Cerus Corporation announced an amendment to the company’s contract with the Biomedical Advanced Research and Development Authority (BARDA). The amendment provides an additional $14 million in available funding, increasing the total potential value of the contract to $214 million.
 
“Our BARDA partnership helps fund the development of the INTERCEPT Blood System for red blood cells (RBC) and is integral to our mission to secure blood safety and availability in the face of pandemic threats,” said Dr. Nina Mufti, Cerus’ vice president, development and RBC program leader. “The INTERCEPT technology for RBCs is an important extension of our current product portfolio for platelets and plasma because it addresses the most frequently transfused component.”
 
The $14 million contract amendment includes additional funding for RedeS, the company’s ongoing Phase 3 U.S. clinical study evaluating the safety and efficacy of INTERCEPT RBCs in patients receiving transfusions in the acute and chronic setting. In addition, the contract expansion provides funding to further evaluate the efficacy of the INTERCEPT Blood System to inactivate SARS-CoV-2 in all three blood components beyond what has already been established for the inactivation of other coronaviruses such as SARS and MERS.
 
The contract provides comprehensive support to fund the development of the INTERCEPT RBC technology including clinical and regulatory programs in support of potential licensure, as well as manufacturing and scale-up activities. BARDA funding is recorded as government contract revenue and as of Dec. 31, 2019, $44 million has been cumulatively recognized under the contract.
 
Cerus is currently conducting two Phase 3 clinical studies evaluating the safety and efficacy of INTERCEPT RBCs: RedeS and ReCePI. As a result of COVID-19, many of our participating clinical trial hospital sites have temporarily suspended enrollment.
 
RedeS is a two-stage study: The first stage of the trial is a double-blind, controlled, parallel group trial where 600 adult patients will be randomized to receive up to 28 days of transfusion support with INTERCEPT-treated RBCs or conventional RBCs, with a primary endpoint of hemoglobin increment following transfusion. In a second optional stage, up to 20,000 patients would receive RBC transfusion support with up to 50,000 RBC units in an open-label, single-arm treatment use study. The objective of the second stage is to provide early access to the INTERCEPT Blood System for RBCs in regions where a substantial proportion of the population has been infected or is at risk of infection by an emerging virus, and the risk of asymptomatic infection among qualified blood donors is recognized.
 
ReCePI is designed to enroll a total of 600 patients requiring transfusion for acute blood loss during complex cardiac surgery in up to 19 participating sites in the United States. The primary efficacy endpoint is the proportion of patients experiencing acute kidney injury as an assessment of RBC efficacy in providing tissue oxygenation, measured as an increase in serum creatinine compared to pre-surgery, baseline levels.
 
BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The development of the INTERCEPT red blood cell program has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600009C.