ProBioGen AG, a technology developer and CDMO for cell line development through GMP manufacturing, announced an important 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 clinical development.
 
ProBioGen 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. GlymaxX is available under a non-exclusive license.
 
ProBioGen’s CHO.RiGHT expression and analytical platform is suited for multispecific formats and complements Zymeworks’ Azymetric technology platform for the development of bispecific and multispecific antibodies. The two platforms resulted in a stable master cell bank, producing high purity of the zanidatamab heterodimer at high titers that exceeded expectations.
 
“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, Chief Scientific Officer at ProBioGen.
 
Mark Hollywood, Zymeworks’ Senior Vice President, 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.”