"BioLineRx Announces Positive Clinical Results from First Part of Phase 2 Trial in r/r AML - Data strongly suggest BL-8040 has potent anti-leukemic activity in combination with Ara-C in AML "-
BioLineRx Ltd. (NASDAQ/TASE: BLRX) today announced 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® (pembrolizumab), MSD’s anti-PD-1 therapy, in patients with metastatic pancreatic cancer.
BL-8040 was safe and well tolerated, and all transplanted recipients were successfully engrafted
x30-50 patients in additional arm will be investigated under the collaboration. Results from combination of BL-8040 and KEYTRUDA® (pembrolizumab) in COMBAT/KEYNOTE-202 study will be reported in H2 2018 as planned.
Data from first lead-in patient cohort prompts Data Monitoring Committee to recommend early continuation to randomized placebo-controlled part 2 of trial.
Transaction increases BioLineRx’s stake by 20%, to 80%, ahead of numerous potential value-creating milestones. Top-line results from ongoing Phase 2a pancreatic cancer study in combination with KEYTRUDA® expected this quarter.
TEL AVIV, Israel, March 27, 2019 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE:BLRX), a clinical-stage biopharmaceutical company focused on oncology, announced today 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 [...]
BioLineRx Presents Preclinical Data From Triple Combination of BL-8040, Anti PD-1 and Chemotherapy Demonstrating Significant Reduction in Pancreatic Tumor Growth and Favorable Changes in Tumor Microenvironment. BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, announced today positive preclinical results further elucidating the mechanism of action of BL-8040 in combination with [...]
BioLineRx Announces Updated Phase 2a Data From Triple Combination Arm of COMBAT/KEYNOTE-202 Study in Patients With Second-line Metastatic Pancreatic Cancer. Combination of BL-8040, KEYTRUDA® and chemotherapy demonstrates a 32% overall response rate and a 77% disease control rate out of 22 currently evaluable patients. Median duration of clinical benefit for all 17 patients with disease [...]
BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, today announced that the European Commission (EC) has granted Orphan Drug Designation to its lead oncology candidate, Motixafortide (BL-8040), for the treatment of pancreatic cancer, based on a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA). Last year, Motixafortide [...]
