How Percheron’s HMBD-002 Is Shaping Up After Positive Phase I Results
Percheron Therapeutics reports encouraging phase I clinical results for HMBD-002, confirming safety and early efficacy signals, while gearing up for a multi-arm phase II trial in 2026.
- Positive phase I clinical trial data for HMBD-002 with favorable safety profile
- Promising preclinical results in triple-negative breast cancer and head & neck cancer
- Multi-arm phase II clinical trial design announced, targeting multiple tumor types
- Transfer of IND sponsorship to Percheron completed with US FDA
- Appointment of two senior executives to lead clinical and technical development
Encouraging Phase I Clinical Outcomes
Percheron Therapeutics has released positive results from the phase I clinical trial of its lead drug candidate, HMBD-002, a monoclonal antibody targeting the immune checkpoint regulator VISTA. Conducted across six prominent US cancer centers, including Stanford and MD Anderson, the trial enrolled 48 patients with advanced metastatic cancers. The data confirmed a very favorable safety profile, with few severe treatment-related adverse events and no maximum tolerated dose reached. Notably, some patients exhibited tumor size reductions and prolonged stable disease, signaling potential clinical benefit in a heavily pretreated population.
Supporting Preclinical Evidence in Challenging Cancers
Complementing the clinical data, Percheron reported promising preclinical findings in two difficult-to-treat cancers – triple-negative breast cancer (TNBC) and squamous cell carcinoma of the head and neck (SCCHN). Studies from Stanford University and the University of Texas Southwestern demonstrated that HMBD-002, especially in combination with radiotherapy or immunotherapy, significantly inhibited tumor growth and extended survival in animal models. These results bolster the rationale for targeting these tumor types in upcoming clinical trials.
Strategic Phase II Trial Design and Regulatory Progress
Looking ahead, Percheron unveiled plans for a modular, multi-arm phase II clinical trial set to commence in 2026. This innovative design allows simultaneous investigation of HMBD-002 across several tumor types, including TNBC, EGFR-mutant non-small-cell lung cancer, HER2-negative esophageal cancer, and endometrial cancer. Each arm will provide early efficacy readouts to guide further development decisions. Additionally, the company has completed the transfer of Investigational New Drug (IND) sponsorship to itself with the US FDA, marking a key regulatory milestone and initiating manufacture of new drug batches for the trial.
Strengthening Leadership and Investor Engagement
To support this next phase of development, Percheron appointed two senior executives – Dr. Eugene Kennedy as Chief Medical Officer, bringing extensive immunotherapy expertise, and Valentina Dubljevic as Chief Technology Officer, with a strong background in biotech innovation. The company also launched an interactive investor hub to enhance communication and transparency with shareholders and stakeholders, reflecting a commitment to keeping the market well-informed.
Financial Position and Outlook
Percheron ended the quarter with $5.68 million in cash and a forecast runway of approximately four quarters, supported by a recent $1.43 million R&D tax incentive rebate. While operating cash outflows reflect ongoing clinical and manufacturing investments, the company expects expenditure patterns to evolve as the HMBD-002 program advances. The successful licensing agreement with Hummingbird Bioscience and the completion of technology transfer underpin the company’s readiness to accelerate clinical development.
Bottom Line?
With phase II trials on the horizon and a strengthened leadership team, Percheron is poised to translate early promise into clinical progress; but investors will watch closely for upcoming trial milestones and financial sustainability.
Questions in the middle?
- How will the modular phase II trial design impact timelines and data readouts for HMBD-002?
- What are the manufacturing scale-up challenges and timelines for supplying the phase II study?
- How might Percheron’s cash runway and funding strategy evolve as clinical activities intensify?
