Exelixis and Arcus Biosciences Collaborate on Zanzalintinib and AB521 Trial for Advanced Renal Cell Carcinoma

5 December 2023

Exelixis, Inc. (Nasdaq: EXEL) and Arcus Biosciences (NYSE: RCUS) have recently announced a collaboration for the clinical trial named STELLAR-009. This trial, a phase 1b/2 investigation, is designed to evaluate the efficacy of zanzalintinib, Exelixis' next-generation tyrosine kinase inhibitor (TKI), in conjunction with AB521, an inhibitor of the transcription factor HIF-2⍺, for patients with advanced solid tumors, including clear cell renal cell carcinoma (ccRCC). Exelixis is taking the lead in sponsoring STELLAR-009, with Arcus participating in co-funding and providing AB521 for the study. The enrollment of patients is anticipated to commence by the conclusion of 2023.

Exelixis, expressed enthusiasm about exploring the potential effects of combining zanzalintinib and Arcus’ HIF-2⍺ inhibitor. The collaboration aims to investigate whether the combination therapy provides superior outcomes compared to individual therapies, given that the two molecules approach inhibiting cancer cell proliferation and tumor angiogenesis from different angles.

Arcus Biosciences, emphasized the significance of the STELLAR-009 study in advancing the development of AB521. The study will involve a dose-finding stage to determine the recommended dose for zanzalintinib in combination with AB521. Further evaluations through expansion cohorts will assess the combination's tolerability and activity in ccRCC, supported by data from monotherapy studies.

Zanzalintinib, identified as a next-generation oral TKI, targets receptor tyrosine kinases implicated in cancer growth. Its current developmental focus includes treating various advanced solid tumors such as genitourinary, colorectal, and head and neck cancers. Meanwhile, AB521, characterized as a small molecule inhibitor of HIF-2⍺, a transcription factor involved in oxygen sensing, is currently under scrutiny in the ARC-20 phase 1/1b study involving cancer patients.

The collaboration addresses kidney cancer, which is estimated to result in 81,800 diagnoses in the U.S. in 2023. Specifically, the trial will focus on clear cell RCC, the most prevalent type of kidney cancer in adults. The collaboration aims to explore potential synergies in combining zanzalintinib and AB521 for treating advanced solid tumors, including ccRCC, with the goal of achieving enhanced therapeutic effects.

 

Source: businesswire.com