ProBioGen, a technology developer and CDMO for cell line development, has announced a clinical milestone for its GlymaxX antibody-dependent cellular cytotoxicity (ADCC) enhancement technology. With Zymeworks' recently announced global Phase III clinical trial of zanidatamab in HER2‑expressing gastroesophageal adenocarcinoma, the GlymaxX technology also reaches Phase III of clinical development.
The company completed cell line development for zanidatamab in 2018 using its CHO.RiGHT expression platform as well as applying its GlymaxX glyco-engineering technology to boost ADCC and cancer cell killing. This technology is available under a non-exclusive license.
ProBioGen's CHO.RiGHT expression and analytical platform is suitable for multispecific formats and complements Zymeworks' technology platform for the development of bispecific and multispecific antibodies. The application of the two platforms resulted in a stable master cell bank, the companies say, producing high purity of the zanidatamab heterodimer at high titers.
"Starting a Phase III clinical trial is an important milestone and we are proud to have successfully contributed to it. For ProBioGen, this is yet another cell line and GlymaxX-enhanced bispecific format demonstrating clinical validation", said Dr. Volker Sandig, CSO at ProBioGen.
Mark Hollywood, Zymeworks' Senior VP, Technical and Manufacturing Operations added: "ProBioGen has been an important partner in the manufacturing of zanidatamab. Their cell line development platform and their innovative GlymaxX technology provided us with a high-quality cell line that contributed to the successful initiation of this Phase III trial."
