Daiichi Sankyo Company, Limited announced that it is making an initial 15 billion yen investment to optimize and enhance its manufacturing capabilities to support its growing 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,” said Katsumi Fujimoto, Ph.D., senior executive officer, head of Supply Chain Division, Daiichi Sankyo. “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 optimize and expand the production of fully synthesized ADCs and ensure a stable supply for future investigational and commercial use.

“We are committed to the continued advancement and acceleration of our ADC franchise, and expanding our manufacturing capabilities will allow us to hone and drive our institutional ADC expertise as we progress development and investigation of these complex medicines,” said Antoine Yver, MD, MSc, executive vice president and global head, Oncology Research and Development, Daiichi Sankyo. “We believe that our researchers have systemically addressed several critical limitations of current ADC technology, so we want to ensure this expertise is carried over to the clinic.”

Antibody drug conjugates (ADCs) are a type of targeted cancer medicine that deliver cytotoxic chemotherapy (“payload”) 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, which has broad application across multiple types of cancer, 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 US. 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). U3-1402 is an investigational and potential first-in-class HER3-targeting ADC currently in phase 1 clinical development for HER3-positive metastatic or unresectable breast cancer.  DS-8201 and U3-1402 have not been approved for any indication in any country.