Partner Therapeutics Announces Contract with US Department of Defense for Advanced Development of Leukine to Treat Sulfur Mustard Gas (HD) Exposure -…

LEXINGTON, Mass., Feb. 17, 2022 /PRNewswire/ -- Partner Therapeutics, Inc. (PTx)today announced a milestone-based Other Transaction Agreement (OTA) with the United States Department of Defense (DoD) to fund development and regulatory activities to support an sBLA of Leukine (sargramostim, rhu-Granulocyte Macrophage Colony Stimulating Factor, "GM-CSF") for the treatment of sulfur mustard gas (HD) exposure under the U.S. Food and Drug Administration's (FDA) "Animal Rule" (21 CFR 314.600-650). The funding includes a base agreement of $5 million, with optional periods that may be exercised to support research and regulatory initiatives. Funding is provided through the DoD's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND). There are currently no medical countermeasures (MCMs) approved by the FDA to treat myelosuppressive effects of HD exposure.

"We are grateful to the DoD's JPEO-CBRND for supporting advanced development of Leukine in HD exposure," said John McManus, Chief Business Officer of Partner Therapeutics, Inc. "Data from Leukine's use in approved indications and data generated to support Leukine's approval for acute radiation syndrome support the hypothesis that administering Leukine after HD exposure could lead to accelerated recovery of immune function and improved outcomes. We look forward to working with the JPEO-CBRND and continuing to expand the utility of Leukine as an MCM in areas of interest to the United States Government."

This collaboration represents PTx's second partnership with the JPEO-CBRND to expand the utility of Leukine as an MCM beyond its current approved use to treat myelosuppressive effects of acute radiation exposure. The JPEO-CBRND previously awarded $39.5 million to support development of Leukine as a therapeutic to enhance immune response in high-risk non-hospitalized patients with COVID-19 and to improve oxygenation and lung function in hospitalized COVID-19 patients receiving oxygen support. Leukine achieved the primary endpoint (improvement in oxygenation) in the hospitalized patient study (iLeukPulm) and results from a 600-patient placebo-controlled study in high-risk non-hospitalized patients (SCOPE) are expected in the next quarter.

"Working with PTx will help advance our fight against HD exposure," said Col. Ryan Eckmeier, the JPEO-CBRND's Joint Project Manager for Chemical, Biological, Radiological, and Nuclear (CBRN) Medical. "Investing in repurposing the broad-spectrum immune modulator Leukine will support our core mission of protecting our nation's warfighters from CBRN threats."

Leukine is FDA-approved for the treatment of acute radiation syndrome (ARS) and is held by the U.S. Government for national preparedness. Leukine is not approved for treatment of sulfur mustard exposure.

About Sulfur Mustard Gas Exposure

Victims of HD exposure experience bone marrow suppression leading to myelosuppression and pancytopenia.1-5 HD acts at different sites in the body as a radio-mimetic with symptoms including headache, nausea, vomiting, anorexia, epigastric pain, leukopenia, thrombocytopenia, and anemia.4-11 Mortality in victims of HD exposure in World War I, World War II and the Iran-Iraq conflict were associated with lymphopenia, leukopenia and septicemia, pointing to the need for an HD MCM that can accelerate recovery of lymphocytes, other white blood cell lineages and platelets, restore immune homeostasis and barrier integrity, and effectively modulate and improve leukocyte function and antimicrobial immunity of the systemic immune system.4-14

ABOUT LEUKINELEUKINE(sargramostim) is a yeast-derived recombinant human granulocyte-macrophage colony stimulating factor (rhuGM-CSF).

Leukine is indicated:

Important Safety Information for Leukine (sargramostim)

Contraindications

Warnings and Precautions

Adverse Reactions

Adverse events occurring in greater than 10 percent of patients receiving LEUKINE in controlled clinical trials and reported in a higher frequency than placebo are:

ABOUT PARTNER THERAPEUTICSPTx, 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 http://www.partnertx.com

References

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SOURCE Partner Therapeutics, Inc.

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Partner Therapeutics Announces Contract with US Department of Defense for Advanced Development of Leukine to Treat Sulfur Mustard Gas (HD) Exposure -...