Bright Peak Therapeutics Announces Dosing of First Patient in Phase 1/2a Clinical Trial of BPT567

Bright Peak Therapeutics Announces Dosing of First Patient in Phase 1/2a Clinical Trial of BPT567, a First-in-Class Bifunctional PD1-IL18 Immunoconjugate

-- BPT567 is the first bifunctional PD1-IL18 immunoconjugate to enter clinical development --

-- Phase 1/2a study will evaluate BPT567 in patients with locally advanced/unresectable or metastatic solid tumors --

BASEL, Switzerland and SAN DIEGO, Oct. 17, 2024 (GLOBE NEWSWIRE) - Bright Peak Therapeutics, a clinical-stage biotechnology company focused on discovering and developing multifunctional immunotherapies for cancer, today announced that the first patient was dosed in its Phase 1/2a trial evaluating BPT567, an investigational bifunctional PD1-IL18 immunoconjugate.

BPT567 is designed to combine two key immuno-stimulatory mechanisms of action into a single molecule, including coordinated PD-1/PD-L1 checkpoint blockade in tandem with the targeted delivery of IL-18 to T cells within the tumor microenvironment (TME). IL-18 is known as a master regulator of innate and adaptive immunity, and as driver of the host immune response to cancer. Preclinical studies have shown that BPT567 mediates potent, synergistic anti-tumor activity superior to PD-1 blockade alone, with activity in both PD-1-sensitive and PD-1-resistant tumor models.

While PD-1 inhibitors have revolutionized cancer immunotherapy, Bright Peak is actively investigating whether the multifunctional biology of BPT567 could not only translate to enhanced efficacy compared to PD-1/PD-L1 blockade alone in indications where checkpoint inhibitors have been approved, but also demonstrate activity in settings where checkpoint inhibitors have not worked to date or in patients who have progressed or recurred despite prior checkpoint inhibitor therapy, all of which represent major areas of unmet need for patients with cancer.

“The dosing of the first patient in this trial marks a significant and exciting milestone in our mission to provide patients with advanced solid tumors with a potentially transformative PD-1 based treatment option,” said Fredrik Wiklund, Chief Executive Officer of Bright Peak.

Jon Wigginton, M.D., President of Research and Development at Bright Peak, added, “Preclinical studies of BPT567 have demonstrated very encouraging results and we are eager to further explore BPT567's dual mechanism, which we believe could have the potential to deliver impactful anti-tumor efficacy, including for patients who have not responded to conventional PD-1 inhibitors alone, and in new indications where current PD-1s are not approved. We look forward to advancing this important Phase 1/2a study in collaboration with participating patients, and leading immuno-oncology centers.”

About the Phase 1/2a Trial
The study is an open-label, dose-escalation clinical trial, designed to assess the safety, antitumor 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 multiple tumor types and patient populations. The study is expected to enroll approximately 100 patients.

About Bright Peak Therapeutics
Bright Peak Therapeutics is a clinical-stage biotechnology company focused on discovering and developing multifunctional immunotherapies for cancer. Using innovative protein engineering and a proprietary chemical protein synthesis and conjugation platform, Bright Peak is developing a pipeline of first-in-class multifunctional molecules. The company's lead program, BPT567, is a bifunctional PD1-IL18 immunoconjugate aimed at activating and enhancing immune responses directly within the tumor microenvironment. Bright Peak is headquartered in Basel, Switzerland, and San Diego, CA, and is supported by a syndicate of leading healthcare investors. For more information, please visit www.brightpeaktx.com.

Contact:
info@brightpeaktx.com