X4 Pharmaceuticals Announces Study of X4P-001 in Patients with Advanced ccRCC

X4 Pharmaceuticals announced dosing of the first patient in the Phase 2 portion of the ongoing Phase 1/2 study evaluating X4P-001, the CXCR4 inhibitor, in combination with Inlyta (axitinib) in patients with advanced clear cell renal cell carcinoma (ccRCC). Full results from the Phase 1 portion of the study including the selection of the once daily oral dose used in the expansion cohort will be presented at an upcoming medical meeting.

In addition to safety and tolerability, the Phase 2 portion of the study will evaluate clinical efficacy as measured by objective response rate (ORR), duration of response (DOR), and progression free survival (PFS) and will explore the correlation of biomarkers with efficacy. Multiple cancer centers with leading renal cell carcinoma researchers in the U.S. and South Korea are participating in the study.

X4 CMO, Sudha Parasuraman said that Efficiently progressing this study into Phase 2 is an important milestone for the development of X4P-001 and the CXCR4-targeted therapeutic approach. Having established the Phase 2 combination dose of X4P-001, they are now focused on augmenting proof of concept data for this critically important biological axis known to play a key role in immune cell trafficking.