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Exelixis In-Licenses Iconic Therapeutics’ Tissue Factor-Targeting Antibody-Drug Conjugate Ahead of Planned Investigational New Drug Application
– Phase 1 clinical trial planned for early 2021, pending the FDA’s acceptance of Exelixis’ planned IND filing – – Under the terms of the companies’
About this update from Exelixis, Inc.
[{"type":"text","content":"\n– Phase 1 clinical trial planned for early 2021, pending the FDA’s acceptance of Exelixis’ planned IND filing –\n\n– Under the terms of the companies’ agreement, Exelixis has made an option exercise payment of $20 million to Iconic Therapeutics –\n\n– Preclinical data underscore best-in-class potential for XB002 (formerly ICON-2) in treatment of solid tumors –\n\n ALAMEDA, Calif., SOUTH SAN FRANCISCO, Calif. & VANCOUVER, British Columbia--(BUSINESS WIRE)--\nExelixis, Inc. (Nasdaq: EXEL), Iconic Therapeutics, Inc. (Iconic) and Zymeworks Inc. (NYSE:ZYME) today announced that Exelixis has exercised its exclusive option for Iconic’s lead oncology antibody-drug conjugate (ADC) program under the companies’ May 2019 agreement. As a result, Exelixis now has responsibility for the future clinical development, commercialization, and manufacturing of the Tissue Factor (TF)-targeting ADC now known as XB002 (formerly ICON-2). A rationally designed next-generation ADC, XB002 comprises a Tissue Factor-targeting antibody with Zymeworks’ proprietary ZymeLink™ linker-payload, creating the potential for an improved therapeutic index and favorable safety profile as compared to earlier-generation, TF-targeting ADCs. Exelixis plans to file an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) for XB002 in the near-term and, pending the FDA’s acceptance of the IND, initiate a phase 1 clinical trial of XB002 in early 2021.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201202005375/en/\n“XB002 is an important addition to the Exelixis pipeline given its potential differentiation from other Tissue Factor-targeting antibody-drug conjugates and its status as the first program in our growing biologics portfolio to reach IND filing stage,” said Peter Lamb, Ph.D., Executive Vice President and Chief Scientific Officer of Exelixis. “Iconic designed a highly promising molecule and advanced it through a rigorous preclinical evaluation, setting the stage for Exelixis to complete our planned IND filing in the coming weeks. We are grateful for Iconic’s partnership over the past 18 months and look forward to fully evaluating the potential of XB002 to help patients with cancer.”\n\nUnder the terms of the May 2019 agreement between Exelixis and Iconic, Exelixis gai...