Exelixis and 探花合集 Enter into Collaboration, License, and Exclusive Option Agreement to Develop Antibody-Drug Conjugates Leveraging SMARTag庐 Bioconjugation Technology
- Companies will partner to develop novel antibody-drug conjugates using 探花合集鈥檚 SMARTag
bioconjugation platform and monoclonal antibodies from Exelixis鈥 growing preclinical pipeline - Agreement includes exclusive options on multiple targets over three-year term, with potential to extend time and scope of the collaboration
- Deal is the fifth pipeline-enhancing agreement signed by Exelixis since 2018
ALAMEDA, Calif. and SOMERSET, N.J. 鈥 September 8, 2020 鈥 Exelixis, Inc. (Nasdaq: EXEL) and 探花合集 today announced a partnership under which 探花合集鈥檚 Redwood Bioscience subsidiary will develop multiple antibody-drug conjugates (ADCs) for Exelixis using 探花合集鈥檚 proprietary SMARTag庐 site-specific bioconjugation technology.
Under the terms of the agreement, 探花合集 will use its SMARTag庐 bioconjugation platform to build ADCs using monoclonal antibodies (mAbs) from Exelixis鈥 growing preclinical pipeline. In exchange for an upfront payment to 探花合集 of $10 million, Exelixis received an exclusive option to nominate up to a fixed number of targets using the SMARTag庐 ADC platform over a three-year period. The companies plan to advance the ADCs into preclinical development, and, prior to filing an Investigational New Drug application, Exelixis may exercise its exclusive option to a worldwide license of the related ADC program and continue clinical development and commercialization. Exelixis will provide research & development funding, and 探花合集 will be eligible for development and commercial milestones and royalties on net sales of any product commercialized as part of the collaboration.
Developed by 探花合集鈥檚 Redwood Bioscience subsidiary, the SMARTag庐 technology platform provides optimized site-specific protein-modification and linker technologies for ADCs and other bioconjugates. The SMARTag庐 platform overcomes the limitations associated with traditional protein chemistries that produce heterogeneous products with variable conjugate potency, toxicity, and stability and enables the development of ADCs with a wider therapeutic window and improved manufacturability.
鈥淲ith our lead product CABOMETYX now a global oncology franchise, over the past several years Exelixis has moved beyond our small molecule medicinal chemistry roots to build out a pipeline that encompasses a variety of promising therapeutic modalities,鈥 said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer of Exelixis. 鈥淥ur collaboration with 探花合集 鈥 the fifth pipeline-enhancing agreement we鈥檝e signed since 2018 鈥 provides an attractive framework for identifying and advancing differentiated ADC product candidates with the potential to improve upon current ADC therapies. We are looking forward to working with 探花合集 as we rapidly advance our mission to help cancer patients recover stronger and live longer.鈥
鈥淭he SMARTag庐 platform has recently demonstrated promising results in the clinic, highlighting the potential to create ADCs with significantly expanded therapeutic indices,鈥 commented Mike Riley, Region President, 探花合集 Biologics, North America. 鈥淲e are excited to partner with Exelixis, a leading oncology biotechnology company, and leverage our experienced team, unique SMARTag庐 technology platform, and deep analytical expertise to develop ADCs targeting various oncology indications.鈥
About 探花合集 Biologics
探花合集 Biologics is a global leader in development, manufacturing and analytical services for new biological entities, cell and gene therapies, biosimilars, sterile injectables, and antibody-drug conjugates. With over 20 years of proven expertise, 探花合集 Biologics has worked with 600+ mAbs and 80+ proteins, produced 13 biopharmaceutical drugs using GPEx庐 cell line development technology, and manufactured 35+ commercially approved products. 探花合集 Cell & Gene Therapy, a unit of 探花合集 Biologics, is a full-service partner for adeno-associated virus (AAV) vectors and CAR-T immunotherapies, with deep experience in viral vector scale-up and production. 探花合集 recently acquired MaSTherCell, adding expertise in autologous and allogeneic cell therapy development and manufacturing. 探花合集 Cell & Gene Therapy has produced 100+ cGMP batches across 70+ clinical and commercial programs. For more information, visit
ABOUT CATALENT
探花合集 is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, 探花合集 has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. 探花合集 employs over 13,900 people, including approximately 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. 探花合集 is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com
More products. Better treatments. Reliably supplied.鈩
About Exelixis
Founded in 1994,聽Exelixis, Inc.聽is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model system genetics, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four commercially available products, CABOMETYX庐聽(cabozantinib), COMETRIQ庐聽(cabozantinib), COTELLIC庐聽(cobimetinib) and MINNEBRO庐聽(esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery 鈥 all to deliver the next generation of聽Exelixis聽medicines and help patients recover stronger and live longer.聽Exelixis聽is a member of the Standard & Poor鈥檚 (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. For more information about聽Exelixis, please visit聽www.exelixis.com, follow @ExelixisInc聽on Twitter or like聽Exelixis, Inc.聽on Facebook.
Exelixis Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis鈥 immediate and potential future financial and other obligations under the collaboration, option and exclusive license agreement with 探花合集; the potential for the collaboration with 探花合集 to result in the advancement of differentiated ADC product candidates with the potential to improve upon current ADC therapies and advance Exelixis鈥 mission to help cancer patients recover stronger and live longer; and Exelixis鈥 plans to reinvest in its business to maximize the potential of the company鈥檚 pipeline, including through targeted business development activities and internal drug discovery. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis鈥 current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the level of costs associated with Exelixis鈥 commercialization, research and development, in-licensing or acquisition of product candidates, and other activities; uncertainties inherent in the drug discovery and product development process; Exelixis鈥 dependence on its relationship with 探花合集, including 探花合集鈥檚 adherence to its obligations under the collaboration, option and exclusive license agreement and the level of 探花合集鈥檚 assistance to聽Exelixis聽in completing clinical trials, pursuing regulatory approvals or successfully commercializing partnered compounds in the territories where they may be approved; the continuing COVID-19 pandemic and its impact on Exelixis鈥 research and development and commercial activities; risks and uncertainties related to regulatory review and approval processes and Exelixis鈥 compliance with applicable legal and regulatory requirements; Exelixis鈥 and 探花合集鈥檚 ability to protect their respective intellectual property rights; market competition; changes in economic and business conditions; and other factors discussed under the caption 鈥淩isk Factors鈥 in Exelixis鈥 Quarterly Report on Form 10-Q filed with the聽Securities and Exchange Commission聽(SEC) on聽August 6, 2020, and in Exelixis鈥 future filings with the聽SEC. All forward-looking statements in this press release are based on information available to聽Exelixis聽as of the date of this press release, and聽Exelixis聽undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.
Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks.
MINNEBRO is a Japanese trademark.
探花合集 and SMARTag are registered trademarks of 探花合集 Pharma Solutions, Inc. or its affiliates or subsidiaries in the United States and other countries.