The purpose behind the pipeline
Our team of experts across the entire spectrum of drug development powers solutions designed to impact patients’ lives.
The safety and efficacy of the following investigational compounds or investigational uses of marketed products have not been established. These uses have not been approved by the U.S. Food and Drug Administration or other regulatory authorities unless otherwise noted.
BioLineRx’s focused pipeline includes novel compounds with best-in-class potential to meet areas of unmet need for patients with cancer and rare diseases.
PRE-CLINICAL
PHASE 1
PHASE 2
PHASE 3
APPROVED
Motixafortide BL-8040
Stem cell mobilizationMultiple Myeloma
Approved
Approved in US
Phase 2
Bridging Study
Asia commercial rights
In September 2023, the U.S. Food and Drug Administration approved APHEXDA™ (motixafortide) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
In October 2023, BioLineRx finalized an agreement that included Gloria Biosciences to develop and commercialize motixafortide across all indications in Asia. GloriaBio will lead a bridging study beginning in 2024 to support potential approval and commercialization of motixafortide in stem cell mobilization for autologous transplantation in patients with multiple myeloma in China.
Sickle Cell Disease
Phase 1
Clinical partner*
Phase 1
Clinical partner*
In March 2023, BioLineRx announced a clinical trial collaboration with Washington University School of Medicine to advance a Phase 1 clinical trial evaluating the safety and feasibility of motixafortide as monotherapy and in combination with natalizumab (VLA-4 inhibitor) to mobilize CD34+ hematopoietic stem cells (HSCs) for gene therapy in patients with sickle cell disease (SCD).
In May 2024, BioLineRx announced a clinical trial collaboration with St. Jude Children’s Research Hospital, Inc. to advance a multi-center Phase 1 clinical trial evaluating the safety, tolerability, and feasibility of single-agent motixafortide for the mobilization and collection of CD34+ hematopoietic stem cells in 12 patients (aged 18 and older) with sickle cell disease.
OncologyPancreatic Cancer
Phase 2
Clinical partner*
Phase 2
Asia commercial rights
In July 2023, BioLineRx announced the initiation of a randomized Phase 2 clinical trial in patients with first-line metastatic pancreatic cancer with sponsor Columbia University. The trial is evaluating motixafortide in combination with PD-1 inhibitor cemiplimab and standard of care combination chemotherapy.
In October 2023, BioLineRx finalized an agreement that included Gloria Biosciences to develop and commercialize motixafortide across all indications in Asia. GloriaBio plans to initiate a large, randomized Phase 2 clinical trial in patients with first-line metastatic pancreatic cancer evaluating motixafortide in combination with PD-1 inhibitor zimberelimab and standard of care combination chemotherapy.
Other/BL-5010
Skin Lesions
Approved
Commercial rights
2016 CE Mark Approved
* Investigator-initiated study
Studies in Planning
Motixafortide
Our lead asset, motixafortide, is an innovative, high-affinity CXCR4 inhibitor. This novel agent leverages the expression of the CXCR4 receptor in a variety of cell populations, including hematopoietic stem cells, immune cells, and cancer cells, making it potentially applicable to multiple indications, such as stem cell mobilization and anti-tumor therapy.
