Daiichi Sankyo Company announced it is making an initial 15 billion yen investment to optimize and enhance its manufacturing capabilities to support its antibody drug conjugate (ADC) pipeline.
"This strategic investment will bolster our leadership and expertise in ADC manufacturing, as we apply our proprietary ADC technology to more than two dozen biologics in preclinical or early stage development," Katsumi Fujimoto, Ph.D., Senior Executive Officer, Head of Supply Chain Division, Daiichi Sankyo said. "Our manufacturing capacities will more than triple by 2021, affording us greater flexibility for research and development, and strengthening our anticipated future commercial production."
The company's investment will build new and refurbish manufacturing lines at three of the company's manufacturing plants in Japan. These improvements will expand the production of fully synthesized ADCs and ensure a stable supply for future investigational and commercial use.
Antibody drug conjugates (ADCs) are a type of targeted cancer medicine that deliver cytotoxic chemotherapy directly to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Daiichi Sankyo's proprietary ADC technology is designed to deliver enhanced cancer cell destruction with less systemic exposure to the cytotoxic payload.
The ADC Franchise of Daiichi Sankyo Cancer Enterprise currently consists of six novel ADCs including DS-8201 and U3-1402 in phase 1 clinical development as well as DS-7300, DS-1062 and two other ADCs with undisclosed targets in pre-clinical development.
DS-8201 is an investigational HER2-targeting ADC currently in phase 1 clinical development for HER2-positive advanced or metastatic breast or gastric cancer, HER2-low-expressing breast cancer, and other HER2-expressing solid cancers. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to DS-8201 for the treatment of HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including ado-trastuzumab emtansine (T-DM1).