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Motixafortide (BL-8040)
Motixafortide (formerly known as BL-8040/BKT140) is a novel selective inhibitor of the CXCR4 chemokine receptor. CXCR4, is a well validated therapeutic target that is involved in the mobilization and trafficking of hematopoietic stem cells, immune cells and cancer cells from the bone marrow and the lymph nodes to the peripheral blood. Motixafortide is being developed as a platform for several indications including mobilization of hematopoietic stem cells (HSCs) for autologous transplantations, treatment of solid tumors, and other hematological malignancies.
Motixafortide’s unique features including high-affinity, long receptor occupancy and inverse agonist activity position it as the best-in-class antagonist of CXCR4.
STUDY CONDITION PHASE STAGE AGENT(S) INFORMATION GENESIS Study - A Phase 3 double blinded study evaluating the safety, tolerability and efficacy of combination treatment of BL-8040 and G-GSF as compared to placebo and G-CSF for the mobilization of hematopoietic stem cells for autologous transplantation in subjects with multiple myeloma
- Stem-cell mobilization for autologous transplantation in multiple myeloma
Phase 3
Completed; long term follow-up is ongoing
BL-8040 + G-CSF
NCT03246529 A Phase 2 study evaluating the safety and efficacy of BL-8040 as a monotherapy for the mobilization of donor hematopoietic stem cells and allogeneic transplantation in patients with advanced hematological malignancies
- Stem cell mobilization for allogeneic and haploidentical transplantation in Acute myelogenous leukemia
- Acute lymphoblastic leukemia
- Chronic myelogenous leukemia
- Non-Hodgkin lymphoma
- Hodgkin Disease
- Chronic lymphocytic leukemia
- Multiple myeloma
- Myelodysplastic syndrome
- Myeloproliferative neoplasm
Phase 2
Completed
BL-8040
NCT02639559 COMBAT cohort 1 - a Phase 2a, multicenter, open-label study to assess the safety and efficacy of the Combination of BL-8040 and pembrolizumab in subjects with metastatic pancreatic cancer
- Metastatic pancreatic adenocarcinoma, treatment lines 2-5
Phase 2a
Completed
BL-8040 + pembrolizumab (Keytruda)
NCT02826486 COMBAT cohort 2 - a Phase 2a, multicenter, open-label study to assess the safety and efficacy of the combination of BL-8040 and pembrolizumab in subjects with metastatic pancreatic cancer
- Metastatic pancreatic adenocarcinoma, second-line patients
Phase 2a
Completed
BL-8040 + pembrolizumab (Keytruda) + Onivyde based chemotherapy
NCT02826486 A Phase 2b study assessing the efficacy, safety and pharmacodynamics effects of Pembrolizumab and BL-8040 in patients with Metastatic Pancreatic Cancer
- Metastatic pancreatic cancer
Phase 2b
Completed
BL-8040 + pembrolizumab (Keytruda)
NCT02907099 A Phase 2 Study with combination chemotherapy (Gemcitabine and Nab-Paclitaxel), BL-8040, and Immune Checkpoint Blockade (Cemiplimab) in METastatic Treatment naïve PANCreas Adenocarcinoma
- Metastatic pancreatic cancer
Phase 2
Recruiting
BL-8040 + cemiplimab (Libtayo) + Chemo
NCT04543071 Phase 1b study to evaluate efficacy and safety of BL-8040 followed by anti-thymocyte globulin, cyclosporine and methyprednisolone in adult subjects
with aplastic anemia or hypoplastic myelodysplastic syndrome- Aplastic Anemia
- Hypoplastic Myelodysplastic
- Syndrome
Phase 1b
Completed
BL-8040 + horse anti-thymocyte globulin (hATG) +
Methylprednisolone + CyclosporineNCT02462252 A Phase 2a Study of BL-8040 in combination with nelarabine for relapsed or refractory T-Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma
- T-Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma
Phase 2a
Completed
BL-8040 + Nelarabine
NCT02763384 A Phase 2a, Study to evaluate the safety and efficacy of escalating doses of BL-8040 in adult subjects with relapsed/refractory acute myeloid leukemia
- Acute myeloid leukemia
Phase 2a
Completed
BL-8040 + Cytarabine (Ara-C)
NCT01838395 A Phase 1, two-part study exploring the safety, tolerability, pharmacodynamic and pharmacokinetic effect of ascending doses of BL-8040 in healthy subjects
- Hematopoietic stem cell mobilization from healthy volunteers for allogeneic and/or autologous transplantation
Phase 1
Completed
BL-8040
NCT02073019 A Phase 1/2a dose-escalation, safety study of BKT140, a CXCR4 antagonist inducing mobilization of progenitor stem cells from the bone marrow to the peripheral blood in patients with multiple myeloma
- Stem cell mobilization for autologous transplantation in multiple myeloma
Phase 1/2a
Completed
BL-8040 + G-CSF + Cyclophosphamide
NCT01010880 A Phase 1b, open-label study designed to evaluate the safety of BL-8040 (a CXCR4 antagonist) in patients with acute respiratory distress syndrome (ARDS) secondary to COVID-19 and other respiratory viral infections
- ARDS secondary to COVID-19 and other respiratory viral infections
Phase 1b
Recruiting
BL-8040
Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects
- Healthy Volunteers
Phase 1
Completed
BL-8040
NCT05293171 -
AGI-134
AGI-134 is a synthetic alpha-Gal glycolipid in development for solid tumors that is highly differentiated from other cancer immunotherapies. AGI-134 is designed to label cancer cells with alpha-Gal via intra-tumoral administration, thereby targeting the body’s pre-existing, highly abundant anti-alpha-Gal (anti-Gal) antibodies and redirecting them to treated tumors. Binding of anti-Gal antibodies to the treated tumors results in activation of the complement cascade, which destroys the tumor cells and creates a pro-inflammatory tumor microenvironment that also induces a systemic, specific anti-tumor (vaccine) response to the patient’s own tumor neo-antigens.
STUDY CONDITION PHASE STAGE AGENT(S) INFORMATION A Phase 1/2a, Multicenter, Two-Parts, Open-Label Study Designed to Evaluate the Safety and Tolerability of Escalating Doses of AGI-134 in Unresectable Metastatic Solid Tumors
- Superficial, Palpable, Unresectable/Metastatic Solid Tumor
- Metastatic Colorectal Cancer
- Head & Neck Squamous Cell Carcinoma
Phase 1/2a
Completed recruitment
AGI-134
NCT03593226 Areas of interest
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Areas of Interest for Motixafortide
BioLineRx’s commitment to oncology is supported not only through our own clinical studies, but also by supporting independent unsolicited research relating to motixafortide by external investigators, organizations, and institutions who approach BioLineRx looking for support for their scientific research proposals where they will serve as the study sponsor. We refer to this research as Investigator Initiated Studies (IIS) program to advance research and enhance disease understanding. IIS proposals submitted to BioLineRx are reviewed by our scientific and medical committees for scientific merit as well as safety, legal, ethical, and budgetary considerations. Support by BioLineRx can take the form of funding, study drug, or a combination of both.
We concentrate our research and development efforts on the areas listed below.
To submit a proposal or for any further information please email IIS@biolinerx.com
- Exploration of stem cell mobilization (SCM) in patients undergoing autologous hematopoietic stem cell transplantation (HSCT) in multiple myeloma who:
- Require rescue therapy after failing to achieve sufficient CD34+ collection.
- Can be candidates for receiving apheresis on the same day as motixafortide administration in combination with granulocyte colony-stimulating factor (GCSF). This can be done only in places in which the apheresis units will be willing to collaborate, and the nurses will be available to come earlier for dosing.
- Exploration of SCM in patients undergoing autologous HSCT in sickle cell disease (SCD).
- Exploration of SCM in patients undergoing autologous HSCT in solid tumors (e.g., germ line tumors).
- Investigation in patients undergoing allogeneic stem cell transplantation (SCT) in any malignancy (e.g., acute leukemias, chronic leukemias, Hodgkin’s lymphoma, myelodysplastic syndrome (MDS), neuroblastoma, primary amyloidosis)
- Exploration in patients undergoing allogeneic SCT in non-malignant diseases (e.g., adrenoleukodystrophy, aplastic anemia, hemoglobinopathies, immune deficiencies, POEMS syndrome)
- Exploration of the role of motixafortide in reducing rates of myelosuppression due to:
- Chemotherapy-induced neutropenia
- Chronic neutropenia
- Administration of CAR-T therapy
- Pharmaco-economic studies (e.g., engraftment studies to assess the added value of transplanting more cells and its pharmaco-economic benefits, reduction in dose, and apheresis sessions in a given SCT population)
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Quality of life (QoL) studies with defined measures to inform how to improve patient outcomes
(Updated March 2022)
- Exploration of stem cell mobilization (SCM) in patients undergoing autologous hematopoietic stem cell transplantation (HSCT) in multiple myeloma who: