On March 27th, the company announced that hematopoietic stem cells (HSCs) mobilized by BL-8040 in combination with granulocyte colony-stimulating factor (G-CSF) were successfully engrafted in all 11 patients participating in the Part 1, lead-in period of the GENESIS trial, a double-blind, placebo-controlled Phase 3 trial comparing BL-8040 and G-CSF to G-CSF alone, in mobilization of HSCs for autologous transplantation in multiple myeloma patients. These data follow previously announced successful mobilization data which led the Data Monitoring Committee (DMC) to recommend proceeding to the randomized placebo-controlled Part 2 of the study.
Highlights and achievements during the fourth quarter 2018 and subsequent period:
Presented data from Phase 2a COMBAT/KEYNOTE-202 pancreatic cancer study in collaboration with Merck at the ESMO 2018 Congress demonstrating that BL-8040 in combination with KEYTRUDA® (pembrolizumab) showed encouraging disease control and overall survival in patients with metastatic pancreatic cancer; compelling pharmacodynamic data also demonstrated T-cell infiltration into tumors and a reduction of the tumor immuno-suppressive microenvironment;
Initiated a triple combination arm of COMBAT/KEYNOTE-202 evaluating the safety, tolerability and efficacy of BL-8040 in combination with KEYTRUDA and chemotherapy;
Entered into agreement with Biokine Therapeutics to increase the Company’s economic stake in BL-8040 to 80% from the previous level of 60%;
Initiated Phase 1/2a multicenter, open-label clinical study in the UK and Israel for AGI-134, a novel immunotherapy evoking a direct anti-tumor response and vaccine effect for the treatment of solid tumors;
Announced FDA Orphan Drug Designation for BL-8040, for the treatment of pancreatic cancer. This is in addition to prior orphan drug designations received for BL-8040 in AML and stem cell mobilization;
Announced FDA Biological Product Designation for AGI-134, providing the Company with eligibility to obtain 12 years of market exclusivity upon approval of the product for commercial use by the FDA; and
Completed an underwritten public offering for gross proceeds of $15.4 million.
Expected significant milestones through end of 2019 and early 2020:
Top-line results from the Phase 2 triple combo pancreatic cancer trial of BL-8040, KEYTRUDA and chemotherapy under collaboration with Merck toward the end of 2019;
Potential interim results from Phase 2 AML consolidation study in the second half of 2019;
Initial safety results from part 1 of Phase 1/2a trial for AGI-134 in second half of 2019;
Top-line results from one or more of the solid tumor trials under collaboration with Genentech, potentially by end of 2019 or early 2020.
Products
Its development pipeline consists of clinical-stage therapeutic candidates, which include BL-8040, a peptide for the treatment of multiple cancer and hematological indications; AGI-134, an immuno-oncology agent in development for solid tumors; and BL-5010, a customized, proprietary, pen-like applicator for the non-surgical removal of benign skin lesions. The company has collaboration agreement with Novartis Pharma AG to facilitate development and commercialization of Israeli-sourced drug candidates for pre-clinical projects of BL-1220 and BL-1230; MSD for the cancer immunotherapy field; MD Anderson Cancer Center to investigate the combination of BL-8040 with Keytruda (pembrolizumab) in pancreatic cancer; and Genentech Inc. to investigate the combination of BL-8040 and Genentech’s Atezolizumab in various Phase 1b/2 studies for in various solid tumors and hematologic malignancies.
About
BioLineRx is a clinical-stage biopharmaceutical company focused on oncology. The Company in-licenses novel compounds, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization. BioLineRx Ltd. was founded in 2003 and is based in Modi’in, Israel.
Stock influences and risk factors
They are a clinical-stage biopharmaceutical development company with a history of operating losses.
If they or their licensees are unable to obtain U.S. and/or foreign regulatory approval for their therapeutic candidates, they will be unable to commercialize their therapeutic candidates.
They generally rely on third parties to conduct preclinical studies and clinical trials and to provide other services, and those third parties may not perform satisfactorily, including by failing to meet established deadlines for the completion of such services.
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