HMBD-002 drug product manufacture completed and released for clinical use
Percheron Therapeutics (ASX: PER) has completed HMBD-002 drug product manufacture, with the product approved for release and clinical use in accordance with Good Manufacturing Practice (GMP) standards. The announcement was dated 23 October 2026.
The drug product is to be shipped to Vanderbilt Health for use in acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS).
Percheron describes the release of the drug product as an important step in having material available to administer to patients in upcoming clinical trials. The material is intended for a forthcoming investigator sponsored study (IST) with Vanderbilt Health.
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Why biologic manufacturing is a meaningful milestone
What makes HMBD-002 complex to produce
According to the announcement, manufacture of biologic drugs such as HMBD-002 is often complex. Unlike “small molecule” chemical drugs, which are made through chemical processes, 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 GMP requirements that are necessary for clinical trials.
HMBD-002 is Percheron’s lead program. It is a monoclonal antibody targeting the immune checkpoint regulator, VISTA.
How the Hummingbird arrangement helped
Under the license agreement between Percheron and Hummingbird, Hummingbird took responsibility for manufacture of one batch of drug substance for use in future clinical trials. The key points from the announcement are:
- Hummingbird’s responsibility for one batch of drug substance both “greatly accelerated and substantially de-risked” availability of clinical material.
- The Percheron team were intimately involved in the campaign as observers, which the company says provided invaluable experience and insight into the specific aspects of HMBD-002 manufacture.
- Future batches will be the sole responsibility of Percheron.
Path to the Vanderbilt Health study
Once FDA approval is received to commence the IST at Vanderbilt Health, the material will be able to be administered to patients in combination with standard of care. The study is for patients with AML and MDS.
The Vanderbilt clinical research agreement positions Vanderbilt to lead trial design, execution and FDA interactions, while Percheron supplies the study drug, a financial grant and technical assistance, with up to 38 patients planned in combination with azacitidine and venetoclax.
The announcement does not disclose an FDA approval timeline, trial size or data readout date. The milestones that are outlined are summarised below.
| Milestone | Status | Timing |
|---|---|---|
| GMP release of drug product | Complete | Announced 23 October 2026 |
| FDA approval to commence IST | Required | No date disclosed |
| Trial startup activities | Expected to commence | CY2026 |
| Patient recruitment | Anticipated | 1H CY2027 |
For investors, the milestones mark tangible steps toward first clinical data for HMBD-002 from the study, following the completed phase I clinical trial in patients with advanced cancer. That trial, according to the company, showed the drug to be generally safe and well-tolerated.
The Phase I results spanned 48 patients across six US centres, with a recommended Phase II dose of 720mg weekly and 27.5% of evaluable patients achieving disease stabilisation, alongside the first public biomarker data supporting VISTA blockade.
Management view and what comes next
Dr Michael Baker, CEO and Managing Director
“It is excellent to tick off another milestone that brings us one step closer to generating clinical data for HMBD-002…”
Dr Baker also said the company is excited to assess the role that HMBD-002, in combination with standard of care treatments, “may play in AML/MDS patients.”
Looking ahead, the sequence runs from FDA approval to commence the IST, to trial startup activities expected in CY2026, and recruitment anticipated in 1H CY2027. Percheron also states it aims to commence further clinical trials in CY2026.
Percheron is listed on the ASX under the ticker PER and on the US OTC market as PERCF.
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