Zai Lab treats first patients in Phase 1b & bridging clinical trials

Zai Lab Limited, a Chinese biopharmaceutical company that innovates novel drugs for autoimmune, infectious and oncology diseases, has recently revealed that its first patients have been diagnosed in two separate clinical trials, namely niraparib plus MGD013 Phase 1b trial and the registrational bridging study for margetuximab along with chemotherapy. For the record, Niraparib Phase 1b trial is centered around evaluating the safety profile of niraparib in combination with MGD013 on advanced or metastatic gastric cancer patients, ascertaining the appropriate dose for Phase 2 study. Whereas, margetuximab’s registrational bridging study focuses on the progression-free survival of patients suffering from metastatic or advanced gastroesophageal junction adenocarcinoma or gastric adenocarcinoma who have failed previous treatment options. This study’s secondary endpoints consist of ORR, overall survival (OS), clinical benefit rate (CBR) and duration of response (DoR), as well as pharmacokinetic and safety profile of margetuximab in Chinese subjects. Prior to this news, Zai Lab had made headlines when it revealed that its advanced drug, polymerase (PARP) poly (ADP-ribose) inhibitor ZL-2306 (Niraparib), has bagged financial backing from the National Major Scientific and Technological Special Project for Significant New Drugs Development in China. Evidently, this financial aid would support the new drug applications and clinical research of ZL-2306. The Significant New Drugs Development program was initiated in 2008 and aims to motivate research institutions and pharmaceutical companies to create drugs for 10 crucial disease areas that severely endanger people’s health in China. This would also advance the country’s drug innovation system. Speaking on the move, Dr. Samantha Du, Founder and Chief Executive Officer, Zai Lab, said that being the first-ever manufactured PARP inhibitor with Category 1 designation in China, the company is pleased that ZL-2306 has received support for Significant New Drugs Development project. According to the latest study, ZL-2306 comes as the first PARP inhibitor that has substantially enhanced PFS when administered as monotherapy in females suffering from first-line platinum responsive ovarian cancer. Source Credit: http://www.zailaboratory.com/pressnews/index.aspx