LEXINGTON, Mass., April 3, 2024 /PRNewswire/ -- 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 in Japan to Nobelpharma in 2022. Leukine is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in yeast. Leukine is not approved outside Japan for aPAP or as an inhalation therapy. Partner Therapeutics will manufacture Sargmalin for Nobelpharma at its manufacturing facility in Lynnwood, WA.
Review Highlights Importance of Leukine with Anti-GD2 Immunotherapy
Results Suggest the Potential Role of LEUKINE as a Host-Directed Immunomodulator
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
Partner Therapeutics Announces Publication of Results from Pre-Clinical Study Evaluating Recombinant Murine GM-CSF in Mouse Models of Down Syndrome and Normal Aging
LONDON--(BUSINESS WIRE)--Tanner Pharma Group, an international distributor of essential medicines, announced that it has significantly increased its inventory of Leukine (sargramostim, yeast-derived rhuGM-CSF) to be held in Europe. This action is being taken in partnership with Leukine’s owner, Partner Therapeutics (PTx), in response to the ongoing war in Ukraine and escalating potential for incidents that could require rapid deployment of medical interventions to treat radiation or chemical exposure.
LEXINGTON, Mass., Sept. 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 HLA-DR, Partner Therapeutics will be able to identify sepsis patients exhibiting an immune suppressed, or immunoparalyzed (IP) state and clinically evaluate Leukine as a study therapy in these individuals. The ability to identify patients with IP sepsis enables a precision medicine approach to maximize clinical benefit from immune boosting study therapy with Leukine.
Enforcement Report - Week of July 21, 2021
LEXINGTON, MA – May 19, 2021 — Partner Therapeutics, Inc. (PTx), a commercial biotech company, announces the publication of results from an investigator-initiated clinical trial (NCT03790670) evaluating the use of Leukine® (sargramostim, yeast-derived rhuGM-CSF) in patients with Parkinson’s Disease. Participants were evaluated for safety and tolerability as well as disease signs and symptoms including a standard Parkinson’s mobility test (Movement Disorder Society (MDS) – Unified Parkinson’s Disease Rating Scale Part III – UPDRS). Howard Gendelman, MD, chair of the University of Nebraska Medical Center (UNMC) Pharmacology and Experimental Neurology (PEN), together with Katherine Olson, PhD, Lee Mosley, PhD and Pamela Santamaria, MD and collaborators at UNMC published their findings in Lancet’s open access journal, EBioMedicine (“Safety, tolerability, and immune-biomarker profiling for year-long sargramostim treatment of Parkinson’s disease”) (Olson, K., et al.) https://doi.org/10.1016/j.ebiom.2021.103380
LEXINGTON, Mass., April 29, 2021 /PRNewswire/ -- Partner Therapeutics, Inc. (PTx), a commercial biotechnology company, announced today that the first patient has been enrolled in the SCOPE clinical trial, a randomized, placebo-controlled, double-blind phase 2 study of inhaled Leukine (sargramostim, rhu-GM-CSF) in 400 non-hospitalized COVID-19 patients (NCT04707664) at higher risk for progression to more severe COVID-19. 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. Sites in the United States and Latin and South America are expected to join the SCOPE study with expansion to additional countries under consideration.