The effort will leverage Partner Therapeutics’ prior experience developing Leukine for Acute Radiation Syndrome
The contract award supports development of a quantitative flow cytometric test able to detect Human Leukocyte Antigen – DR isotype protein to identify patients in an immune suppressed state.
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 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.
“We are grateful to BARDA for their support of this program, which has potential to advance medical care for sepsis patients by selecting patients with immunoparalysis who would be most likely to benefit from immune enhancement by Leukine,” stated Debasish Roychowdhury, MD, Chief Technology Officer of Partner Therapeutics, Inc. “We look forward to working with Labcorp Drug Development to develop and validate the HLA-DR LDT and utilizing the LDT in two upcoming placebo-controlled studies of Leukine to enroll more than 1,000 patients with IP sepsis.”
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.
