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    [{"orgOrder":0,"company":"VBI Vaccines","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"VBI Vaccines Announces Positive Interim Phase 2a Data from VBI-1901 in Recurrent GBM","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Vaccine","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Gliknik","sponsor":"First In Ventures","pharmaFlowCategory":"D","amount":"$11.5 million","upfrontCash":"Undisclosed","newsHeadline":"Gliknik Inc. 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              VBI Vaccines

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              VBI Vaccines to Present New Overall Survival Data from Phase 2a Study in Recurrent GBM at the World Vaccine & Immunotherapy Congress 2021

              Details:

              US FDA grants fast track designation to VBI-1901 for the treatment of recurrent GBM patients with first tumor has achieved progression-free survival beyond 86 weeks, demonstrating 93% tumor reduction relative to baseline recurrence.

              Lead Product(s): VBI-1901,GM CSF

              Therapeutic Area: Oncology Product Name: VBI-1901

              Highest Development Status: Phase I/ Phase II Product Type: Vaccine

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 01, 2021

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              Greenwich LifeSciences

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              Greenwich LifeSciences Provides Clinical Update on Upcoming Phase III Clinical Trial, FLAMINGO-01

              Details:

              GP2 immunotherapy generated GP2-specific immune responses, leading to no metastatic breast cancer recurrence in the HER2/neu 3+ population in the Phase IIb clinical trial, thus supporting GP2’s mechanism of action.

              Lead Product(s): GP2 Peptide,GM CSF

              Therapeutic Area: Oncology Product Name: GP2

              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 November 10, 2021

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              Greenwich LifeSciences

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              Greenwich LifeSciences Provides Updated Corporate Presentation and Webcasts

              Details:

              The broad based immune response suggests the potential for GP2 to treat other HER2/neu 1-3+ expressing cancers. GP2 treatment was well tolerated and no serious adverse events were observed related to GP2 immunotherapy.

              Lead Product(s): GP2 Peptide,GM CSF

              Therapeutic Area: Oncology Product Name: GP2

              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 November 09, 2021

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              Greenwich LifeSciences

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              Greenwich LifeSciences Provides Updates on Recent and Upcoming Developments

              Details:

              GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein. In a randomized, single-blinded, placebo-controlled, multi-center Phase IIb clinical trial, no recurrences were observed after median 5 years of follow-up.

              Lead Product(s): GP2 Peptide,GM CSF

              Therapeutic Area: Oncology Product Name: GP2

              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 September 09, 2021

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              Gliknik

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              Gliknik Inc. Raises $11.5 Million in Series C Financing

              Details:

              Funding will help advance Gliknik clinical and pre-clinical programs, including: A randomized double-blind, placebo-controlled phase 2 study of Gliknik immuno-oncology compound biropepimut-S, which is nearing completion.

              Lead Product(s): Biropepimut-S,GM CSF,Cyclophosphamide

              Therapeutic Area: Oncology Product Name: GL-0817

              Highest Development Status: Phase II Product Type: Vaccine

              Partner/Sponsor/Collaborator: First In Ventures

              Deal Size: $11.5 million Upfront Cash: Undisclosed

              Deal Type: Series C Financing June 24, 2021

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              Greenwich LifeSciences

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              Greenwich LifeSciences Publishes Additional Positive Safety Data from GP2 Phase IIb Trial at ASCO 2021

              Details:

              GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein. Final safety conclusions are that GP2 immunotherapy is well tolerated and that no serious adverse events related to GP2 immunotherapy were reported over the full 5 year follow-up period.

              Lead Product(s): GP2,GM CSF

              Therapeutic Area: Oncology Product Name: GP2

              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 June 07, 2021

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              Greenwich LifeSciences

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              Greenwich LifeSciences Announces Poster Presentation of Five Year Data for GP2 Phase IIb Clinical Trial

              Details:

              According to Greenwich, Kaplan-Meier curves show the disease-free survival (DFS) rate was 100% at the final five-year median follow-up in HER2/neu 3+ patients treated with GP2 plus GM-CSF following adjuvant Herceptin, versus 89.4% for GM-CSF alone.

              Lead Product(s): GP2,GM CSF

              Therapeutic Area: Oncology Product Name: GP2

              Highest Development Status: Phase III Product Type: Vaccine

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 09, 2020

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              Y-mAbs Therapeutics

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              FDA Approves Y-mAbs’ DANYELZA® (naxitamab-gqgk) for the Treatment of Neuroblastoma

              Details:

              U.S. Food and Drug Administration has approved DANYELZA (naxitamab-gqgk) 40mg/10ml. DANYELZA is a humanized, monoclonal antibody that targets the ganglioside GD2, which is highly expressed in various neuroectoderm-derived tumors and sarcomas.

              Lead Product(s): Naxitamab,GM CSF

              Therapeutic Area: Oncology Product Name: Danyelza

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 25, 2020

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              Greenwich LifeSciences

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              Greenwich LifeSciences Announces Second Publication and Poster Presentation of Phase III Clinical Trial of Potential Breakthrough Technology for Recurring Breast Cancer

              Details:

              The study aims to reproduce the Phase IIb study which concluded that completion of the first 6 intradermal injections of GP2 + GM-CSF safely elicited a potent immune response and reduced recurrence rates to 0% in HER2/neu 3+ patients, who received trastuzumab after surgery.

              Lead Product(s): GP2,GM CSF

              Therapeutic Area: Oncology Product Name: GP2

              Highest Development Status: Phase III Product Type: Vaccine

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 23, 2020

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              VBI Vaccines

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              VBI Vaccines Announces Positive Interim Phase 2a Data from VBI-1901 in Recurrent GBM

              Details:

              Interim data show promising disease control rates in patients vaccinated with VBI-1901 combined with the GM-CSF adjuvant (40%), and with VBI-1901 combined with GSK’s adjuvant AS011 (56%).

              Lead Product(s): VBI-1901,GM CSF

              Therapeutic Area: Oncology Product Name: VBI-1901

              Highest Development Status: Phase I/ Phase II Product Type: Vaccine

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 19, 2020

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              Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
              Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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