Integrated biotechnology company Partner Therapeutics Inc (PTx) on Thursday announced a collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) at the US Department of Health and Human Services.

The agreement will fund a phase 2 study in patients with sepsis to assess the safety and enable dose selection of LEUKINE (sargramostim, rhu GM-CSF). The partners will also evaluate monocyte human leukocyte antigen-DR (mHLA-DR) and other biomarkers of immune status that could enable more precise identification of patients with sepsis who could benefit from LEUKINE treatment in addition to standard of care.

The PTx-BARDA partnership seeks to enhance patient care through restoration of immune homeostasis in patients with sepsis exhibiting a persistent immune suppressed state. Research shows that patients with sepsis with persistent immune suppression are unable to mount a sufficient immune response and experience significant mortality. The clinical study will further evaluate the safety of LEUKINE in these critically ill patients and seeks to confirm the utility of mHLA-DR as a marker to identify sepsis-associated immune dysregulation. Additional promising biomarkers of immune status in patients with sepsis will also be evaluated. Under a prior collaboration, BARDA and PTx supported the establishment of a Laboratory Developed Test (LDT) for mHLA-DR, which will be utilised in this collaboration.

John L McManus, president of Health Security and Critical Care at Partner Therapeutics, said that the programme has the potential to advance medical care for patients with sepsis by evaluating potential tools for measuring immune status to inform targeted immunomodulatory therapy.