ProBioGen has announced the commercial availability of Ziihera (zanidatamab-hrii), a therapeutic antibody developed using its proprietary GlymaxX technology. This milestone follows the FDA approval late last year for the treatment of HER2-positive biliary tract cancer (BTC), representing a significant advancement in targeted cancer therapy.
"The market availability of a bispecific therapeutic antibody developed with the GlymaxX technology represents an important milestone," said Dr. Gabriele Schneider, Chief Business Officer at ProBioGen. "It is rewarding to see our technology play a role in therapies that can make a real difference for patients. We are proud to have contributed to Ziihera's journey by providing our cell line, media, and our proprietary technology to help bring this innovative treatment to market."
The Power of GlymaxX Technology
ProBioGen's GlymaxX technology optimizes antibody activity by enhancing antibody-mediated cell killing of cancerous cells, a process known as Antibody-Dependent Cellular Cytotoxicity (ADCC). The technology works by stably introducing a gene into producer cells that encodes an enzyme blocking the cells' fucose biosynthesis pathway. This prevents the addition of fucose to the antibody's N-linked carbohydrate structure, significantly enhancing ADCC activity.
A unique feature of GlymaxX is its flexibility. The technology can be applied to both new and existing antibody producer cell lines without negatively affecting cellular productivity or other product characteristics. A single GlymaxX cell line can produce differently fucosylated products depending on the upstream process: in fucose-free medium, the antibody is afucosylated, while in fucose-containing medium, it produces fully fucosylated antibodies.
Advancing Treatment for HER2-Positive Biliary Tract Cancer
Biliary tract cancer represents a significant unmet medical need, with limited treatment options available until now. HER2-positive BTC is particularly challenging to treat, making the availability of Ziihera a welcome addition to the therapeutic landscape.
The bispecific antibody Ziihera targets HER2, a protein that promotes cancer cell growth. By precisely targeting HER2-positive cancer cells, Ziihera offers a more targeted approach compared to conventional chemotherapy, potentially improving outcomes while reducing side effects.
ProBioGen's Comprehensive Contribution
Beyond providing the GlymaxX technology, ProBioGen also developed the superior cell line and applied its proprietary media for this antibody. This comprehensive approach highlights the company's integrated capabilities in biopharmaceutical development.
"We look forward to continuing to support groundbreaking advancements in biopharmaceuticals," added Dr. Schneider. The company expects further GlymaxX-enabled achievements in the near future, reinforcing its commitment to advancing precision medicine.
About ProBioGen
Berlin-based ProBioGen has been operational for over 30 years, specializing in developing and manufacturing biopharmaceutical active ingredients, viral vectors, and vaccines. With 300 employees across four locations in Berlin, the company combines state-of-the-art development services with its CHO.RiGHT expression and manufacturing platform.
ProBioGen offers its GlymaxX technology royalty-free and non-exclusively as a service or as an individual license, making this innovative approach accessible to partners developing novel therapeutics. The company's growth strategy focuses on expanding its service value chain while enabling the development of biopharmaceuticals for tomorrow.
As precision medicine continues to evolve, ProBioGen remains dedicated to supporting biopharma innovators through cutting-edge technologies and tailored services that drive therapeutic success. The commercial availability of Ziihera represents not just a milestone for ProBioGen, but a significant step forward in providing targeted treatment options for patients with HER2-positive biliary tract cancer.
