Oncology | Phase III Developments | ISRAEL

BioLineRx

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ISRAEL Israel

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BioLineRx Achieves Enrollment Target in Phase 3 GENESIS Trial for Planned Interim Analysis

Lead Product(s): Motixafortide,G-CSF

Therapeutic Area: Oncology Product Name: BL-8040

Highest Development Status: Phase III Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 19, 2020

Details:

This ongoing registrational study is investigating motixafortide (BL-8040) for the mobilization of hematopoietic stem cells (HSCs) for autologous transplantation in patients with multiple myeloma.

VBL Therapeutics

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ISRAEL Israel

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VBL Therapeutics Announces Second Successful Pre-planned Interim Analysis with a Positive Data Safety Monitoring Committee Review for OS

Lead Product(s): Ofranergene obadenovec,Paclitaxel

Therapeutic Area: Oncology Product Name: VB-111

Highest Development Status: Phase III Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 12, 2020

Details:

Data Safety Monitoring Committee has completed its second, pre-planned interim analysis of OVAL Phase 3 study investigating ofranergene obadenovec in patients with platinum-resistant ovarian cancer, and unanimously recommended that the study continue as planned.

VBL Therapeutics

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ISRAEL Israel

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VBL Presents Positive Interim Data from the OVAL Phase 3 Pivotal Study in Ovarian Cancer at the ASCO20

Lead Product(s): Ofranergene obadenovec,Paclitaxel

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 01, 2020

Details:

DSMC reviewed un-blinded data and determined that the study has met the interim pre-specified criterion of an absolute percentage advantage of 10% or higher in CA-125 response in the VB-111 treated arm compared to control. Study to proceed without modification.

Medison Pharma

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ISRAEL Israel

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BeiGene and Medison Pharma Announce Exclusive Distribution Agreement and NDA Acceptance for BTK Inhibitor BRUKINSA™ (zanubrutinib) in Isra...

Lead Product(s): Zanubrutinib

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: BeiGene

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement May 21, 2020

Details:

Medison will commercialize BeiGene’s BTK inhibitor BRUKINSA™ (zanubrutinib) in Israel and the acceptance of a new drug application (NDA) in Israel for BRUKINSA for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

VBL Therapeutics

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ISRAEL Israel

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Following Positive Interim Analysis, VB-111 Global Study in Ovarian Cancer to Extend to Japan via Collaboration with NanoCarrier

Lead Product(s): Ofranergene obadenovec,Paclitaxel

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 02, 2020

Details:

Following the positive interim analysis in the OVAL study, NanoCarrier, intends to extend the ongoing global Phase 3 OVAL clinical trial in ovarian cancer to patients in Japan.

VBL Therapeutics

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ISRAEL Israel

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VBL Therapeutics Announces Publication of Phase 2 and Phase 3 Data of VB-111 in Recurrent Glioblastoma Supporting Continued Development in I...

Lead Product(s): Ofranergene obadenovec,Bevacizumab

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 08, 2020

Details:

In the Phase 2 study, patients with rGBM who were primed with VB-111 monotherapy that was continued after progression with the addition of bevacizumab (Avastin®) showed significant survival.

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Find Oncology Drugs in Phase III Clinical Development in ISRAEL

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BioLineRx

BioLineRx Achieves Enrollment Target in Phase 3 GENESIS Trial for Planned Interim Analysis

VBL Therapeutics

VBL Therapeutics Announces Second Successful Pre-planned Interim Analysis with a Positive Data Safety Monitoring Committee Review for OS

VBL Therapeutics

VBL Presents Positive Interim Data from the OVAL Phase 3 Pivotal Study in Ovarian Cancer at the ASCO20

Medison Pharma

BeiGene and Medison Pharma Announce Exclusive Distribution Agreement and NDA Acceptance for BTK Inhibitor BRUKINSA™ (zanubrutinib) in Isra...

VBL Therapeutics

Following Positive Interim Analysis, VB-111 Global Study in Ovarian Cancer to Extend to Japan via Collaboration with NanoCarrier

VBL Therapeutics

VBL Therapeutics Announces Publication of Phase 2 and Phase 3 Data of VB-111 in Recurrent Glioblastoma Supporting Continued Development in I...