US-based biotechnology firm X4 Pharmaceuticals has begun the Phase II portion of its ongoing Phase I/II clinical trial with dosing of X4P-001 in combination with Inlyta (axitinib) in advanced clear cell renal cell carcinoma (ccRCC) patients.

X4P-001 is an oral, small molecule inhibitor of C-X-C receptor type 4 (CXCR4), a receptor for the chemokine CXCL12, while Inlyta is an inhibitor VEGF kinase.

The primary receptor-ligand pairing of CXCR4/CXCL12 is reportedly used by cancer and surrounding stromal cells to inhibit immune function and promote angiogenesis.

The Phase II part of the Phase I/II trial will assess the safety, tolerability, objective response rate (ORR), duration of response (DOR) and progression-free survival (PFS).

The trial is currently being conducted at various sites in the US and South Korea, and will also evaluate the correlation between biomarkers and efficacy.

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"Efficiently progressing this study into Phase II is an important milestone for the development of X4P-001 and the CXCR4-targeted therapeutic approach."

X4 Pharmaceuticals chief medical officer Sudha Parasuraman said: “Efficiently progressing this study into Phase II is an important milestone for the development of X4P-001 and the CXCR4-targeted therapeutic approach.

“Having established the Phase II combination dose of X4P-001, we 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.”

X4P-001 is being further studied as a combination therapy to treat various types of cancer, based on data from pre-clinical studies.

Another Phase I/II trial is currently evaluating the drug in combination with Opdivo (nivolumab) for the treatment of patients with advanced ccRCC, while a Phase Ib biomarker trial is assessing it in combination with Keytruda (pembrolizumab)  in advanced melanoma patients.

Image: Micrograph of a clear cell renal cell carcinoma. Photo: courtesy of nephron.