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This marks the first time a biologic manufactured in China has been released for use in a clinical trial in Europe.
WuXi Biologics, a wholly owned subsidiary of WuXi AppTec, and Prima BioMed, an immuno-oncology company, announced on March 2, 2016 that through a strategic supply partnership, Prima’s immuno-oncology product candidate IMP321 (LAG-3 Ig fusion protein), manufactured at WuXi’s cGMP facility in China, has been dosed in a Phase IIb clinical trial in Belgium.
Prima’s Phase IIb clinical trial is to investigate the drug candidate’s efficacy in the treatment of metastatic breast cancer, and according to the companies, this is the first time a biologic manufactured in China has been released for use in a clinical trial in the EU. According to the announcement, it is also the first time a patient was dosed with Active Immunotherapy PAClitaxel (AIPAC). WuXi is supplying IMP321 to Prima’s AIPAC trial, which is being conducted in Europe, as well as to its TACTI-Mel Phase I melanoma trial, currently recruiting in Australia.
Phase I clinical trials of IMP321, completed in 2010, examined its efficacy in 30 patients with metastic breast cancer. The patients received three cohorts (doses: 0.25, 1.25, and 6.25). According to results published in the Journal of Translational Medicine, “clinical benefit was observed in 90% of patients with only 3 progressors at 6 months.” The results showed an objective tumor response rate of 50%, compared with a 25% rate in the historical control group. The phase I study's primary sponsor, Immutep SA, was purchased by Prima BioMed in October 2014.
According to the company, Belgium’s Federal Agency for Medicines and Health Products approved the Clinical Trial Application (CTA) for the Phase IIb trial on October 25, 2015. The clinical trial authorization was also granted in the Netherlands and is pending in several other EU countries.
Source: WuXi Biologics/Prima BioMed