Partner Therapeutics’ New Approach to Stratify Sepsis Patients Supported by BARDA

The effort will build on Partner Therapeutics’ previous experience in the development of Leukine for acute radiation syndrome

The contract award supports the development of a quantitative flow cytometry assay capable of detecting human leukocyte antigen – DR isotype protein to identify patients in an immunosuppressed state.

Partner Therapeutics, Inc. (PTx) announcement a collaboration with the Biomedical Advanced Research and Development Authority (BARDA), which is part of the office of the Assistant Secretary for Preparedness and Response of the US Department of Health and Human Services, and Labcorp Drug Development to advance a new approach diagnostic to select immunoparalyzed sepsis patients who could benefit the most from Leukine (sargramostim).

Thanks to the advancement of a laboratory-developed test (LDT) for the monocyte biomarker HLA-DR (Human Leukocyte Antigen – DR isotype), PTx will be able to identify patients with sepsis presenting with an immunocompromised or immunoparalysis ( PI), status and clinically evaluate Leukine for therapy in these individuals.

Sepsis is a life-threatening complication of infection that occurs when the body has an extreme host response, which can lead to organ failure and death. While some patients with sepsis present with severe systemic inflammation, a subset of patients present or progress to an immunocompromised IP stage. This diversity, or heterogeneity of patients, presents significant challenges for effective therapeutic approaches.

Although therapies that help modulate the immune system may be an effective approach to restoring immune balance in patients with IP sepsis, there is currently no FDA-approved therapy or associated diagnostic approach that effectively identifies them. patients who could benefit from such treatment.

The partnership will build on Partner Therapeutics’ previous experience in the development of leukine for acute radiation syndrome, an FDA-approved indication, as well as current clinical research for the use of leukine in patients. with various immunocompromised conditions. The use of Leukine in patients with sepsis could broaden the indication for this therapy.

In addition, the measurement of HLA-DR levels of monocytes will allow an endotyping approach (identification via associated biomarkers) to determine whether clinical outcomes can be improved through such a stratification approach. This test, if successful, has the potential to endotype patients with sepsis and allow targeted clinical management.

“We are grateful to BARDA for its support of this program, which has the potential to advance medical care for patients with sepsis by selecting patients with immunoparalysis who would be most likely to benefit from immune enhancement by Leukine, “said Debasish Roychowdhury, MD, chief technology officer. Head of Partner Therapeutics, Inc. “We look forward to working with Labcorp Drug Development to develop and validate LDT HLA-DR and use LDT in two upcoming placebo-controlled studies of Leukine to enroll over 1,000 patients with IP sepsis. . “

The contract award supports the development of a quantitative flow cytometric LDT capable of detecting the HLA-DR protein on monocyte immune cells in order to identify patients in a PI state. The award supports the initial development of HLA-DR LDT and facilitates subsequent validation studies in clinical trials of sepsis in adults and children.

Partner Therapeutics will also work with a partner to initiate the transition from HLA-DR LDT to a commercial product and support the activation activities of a New Investigational Drug (IND) for the Leukine Sepsis indication with companion diagnostic.

If successful, the development of the HLA-DR companion diagnostic would address the clinical need to match therapies to the appropriate patient population in order to maximize clinical outcomes. This matching approach, also known as precision medicine, has enormous potential to impact clinical management and improve patient outcomes. Further development of HLA-DR-based endotyping technology could expand treatment options for hospitalized patients with sepsis.

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