Daiichi Sankyo Enters Worldwide Licensing Agreemen

Daiichi Sankyo Enters Worldwide Licensing Agreement with Glycotope for Gatipotuzumab Antibody Drug Conjugate

Tokyo, Berlin, Basking Ridge, NJ – (July 30, 2018) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and Glycotope GmbH (hereafter, Glycotope) have entered into an exclusive worldwide licensing agreement to develop an antibody drug conjugate (ADC) by combining Daiichi Sankyo’s proprietary ADC technology with Glycotope’s investigational tumor-associated TA-MUC1 antibody gatipotuzumab (formerly PankoMab-GEX ^® ), building on a previous 2017 option agreement.

Under the terms of the licensing agreement, Daiichi Sankyo has worldwide exclusive rights to develop and commercialize gatipotuzumab as an ADC. Glycotope will receive an upfront payment and is eligible for clinical, regulatory and sales milestone payments, as well as royalties on net sales worldwide from Daiichi Sankyo. Specific financial terms have not been disclosed.

“With the licensing of gatipotuzumab with the intention of developing an ADC, we now have seven novel ADCs in development, which demonstrate our commitment to maximizing the potential of our proprietary ADC payload and linker technology to help address the unmet needs of patients with cancer worldwide,” said Tom Held, Vice President, Head, Antibody Drug Conjugate Task Force, Oncology Research and Development, Daiichi Sankyo. “We are excited by the rapid progress we have made in our collaboration with Glycotope and look forward to the continued clinical development of this potentially first-in-class TA-MUC1-targeting ADC.”

“This agreement with Daiichi Sankyo highlights the potential and wide applicability of gatipotuzumab,” said Henner Kollenberg, Managing Director of Glycotope. “Our world-leading glyco-biology expertise has allowed us to create a novel anti-TA-MUC1 monoclonal antibody with carbohydrate mediated tumor-specificity and high affinity binding. We look forward to continuing to work with Daiichi Sankyo on this ADC program and on the further development of gatipotuzumab in other formats.”

ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy (“payload”) 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 target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered. Gatipotuzumab is an investigational monoclonal antibody that enables tumor-specific binding to a novel carbohydrate-induced conformational epitope, TA-MUC1, which is extensively expressed in many tumor types including ovarian, lung and breast. ¹

About Glycotope Glycotope is a clinical-stage immuno-oncology company built on world-leading glyco-biology expertise. The company draws on its long experience in glyco-biology to create highly specific mAbs targeting glyco-epitopes, and glyco-optimized mAbs with enhanced performance. Glycotope has a growing pipeline of high-value cancer therapies focused around the glyco-optimized antibody, gatipotuzumab, which targets the novel glyco-epitope target TA-MUC1. Its lead clinical program is in phase 1b in combination with tomuzotuximab, a glyco-optimized second-generation anti-EGFR mAb. Glycotope has entered a partnership with Daiichi Sankyo for antibody drug conjugates (ADCs) and is also exploring multiple additional formats based on gatipotuzumab. Visit http://www.glycotope.com/ .

About Daiichi Sankyo Cancer Enterprise The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. Compounds in pivotal stage development include: DS-8201, an antibody drug conjugate (ADC) for HER2-expressing breast, gastric and other cancers; quizartinib, an oral selective FLT3 inhibitor, for newly-diagnosed and relapsed/refractory FLT3 -ITD acute myeloid leukemia (AML); and pexidartinib, an oral CSF1R inhibitor, for tenosynovial giant cell tumor (TGCT). For more information, please visit: www.DSCancerEnterprise.com .

About Daiichi Sankyo Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. For more information, please visit: www.daiichisankyo.com . Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. For more information on Daiichi Sankyo, Inc., please visit: www.dsi.com .

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References:

1. Fidler W, et al. Eur J Cancer. 2016; 63:55-63.