BioLineRx declares partial results for BL-8040’s Phase 2a COMBAT study

BioLineRx, committed to oncology and immunology declared partial results from the monotherapy portion of BL-8040’s Phase 2a COMBAT study. The study reveals that BL-8040 increases infiltration of T cells into the tumor in patients suffering from metastatic pancreatic cancer. BL-8040 is a CXCR4 antagonist that has been shown in several clinical trials to be a robust mobilizer of immune cells to peripheral blood and to be effective at inducing direct tumor cell death. The Phase 2a study, named the COMBAT study, is an open-label, multicenter, single-arm trial designed to evaluate the safety and efficacy of the combination of BL-8040 and KEYTRUDA.

BL-8040 was safe and well-tolerated. BL-8040 also induced an increase in the number of total immune cells in the peripheral blood, while the frequency of peripheral blood regulatory T cells (Tregs) implied to hinder the anti-tumor immune response was lessened. analysis of available biopsies (N = 7) showed infiltration of various types of effector T cells, known to attack cancer cells, into the tumor periphery and tumor micro-environment (TME). In this regard, the results show up to a 15-fold increase in CD3+ T cells, and up to a 2-fold increase in CD8+ T cells, in the TME of 43% (3/7) of the patients, after five days of BL-8040 monotherapy.

Philip Serlin, Chief Executive Officer of BioLineRx said “These results support the mechanism of action proposed by pre-clinical studies, namely that BL-8040 mobilizes immune cells into the peripheral blood and promotes T cell infiltration into tumors. As previously reported, enrollment of the study has been completed and we expect to meet our timelines for conclusion of the study and top-line results by the second half of 2018.”