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[{"orgOrder":0,"company":"Partner Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Partner Therapeutics Announces Initiation of Clinical Trial to Evaluate Leukine","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Undisclosed","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"March 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Undisclosed"},{"orgOrder":0,"company":"Partner Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Partner Therapeutics Announces Start of Clinical Trial to Evaluate Leukine in Respiratory Illness in Patients with COVID-19","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Partner Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Partner Therapeutics Starts Clinical Trial Evaluating Leukine\u00ae in T Cell Replete HLA-mismatched Haploidentical Stem Cell Transplant","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Partner Therapeutics","sponsor":"U.S. Department of Defense","pharmaFlowCategory":"D","amount":"$35.0 million","upfrontCash":"Undisclosed","newsHeadline":"Partner Therapeutics Announces $35 Million Deal with U.S. DOD for Advanced Development and Emergency Use of Leukine for COVID-19","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Partner Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Partner Therapeutics Initiates Patient Enrollment in U.S. Clinical Trial Evaluating Leukine\u00ae (rhuGM-CSF, sargramostim) in COVID-19 Patients","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Partner Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"SARPAC Clinical Trial of Leukine in Hospitalized COVID-19 Patients Meets Primary Endpoint of Significant Improvement in Lung Function","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase IV"},{"orgOrder":0,"company":"Partner Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"SARPAC Clinical Trial of Leukine\u00ae in Hospitalized COVID-19 Patients Meets Primary Endpoint of Significant Improvement in Lung Function","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase IV"},{"orgOrder":0,"company":"Partner Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Partner Therapeutics Initiates Patient Enrollment in Clinical Trial Evaluating Leukine in High-risk Non-hospitalized COVID-19 Patients","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase IV"},{"orgOrder":0,"company":"Partner Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Second Randomized Trial of Leukine\u00ae (sargramostim) in COVID-19 Demonstrates Improvement in Lung Function","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase IV"},{"orgOrder":0,"company":"Partner Therapeutics","sponsor":"University of Colorado","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Partner Therapeutics Announces Publication of Results from Pre-Clinical Study Evaluating Recombinant Murine GM-CSF in Mouse Models of Down Syndrome and Normal Aging","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Preclinical"},{"orgOrder":0,"company":"Partner Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Partner Therapeutics Announces Publication of a Retrospective Cohort Review of 15 LEUKINE\u00ae Treated Patients with Pediatric Malignancies and Invasive Fungal Disease Refractory to Antifungal Therapy","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"}]

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            Details:

            Leukine (sargramostim) is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in yeast.

            Lead Product(s): Sargramostim

            Therapeutic Area: Oncology Product Name: Leukine

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 15, 2022

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            Details:

            People with Down syndrome are at higher risk for Alzheimer’s, and showed that GM-CSF improves cognition and brain pathology in AD mice and that Leukine® (sargramostim, glycosylated, yeast-derived rhuGM-CSF) improved cognition and reduced blood biomarkers of neuronal damage.

            Lead Product(s): Sargramostim

            Therapeutic Area: Genetic Disease Product Name: Leukine

            Highest Development Status: Preclinical Product Type: Large molecule

            Partner/Sponsor/Collaborator: University of Colorado

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 29, 2022

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            Safety and efficacy of inhaled sargramostim for the treatment of COVID-19 has not been established and sargramostim is not approved for treatment of COVID-19. Sargramostim has a different mechanism of action from recombinant G-CSFs products and data should not be extrapolated.

            Lead Product(s): Sargramostim

            Therapeutic Area: Infections and Infectious Diseases Product Name: Leukine

            Highest Development Status: Phase IV Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 28, 2021

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            Details:

            This study will evaluate the role of Leukine in reducing progression and need for hospitalization in COVID-19 patients. Primary study endpoints are: COVID-19-related emergency room visit, COVID-19- related hospitalization, or death.

            Lead Product(s): Sargramostim

            Therapeutic Area: Infections and Infectious Diseases Product Name: Leukine

            Highest Development Status: Phase IV Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 29, 2021

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            Details:

            SARPAC Clinical Trial of Leukine® met the primary endpoint of improved oxygenation after five days of treatment with inhaled sargramostim in combination with standard of care (SOC) compared with SOC alone.

            Lead Product(s): Sargramostim

            Therapeutic Area: Infections and Infectious Diseases Product Name: Leukine

            Highest Development Status: Phase IV Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 26, 2021

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            Details:

            Data showed that five days of inhaled sargramostim plus standard of care (SOC) treatment improved oxygenation in patients, thereby meeting the primary endpoint.

            Lead Product(s): Sargramostim

            Therapeutic Area: Infections and Infectious Diseases Product Name: Leukine

            Highest Development Status: Phase IV Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 26, 2021

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            Details:

            First patient has been enrolled in the iLeukPulm clinical trial, a randomized phase 2 study of inhaled Leukine in hospitalized COVID-19 patients with acute hypoxemia.

            Lead Product(s): Sargramostim

            Therapeutic Area: Infections and Infectious Diseases Product Name: Leukine

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 25, 2020

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            Details:

            Funding will support two clinical studies of inhaled Leukine® (sargramostim, rhu-Granulocyte Macrophage-Colony Stimulating Factor “GM-CSF”) in patients with COVID-19 associated acute hypoxemia.

            Lead Product(s): Sargramostim

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Leukine

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: U.S. Department of Defense

            Deal Size: $35.0 million Upfront Cash: Undisclosed

            Deal Type: Agreement August 04, 2020

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            Details:

            The trial will evaluate the effectiveness of Leukine compared to a matched control cohort of G-CSF treated patients, as well as evaluate the immune reconstitution profile of the treated patients compared to a contemporaneous cohort of 20 patients who receive G-CSF.

            Lead Product(s): Sargramostim

            Therapeutic Area: Oncology Product Name: Leukine

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 11, 2020

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            Details:

            Company to initiate an investigator-initiated randomized, double-blind, placebo-controlled clinical trial of Leukine(sargramostim, rhu-GM-CSF) in patients with acute respiratory failure associated with COVID-19, conducted at Singapore General Hospital.

            Lead Product(s): Sargramostim

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 28, 2020

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