Partner Therapeutics, Inc. (PTx)

A review published in Cancers summarizes the mechanistic rationale and data for using Leukine to manage GI adverse events from ICIs in cancer treatment.

Nobelpharma received PMDA approval for inhaled Leukine (Sargmalin) to treat aPAP in Japan, marking the first regulatory approval of an inhaled recombinant GM-CSF product for this indication.

A review in the International Journal of Cancer summarizes the efficacy and safety of anti-GD2 mAbs in combination with Leukine for high-risk pediatric neuroblastoma.

Open Forum Infectious Diseases published results from the SCOPE study, a prospective, multicenter study of inhaled Leukine in non-hospitalized COVID-19 patients.

A clinical trial published in the European Respiratory Journal showed that 89% of patients taking inhaled Leukine did not require further whole lung lavage over 30 months.

A review published in Open Forum Infectious Diseases details outcomes for pediatric malignancy patients with invasive fungal disease treated with Leukine.

Pre-clinical research showed recombinant murine GM-CSF reversed cognitive impairment in Down syndrome models and improved cognitive function in aged mice.

PTx entered a milestone-based agreement with the DoD to fund development and regulatory activities for Leukine to treat sulfur mustard gas exposure.

A clinical trial evaluating Leukine in Parkinson's Disease patients showed promise for immune transformation and disease management.

A systematic review in Frontiers in Immunology chronicles Leukine's 30-year history in oncology and its potential in various diseases, including cancer, sepsis, neurodegenerative, and respiratory diseases.

The SARPAC study of inhaled Leukine in hospitalized COVID-19 patients showed significant improvement in lung function, safety, and a COVID-19 specific immune response.

The EMA's Committee for Medicinal Products for Human Use recommended approval of IMREPLYS for treating patients of all ages exposed to myelosuppressive doses of radiation.

Results from the global, multicenter eNRGy study evaluating BIZENGRI in NRG1+ cancer were published in the New England Journal of Medicine.

PTx and BARDA are collaborating on a phase 2 study to assess LEUKINE in sepsis, focusing on safety, dose selection, and biomarker-driven patient identification.

BIZENGRI® is the first and only therapy approved by the FDA specifically for pancreatic adenocarcinoma and NSCLC that harbor NRG1 gene fusions and are advanced unresectable or metastatic. Merus and Partner Therapeutics announced a license agreement for U.S. commercialization.

Merus and Partner Therapeutics entered into an agreement in which Merus has exclusively licensed to PTx the right to commercialize zenocutuzumab (Zeno) for the treatment of NRG1 fusion-positive (NRG1+) cancer in the U.S.

A clinical trial published in the European Respiratory Journal showed that 89% of patients taking inhaled Leukine did not require further whole lung lavage over 30 months.

Pre-clinical research showed recombinant murine GM-CSF reversed cognitive impairment in Down syndrome models and improved cognitive function in aged mice. The CU Anschutz Medical Campus team was awarded an NIH grant to study Leukine® treatment in young adults with Down syndrome.

PTx entered a milestone-based agreement with the DoD to fund development and regulatory activities for Leukine to treat sulfur mustard gas exposure.

PTx announced a collaboration with BARDA and Labcorp Drug Development to advance a new diagnostic approach to select immunoparalyzed sepsis patients that could benefit most from Leukine.

The U.S.-based iLeukPulm clinical trial of inhaled Leukine in hospitalized COVID-19 patients met its primary endpoint for improvement in oxygenation and demonstrated safety and tolerability.

PTx initiated the SCOPE clinical trial, a randomized, placebo-controlled, double-blind phase 2 study of inhaled Leukine in 400 non-hospitalized COVID-19 patients at higher risk for progression.

A clinical trial showed that patients with mild-to-moderate Alzheimer’s disease receiving Leukine experienced significant reversal of cognitive loss and biomarkers of disease progression.

Studies showed statistically significant improvements in survival in subjects treated with Leukine after acute, high dose radiation exposure, providing the basis for FDA approval for ARS.

PTx announced a $35 million milestone-based agreement with the U.S. Department of Defense to fund two clinical studies of inhaled Leukine in COVID-19 associated acute hypoxemia.

PTx initiated the iLeukPulm clinical trial, a randomized phase 2 study of inhaled Leukine in hospitalized COVID-19 patients with acute hypoxemia, supported by a $35 million DoD contract.