BioLineRx Ltd. is a clinical stage biopharmaceutical company, which engages in the research and development of treatments that focus on cancer. Its product pipeline includes Motaxafortide (BL-8040), which is used for stem-cell mobilization, solid tumors, and acute myeloid lukemia; and AGI-134, which is an immunotherapy treatment used for multiple solid tumors. The company was founded in 2003 and is headquartered in Modi'in, Israel.
Clinical Trials
31
11 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2003
Active, not recruiting
11
35.5%
Completed
13
41.9%
Recruiting
2
6.5%
Terminated
4
12.9%
Unknown
1
3.2%
No approval data available
- BioLineRx is on track to initiate a Phase 1/2a clinical trial of GLIX1 for glioblastoma treatment by the end of March 2026, marking the first-in-human study of this novel DNA damage response inhibitor. - The company received USPTO patent allowance for GLIX1 covering 90% of all cancers where cytidine deaminase is not over-expressed, extending patent protection until 2040 with possible five-year extension. - BioLineRx reported $1.2 million in revenues for 2025 from APHEXDA royalties and maintains $20.9 million cash runway extending into the first half of 2027. - The CheMo4METPANC Phase 2b trial of motixafortide in metastatic pancreatic cancer has accelerated enrollment, with interim analysis expected in 2026.
- BioLineRx received USPTO Notice of Allowance for a key patent covering GLIX1 use in cancers where cytidine deaminase is not over-expressed, representing over 90% of all cancers. - The patent strengthens GLIX1's intellectual property protection until 2040 with possible five-year extension, supporting expansion beyond initial glioblastoma indication. - The company plans to initiate first-in-human GLIX1 trials in glioblastoma patients in Q1 2026 while advancing preclinical studies in other cancer models. - GLIX1 targets DNA damage response in cancer cells through a unique mechanism of action, offering potential treatment for difficult-to-treat cancers.
- BioLineRx's CheMo4METPANC Phase 2 pilot study demonstrated a 64% overall response rate and 91% disease control rate in first-line pancreatic cancer patients treated with motixafortide combination therapy. - Four of eleven patients remained progression-free after more than one year, with two patients achieving complete responses and undergoing definitive surgical treatment. - The combination therapy increased CD8+ T-cell tumor infiltration across all patients, suggesting enhanced immune system activation against pancreatic tumors. - The trial has been expanded from 30 to 108 patients based on encouraging results, representing the first large randomized study of motixafortide with PD-1 inhibitor in pancreatic cancer.
- DelveInsight's 2025 assessment reveals a robust sickle cell disease pipeline with 55+ companies developing 60+ therapeutic candidates across various clinical development stages. - Recent clinical milestones include Rigel Pharmaceuticals enrolling the first patient in a Phase I trial of fostamatinib and Beam Therapeutics presenting updated BEACON trial data for BEAM-101. - The pipeline encompasses diverse therapeutic approaches including gene therapies, small molecules, and monoclonal antibodies, with treatments administered through multiple routes from oral to intravenous. - Key marketed therapies include Vertex Pharmaceuticals' CASGEVY, a CRISPR/Cas9 gene-edited cell therapy, and Emmaus Medical's ENDARI, an oral L-glutamine treatment for reducing acute complications.
• Genentech USA is developing RO-7759065, a novel parenteral treatment targeting metastatic solid tumors, expanding their robust oncology pipeline. • The drug candidate is undergoing clinical evaluation with GlobalData tracking its phase transition and likelihood of approval based on 18 years of historical drug development data. • Genentech, a Roche subsidiary, brings significant expertise in oncology drug development, supported by partnerships with BioLineRx, Charles River Laboratories, and Amunix.
- BioLineRx's APHEXDA (motixafortide) receives FDA approval for stem cell mobilization in multiple myeloma patients, marking a significant advancement in over a decade. - Commercial launch of APHEXDA in the U.S. is underway, with positive feedback from transplant centers indicating it addresses a critical unmet need for effective mobilization. - Clinical trials explore motixafortide's potential in pancreatic cancer and sickle cell disease, demonstrating versatility across hematological and solid tumor cancers. - Gloria Biosciences partners with BioLineRx for development and commercialization of motixafortide in Asia, including a bridging study in China for stem cell mobilization.
