\nExelixis, Inc. (Nasdaq: EXEL), Iconic Therapeutics, Inc. (Iconic) and Zymeworks Inc. (NYSE:ZYME) today announced that Exelixis has exercised its exclusive option for Iconic\u2019s lead oncology antibody-drug conjugate (ADC) program under the companies\u2019 May 2019 agreement<\/a>. 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\u2019 proprietary ZymeLink\u2122 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\u2019s acceptance of the IND, initiate a phase 1 clinical trial of XB002 in early 2021.\n<\/p>\n
This press release features multimedia. View the full release here: https:\/\/www.businesswire.com\/news\/home\/20201202005375\/en\/<\/a><\/p>\n \n\u201cXB002 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,\u201d said Peter Lamb, Ph.D., Executive Vice President and Chief Scientific Officer of Exelixis. \u201cIconic 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\u2019s partnership over the past 18 months and look forward to fully evaluating the potential of XB002 to help patients with cancer.\u201d\n<\/p>\n \nUnder the terms of the May 2019 agreement between Exelixis and Iconic, Exelixis gained an exclusive option to license XB002 (then ICON-2) in exchange for an upfront payment to Iconic of $7.5 million and a commitment of preclinical development funding. In exercising its exclusive option, Exelixis has made an additional option exercise payment of $20 million to Iconic. Iconic is now also eligible for future development, regulatory and commercialization milestone payments, as well as royalties on potential sales. The ZymeLink ADC technology in XB002 was originally licensed to Iconic from Zymeworks. Under the terms of their 2019 agreement, Zymeworks will receive a share of the $20 million option fee and is eligible to receive a share of all future revenue received by Iconic, as well as tiered royalties on worldwide sales.\n<\/p>\n \n\u201cExelixis\u2019 decision to in-license our lead oncology program provides important validation of Iconic\u2019s discovery and development capabilities, our platform of proprietary anti-Tissue Factor molecules designed to efficiently but safely bind Tissue Factor, and the potential of Tissue Factor as an oncology antibody-drug conjugate target,\u201d said William L. Greene, M.D., Chief Executive Officer of Iconic Therapeutics. \u201cPreclinical data presented earlier this year<\/a> demonstrate that XB002 binds Tissue Factor without affecting the coagulation cascade, which has hindered prior development of Tissue Factor-targeting molecules, has activity in multiple solid tumor cancer models and has improved tolerability compared to other Tissue Factor-targeting ADCs. We are excited to see XB002 make further progress as part of Exelixis\u2019 highly-regarded clinical development organization.\u201d\n<\/p>\n \n\u201cWe are excited to see this promising molecule take an important step towards clinical trials backed by the experienced clinical team at Exelixis,\u201d said Tony Polverino, Ph.D., Executive Vice President, Early Development and Chief Scientific Officer of Zymeworks. \u201cThis would mark the second ZymeLink-based therapeutic to enter the clinic in addition to our bispecific HER2 antibody-drug conjugate, ZW49, further highlighting the differentiative potential of our novel antibody-drug conjugate platform.\u201d\n<\/p>\n \nPending the completion of Exelixis\u2019 planned IND and the FDA\u2019s acceptance of the filing, Exelixis intends to initiate a phase 1 dose escalation and expansion study of XB002 in subjects with inoperable locally advanced or metastatic solid tumors early in 2021.\n<\/p>\n About Exelixis<\/b><\/p>\n \nFounded in 1994, Exelixis, Inc. (Nasdaq: EXEL) 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\u00ae<\/sup> (cabozantinib), COMETRIQ\u00ae<\/sup> (cabozantinib), COTELLIC\u00ae<\/sup> (cobimetinib) and MINNEBRO\u00ae<\/sup> (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 – all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poor\u2019s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. In November 2020, the company was named to Fortune<\/i>\u2019s 100 Fastest-Growing Companies list for the first time, ranking 17th<\/sup> overall and the third-highest biopharmaceutical company. For more information about Exelixis, please visit www.exelixis.com<\/a><\/i>, follow @ExelixisInc<\/a> on Twitter or like Exelixis, Inc.<\/a> on Facebook.\n<\/p>\n About Iconic Therapeutics<\/b><\/p>\n \nIconic Therapeutics, Inc. is a biopharmaceutical company dedicated to leveraging its deep insight into tissue factor biology and TF\u2019s role in inflammation, tumor growth, and angiogenesis to develop new therapeutics for serious diseases including retinal disease and cancer. The Company has developed a portfolio of proprietary molecules which bind to and antagonize TF expressed in several disease states. In May, 2019, Iconic Therapeutics entered into a licensing agreement with Zymeworks that granted to Iconic non-exclusive rights to Zymeworks\u2019 proprietary ZymeLink\u2122 antibody-drug conjugate (ADC) platform. Please visit www.iconictherapeutics.com<\/a> for additional information.\n<\/p>\n About Zymeworks<\/b><\/p>\n \nZymeworks is a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics. Zymeworks\u2019 suite of therapeutic platforms and its fully integrated drug development engine enable precise engineering of highly differentiated product candidates. Zymeworks\u2019 lead clinical candidate, zanidatamab (ZW25), is a novel Azymetric\u2122 bispecific antibody which has been granted Breakthrough Therapy designation by the FDA and is currently enrolling in a registration-enabling clinical trial for refractory HER2+ biliary tract cancer as well as several Phase 2 clinical trials for HER2+ gastroesophageal and breast cancers. Zymeworks\u2019 second clinical candidate, ZW49, is a bispecific antibody-drug conjugate currently in Phase 1 clinical development and combines the unique design and antibody framework of zanidatamab with Zymeworks\u2019 proprietary ZymeLink\u2122 linker-cytotoxin. Zymeworks is also advancing a deep preclinical pipeline in oncology (including immuno-oncology agents) and other therapeutic areas. In addition, its therapeutic platforms are being leveraged through strategic partnerships with nine biopharmaceutical companies. For additional information about Zymeworks, visit www.zymeworks.com<\/a> and follow @ZymeworksInc<\/a> on Twitter.\n<\/p>\n Exelixis Forward-Looking Statements<\/b><\/p>\n \nThis press release contains forward-looking statements, including, without limitation, statements related to: Exelixis\u2019 plans to file an IND with the FDA for XB002 in the near-term and, pending the FDA\u2019s acceptance of the IND, initiate a phase 1 clinical trial of XB002 in early 2021; the therapeutic potential of XB002 for cancer patients and favorable safety profile of the molecule as compared to earlier-generation, TF-targeting ADCs; Exelixis\u2019 potential future financial and other obligations under the exclusive option and license agreement with Iconic; and Exelixis\u2019 plans to reinvest in its business to maximize the potential of the company\u2019s 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\u2019 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\u2019 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\u2019 dependence on its relationship with Iconic, including Iconic\u2019s adherence to its obligations under the exclusive option and license agreement and the level of Iconic\u2019s assistance to Exelixis 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\u2019 research and development operations; complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere; Exelixis\u2019 and Iconic\u2019s continuing compliance with applicable legal and regulatory requirements; Exelixis\u2019, Iconic\u2019s and Zymeworks\u2019 ability to protect their respective intellectual property rights; market competition; changes in economic and business conditions; and other factors affecting Exelixis and its product pipeline discussed under the caption \u201cRisk Factors\u201d in Exelixis\u2019 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 5, 2020, and in Exelixis\u2019 future filings with the SEC. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.\n<\/p>\n Zymeworks Forward-Looking Statement<\/b><\/p>\n \nThis press release includes \u201cforward-looking statements\u201d within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and \u201cforward-looking information\u201d within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements that relate to the payment to Zymeworks of a share of the $20 million option fee received by Iconic, Zymeworks\u2019 eligibility to receive a share of future revenue received by Iconic as well as tiered royalties on worldwide sales, Zymeworks\u2019 clinical and preclinical development of its product candidates, and other information that is not historical information. When used herein, words such as \u201cwill\u201d, \u201cplan\u201d, \u201cintend\u201d, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks\u2019 current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation, market conditions and the factors described under \u201cRisk Factors\u201d in Zymeworks\u2019 Quarterly Report on Form 10-Q for its quarter ended September 30, 2020 (a copy of which may be obtained at www.sec.gov<\/a> and www.sedar.com<\/a>). Consequently, forward-looking statements should be regarded solely as Zymeworks\u2019 current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance, or achievements. Zymeworks does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.\n<\/p>\n Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks. MINNEBRO is a registered Japanese trademark.<\/i><\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20201202005375\/en\/<\/a><\/span><\/p>\n EXELIXIS CONTACTS:<\/b><\/p>\n Investor Inquiries: Media Contact: ICONIC CONTACTS:<\/b><\/p>\n Media and Investor Inquiries: ZYMEWORKS CONTACTS:<\/b><\/p>\n Investor Inquiries:\u202f\u202f KEYWORDS:<\/b> California United States North America Canada<\/p>\n INDUSTRY KEYWORDS:<\/b> Biotechnology Health Pharmaceutical Clinical Trials Oncology<\/p>\n<\/p>\n
\n<\/b>
Susan Hubbard
\n
Executive Vice President,
\n
Public Affairs & Investor Relations
\n
(650) 837-8194
\n
shubbard@exelixis.com<\/a><\/p>\n
\n<\/b>
Hal Mackins for Exelixis, Inc.
\n
(415) 994-0040
\n
hal@torchcommunications.com<\/a><\/p>\n
\n<\/b>
Shari Annes
\n
(650) 888-0902
\n
sannes@annesassociates.com<\/a><\/p>\n
\n<\/b>
Ryan Dercho, Ph.D.\u202f\u202f
\n
(604) 678-1388\u202f\u202f
\n
ir@zymeworks.com<\/a>\u202f\u202f
\n
\u202f
\n
Tiffany Tolmie\u202f\u202f
\n
(604) 678-1388\u202f\u202f
\n
ir@zymeworks.com<\/a>\u202f\u202f
\n
\u202f
\n
Media Inquiries:\u202f\u202f
\n<\/b>
Mary Klem
\n
(604) 678-1388\u202f\u202f
\n
media@zymeworks.com<\/a><\/p>\n
![\"Logo\"](\"https:\/\/mms.businesswire.com\/media\/20201202005375\/en\/610803\/3\/exelixis_id_rgb_2c.jpg\")
<\/td>\n<\/tr>\n![\"Logo\"](\"https:\/\/mms.businesswire.com\/media\/20201202005375\/en\/821218\/3\/logo_228x70px-1.jpg\"){kind=logo}
<\/td>\n<\/tr>\n![\"Logo\"](\"https:\/\/mms.businesswire.com\/media\/20201202005375\/en\/843258\/3\/Zymeworks_Logo_Colour.jpg\"){kind=logo}
<\/td>\n<\/tr>\n