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
ApprovedApproved in US

Approved in US

Phase 2Bridging Study

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*

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).

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.

AGI-134

OncologySolid Tumors
Phase 2

AGI-134 is being developed as a novel cancer immunotherapy for the treatment of solid tumors. This synthetic alpha-Gal glycolipid is injected intratumorally and coats tumor cells. Pre-existing anti alpha-Gal antibodies bind the alpha-Gal-coated tumor cells and trigger a cascade of immune responses against the injected as well as distal un-injected tumors.

Other/BL-5010

Skin Lesions
Approved2016 CE Mark 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.

White Curve shaped
White Curve shaped
The purpose behind the pipeline

Our team of experts across the entire spectrum of drug development powers solutions designed to impact patients’ lives.