Treatment will be Marketed by Nobelpharma Co. Ltd. Under the Trade Name Sargmalin^®

PMDA Approval of Sargmalin is the first regulatory approval of an inhaled recombinant GM-CSF product for aPAP

Lexington, MA – April 3, 2024 — Partner Therapeutics, Inc. (PTx) announced that its partner Nobelpharma received approval from the Japanese Pharmaceuticals and Medical Device Agency (PMDA) for the inhaled use of Leukine (sargramostim), branded in Japan as Sargmalin, to treat aPAP. PTx licensed rights for certain indications ...

Lexington, MA – January 17, 2024 – Partner Therapeutics, Inc. (PTx) announced today the publication of a comprehensive review by Mora et al. in the International Journal of Cancer which summarizes the efficacy and safety of anti-GD2 monoclonal antibodies (mAbs) (dinutuximab, dinutuximab beta, and naxitamab) in children with high-risk neuroblastoma when given in combination with Leukine (sargramostim; glycosylated, yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor [rhu GM-CSF]), recombinant human granulocyte colony-stimulating factor (G-CSF) or no cytokine.¹

The review provides ...

Results of a prospective, randomized, placebo-controlled study of inhaled Leukine^® in non-hospitalized patients at risk for severe COVID-19

LEXINGTON, Ma – December 20, 2023 – Partner Therapeutics, Inc. (PTx) announced today that Open Forum Infectious Diseases recently published the results from the SCOPE study (doi.org/10.1093/ofid/ofad500.351).^[i] These data were also presented at IDWeek 2023. The study was a prospective, multicenter study of 600 non-hospitalized COVID-19 patients randomized to receive either inhaled Leukine^® (sargramostim; yeast-derived, glycosylated recombinant human granulocyte-macrophage colony-stimulating ...

89% (8/9) of Patients Taking Inhaled Leukine Did Not Require Further Whole Lung Lavage in the 30-month Period

LEXINGTON, Mass., Nov. 30, 2023 /PRNewswire/ — Partner Therapeutics, Inc. (PTx) announced today that the European Respiratory Journal published the results of a prospective, randomized clinical trial of Leukine in patients with moderate to severe autoimmune pulmonary alveolar proteinosis (aPAP) (DOI: 10.1183/13993003.01233-2023).

aPAP is a progressive lung disorder driven by blockage of GM-CSF signaling due to ...

Lexington, MA – December 15, 2022 – Partner Therapeutics, Inc. (PTx) announced publication of a single institution retrospective cohort review of 15 patients with pediatric malignancies and invasive fungal diseases that were refractory to antifungal therapy and treated adjunctively with Leukine (sargramostim; yeast-derived, glycosylated recombinant human granulocyte-macrophage colony-stimulating factor [rhu GM-CSF]).¹ Additionally, the publication included a systematic review of 50 published reports of rhu GM-CSF use for invasive fungal disease. Open Forum Infectious Diseases published the manuscript entitled ...

Pre-clinical study with recombinant murine GM-CSF reversed cognitive impairment in Dp16 model of Down syndrome and improved cognitive function in aged normal mice

The CU Anschutz Medical Campus team recently awarded a grant from the National Institutes of Health/National Institute on Aging to study Leukine® treatment in young adults with Down syndrome

Lexington, MA – March 29, 2022 — Partner Therapeutics, Inc. (PTx), a commercial biotech company, announces publication of results from investigator-sponsored pre-clinical research evaluating use of ...

LEXINGTON, MA – February 17, 2022 – Partner Therapeutics, Inc. (PTx) today announced a milestone-based Other Transaction Agreement (OTA) with the United States Department of Defense (DoD) to fund development and regulatory activities to support an sBLA of Leukine® (sargramostim, rhu-Granulocyte Macrophage Colony Stimulating Factor, “GM-CSF”) for the treatment of sulfur mustard ...

Lexington, MA – September 20, 2021 /PRNewswire/ — Partner Therapeutics, Inc. (PTx) announced a collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, and Labcorp Drug Development to advance a new diagnostic approach to select immunoparalyzed sepsis patients that could benefit most from Leukine (sargramostim).  Through advancement of a Laboratory Developed Test (LDT) for monocyte ...

Authors also highlight promising data in neurodegenerative diseases, fungal infection, and respiratory diseases including aPAP and COVID-19

Lexington, MA – August 17, 2021 /PRNewswire/ — Partner Therapeutics, Inc. (PTx) announced today that Frontiers in Immunology published a systematic review of LEUKINE® titled, “Sargramostim (rhu GM-CSF) as Cancer Therapy (Systematic Review) and An Immunomodulator.  A Drug Before Its Time?” This manuscript chronicles Leukine’s 30-year history in oncology research, including 27 studies that each enrolled 50 or more patients.  Importantly, this ...

Department of Defense (DOD) Sponsored U.S. Study Met Primary Endpoint for Improvement in Oxygenation and Demonstrated Treatment with Inhaled Leukine Was Safe and Well Tolerated

Lexington, MA – June 28, 2021 /PRNewswire/ — Partner Therapeutics, Inc. (PTx) announced top-line results of the U.S.-based iLeukPulm clinical trial of inhaled Leukine (sargramostim, yeast-derived recombinant human granulocyte macrophage colony stimulating factor (GM-CSF)) in hospitalized COVID-19 patients (NCT04411680).¹  This prospective, randomized, controlled, open-label study was conducted at 11 U.S. hospitals.  The ...