[{"orgOrder":0,"company":"VBI Vaccines","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"","productType":"Vaccine","year":"2020","type":"Not Applicable","leadProduct":"GM-CSF","moa":"GB\/pp65 antigen","graph1":"Oncology","graph2":"Phase II","graph3":"VBI Vaccines","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Injectable\/Injection","sponsorNew":"VBI Vaccines \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"VBI Vaccines \/ Not Applicable"},{"orgOrder":0,"company":"Greenwich LifeSciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"","productType":"Vaccine","year":"2020","type":"Not Applicable","leadProduct":"GM-CSF","moa":"","graph1":"Oncology","graph2":"Phase III","graph3":"Greenwich LifeSciences","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Intradermal injection","sponsorNew":"Greenwich LifeSciences \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Greenwich LifeSciences \/ Not Applicable"},{"orgOrder":0,"company":"Y-mAbs Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"","productType":"Large molecule","year":"2020","type":"Not Applicable","leadProduct":"Naxitamab","moa":"","graph1":"Oncology","graph2":"Approved","graph3":"Y-mAbs Therapeutics","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Intravenous Injection","sponsorNew":"Y-mAbs Therapeutics \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Y-mAbs Therapeutics \/ Not Applicable"},{"orgOrder":0,"company":"Greenwich LifeSciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"","productType":"Vaccine","year":"2020","type":"Not Applicable","leadProduct":"GM-CSF","moa":"","graph1":"Oncology","graph2":"Phase III","graph3":"Greenwich LifeSciences","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Intradermal injection","sponsorNew":"Greenwich LifeSciences \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Greenwich LifeSciences \/ Not Applicable"},{"orgOrder":0,"company":"Greenwich LifeSciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"","productType":"Peptide","year":"2021","type":"Not Applicable","leadProduct":"GM CSF","moa":"","graph1":"Oncology","graph2":"Phase III","graph3":"Greenwich LifeSciences","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Intradermal Injection","sponsorNew":"Greenwich LifeSciences \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Greenwich LifeSciences \/ Not Applicable"},{"orgOrder":0,"company":"Gliknik","sponsor":"First In Ventures","pharmaFlowCategory":"D","therapeuticArea":"Oncology","country":"","productType":"Vaccine","year":"2021","type":"Series C Financing","leadProduct":"Biropepimut-S","moa":"","graph1":"Oncology","graph2":"Phase II","graph3":"Gliknik","amount2":0.01,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Oncology","amount2New":0.01,"dosageForm":"Intravenous Injection","sponsorNew":"Gliknik \/ First In Ventures","highestDevelopmentStatusID":"8","companyTruncated":"Gliknik \/ First In Ventures"},{"orgOrder":0,"company":"Greenwich LifeSciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"","productType":"Peptide","year":"2021","type":"Not Applicable","leadProduct":"GP2 Peptide","moa":"","graph1":"Oncology","graph2":"Phase III","graph3":"Greenwich LifeSciences","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Intradermal Injection","sponsorNew":"Greenwich LifeSciences \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Greenwich LifeSciences \/ Not Applicable"},{"orgOrder":0,"company":"Greenwich LifeSciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"","productType":"Peptide","year":"2021","type":"Not Applicable","leadProduct":"GP2 Peptide","moa":"","graph1":"Oncology","graph2":"Phase III","graph3":"Greenwich LifeSciences","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Intradermal Injection","sponsorNew":"Greenwich LifeSciences \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Greenwich LifeSciences \/ Not Applicable"},{"orgOrder":0,"company":"Greenwich LifeSciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"","productType":"Peptide","year":"2021","type":"Not Applicable","leadProduct":"GP2 Peptide","moa":"","graph1":"Oncology","graph2":"Phase III","graph3":"Greenwich LifeSciences","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Intradermal Injection","sponsorNew":"Greenwich LifeSciences \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Greenwich LifeSciences \/ Not Applicable"},{"orgOrder":0,"company":"VBI Vaccines","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"","productType":"Vaccine","year":"2021","type":"Not Applicable","leadProduct":"GM-CSF","moa":"GB\/pp65 antigen","graph1":"Oncology","graph2":"Phase II","graph3":"VBI Vaccines","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Injectable\/Injection","sponsorNew":"VBI Vaccines \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"VBI Vaccines \/ Not Applicable"}]

Find Clinical Drug Pipeline Developments & Deals for GM CSF

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                          Top Deals by Deal Size (USD bn)

                          01

                          American Pharma Summit
                          Not Confirmed
                          American Pharma Summit
                          Not Confirmed

                          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.

                          Brand Name : VBI-1901

                          Molecule Type : Vaccine

                          Upfront Cash : Not Applicable

                          December 01, 2021

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

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase I/ Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          02

                          American Pharma Summit
                          Not Confirmed
                          American Pharma Summit
                          Not Confirmed

                          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.

                          Brand Name : GP2

                          Molecule Type : Peptide

                          Upfront Cash : Not Applicable

                          November 10, 2021

                          Lead Product(s) : GP2 Peptide,GM CSF

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          03

                          American Pharma Summit
                          Not Confirmed
                          American Pharma Summit
                          Not Confirmed

                          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.

                          Brand Name : GP2

                          Molecule Type : Peptide

                          Upfront Cash : Not Applicable

                          November 09, 2021

                          Lead Product(s) : GP2 Peptide,GM CSF

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          04

                          American Pharma Summit
                          Not Confirmed
                          American Pharma Summit
                          Not Confirmed

                          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.

                          Brand Name : GP2

                          Molecule Type : Peptide

                          Upfront Cash : Not Applicable

                          September 09, 2021

                          Lead Product(s) : GP2 Peptide,GM CSF

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          05

                          American Pharma Summit
                          Not Confirmed
                          American Pharma Summit
                          Not Confirmed

                          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.

                          Brand Name : GL-0817

                          Molecule Type : Vaccine

                          Upfront Cash : Undisclosed

                          June 24, 2021

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

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase II

                          Sponsor : First In Ventures

                          Deal Size : $11.5 million

                          Deal Type : Series C Financing

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                          06

                          American Pharma Summit
                          Not Confirmed
                          American Pharma Summit
                          Not Confirmed

                          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...

                          Brand Name : GP2

                          Molecule Type : Peptide

                          Upfront Cash : Not Applicable

                          June 07, 2021

                          Lead Product(s) : GP2,GM CSF

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          07

                          American Pharma Summit
                          Not Confirmed
                          American Pharma Summit
                          Not Confirmed

                          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.

                          Brand Name : GP2

                          Molecule Type : Vaccine

                          Upfront Cash : Not Applicable

                          December 09, 2020

                          Lead Product(s) : GP2,GM CSF

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          08

                          American Pharma Summit
                          Not Confirmed
                          American Pharma Summit
                          Not Confirmed

                          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.

                          Brand Name : Danyelza

                          Molecule Type : Large molecule

                          Upfront Cash : Not Applicable

                          November 25, 2020

                          Lead Product(s) : Naxitamab,GM CSF

                          Therapeutic Area : Oncology

                          Highest Development Status : Approved

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          09

                          American Pharma Summit
                          Not Confirmed
                          American Pharma Summit
                          Not Confirmed

                          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 trastu...

                          Brand Name : GP2

                          Molecule Type : Vaccine

                          Upfront Cash : Not Applicable

                          November 23, 2020

                          Lead Product(s) : GP2,GM CSF

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          10

                          American Pharma Summit
                          Not Confirmed
                          American Pharma Summit
                          Not Confirmed

                          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%).

                          Brand Name : VBI-1901

                          Molecule Type : Vaccine

                          Upfront Cash : Not Applicable

                          November 19, 2020

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

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase I/ Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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