Synthon Biopharmaceuticals has opened a GMP antibody-drug conjugate (ADC) production facility in Nijmegen.
The Nijmegen facility will produce ADCs, which combine specific anti-cancer antibody or antibody fragment to an anti-cancer therapeutic, required for Phase III trials and early launches.
Company has also reported positive preclinical results with its HER2-ADC that induced complete tumor remission when dosed alone in xenograft studies.
Toxicity experiments demonstrated improved therapeutic index and a considerable safety profile of HER2-ADC.
Synthon Biopharmaceuticals chief scientific officer Dr. Marco Timmers said the HER2-binding antibody trastuzumab is incorporated into the company’s first ADC program.
“The primary objective is to develop a broad therapeutic spectrum by targeting tumors that over-express HER2, such as metastatic breast cancer and non-small-cell lung cancer,” Dr. Timmers added.
“As a result of our unique linker-drug technology, this ADC program is delivering on its promise and giving us exciting preclinical results with the opportunity to become a Best-in-Class therapy.”
The drug candidate that will be produced in the newly opened GMP facility is expected to enter into clinical trials in 2014.