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Details:

Tysabri® (natalizumab) - a monotherapy for adult patients with relapsing-remitting multiple sclerosis (RRMS) and adults with moderately-to-severely active Crohn’s disease.


Lead Product(s): Natalizumab

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 29, 2022

Details:

PB006 (natalizumab) is mAB that acts as α4 integrin antagonist to prevent leukocyte trafficking into central nervous system, demonstrated high efficacy in Phase III trials by reducing annualized relapse rate, preventing multiple sclerosis lesion accumulation.


Lead Product(s): Natalizumab

Therapeutic Area: Neurology Product Name: PB006

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Sandoz B2B

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 25, 2022

Details:

Natalizumab a proposed biosimilar to Tysabri is a humanised monoclonal antibody that blocks integrin α4β1-mediated leukocyte migration from blood vessels to the brain and prevent highly active relapsing-remitting multiple sclerosis.


Lead Product(s): Natalizumab

Therapeutic Area: Neurology Product Name: PB006

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Sandoz B2B

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 14, 2022

Details:

Tyruko (natalizumab-sztn - biosimilar) is a highly effective anti-α4 integrin monoclonal antibody. It is indicated for the treatment of relapsing-remitting forms of multiple sclerosis.


Lead Product(s): Natalizumab

Therapeutic Area: Neurology Product Name: Tyruko

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 31, 2024

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BioLineRx initiated Phase I clinical trial studies evaluating BL-8040 (motixafortide), CXCR4/SDF-1 inhibitor, as monotherapy and in combination with natalizumab for the treatment of sickle cell disease.


Lead Product(s): Motixafortide,Natalizumab

Therapeutic Area: Hematology Product Name: BL-8040

Highest Development Status: Phase IProduct Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 21, 2023

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Aphexda (motixafortide) is a CXCR4 antagonist , which is investigated in combination with gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancers.


Lead Product(s): Motixafortide,Natalizumab

Therapeutic Area: Oncology Product Name: Aphexda

Highest Development Status: Phase IIProduct Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 28, 2023

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Natalizumab biosimilar is mAB that acts as α4 integrin antagonist to prevent leukocyte trafficking into central nervous system, demonstrated high efficacy in Phase III trials by reducing annualized relapse rate, preventing multiple sclerosis lesion accumulation.


Lead Product(s): Natalizumab

Therapeutic Area: Neurology Product Name: PB006

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 24, 2023

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BL-8040 (motixafortide) inhibits CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including pancreatic ductal adenocarcinoma (PDAC).


Lead Product(s): Motixafortide,Natalizumab

Therapeutic Area: Oncology Product Name: BL-8040

Highest Development Status: Phase IIProduct Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 17, 2023

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The aim of the collaboration is to advance a Phase 1 clinical trial that will evaluate the safety and feasibility of BL-8040 (motixafortide) to mobilize CD34+ hematopoietic stem cells (HSCs) for gene therapies in sickle cell disease (SCD).


Lead Product(s): Motixafortide,Natalizumab

Therapeutic Area: Genetic Disease Product Name: BL-8040

Highest Development Status: Phase IProduct Type: Peptide

Partner/Sponsor/Collaborator: Washington University School of Medicine

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration March 06, 2023

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An updated analysis of Tysabri, confirms results from earlier analyses, which found that EID with IV administration of natalizumab is associated with a significantly lower risk of progressive multifocal leukoencephalopathy (PML) than the approved every four-week (Q4W) dosing.


Lead Product(s): Natalizumab

Therapeutic Area: Neurology Product Name: Tysabri

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 04, 2022

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TYSABRI is a well-established treatment indicated for relapsing forms of multiple sclerosis (MS) in adults that has been proven in clinical trials to slow physical disability progression, reduce the formation of new brain lesions and cut relapses.


Lead Product(s): Natalizumab

Therapeutic Area: Neurology Product Name: Tysabri

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 13, 2021

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The SC and IV formulations of Tysabri are dosed 300mg, every four weeks by a healthcare provider, but the SC option expands the clinical settings for treatment beyond infusion centres, and offers a shortened time-frame for administration.


Lead Product(s): Natalizumab

Therapeutic Area: Neurology Product Name: Tysabri

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 07, 2021

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