On May 16, 2019 Exelixis, Inc. (Nasdaq: EXEL) reported that it has entered into an exclusive option and license agreement with Iconic Therapeutics, Inc. (Iconic), a private biopharmaceutical company focused on cancer and retinal disease, to advance an innovative next-generation antibody-drug conjugate (ADC) program for cancer (Press release, Exelixis, MAY 16, 2019, View Source [SID1234536439]). This collaboration reflects Exelixis’ ongoing strategy to build a pipeline beyond its lead product, CABOMETYX, through both internal drug discovery and external business development. This agreement with Iconic is Exelixis’ second strategic collaboration focused on novel biologics, following the company’s collaboration with Invenra, Inc. announced in May 2018. This exclusive agreement is Iconic’s first strategic collaboration in oncology and leverages the company’s innovative Tissue Factor antibody expertise.
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Under the terms of the agreement, Exelixis will gain an exclusive option to license ICON-2, Iconic’s lead oncology ADC program, in exchange for an upfront option payment to Iconic of $7.5 million and a commitment of preclinical development funding. Exelixis would exercise its option at the time of a potential IND application, and upon doing so would make an option exercise payment to Iconic and assume responsibilities for all subsequent clinical development and commercialization activities. Should Exelixis elect to exercise its option, Iconic will become eligible for future development, regulatory and commercialization milestone payments, as well as royalties on potential sales.
"Iconic Therapeutics is pursuing an innovative approach to targeting Tissue Factor, a promising target with early clinical validation and potential applicability across a wide variety of cancers," said Peter Lamb, Ph.D., Executive Vice President and Chief Scientific Officer of Exelixis. "This agreement provides Exelixis with an attractive entry into the antibody-drug conjugate space, and reflects our preference for success-based terms that reward our partners for long-term shared success. We’re looking forward to working with the Iconic team to advance this exciting program, which is complementary to Exelixis’ small molecule and emerging biologics capabilities."
ICON-2 represents a potential best-in-class program targeting TF in solid tumors. TF is highly expressed on tumor cells and in the tumor microenvironment. TF overexpression, while not oncogenic itself, facilitates angiogenesis, metastasis and other processes important to tumor development and progression. ICON-2 is a rationally designed second-generation ADC with potential for an improved therapeutic index and safety profile.
"We believe this partnership with a premier oncology company provides further validation of our novel approach," said William L. Greene, M.D., Chief Executive Officer of Iconic Therapeutics. "Exelixis’ clinical development and commercialization expertise, evidenced by the growing success of the cabozantinib franchise, make it the ideal partner as we advance this promising program towards the clinic. Iconic Therapeutics’ deep expertise in Tissue Factor biology and antibody-drug conjugate design sets the ICON-2 program apart from other approaches to this historically challenging target," Dr. Greene added.