Company Update (NASDAQ:BLRX): Bioline RX Ltd Announces Initiation of Phase 2a Trial of BL-8040 in Combination With KEYTRUDA® (pembrolizumab) for Treatment of Pancreatic Cancer

Bioline RX Ltd (NASDAQ:BLRX) announced the initiation of a Phase 2a trial investigating BL-8040 in combination with KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy, in patients with metastatic pancreatic cancer.

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 in up to 30 subjects with metastatic pancreatic adenocarcinoma. The study is designed to evaluate the clinical response, safety and tolerability of the combination of these therapies as well as multiple pharmacodynamic parameters, including the ability to improve infiltration of T cells into the tumor and their reactivity. The study will be conducted in the US, Israel and additional territories.

In January 2016, BioLineRx entered into an immunotherapy collaboration with MSD, known as Merck in the US and Canada, 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 both tumor cells and healthy cells, BL-8040 has the potential to enable activated T cells to better reach tumor cells in the fight against pancreatic cancer.

Philip Serlin, Chief Financial and Operating Officer of BioLineRx, stated, “We are looking forward to conducting this combination study of our lead oncology product and MSD’s immune checkpoint inhibitor, which will be the first study of BL-8040 in the exciting and promising field of cancer immunotherapy. We believe that the combination of BL-8040 with KEYTRUDA has the potential to expand the benefit of immunotherapy to cancer types currently resistant to immuno-oncology treatments, such as pancreatic cancer, which represent a significant unmet medical need.”

“Furthermore, we view BL-8040’s inhibition of CXCR4, which effects a change in the protective tumor micro-environment, as potentially synergistic with immune checkpoint inhibitors in additional oncological indications. To this end, as announced earlier this month, we have entered into a significant cancer immunotherapy collaboration with another global pharma company to support several Phase 1b studies investigating BL-8040 in combination with another immune check point inhibitor in multiple cancer indications. Upon completion of the expected multiple studies, under collaboration with these two world leaders in cancer immunotherapy, each of the parties will have the option to expand the collaboration to include pivotal registration studies,” added Mr. Serlin. (Original Source)

Shares of Biolinerx are up 4% to $0.995 in pre-market trading. BLRX has a 1-year high of $1.82 and a 1-year low of $0.71. The stock’s 50-day moving average is $0.88 and its 200-day moving average is $0.92.

On the ratings front, Biolinerx has been the subject of a number of recent research reports. In a report issued on September 8, Roth Capital analyst Joseph Pantginis maintained a Buy rating on BLRX, with a price target of $7.00, which represents a potential upside of 629% from where the stock is currently trading. Separately, on September 7, Maxim’s Jason Kolbert reiterated a Hold rating on the stock and has a price target of $1.00.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joseph Pantginis and Jason Kolbert have a total average return of 7.0% and -16.1% respectively. Pantginis has a success rate of 37% and is ranked #351 out of 4166 analysts, while Kolbert has a success rate of 29% and is ranked #4052.

BioLineRx Ltd. is a clinical-stage biopharmaceutical company. Its activities include indentifying, in-licensing, and developing therapeutic candidates. It in-licenses novel compounds primarily from academic institutions and biotech companies based in Israel, and develops them through pre-clinical stages, and then partners with pharmaceutical companies clinical development and commercialization.


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