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Summary of Highlights
On June 2018 BioLineRx announced the presentation of new overall survival data from Phase 2a study for BL-8040 in r/r AML patients
New data presented at the 23rd Annual Congress of the European Hematology Association (EHA), held in Stockholm, Sweden, shows that BL-8040, combined with high dose Cytarabine (HiDAC), significantly enhanced overall survival in difficult-to-treat relapsed or refractory AML (r/r AML) patients in a Phase 2a clinical trial.
BioLineRx released its quarterly report on May 22, 2018 detailing the following:
BioLineRx's quarterly progress is in line with our clinical development expectations for its Oncology programs, as per our Annual 2017 report dated 23 March, 2017.
- Partial results from Phase 2a COMBAT study, investigating the combination of BL-8040 and Merck's PD-1 inhibitor, Keytruda® (pembrolizumab) in pancreatic cancer were encouraging and top-line results are expected in H2 2018.
- Positive results from Phase 2 study for BL-8040 as novel stem cell mobilization treatment for allogeneic bone-marrow transplantation
- Grant of European patent covering use of BL-8040 with Cytarabine for treating AML; valid through March 2034 with up to five years' patent term extension
- Initiation of Phase 3 study for BL-8040 as novel stem cell mobilization treatment, see below for details.
- A Phase 2b study as an AML consolidation treatment is ongoing with possible interim analysis on this study predicted for second half of 2018 and with top-line results expected in 2020.
- In addition, the company has a collaboration agreement with Genentech, a member of the Roche Group, to investigate the combination of BL-8040 and Genentech's atezolizumab in several Phase 1b/2 studies for multiple solid tumor indications and AML. Genentech commenced a Phase 1b/2 study for the treatment of pancreatic cancer in July 2017, Phase 1b/2 study in gastric cancer in October 2017. An additional Phase 1b/2 study in lung cancer will be initiated in 2018. In September 2017, BioLineRx initiated as well a Phase 1b/2 study under this collaboration in acute myeloid leukemia.
- AGI-134 near-clinical therapeutic candidate's advancements:
- Presentation at ASCO-SITC positive pre-clinical data showing direct regression of established primary tumors in mice after injection with AGI-134
- Notice of Allowance issued by the United States Patent and Trademark Office (USPTO) for a patent application claiming the use of AGI-134 for the treatment of solid cancer tumors (when issued, will be valid until May 2035) with a possibility of up to five years patent term extension)
- Planned initiation of Phase 1/2a immuno-oncology study for AGI-134 in several solid tumor indications is expected in mid-2018
We update BioLineRx's equity value to $156.1M / NIS 557M, which remains within a target price ranging between NIS 5.01 and NIS 5.30; a mean of NIS 5.15. This corresponds to a mean value of $1.44 per ADS (representing one ordinary share).
- BioLineRx has a strong balance with adequate cash ($44.2M as of 31 March, 2018) to further support its clinical and regulatory strategy until early H1-2020 without additional capital raising.
- Pending achievements, several major clinical milestones forecasted for 2018 may increase the commercial market value of the company's stock.
About the company - BioLineRx Ltd. (hereinafter: "BioLineRx" or "the Company") is an Israeli clinical-stage biopharmaceutical company focused on oncology and immunology. In 2007, the company was listed on the Tel Aviv Stock Exchange (TASE). In July 2011, the company registered American Depositary Shares (ADSs) with the NASDAQ. The Company in-licenses compounds, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization. BioLineRx's leading therapeutic clinical platform is BL-8040, a cancer therapy platform. A Phase 2a study was successfully completed for relapsed/refractory AML, a Phase 2b study as an AML consolidation treatment is ongoing, a Phase 2 study in stem cell mobilization for allogeneic transplantation is also ongoing and a Phase 3 in autologous transplantation was initiated in Q4 2017. please click here (https://ww2.frost.com/research/equity-research/)
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