Synthon Biopharmaceuticals has reported positive early pre-clinical results of its second generation HER2-antibody-drug conjugate (ADC).
The research revealed that when HER2-ADC was dosed alone, a complete tumour remission was induced in several xenograft models such as primary human breast cancer and non-small-cell lung cancer.
Toxicity experiments have discovered the improved therapeutic index with at least one order of magnitude compared to other armed antibodies and significant safety profile of HER2-ADC.
Synthon chief scientific officer Dr Marco Timmers said the company's first ADC program includes the HER2-binding antibody trastuzumab.
"The primary objective is to develop a broad therapeutic spectrum by targeting tumours that over-express HER2, such as metastatic breast cancer and non-small-cell lung cancer," Timmers said.
"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 ADC linker-drug technology based on duocarmycin analogs connects the antibody to the duocarmycin drug, causing elevated stability in circulation while inducing efficient cytotoxin release in the tumour cell.
Synthon anticipates advancing the drug candidate into clinical trials in 2014.
The company has opened a new GMP facility in Nijmegen, the Netherlands, to produce ADCs for Phase III trials and early launches.
"We strongly believe that advancing this second generation ADC technology will lead to a new class of effective, targeted medicines in oncology. Our GMP plant will also accelerate future patient access to oncology products based on this pioneering technology," Timmers said.