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
LICENSED
Motixafortide
Solid tumorsPancreatic Cancer
Phase 2
*
Asia development and 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.
Stem cell mobilizationMultiple Myeloma
Approved
Approved in US
Global development and commercial rights except Asia**
Bridging Study
Global development and commercial rights except Asia**
Bridging Study
Asia development and commercial rightsAsia commercial rights
In November 2024, BioLineRx and Ayrmid Ltd., the parent company of Gamida Cell Ltd., announced that the companies entered into a license agreement for motixafortide (commercially sold in the U.S. as APHEXDA® ), BioLineRx’s FDA-approved stem cell mobilization agent. BioLineRx granted Ayrmid an exclusive license to develop and commercialize APHEXDA® (motixafortide) across all indications, excluding solid tumor indications, and in all territories other than Asia.
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 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
*
Phase 1
*
Global development and commercial rights except Asia**
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). Through our APHEXDA® development and commercialization agreement with Ayrmid, Gamida Cell is leading this program.
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. Through our APHEXDA® development and commercialization agreement with Ayrmid, Gamida Cell is leading this program.
* Investigator-initiated study
** Rights exclude solid-tumors
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 anti-tumor therapy.
