FORT DETRICK, Md. – August 4, 2020 – The Department of Defense (DOD) awarded a $35 million other transaction agreement (OTA) to biotechnology company Partner Therapeutics (PTx) for two Phase II clinical studies that will assess the benefits of Leukine® (sargramostim, rhu-GM-CSF) in the treatment of patients with acute hypoxemia due to COVID-19.
Approved by the FDA in 1991, Leukine® has an established safety profile based on treatment of more than 500,000 patients. The drug is currently approved for six indications, including the treatment of acute radiation syndrome (ARS); accelerating myeloid reconstitution in cancer patients following bone marrow transplantations; and reducing the incidence of severe, life-threatening, or fatal infections following induction chemotherapy.
Repurposing an already FDA-approved compound is a rapid and efficient way of determining if a drug is safe and efficacious for the treatment of other diseases, such as COVID-19. Through this award, the DOD and PTx will determine whether Leukine® benefits patients with acute respiratory distress and potentially reduces long-term complications from the disease. Funding will also support regulatory filings for potential emergency use authorization (EUA) by the end of the calendar year and expansion of production capacity to meet increased demand.
The DOD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological and Nuclear Medical (JPM CBRN Medical), with support from the Chemical Biological Defense Program, executed the OTA with PTx for this effort through the Medical CBRN Defense Consortium (MCDC). While the agreement is intended to specifically address the threat COVID-19 currently poses to both U.S. civilians and service members, the technology’s potential to also treat the effects of other biological threats our service members may face, such as acute hypoxemic respiratory failure, makes it a particularly worthwhile DOD investment. The JPEO-CBRND is committed to working with our partners to ensure safe and effective medical countermeasures are approved, licensed or cleared by the FDA for use by our warfighters.
“Our work with Partner Therapeutics to repurpose an already FDA-approved drug is critical to addressing the threat of COVID-19,” said Joint Program Executive Officer for Chemical, Biological, Radiological and Nuclear Defense, Douglas Bryce. “Using compounds like these that have proven safety profiles for other indications to treat novel diseases like COVID-19 is a faster and smarter way to get a potentially effective treatment into the hands of both our warfighters and U.S. civilians.”
To learn more about this effort, please visit: https://www.prnewswire.com/news-releases/partner-therapeutics-announces-35-million-contract-with-us-department-of-defense-for-advanced-development-and-emergency-use-of-leukine-rhugm-csf-for-covid-19-acute-hypoxemic-respiratory-failure-ahrf-301105346.html
About the JPEO-CBRND: The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint Force by providing medical countermeasures and defense equipment against chemical, biological, radiological and nuclear (CBRN) threats. JPEO-CBRND’s goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. JPEO-CBRND facilitates the rapid response, advanced development, manufacturing and acquisition of medical solutions, such as vaccines, therapeutics, and diagnostics, to combat CBRN and emerging threats such as COVID-19. To learn more about JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus or follow JPEO-CBRND on social media at @JPEOCBRND.