BARDA is collaborating with Partner Therapeutics (PTx) to advance a new diagnostic approach to stratify sepsis patients who are most likely to benefit from PTx’s U.S. Food and Drug Administration (FDA)-approved therapeutic, Leukine (sargramostim) and potentially aid in precision medicine for these patients. Through the advancement of a Laboratory Developed Test (LDT) for the biomarker monocyte HLA-DR (Human Leukocyte Antigen – DR isotype), PTx will be able to identify sepsis patients exhibiting an immune suppressed, or immunoparalysis (IP), state and clinically evaluate Leukine as a therapy in these individuals.
Sepsis is a life-threatening complication of an infection that occurs when the body has an extreme host response, potentially leading to organ failure and death. While some sepsis patients present with severe, systemic inflammation, a subset of patients present or transition to an immune suppressed IP stage. This diversity, or patient heterogeneity, presents significant challenges for effective treatment approaches.
Although therapeutics that help modulate the immune system may be an effective approach to restore immune balance in IP sepsis patients, there are currently no approved FDA therapeutics nor companion diagnostic approaches that effectively identifies patients who could benefit from such treatment.
The partnership will leverage Partner Therapeutics’ prior experience developing Leukine for Acute Radiation Syndrome, an FDA-approved indication, as well as current clinical research for use of Leukine in patients with a variety of immunosuppressed conditions. Use of Leukine in sepsis patients could expand the indication of this therapeutic. In addition, the measurement of monocyte HLA-DR levels will enable an endotyping approach (identification via associated biomarkers) to determine if clinical outcomes can be improved through such a stratification approach. This assay, if successful, has the potential to endotype sepsis patients and enable targeted clinical management.
The contract award supports development of a quantitative flow cytometric LDT able to detect HLA-DR protein on monocyte immune cells to identify patients in an IP state. The award supports initial development of the HLA-DR LDT and facilitates subsequent validation studies in adult and pediatric sepsis clinical trials. Partner Therapeutics also will collaborate with a partner to initiate transition of the HLA-DR LDT to a commercial product and support Investigational New Drug (IND)-enabling activities for the Sepsis indication of Leukine with the companion diagnostic.
If successful, development of the HLA-DR companion diagnostic would address the clinical need to match therapeutics to the appropriate patient population to maximize clinical outcomes. This matching approach, also known as precision medicine, has tremendous potential to impact clinical management and improve patient outcomes. Further development of the HLA-DR based endotyping technology may enable expanded treatment options for hospitalized sepsis patients.
About Partner Therapeutics:
The following information is provided by company and does not indicate endorsement by the federal government of the company or its products.
PTx, an integrated biotechnology company, focuses on development and commercialization of late-stage therapeutics to improve health outcomes in treatment of cancer and other serious diseases. The company believes in delivering products and supporting medical teams with the purpose of achieving superior outcomes for patients and their families. Visit www.partnertx.com. LEUKINE® (sargramostim) is a yeast-derived recombinant human granulocyte-macrophage colony stimulating factor (rhuGM-CSF). Leukine is approved by the U.S. Food and Drug Administration (FDA) and is also held by the U.S. government for national preparedness.