Biotheus Announces Clinical Trial Collaboration with MSD to Evaluate BJ-001 in Combination with KEYTRUDA®

ShanghaiMarch 28, 2023PR Newswire -- Boji Biomedical Technology Co., Ltd. (hereinafter referred to as "the Company" or "Boji"), a biopharmaceutical company focused on the research and development of innovative cancer immunotherapy biologics, today announced that it has entered into a clinical trial collaboration and supply agreement with MSD (MSD is the trade name of Merck & Co., Inc., located in Rahway, New Jersey, USA). The collaboration will study BJ-001 (a tumor-targeting IL-15 fusion protein designed by Boji) in combination with MSD's PD-1 inhibitor KEYTRUDA in an ongoing Phase I clinical trial.^®(The safety and efficacy of pembrolizumab combination therapy.)

In this clinical trial, Boji will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and anti-tumor activity of BJ-001 in combination with pembrolizumab in patients with locally advanced/metastatic solid tumors. In the monotherapy dose-escalation phase of the trial, BJ-001 demonstrated good safety, PK/PD characteristics consistent with expectations, and encouraging preliminary efficacy results.

"MSD is a world-renowned multinational pharmaceutical company. Boji is very pleased to have the opportunity to collaborate with MSD," said Dr. Haizhou Zhang, Co-founder and CEO of Boji. "As is well-known, pembrolizumab is one of the gold-standard drugs in the field of cancer immunotherapy. BJ-001 is a highly promising new therapeutic approach in this field. Our preclinical animal studies have shown that the combination of BJ-001 and a PD-1 inhibitor demonstrates better anti-tumor effects compared to either drug alone, with good tolerability. BJ-001 is an IL-15 fusion protein with tumor-targeting properties. We believe that BJ-001 holds great potential. Investigating the combination of BJ-001 and pembrolizumab as a novel treatment modality has the potential to benefit more cancer patients. The combination therapy of BJ-001 and pembrolizumab is a key component of our BJ-001 clinical development program."

KEYTRUDA^® Is a registered trademark, with the trademark owner being Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. located in Rahway, New Jersey, USA.