Stock Update (NASDAQ:BLRX): Bioline RX Ltd Announces Regulatory Submissions for Phase 2a Trial of BL-8040 in Combination with KEYTRUDA for Treatment of Pancreatic Cancer

Bioline RX Ltd (NASDAQ:BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today the filing of regulatory submissions required to commence a Phase 2a trial for BL-8040 in combination with KEYTRUDA® (pembrolizumab) for the treatment of patients with pancreatic cancer. The study is expected to commence shortly after receipt of regulatory approval, anticipated in the third quarter of 2016.

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), MSD’s anti-PD-1 therapy, 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. It is expected to take place in the US, Israel and additional territories.

In January 2016, BioLineRx entered into a collaboration with MSD, known as Merck in the US and Canada, to support a Phase 2 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.

“We are looking forward to commencing this combination study of our lead oncology product and Merck’s immune checkpoint inhibitor, which marks the entrance of BL-8040 into the exciting and promising field of cancer immunotherapy,” stated Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx. “Over the past few months, we have worked closely with Merck’s clinical team on the design and finalization of the study protocol. 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.” (Original Source)

Shares of Biolinerx closed yesterday at $0.791, up $0.001 or 0.13%. BLRX has a 1-year high of $2.80 and a 1-year low of $0.71. The stock’s 50-day moving average is $0.91 and its 200-day moving average is $1.03.

On the ratings front, Biolinerx has been the subject of a number of recent research reports. In a report issued on May 16, Maxim Group analyst Jason McCarthy reiterated a Buy rating on BLRX, with a price target of $4, which implies an upside of 405.7% from current levels. Separately, on March 29, Roth Capital’s Joseph Pantginis maintained a Buy rating on the stock and has a price target of $7.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason McCarthy and Joseph Pantginis have a total average return of -1.9% and 6.3% respectively. McCarthy has a success rate of 33.9% and is ranked #3018 out of 3967 analysts, while Pantginis has a success rate of 35.6% and is ranked #277.

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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