On March 27, 2023 BJ Bioscience, Inc. BJ Bioscience, a biotech company focusing on discovery and development of novel biologics for cancer immunotherapy, reported that it entered into a clinical trial collaboration and supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA) (Press release, BJ Bioscience, MAR 27, 2023, View Source [SID1234629396]). The collaboration will allow for the evaluation of safety and efficacy of BJ-001, a tumor-targeting IL-15 fusion protein, in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in an ongoing Phase 1 clinical trial.
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BJ Bioscience will evaluate BJ-001 plus KEYTRUDA as part of the company’s ongoing trial in patients with locally advanced/metastatic solid tumors. In this trial, BJ-001 is studied as monotherapy or in combination with KEYTRUDA, for safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity.
In monotherapy dose escalation cohorts, BJ-001 has demonstrated tolerable safety profiles, favorable PK/PD profiles, and encouraging preliminary efficacy results.
"BJ Bioscience is excited to collaborate with MSD, one of the world’s leading multinational pharmaceutical companies," said Joe Zhang, MD, PhD, cofounder and CEO of BJ Bioscience. "Many consider KEYTRUDA to be one of the gold-standard medicines in the cancer immunotherapy arena. We believe BJ-001 may be a promising addition to this area. Our preclinical studies demonstrated that the combination of BJ-001 and an anti-PD-1 antibody was well-tolerated and showed promising early antitumor activity compared to either drug alone as monotherapy. With its tumor-targeting properties, we’re looking forward to evaluating BJ-001 in combination with KEYTRUDA as a potential new treatment option to benefit more cancer patients. This investigational combination is a key component of our BJ-001 development program."
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About BJ-001
BJ-001 is a tumor-targeting IL-15 fusion protein, designed to expand and activate cancer-fighting natural killer (NK) cells and CD8+ T cells, and to have selected distribution in tumors with high integrin-expression. Preclinical data have demonstrated the ability of BJ-001 to accumulate in integrin-expressing tumors. Clinical data to date have shown Best-in-Class properties of BJ-001, including tolerable safety, dose-dependent and encouraging magnitude of stimulation and expansion of NK cells and CD8+ T cells with no impact on immunosuppressive regulatory T cells.