Baekje Shenzhou was the first patient to be included in the clinical phase I trial of PD-1 monoclonal antibody BGB-A317

Baekje Shenzhou was the first patient to be included in the clinical phase I trial of PD-1 monoclonal antibody BGB-A317

June 08, 2015 Source: New Drugs

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-- Baekje Shenzhou is committed to the development of innovative drugs for tumor-targeted innovative drugs and immunotherapy. In the past 18 months, there were 3 small molecule targeted drugs and 1 macromolecular immunosuppressive agent, and 4 innovative drug candidates entered clinical trials.

——PD-1 monoclonal antibody will test single drug performance and preliminary anti-tumor effect on malignant tumor in clinical phase I dose escalation test and extended cohort test

Beijing, China (June 5) Baekje Shenzhou today announced that its first phase of BGB-A317 clinical trials for advanced cancer treatment has been enrolled. Baekje Shenzhou is a company dedicated to the development of innovative drugs for targeting and immune tumors. BGB-A317 is a highly selective and potent all-human monoclonal antibody candidate against PD-1.

PD-1 is an important immunosuppressive molecule. It regulates and inhibits T cell activation of the ligand signaling pathway and plays a key role in tumor progression.

“We have been accelerating the development of our innovative drugs. Over the past 18 months, we have had 4 different targets, and very promising candidates have entered clinical trials,” said Baekje’s CEO Mr. Laiqiang said. “Our fourth drug candidate, BGB-A317, has entered clinical trials, once again demonstrating the effectiveness of our innovative translational medicine platform and reflecting our ability to achieve major drug clinical development milestones. We look forward to the future. Within a few months, new preclinical candidates can enter clinical trials."
In addition to this BGB-A317 project, Baekje Shenzhou's three other small molecule targeted drugs: BGB-3111 (BTK inhibitor), BGB-283 (BRAF dual inhibitor) and BGB-290 (PARP inhibitor) All have entered the clinical phase I trial.

About this research
BGB-A317 began a clinical phase I trial of multicenter, unblinded, dose escalation, and cohort expansion. This clinical trial focused on the properties of BGB-A317 as a single drug for safety, tolerability, pharmacokinetics, and antitumor activity. The key research objectives of this trial were to determine the maximum tolerated dose of BGB-A317 drug, to determine the therapeutic dose for clinical phase II trials, and to initially understand its anti-tumor effect in different tumors.

About Baekje Shenzhou
Baekje Shenzhou is a company dedicated to the research and development and commercialization of innovative drugs for tumor-targeted innovative drugs and immuno-tumor treatments, and has an innovative drug conversion research platform that can effectively combine tumor biology and patient biopsy data. Baekje Shenzhou currently has more than 170 R&D and support teams, and its product line includes innovative oral small molecule and monoclonal antibody oncology drugs.

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