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Msg  30461 of 30669  at  12/4/2023 8:05:52 AM  by

minxmrphd


EXEL / RCUS collaboration

Exelixis and Arcus Biosciences Announce Clinical Trial Collaboration to Evaluate Zanzalintinib in Combination with AB521 in Patients with Advanced Renal Cell Carcinoma

8:00 AM ET, 12/04/2023 - Business Wire

– Phase 1b/2 clinical trial expected to begin enrolling patients before year-end 2023 –

ALAMEDA, Calif. & HAYWARD, Calif.--(BUSINESS WIRE)--Dec. 4, 2023-- Exelixis, Inc. (Nasdaq: EXEL) and Arcus Biosciences (NYSE: RCUS) today announced that the companies have entered into a clinical trial collaboration for STELLAR-009, a phase 1b/2 trial evaluating zanzalintinib, Exelixis’ next-generation tyrosine kinase inhibitor (TKI), in combination with AB521, an inhibitor of the transcription factor HIF-2⍺, in patients with advanced solid tumors, including clear cell renal cell carcinoma (ccRCC). Exelixis is sponsoring STELLAR-009, and Arcus is co-funding the study and providing AB521 for use in the trial. Patient enrollment for STELLAR-009 is expected to begin before the end of 2023.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231203437225/en/

“We are excited to learn more about the potential effects of zanzalintinib plus Arcus’ HIF-2⍺ inhibitor, as these two molecules approach the inhibition of cancer cell proliferation and tumor angiogenesis from differing angles, and combination therapy may provide better outcomes than either therapy alone,” said Amy Peterson, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. “We have a long-established commitment to advancing treatment options in kidney cancer, and we are eager to maximize the potential of zanzalintinib through this collaboration with Arcus and look forward to advancing the combination in the clinic.”

“We are excited to partner with Exelixis on the STELLAR-009 study to determine the best-in-class potential of AB521 in combination with zanzalintinib and look forward to generating a robust set of data to move this combination into full development,” said Dimitry S.A. Nuyten, M.D., Ph.D., Chief Medical Officer of Arcus Biosciences. “The STELLAR-009 study is an important step in the development of AB521 and enables a cost-effective path to evaluating our HIF-2⍺ inhibitor with a next-generation TKI.”

The dose-finding stage of this open-label study will determine a recommended dose for zanzalintinib in combination with AB521 in patients with advanced solid tumors and in patients with advanced ccRCC. Expansion cohorts will further evaluate the tolerability and activity of this combination in ccRCC as well as investigate the contribution of components, supported by activity data generated from monotherapy studies in ccRCC patients, to support full development.

More information about this trial will be available soon on ClinicalTrials.gov.

About Zanzalintinib Zanzalintinibis a next-generation oral TKI that inhibits the activity of receptor tyrosine kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis and resistance to multiple therapies, including immune checkpoint inhibitors (ICIs). With zanzalintinib, Exelixis sought to build upon its extensive experience with the target profile of cabozantinib, the company’s flagship medicine, while improving key characteristics, including pharmacokinetic half-life. Zanzalintinib is currently being developed for the treatment of advanced solid tumors, including genitourinary, colorectal and head and neck cancers.

 


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30462 Re: EXEL / RCUS collaboration JoeFlow 4 12/4/2023 8:48:05 AM




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