BioLineRx Ltd (BLRX)

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BioLineRx Provides Highlights from Oral Presentation Delivered at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition

https://finance.yahoo.com/news/biolinerx-provides-highlights-oral-presentation-120000207.html

- Presentation highlighted successful GENESIS Phase 3 pivotal trial of Motixafortide plus G-CSF for stem cell mobilization in multiple myeloma patients -

- Pre-NDA meeting imminent; NDA submission anticipated in H1 2022 -

TEL AVIV, Israel, Dec. 17, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical Company focused on oncology, today provided updates from an oral presentation delivered by Dr. Zachary Crees from the Washington University School of Medicine in St. Louis (WUSTL) at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition, which was held December 11-14, 2021, in Atlanta, GA, and virtually.

The oral presentation, entitled, "Motixafortide (BL-8040) and G-CSF Versus Placebo and G-CSF to Mobilize Hematopoietic Stem Cells for Autologous Stem Cell Transplantation in Patients with Multiple Myeloma: The GENESIS Trial" elaborated on the successful results of the Company's GENESIS Phase 3 pivotal trial which assessed Motixafortide plus G-CSF for the mobilization of stem cells in multiple myeloma patients. The study showed highly significant and clinically meaningful results supporting the use of Motixafortide on top of G-CSF for mobilization of stem cells for subsequent collection and transplantation in patients with multiple myeloma.

Recapping the efficacy data previously reported, Dr. Crees noted that 92.5% of patients in the Motixafortide+G-CSF arm achieved the primary endpoint (the mobilization of ≥6M CD34+ cells/kg in up to two apheresis sessions, p<0.0001), versus 26.2% for the placebo+G-CSF arm. Furthermore, 88.8% of patients in the Motixafortide+G-CSF arm achieved the secondary endpoint (the mobilization of ≥6M CD34+ cells/kg in one apheresis session, p<0.0001), versus 9.5% for the placebo+G-CSF arm.

Of note, Dr. Crees also indicated that 15–35% of patients still failed to yield optimal stem cell yields of ≥6M CD34+ cells/kg in two previously published plerixafor trials, even with up to four apheresis sessions. Additionally, Dr. Crees noted that advances in modern induction therapies for multiple myeloma patients have made the harvesting of a sufficient number of stem cells even more challenging, a trend that is expected to continue in the future, thus highlighting the need for new and improved mobilization therapies.

"We were very pleased that Dr. Crees had an opportunity to deliver an oral presentation at ASH, one of the most prestigious and well attended oncology gatherings of the year, to provide additional details on the outstanding results from our GENESIS Phase 3 trial," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Along with the outstanding efficacy data from the trial and the positive results from the pharmacoeconomic study that we reported on previously, trends in the treatment paradigm, whereby new induction therapies in patients make the mobilization of stem cells ever more challenging, give us great enthusiasm for this molecule and emphasize its place as part of the standard of care in autologous stem cell transplantation. We look forward to a pre-NDA meeting with FDA in the coming days."