Tomuzotuximab

Glycotope Announces Poster Presentations at the 2021 American Society of Clinical Oncology (ASCO) Virtual Annual Meeting Berlin, Germany, April 30, 2021 - Glycotope GmbH, a biotechnology company developing antibodies against proteins carrying tumor-specific carbohydrate structures, today announced it will present two posters at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, which is being held virtually this year due to COVID-19. Poster details are as follows: Poster 2254Title: Safety and tolerability results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody Gatipotuzumab with the anti-EGFR Tomuzotuximab or Panitumumab in patients with refractory solid tumorsSession: Poster Session: Developmental Therapeutics—ImmunotherapyAbstract ID: 332635 Poster 2252Title: Activity results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody Gatipotuzumab with the anti-EGFR Tomuzotuximab or Panitumumab in patients with refractory solid tumorsSession: Poster Session: Developmental Therapeutics—ImmunotherapyAbstract ID: 329709 Due to the virtual format, all oral, poster, and poster discussion sessions, as well as track-based Clinical Science Symposia, will be available on demand, beginning 4 June 2021 at 9 a.m. EDT, for registered attendees of the conference. Contact Information: About GATTO The multicenter, open label phase Ib GATTO study explored the feasibility, tolerability and preliminary activity of combining Gatipotuzumab, a novel humanized monoclonal antibody binding to a tumor-associated epitope of mucin-1 (TA-MUC1) and an anti-EGFR antibody. Based on compelling preclinical evidence suggesting a complex interaction between EGFR and TA-MUC1 expressed on the tumor cell surface in driving carcinogenesis, this study assessed the tolerability, safety and preliminary activity of targeting EGFR and TA-MUC1 with glyco-engineered antibodies. In this study, 50 patients with refractory solid tumors were treated with both antibodies in 5 centers in Germany, Italy and Spain. The results analysis demonstrated that combination of TA-MUC1 and EGFR targeting antibody is safe and feasible. Encouraging anti-tumor activity was observed in heavily pretreated CRC and NSCLC patients. Levels of soluble TA-MUC1 may have predictive value and potentially be a companion biomarker for further development of the combination. About Glycotope Glycotope is a biotechnology company utilizing a proprietary technology platform to develop highly tumor-specific monoclonal antibodies called GlycoBodies. GlycoBodies bind to targets (GlycoTargets) tumor-specific carbohydrate structure dependent, enabling the development of highly-specific immunotherapies across a broad range of cancer indications. Glycotope has to date discovered in excess of 150 GlycoTargets with GlycoBodies against eight of these targets currently under development. Each GlycoBody can be developed in an array of modalities with different modes of action such as Antibody-drug conjugates, CAR/cell therapies or bispecifics, providing a unique offering in the (immuno) oncology space. Currently six clinical and pre-clinical programs based on the GlycoBody technology are under development by Glycotope or its licensing partners. Visit .

PDF (242KB)PDF For Immediate Release Company name: DAIICHI SANKYO COMPANY, LIMITED Representative: Sunao Manabe, Representative Director, President and COO (Code no.: 4568, First Section, Tokyo Stock Exchange) Please address inquiries to Koji Ogawa, Corporate Officer, Vice President, Corporate Communications Department Telephone: +81-3-6225-1126 https://www.daiichisankyo.com 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/Open new window.. 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.comOpen new window.. 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.comOpen new window.. Contact Daiichi Sankyo: Jennifer Brennan Daiichi Sankyo, Inc. jbrennan2@dsi.com +1 908 992 6631 (office) +1 201 709 9309 (mobile) Glycotope: Henner Kollenberg Glycotope GmbH contact@glycotope.com +49 30 9489 2600 References: 1. Fidler W, et al. Eur J Cancer. 2016; 63:55-63.