Percheron Therapeutics Advances HMBD-002 to Phase II Following Positive Safety Data in Cancer Trial
核心洞察
Percheron Therapeutics (搜索) completed phase I testing of HMBD-002, demonstrating a favorable safety profile in 48 patients with advanced metastatic cancers (搜索) across six US sites.
The monoclonal antibody showed encouraging efficacy signals, including a 27% tumor reduction in one triple-negative breast cancer (搜索) patient after five weeks of combination therapy with pembrolizumab.
The company has finalized an adaptive phase II trial design targeting multiple tumor types in parallel, with recruitment expected to begin during 2026.
Percheron Therapeutics (搜索) Ltd has positioned its lead oncology program HMBD-002 to advance into phase II testing following the completion of phase I clinical trials that demonstrated a strong safety profile and early efficacy signals in heavily pre-treated cancer patients.
The Australian biotechnology company announced final results from its phase I study (NCT05082610) in October 2025, showing that the monoclonal antibody was generally well tolerated both as monotherapy and in combination with Keytruda (pembrolizumab). The study enrolled 48 patients with advanced metastatic cancers (搜索) across six US sites.
Phase I Results Demonstrate Safety and Early Efficacy
The completed phase I trial evaluated HMBD-002 across multiple dosing regimens, with 28 patients receiving the drug alone across seven dose cohorts and an additional 20 patients treated with the combination therapy. Percheron reported few treatment-related adverse events above grade 3, with no clear increase in toxicity at higher dose levels and insufficient dose-limiting toxicities to formally define a maximum tolerated dose.
Several patients demonstrated clinical benefit, including reductions in tumor size or prolonged disease stabilization. Most notably, one patient with triple-negative breast cancer (搜索) experienced a 27% reduction in tumor size after five weeks of combination therapy with pembrolizumab.
"The second half of CY2025 was a highly productive period for Percheron, focused on taking control of HMBD-002 from our licensor, managing the completion of the successful phase I clinical trial, and planning the way forward for the drug," said James Garner, Percheron's managing director and CEO.
Adaptive Phase II Design Targets Multiple Tumor Types
Building on the phase I results, Percheron has developed an adaptive phase II trial design that will assess HMBD-002 across multiple tumor types simultaneously. The modular structure allows individual tumor-specific arms to commence, report results, and progress independently, with each arm beginning with a small exploratory cohort before advancing to larger randomized confirmatory stages for those showing positive signals.
Initial tumor types identified for investigation include triple-negative breast cancer (搜索), EGFR-mutant non-small-cell lung cancer (搜索), HER2 (搜索)-negative esophageal cancer, and endometrial cancer (搜索). The company expects recruitment to begin during 2026.
According to Percheron, this design is intended to maximize news flow while managing development risk by limiting exposure to less promising indications.
Manufacturing and Financial Position
Under its licensing agreement with Hummingbird Bioscience (搜索), the manufacture of new drug substance for phase II will be funded and overseen by the licensor, with completion targeted for the June 2026 quarter. Percheron will handle fill-and-finish activities ahead of clinical use.
The company reported a cash balance of $4.46 million at December 31, 2025, down from $5.68 million in the prior quarter, with net operating cash outflows of $1.23 million including $550,000 in research and development spending. Management forecasts a runway of 3.7 quarters based on current cash position.
"With the new year upon us, we now shift our attention to initial implementation of the planned phase II clinical trial," Garner added.