X4 Pharmaceuticals Announces Dosing of the First Patient in Phase 1/2 Study of X4P-001
January 26, 2017 at 01:30 pm
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X4 Pharmaceuticals announced dosing of the first patient in a Phase 1/2 study of X4P-001, the company’s lead CXCR4 inhibitor, in patients with advanced clear cell renal cell carcinoma (ccRCC). This is the second clinical study of X4P-001 that combines the company’s CXCR4 inhibitor with an approved cancer therapy for the treatment of ccRCC. The primary objective of the newly-initiated study is to evaluate the safety and tolerability of X4P-001 in combination with Opdivo® (nivolumab), an approved immunotherapy for the treatment of advanced RCC after failure of prior anti-angiogenic therapy that blocks a signal preventing T-cells from attacking cancer. The study will enroll patients who have not responded to nivolumab. In addition to safety and tolerability, the trial will evaluate early signs of biological activity using biomarkers, and clinical efficacy as measured by objective response rate and progression free survival over a 12 month time frame. Multiple U.S. cancer centers with leading renal cell carcinoma researchers will participate in the study. In addition to this new Phase 1/2 study of X4P-001 in combination with Opdivo®, X4 has another Phase 1/2 study ongoing in patients with advanced ccRCC to evaluate X4P-001 in combination with Inlyta® (axitinib), a kinase inhibitor approved for the treatment of advanced RCC after failure of one prior systemic therapy, and a Phase 1b biomarker study in patients with advanced melanoma to evaluate X4P-001 in combination with Keytruda® (pembrolizumab).
X4 Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on discovering and developing novel therapeutics for the treatment of rare diseases and those with limited treatment options, with a focus on conditions resulting from dysfunction of the immune system. Its lead clinical candidate is mavorixafor, a small-molecule selective antagonist of chemokine receptor CXCR4, that is being developed as an oral, once-daily therapy. It has developed a pipeline of small-molecule, oral antagonists of the chemokine receptor C-X-C receptor type 4 (CXCR4). It has two pre-clinical candidates: X4P-003, a second-generation CXCR4 antagonist designed to have enhanced properties relative to mavorixafor, potentially enabling opportunities in CXCR4-dependent disorders and primary immunodeficiencies, and X4P-002, a CXCR4 antagonist with a distribution profile and a demonstrated ability to cross the blood-brain barrier.
X4 PHARMACEUTICALS, INC. 
