Bioline RX Ltd (NASDAQ:BLRX) gave investors reason for excitement today after announcing the initiation of a second Phase 2a trial investigating BL-8040 in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, in patients with metastatic pancreatic cancer. The study is part of a research collaboration between MSD and MD Anderson Cancer Center.
The open-label, single center, single-arm Phase 2a study aims to evaluate the potential of BL-8040 in combination with KEYTRUDA in pancreatic cancer and focuses on the mechanism-of-action by which both drugs might synergize. In addition to assessing clinical response, the study includes multiple assessments to evaluate the biological anti-tumor effects induced by the combination.
In August 2016, the Company announced the signing of a collaboration agreement with The University of Texas MD Anderson Cancer Center for the investigation of BL-8040 in combination with KEYTRUDA in pancreatic cancer. The investigator-sponsored study is part of a strategic, immuno-oncology, clinical research collaboration between MSD (known as Merck in the US and Canada) and MD Anderson Cancer Center aimed at evaluating Merck’s anti-PD-1 therapy, KEYTRUDA, in combination with various treatments and novel drugs.
Philip Serlin, Chief Executive Officer of BioLineRx, said, “This is the second Phase 2 immuno-oncology trial taking place to investigate the combination of BL-8040 and KEYTRUDA for the treatment of pancreatic cancer. In September 2016, we announced the initiation of the COMBAT study, our first Phase 2a study for evaluating the clinical efficacy of BL-8040 in combination with KEYTRUDA, also for the treatment of patients with pancreatic cancer. The COMBAT study, which is being conducted by BioLineRx under a collaboration agreement between BioLineRx and MSD is also currently recruiting patients. We believe that the trial announced today will support the COMBAT study and deepen our understanding of the mechanism-of-action of the combination treatment.”
“We also believe that the combination of BL-8040 with KEYTRUDA has the potential to expand the benefit of immunotherapy to non-respondent patients and cancer types currently resistant to immuno-oncology treatments, such as pancreatic cancer. Furthermore, BL-8040’s inhibition of CXCR4, which may affect the immunosuppressive tumor micro-environment, is potentially synergistic with immune checkpoint inhibitors in additional oncological indications,” added Mr. Serlin.
Dr. David Fogelman, from MD Anderson Cancer Center, the principal investigator of the trial, stated, “We hope that BL-8040 will prime the immune system and increase the anti-tumor activity of Keytruda. We have designed the study to look for evidence of this, both in the tumors themselves and in the patient as a whole. If this combination is successful, we will move pancreatic cancer research forward in a new direction.”
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, BL-8040 has the potential to enable activated T cells to better reach tumor cells in the fight against pancreatic cancer.
Shares of Biolinerx are currently rising 10.50% to $1.000, or up $0.095 in pre-market trading Tuesday. BLRX has a 1-year high of $1.42 and a 1-year low of $0.71. The stock’s 50-day moving average is $0.96 and its 200-day moving average is $0.96.
On the ratings front, Biolinerx has been the subject of a number of recent research reports. In a report issued on December 5, Roth Capital analyst Joseph Pantginis reiterated a Buy rating on BLRX, with a price target of $7, which implies an upside of 673% from current levels. Separately, on November 22, Maxim’s Jason Kolbert reiterated a Hold rating on the stock and has a price target of $1.00.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joseph Pantginis and Jason Kolbert have a yearly average loss of -17.6% and -15.1% respectively. Pantginis has a success rate of 30% and is ranked #4289 out of 4349 analysts, while Kolbert has a success rate of 30% and is ranked #4288.
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.