Comprehensive Review Highlights Potential Benefits of Leukine® in Management of Gastrointestinal (GI) Adverse Events Associated with Immune Checkpoint Inhibitors (ICIs) in the Treatment of Cancer

NCI sponsored, ECOG-ACRIN Phase 3 Study of Leukine in Combination with Ipilimumab and Nivolumab in Front Line Treatment of Melanoma Heads to Last Stages of Enrollment

Lexington, MA – April 18, 2024 — Partner Therapeutics, Inc. (PTx) announced publication of a comprehensive review by Dougan et al.1 in Cancers summarizing the mechanistic rationale and pre-clinical and clinical data regarding the use of Leukine (sargramostim; glycosylated, yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor [rhu GM-CSF]) to manage gastrointestinal ...

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Partner Therapeutics’ Leukine® (sargramostim) Receives Approval in Japan to Treat Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

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 ...

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Comprehensive Review Highlights Importance of Leukine® in Combination with Anti-GD2 Immunotherapy for Treatment of High-Risk Pediatric Neuroblastoma

 

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 ...

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Exploratory Results Suggest the Potential Role of LEUKINE® as a Host-Directed Immunomodulator

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 ...

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Partner Therapeutics Announces Publication of 30-month Randomized Open Label Study of LEUKINE® in Combination with Whole Lung Lavage for Treatment of Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

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 ...

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Partner Therapeutics Announces Publication of a Retrospective Cohort Review of 15 LEUKINE® Treated Patients with Pediatric Malignancies and Invasive Fungal Disease Refractory to Antifungal Therapy

 

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 ...

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Partner Therapeutics Announces Publication of Results from Pre-Clinical Study Evaluating Recombinant Murine GM-CSF in Mouse Models of Down Syndrome and Normal Aging

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 ...

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Partner Therapeutics Announces Contract with U.S. Department of Defense for Advanced Development of Leukine® to Treat Sulfur Mustard Gas (HD) Exposure

Funding will support development activities required for supplemental biological license application (sBLA) for Leukine to treat myelosuppressive effects and restore hematopoietic and immune function after HD exposure

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 ...

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BARDA and Partner Therapeutics foster a new partnership around their FDA-approved drug, Leukine® to improve patient care for sepsis patients

 

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 ...

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“A Drug Before Its Time?” LEUKINE® systematic review highlights innate and adaptive immune activity that may improve cancer outcomes and reduce toxicity

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 ...

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