On November 20, 2017 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that an abstract with partial results from the monotherapy portion of BL-8040’s Phase 2a COMBAT study in pancreatic cancer was accepted for presentation at the ASCO (Free ASCO Whitepaper) 2018 Gastrointestinal Cancers Symposium, to take place January 18-20, 2018 in San Francisco, CA (Press release, BioLineRx, NOV 20, 2017, View Source;p=RssLanding&cat=news&id=2317838 [SID1234522148]).
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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 (pembrolizumab), an anti-PD-1 therapy marketed by Merck & Co., Inc., (known as MSD outside the United States and Canada), in up to 30 subjects with metastatic pancreatic adenocarcinoma. The study is primarily designed to evaluate the clinical response, safety and tolerability of the combination of these therapies. In addition, the study will evaluate multiple pharmacodynamic parameters, including the ability to improve infiltration of T cells into the tumor and their reactivity, for both BL-8040 as a monotherapy, as well as for the combination of BL-8040 and KEYTRUDA. The study is being conducted in the US, Israel and additional territories.
"We are very pleased that the abstract presenting our partial monotherapy results for the COMBAT study were accepted to this important clinical conference. Because of the embargo policy of the conference, we won’t be able to share the data by the end of the year, but rather disclose it in January 2018, when the abstracts are released," commented Philip Serlin, Chief Executive Officer of BioLineRx. "As for today, we can report that enrollment of the study has been completed and we are meeting our timelines for conclusion of the study and topline results by the second half of 2018. We are excited about the upcoming topline results in 2018, and continue to fully support our development plan in combination with immune checkpoint inhibitors".
In September 2016, BioLineRx announced the initiation of the COMBAT study, its first Phase 2a study for evaluating the clinical efficacy of BL-8040 in combination with KEYTRUDA, for the treatment of patients with metastatic pancreatic cancer who relapse to previous therapies. The COMBAT study is being conducted by BioLineRx under a collaboration agreement between BioLineRx and MSD, through a subsidiary, to support a Phase 2a study investigating BioLineRx’s BL-8040 in combination with KEYTRUDA in patients with metastatic pancreatic cancer.
BL-8040, BioLineRx’s lead oncology platform, is a CXCR4 antagonist that has been shown in several clinical trials to be a robust mobilizer of immune cells and to be effective at inducing direct tumor cell death. Additional findings in the field of immuno-oncology suggest that CXCR4 antagonists may be effective in inducing the infiltration of anti-tumor T cells into the tumor. Therefore, when combined with KEYTRUDA, which blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect tumor cells survival, BL-8040 has the potential to enable activated larger amount of T cells to better reach tumor cells in the fight against pancreatic cancer.
About BL-8040
BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and stem cell mobilization. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells and immune-cells from the bone marrow, thereby sensitizing cancer cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing cell death (apoptosis) and mobilizing immune-cells. In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.