BioLineRx Begins Trial On BL-8040/ Keytruda Combination

 | Sep 20, 2016 11:17PM ET

BioLineRx, Ltd. (NASDAQ:BLRX) announced the initiation of a phase IIa trial on its lead oncology candidate, BL-8040, in combination with Merck & Co., Inc.’s (NYSE:MRK) lung cancer drug Keytruda (pembrolizumab), for the treatment of patients with metastatic pancreatic cancer.

BL-8040 is a short peptide that functions as a high-affinity antagonist for CXCR4, a chemokine receptor directly involved in tumor progression, angiogenesis, metastasis and cell survival.

Phase IIa COMBAT is an open-label, multicenter, single-arm trial designed to evaluate the safety and efficacy of the combination of BL-8040 and Keytruda in up to 30 patients suffering from metastatic pancreatic adenocarcinoma, the most common type of pancreatic cancer.

The COMBAT study is also designed to assess the ability of the candidate in improving the infiltration of T cells into the tumor and their reactivity in patients suffering from pancreatic cancer.

The COMBAT study will be conducted in the U.S., Israel and other countries.

According to the company’s press release, in the U.S., 50,000 patients were diagnosed with pancreatic cancer in 2015, among which pancreatic adenocarcinoma accounted for about 85%. This demonstrates the huge market potential for this combination therapy.

Earlier this month, BioLineRx inked a collaboration agreement with a global pharma company — Genentech, a subsidiary of Roche Holding (SIX:ROG) AG (OTC:RHHBY) — for conducting several phase Ib studies on BL-8040, in combination with atezolizumab, in the treatment of multiple cancer indications.

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