Bright Peak Therapeutics Begins Phase 1/2a Trial of BPT567 with First Patient Dosed

Bright Peak Therapeutics, a biotechnology company in the clinical stage specializing in multifunctional immunotherapies for cancer, has announced the commencement of its Phase 1/2a trial for BPT567. This innovative treatment, a bifunctional PD1-IL18 immunoconjugate, has been administered to the first patient as part of the study. The trial is focused on patients with locally advanced, unresectable, or metastatic solid tumors.

BPT567 is a novel therapeutic approach designed to combine two key immune-stimulating actions into one molecule. This includes a coordinated PD-1/PD-L1 checkpoint blockade alongside the targeted delivery of IL-18 to T cells within the tumor microenvironment. IL-18 is a potent regulator of both innate and adaptive immunity, essential for the host's immune response to cancer. Preclinical research indicates that BPT567 exhibits strong, synergistic anti-tumor activity that surpasses the efficacy of PD-1 blockade alone. This enhanced activity has been observed in both PD-1-sensitive and PD-1-resistant tumor models.

Checkpoint inhibitors such as PD-1 inhibitors have significantly advanced cancer immunotherapy. Bright Peak is exploring whether the multifunctional capabilities of BPT567 can lead to greater efficacy compared to PD-1/PD-L1 blockade alone. This includes investigating its potential in scenarios where checkpoint inhibitors have not been effective or in patients who have experienced progression or recurrence despite previous checkpoint inhibitor therapy. These areas represent significant unmet needs in cancer treatment.

Fredrik Wiklund, Chief Executive Officer of Bright Peak, remarked that dosing the first patient is a crucial milestone in their goal to provide advanced solid tumor patients with a potentially transformative PD-1-based treatment. Jon Wigginton, M.D., President of Research and Development at Bright Peak, added that preclinical studies of BPT567 have shown promising results. The team is eager to further explore the dual mechanism of BPT567, which may deliver significant anti-tumor efficacy, especially for patients unresponsive to conventional PD-1 inhibitors and in new indications where current PD-1 treatments are not available. They look forward to advancing the Phase 1/2a study in collaboration with patients and leading immuno-oncology centers.

The Phase 1/2a trial is an open-label, dose-escalation study designed to evaluate the safety, anti-tumor activity, pharmacokinetics, and pharmacodynamics of BPT567 in patients with locally advanced/unresectable or metastatic solid tumors. The trial includes a dose-escalation phase followed by dose expansion across various tumor types and patient populations. It is expected to enroll approximately 100 patients.

Bright Peak Therapeutics is at the forefront of developing multifunctional immunotherapies for cancer. Utilizing advanced protein engineering and a proprietary chemical protein synthesis and conjugation platform, Bright Peak is building a pipeline of first-in-class multifunctional molecules. The company’s lead program, BPT567, aims to activate and enhance immune responses directly within the tumor microenvironment. With headquarters in Basel, Switzerland, and San Diego, California, Bright Peak is backed by prominent healthcare investors.