High Impact Relationships Accelerate Results
In medicine, we know that successful treatment regimens require an understanding of how to develop and deploy the right drug or drug combination at the right time. That’s why Exelixis has a long history of leveraging productive partnerships and collaborations to move our molecules and our business forward. Our model for value creation is built upon a disciplined use of resources and a vast oncology clinical development and commercialization network. Our strategy is enhanced by our history of prolific drug discovery, aptitude for recognizing the missed potential of validated targets and ability to focus on oncology assets that are asymmetrically valued or misunderstood. With a focused, nimble team, we fully commit to our programs and partnerships.
Today, we’re oriented around three types of collaborative relationships:
Maximizing the opportunities for our flagship product, cabozantinib: We have an extensive, long-term pipeline strategy for cabozantinib and are focused on expanding the therapeutic potential of the molecule through broad clinical development. See our collaborations with Ipsen, Takeda, Bristol Myers Squibb, and Genentech.
Working together to identify the next generation of Exelixis medicines: In addition to conducting its own internal drug discovery activities, Exelixis is actively seeking in-licensing or acquisition opportunities to bring promising technologies, product candidates or other assets into its pipeline. See our collaborations with Invenra, Iconic, Aurigene, Catalent, and NBE-Therapeutics.
Exelixis discoveries moving forward in the hands of partners: Our history of productive drug discovery includes partnering multiple compounds and programs with leading pharmaceutical and biopharmaceutical companies. See our collaborations with Daiichi Sankyo, and Genentech.
Adagene
In February 2021, Exelixis entered into a collaboration and license agreement with Adagene Inc. (Adagene) under which Exelixis will utilize Adagene’s SAFEbody™ technology platform to generate masked versions of monoclonal antibodies from Exelixis’ growing preclinical pipeline for the development of antibody-drug conjugates or other innovative biologics against Exelixis-nominated targets. Adagene’s SAFEbody platform is designed to improve tumor-specific targeting of biologic therapies while minimizing on-target toxicity in healthy tissues. Under the terms of the agreement, Exelixis made an upfront payment to Adagene and has the ability to nominate two targets during the collaboration term. Adagene is eligible for development and commercialization milestones, as well as royalties on net sales of products developed around each of these targets.
Aurigene
In July 2019, Exelixis entered into an exclusive collaboration, option and license agreement with Aurigene Discovery Technologies Limited (Aurigene) to discover and develop novel small molecule therapies for cancer. Following the expansion of the collaboration in 2021, the agreement gives Exelixis the opportunity to in-license as many as nine programs from Aurigene, which has developed a focused approach to drug discovery that targets differentiated first-in-class and best-in-class opportunities with diverse mechanisms of action. Exelixis is also contributing research funding to Aurigene to facilitate discovery and preclinical development work on all nine programs. Exelixis may exercise its option for a program at any time up until the first Investigational New Drug application for the program has been approved by the FDA. Exelixis has exercised options on two programs thus far (XL102 and XL114). If and when Exelixis exercises a future option, it will make an option exercise payment to Aurigene and assume responsibility for that program’s future clinical development and commercialization including global manufacturing. Once Exelixis exercises its option for a program, Aurigene will be eligible for clinical development, regulatory and sales milestones, as well as royalties on future potential sales of the compound. Under the terms of the agreement, Aurigene retains limited development and commercial rights for India and Russia.
BioInvent
In June 2022, Exelixis entered into an exclusive option and license agreement with BioInvent International AB (BioInvent) to identify and develop novel antibodies for use as oncology therapeutics, which supports Exelixis’ plans to expand its portfolio of antibody-based therapies. In exchange for an upfront payment, Exelixis gained the rights to select three targets identified using BioInvent’s proprietary F.I.R.S.T™ screening platform, which simultaneously identifies both targets and the antibodies that bind to them, along with access to BioInvent’s n-CoDer® antibody library. If Exelixis exercises an option to in-license any of the target programs upon identification of a development candidate directed to that target, the company will pay BioInvent an option exercise fee and will assume responsibility for all future development and commercialization activities for the candidate, including potential antibody-drug conjugate and bispecific antibody engineering activities. BioInvent will be eligible for success-based development and commercialization milestones, as well as tiered royalties on the annual net sales of any products that are successfully commercialized under the collaboration.
Bristol Myers Squibb Company
In February 2017, Exelixis entered into a clinical collaboration agreement with BMS for the purpose of conducting clinical studies combining CABOMETYX® (cabozantinib) tablets with BMS’ OPDIVO® (nivolumab) and YERVOY® (ipilimumab). As part of this collaboration, Exelixis and BMS initiated CheckMate -9ER, a phase 3 trial evaluating OPDIVO in combination with CABOMETYX versus sunitinib in patients with previously untreated, advanced or metastatic renal cell carcinoma (RCC); CheckMate 040, a phase 1/2 trial evaluating the same combination and also cabozantinib with nivolumab and ipilimumab versus sorafenib in patients with both previously treated and previously untreated advanced hepatocellular carcinoma; and COSMIC-313, a phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus the latter two therapies in patients with previously untreated advanced RCC with intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium.
In June 2021, Exelixis entered into a clinical trial collaboration and supply agreement with BMS for STELLAR-002, a new phase 1b trial evaluating XL092, Exelixis’ novel next-generation tyrosine kinase inhibitor, in combination with immuno-oncology therapies in advanced solid tumors. The Exelixis-sponsored trial was designed to evaluate the safety, tolerability and efficacy of XL092 in combination with: nivolumab; nivolumab and ipilimumab; and nivolumab and bempegaldesleukin, an investigational CD122-preferential IL-2 pathway agonist, which is being supplied to BMS by Nektar Therapeutics through the existing global development and commercialization collaboration between the two companies. Following an initial dose-escalation phase evaluating the investigational combination regimens, STELLAR-002 may enroll patients with forms of renal, bladder, and prostate cancer.
Catalent
Exelixis and Catalent have a collaboration and license agreement under which Catalent’s Redwood Bioscience subsidiary will develop multiple antibody-drug conjugates (ADC) for Exelixis using Catalent’s proprietary SMARTagⓇ site-specific bioconjugation technology. The companies entered a new license agreement under which Catalent’s Redwood Bioscience subsidiary granted Exelixis an exclusive license to three target programs with lead antibody and/or ADC candidates. The ADC candidates were developed using Catalent’s proprietary SMARTag® technology, and each of the licensed antibodies have potential for development as an ADC or other biologic therapy using a variety of technologies to which Exelixis has access through its partner network.
Cybrexa Therapeutics
Exelixis and Cybrexa Therapeutics have an exclusive collaboration agreement providing Exelixis the right to acquire CBX-12 (alphalex™ exatecan), a clinical-stage, first-in-class peptide-drug conjugate that utilizes Cybrexa’s proprietary alphalex technology to enhance delivery of exatecan to tumor cells.
Daiichi Sankyo
In March 2006, Exelixis entered into a collaboration agreement with Daiichi Sankyo for the discovery, development and commercialization of novel therapies targeting the mineralocorticoid receptor. One of the compounds developed during this research collaboration is esaxerenone (CS-3150), an oral, non-steroidal, selective blocker of the mineralocorticoid receptor (MR), which Daiichi Sankyo subsequently took forward. In January 2019, the Japanese Ministry of Health, Labour and Welfare approved esaxerenone as a treatment for patients with hypertension in Japan, where the medicine is marketed as MINNEBRO®. Daiichi Sankyo is also conducting additional clinical trials of esaxerenone in Japan. Exelixis is eligible to receive commercialization milestones, as well as low double-digit royalties on sales of esaxerenone.
Roche / Genentech
In December 2006, Exelixis out-licensed cobimetinib, which it discovered internally, to Genentech via a worldwide collaboration agreement. Approved in 2015 for the treatment of a form of advanced melanoma and marketed as COTELLIC®, Exelixis and Genentech share in commercialization costs and ultimately profits/losses from COTELLIC in the United States, where Exelixis also has co-promotion rights. Outside the U.S., Exelixis is eligible to receive and is receiving royalties on COTELLIC sales.
In addition to its cobimetinib partnership, Exelixis is collaborating with Genentech’s parent company, Roche, on clinical development activities evaluating cabozantinib in combination with atezolizumab, Roche’s anti-PD-L1 immune checkpoint inhibitor. This work began with COSMIC-021, a phase 1b trial in multiple locally advanced or metastatic solid tumors, which has informed late-stage clinical development plans including the COSMIC-312 trial in advanced hepatocellular carcinoma. Based on the COSMIC-021 experience, in December 2019, Exelixis and Roche entered into another clinical collaboration for three additional phase 3 pivotal trials of the cabozantinib/atezolizumab combination in forms of non-small cell lung cancer (CONTACT-01), castration-resistant prostate cancer (CONTACT-02), and renal cell carcinoma (CONTACT-03).
Iconic Therapeutics
In May 2019, Exelixis entered into an exclusive option and licensing agreement with Iconic Therapeutics, Inc. (ICONIC) to advance an innovative next-generation antibody-drug conjugate (ADC) program for cancer. The agreement grants Exelixis an exclusive option to license ICON-2, Iconic’s lead oncology ADC, a potential best-in-class program targeting Tissue Factor in solid tumors. If Exelixis elects to exercise its option at the time of a potential investigational new drug filing, it will assume all further clinical development and commercialization activities, while Iconic will become eligible for future milestone payments and royalties on potential sales.
Invenra
In May 2018, Exelixis entered into a collaboration with Invenra to discover and develop novel biologics to treat cancer. The agreement grants Exelixis an exclusive, worldwide license to one preclinical asset, currently in lead selection against an undisclosed target, and forms a collaborative partnership enabling the two companies to pursue up to six additional discrete projects, in total directed to three discovery programs, through the use of Invenra’s B-Body™ technology platform. Exelixis will lead investigational new drug (IND)-enabling studies, manufacturing, clinical development in single-agent and combination therapy regimens, as well as future regulatory and commercialization activities. Invenra will be responsible for antibody lead discovery and generation and will be eligible to receive pre-clinical, clinical development, regulatory and commercialization milestones for any product containing a lead preclinical asset in the first indication as well as royalties on net sales.
Ipsen
In February 2016, Exelixis entered into an exclusive licensing agreement with Ipsen for the commercialization and further development of cabozantinib. Ipsen is now Exelixis’ global partner for cabozantinib in all geographies outside of the United States and Japan. Exelixis has received to date significant development and regulatory milestone payments from this collaboration, and is eligible to receive additional capital from commercial milestones and royalties on net sales of cabozantinib in Ipsen’s territories. Ipsen can opt in to funding additional cabozantinib clinical trials, thereby gaining access to the results to support potential future regulatory submissions in its territories.
Merck KGaA, Darmstadt, Germany and Pfizer
In March 2021, Exelixis entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer to evaluate XL092, Exelixis’ novel next-generation tyrosine kinase inhibitor, in combination with avelumab (BAVENCIO®), an anti-PD-L1 immune checkpoint inhibitor that is being co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer. Under the terms of the agreement, Exelixis expanded STELLAR-001, its phase 1b dose escalation trial of XL092 alone and in combination with other anti-cancer therapies, to add three new expansion cohorts evaluating XL092 and avelumab in various bladder cancer therapy settings.
NBE-Therapeutics
In September 2020, Exelixis entered into a collaboration and license option agreement with NBE-Therapeutics to discover and develop multiple antibody-drug conjugates (ADCs) for oncology applications by leveraging NBE’s unique expertise and proprietary platforms in ADC discovery, including SMACTechnology™ (a site-specific conjugation technology) and novel payloads. The agreement provides Exelixis an exclusive option to nominate four targets on NBE’s ADC platform over a two-year period. The companies will seek to advance multiple ADCs into preclinical development, with Exelixis contributing R&D support. For each individual target program, prior to filing an Investigational New Drug application, Exelixis will be able to exercise its option to an exclusive worldwide license, and afterwards continue clinical development and commercialization activities for that target program. Upon exercise of any option, NBE will be eligible for development and commercialization milestones, as well as royalties on net sales of any potential products resulting from that target program.
Ryvu Therapeutics
In July 2022, Exelixis entered into an exclusive license agreement with Ryvu Therapeutics S.A. (Ryvu) to develop novel targeted therapies utilizing Ryvu’s STING (STimulator of INterferon Genes) technology. In exchange for an upfront payment, Exelixis gained certain rights to Ryvu’s STING agonist molecules, which it will seek to incorporate into targeted therapies such as antibody-drug conjugates. Exelixis will lead all research activities and, upon selection of each development candidate, will be responsible for development and commercialization activities. Ryvu will be eligible to receive development, regulatory and commercialization milestone payments, as well as tiered royalties on the annual net sales of any products that are successfully commercialized under the collaboration. The STING pathway can be activated in immune cells in the tumor microenvironment and in tumor cells, and induces both innate and adaptive immunity. Ryvu’s STING agonists have been rationally designed for differentiation from competitor compounds, and targeted delivery of STING agonist payloads from an Exelixis-developed biotherapeutic could therefore provide a differentiated and novel mechanism of action for killing cancer cells.
Takeda
In 2017, Exelixis and Takeda announced an exclusive licensing agreement for the commercialization and further development of cabozantinib in Japan. As part of this collaboration, Exelixis will receive development and regulatory milestone payments and is also eligible to receive additional capital from commercial milestones and royalties on net sales in Japan. In additional, Takeda is responsible for a portion of the costs associated with the global cabozantinib development plan, provided Takeda chooses to participate in such trials, as well as the entire cost of cabozantinib development activities that are exclusively for the benefit of Japan.