Percheron Therapeutics Ltd (ASX:PER, OTC:PERCF) has ticked off several milestones for its lead oncology asset HMBD-002, laying the groundwork for a Phase II clinical trial in 2026.
The Melbourne-based biotech said the technology transfer of HMBD-002 from Singapore’s Hummingbird Bioscience was now largely complete, with Percheron now taking possession of all relevant data and existing drug supplies. The Investigational New Drug (IND) application with the US Food and Drug Administration has also shifted from Hummingbird to Percheron, making the company formally responsible for the program’s future development.
Percheron has thus assumed control of intellectual property linked to HMBD-002 and is working directly with global patent authorities to prosecute and maintain associated patents.
Under its licensing deal, Hummingbird has begun manufacturing a fresh batch of HMBD-002 drug substance on Percheron’s behalf, with completion targeted for the first half of calendar 2026. This material is earmarked for use in the upcoming Phase II trial.
“We have made excellent progress in bringing HMBD-002 under our oversight,” said Percheron CEO James Garner.
“Of note, we expect to share full Phase I data on Tuesday, 7 October, following receipt of the CSR from our licensor, and then we hope to provide an initial overview of our planned Phase II study during the fourth quarter,” he added.
“Following these two discussions, investors should have a full perspective on the drug’s existing data, and a clear view of the path forward.”
Strategic moves and internal changes
To bolster its capabilities, Percheron has added two senior executives with extensive experience developing biologic cancer therapies. The company is also engaging leading US scientists and clinicians to shape the Phase II trial design, which it plans to outline in the December quarter of 2025.
Next Steps
A clinical study report for the completed Phase I trial in patients with advanced cancer is nearing finalisation. Percheron will host a webinar on October 7 to brief investors on the Phase I findings.
The planned Phase II study, slated to start recruiting in calendar 2026, is being designed to generate data that can support future development and potential licensing while keeping costs in check. Percheron says it has sought significant expert input to ensure the trial captures a broad range of efficacy and safety outcomes relevant to novel immunotherapies.
With regulatory control, intellectual property and manufacturing arrangements now in place, the company is positioning HMBD-002 as a key driver of its oncology pipeline and a potential partnering opportunity for larger pharmaceutical players.