Daiichi Sankyo is making an initial Japanese ¥ 15 billion (US $ 135 million) investment to optimize and enhance its manufacturing capabilities to support its growing antibody-drug conjugate 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,” noted 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,” he further noted.

New and refurbish manufacturing lines
The company’s investment will build new and refurbish manufacturing lines at three of the company’s manufacturing plants in Japan. These improvements are expected to optimize and expand the production of fully synthesized antibody-drug conjugates (ADCs) and ensure a stable supply for both future investigational and commercial use.

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Acceleration of ADC franchise
“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,” explained 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,” he added.

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.

Current pipeline
Daiichi Sankyo Cancer Enterprise currently includes six novel antibody-drug conjugates including DS-8201 and U3-1402 in phase I 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 I 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 (Kadcyla®; Genentech/Roche).

U3-1402 is an investigational and potential first-in-class HER3-targeting ADC currently in phase I clinical development for HER3-positive metastatic or unresectable breast cancer. Both agents, DS-8201 and U3-1402, have not been approved for any indication in any country.

Strategic Goal
Anchored by its antibody-drug conjugate and acute myeloid leukemia (AML) franchises, Daiichi Sankyo cancer pipeline includes more than 20 small molecules, monoclonal antibodies and ADCs stemming from powerful research laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon, a small molecule structure-guided R&D center in Berkeley, CA.

In addition to a number of ADCs, Daiichi Sankyo is also developing quizartinib, an oral FLT3 inhibitor, for FLT3-ITD+ AML and pexidartinib, an oral CSF-1R inhibitor, for tenosynovial giant cell tumor (TGCT) which is also being explored in a range of solid tumors in combination with the anti-PD1 immunotherapy pembrolizumab (Keytruda®; Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.)

Daiichi Sankyo research and development is primarily focused on developing novel therapies in oncology, including immuno-oncology as well as novel agents in pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.  Combined with a strong portfolio of medicines for hypertension and thrombotic disorders, Daiichi Sankyo goal is to be a global pharma innovator with a competitive advantage in oncology.

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