Percheron Therapeutics has reported encouraging safety and efficacy signals from its HMBD-002 phase I trial, and outlined an innovative modular phase II trial design targeting multiple cancers in 2026.
- Positive safety and efficacy signals from HMBD-002 phase I trial
- Modular, multi-arm phase II trial design targeting several tumour types
- Manufacture of new drug batch scheduled for Q2 2026 by licensor Hummingbird Bioscience
- Quarter-end cash balance of $4.46 million with 3.7 quarters runway
- Launch of interactive investor hub to enhance shareholder engagement
Positive Phase I Results Mark a Milestone
Percheron Therapeutics Limited, an ASX-listed biotech focused on oncology and rare diseases, has delivered a significant update on its lead drug candidate, HMBD-002. The company announced final data from its completed phase I clinical trial, which demonstrated a very favourable safety profile and encouraging signs of efficacy in patients with advanced metastatic cancers. Conducted across six prominent US cancer centres, including Stanford and MD Anderson, the trial enrolled 48 patients and tested HMBD-002 both as a monotherapy and in combination with Keytruda.
Notably, the drug was well tolerated across all dose levels, with few severe adverse events and no maximum tolerated dose established. Several patients showed tumour size reductions, including a triple-negative breast cancer patient who nearly met the criteria for a partial response. Others experienced prolonged stable disease, suggesting potential to extend progression-free survival in a heavily pre-treated population.
Innovative Modular Phase II Trial Design
Building on these promising results, Percheron has unveiled a novel, adaptive phase II clinical trial design. This multi-arm, modular study will evaluate HMBD-002 across several tumour types in parallel, including triple-negative breast cancer, EGFR-mutant non-small-cell lung cancer, HER2-negative oesophageal cancer, and endometrial cancer. Each arm will operate independently, allowing early data read-outs to guide further development decisions without waiting for other arms to complete.
The trial will feature an initial exploratory stage to assess efficacy in small patient cohorts, followed by a confirmatory randomised controlled stage for arms showing positive signals. This approach aims to accelerate data generation and optimise resource allocation, potentially speeding the path to regulatory milestones.
Manufacturing and Financial Position
Percheron’s licensor, Hummingbird Bioscience, is responsible for manufacturing a new batch of HMBD-002 drug substance, scheduled for completion in the second quarter of 2026. Following this, Percheron will undertake the fill and finish process to prepare the drug for clinical use. Financially, the company closed the quarter with $4.46 million in cash, providing an estimated 3.7 quarters of operational runway based on current expenditure levels. Operating cash outflows were $1.23 million for the quarter, primarily driven by research and development and corporate overheads.
Engaging Investors with New Digital Hub
To enhance communication with shareholders and the broader investment community, Percheron has launched an interactive investor hub. This platform will host a range of content including videos, educational materials, interviews, and corporate research, aiming to provide timely and transparent updates as the company advances its clinical programs.
Overall, Percheron’s latest quarterly report reflects a biotech company transitioning from early clinical validation to a more dynamic and data-driven development phase. The modular trial design and positive phase I data position HMBD-002 as a candidate to watch in the competitive oncology landscape.
Bottom Line?
Percheron’s innovative trial approach and solid phase I data set the stage for pivotal developments in 2026.
Questions in the middle?
- When will Percheron announce initial data read-outs from the phase II trial’s exploratory arms?
- How will the modular trial design impact regulatory interactions and potential accelerated approvals?
- Will additional funding be required to sustain operations beyond the current cash runway?