patients, initially focusing on dose optimisation. Vanderbilt will lead trial design and execution, while Percheron will supply HMBD-002, provide technical assistance and a financial grant, retaining full access to the resulting clinical data. The A$2.3m September placement was intended to fund these commitments.

Together with the recent completion of clinical drug manufacture, this removes another hurdle towards bringing HMBD-002 back into the clinic. We view Vanderbilt’s involvement as a capital-efficient route to generating preliminary clinical evidence, supported by Percheron’s A$2.3m September placement. Recruitment is expected in H1 CY27. Although the smaller, uncontrolled study may limit conclusions on incremental efficacy, early safety and response signals could help validate HMBD-002’s clinical potential and support future development and partnering discussions.