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Sargmalin (sargramostim) is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF). It is approved for the treatment of autoimmune pulmonary alveolar proteinosis.
Lead Product(s): Sargramostim
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Sargmalin
Highest Development Status: ApprovedProduct Type: Large molecule
Recipient: Nobelpharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 03, 2024
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 IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2022
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: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: University of Colorado
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 29, 2022
Details:
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 IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 28, 2021
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 IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 29, 2021
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 IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2021
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 IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2021
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 IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 25, 2020
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 IIProduct 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
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 IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2020