Cerus ($CERS) announced an agreement with the Biomedical Advanced Research and Development Authority (BARDA) to support clinical development of its Intercept Blood System in the area of pathogen reduction of red blood cell components. The Intercept system is already widely used throughout the U.S. in the areas of platelets and plasma.
The Concord, CA-based company, which focuses on improving blood transfusion safety, could receive over $180 million in funding throughout the 5-year contract, the announcement explained.
The Intercept Blood System aims to reduce pathogens in donated blood. The system, according to the announcement, can reduce the risk of infections being transmitted during a transfusion by inactivating pathogens like viruses, bacteria, parasites and leukocytes.
This sort of tech could prove particularly useful in cases of virus outbreaks, such as the current Zika outbreak. "Pathogen reduction treatment of blood components offers the opportunity to improve national emergency preparedness for epidemic and endemic blood-borne pathogens such as Zika, dengue, and chikungunya, and to further protect patients undergoing routine care, especially in regions with rapidly emerging epidemic pathogens," the announcement explained.
"We believe that T-cell inactivation levels with Intercept provide the opportunity for future replacement of gamma irradiation, which would also align with the Department of Homeland Security's initiative to eliminate nuclear source irradiators in the U.S. through the introduction of non-nuclear technologies," Dr. Laurence Corash, chief scientific officer at Cerus, said in the announcement.
While the specific use of Intercept for pathogen reduction of red blood cell components is still in development, Intercept for platelets and plasma has been widely used in the U.S. and other countries for quite some time--over 10 years in Europe already. The tech was used often in French Polynesia and the French West Indies during a 2013 to 2014 Zika outbreak.
Cerus also received FDA approval for its system for both platelets and plasma in December 2014, and Intercept was approved for platelets and plasma in Brazil a year later. The American Red Cross recently announced a partnership with Cerus--a timely move considering the current Zika outbreak. Should all go well in the U.S., the organization could consider using Intercept as a standard across the International Red Cross and Red Crescent.
The initial funding of $30.75 million will be put toward a clinical trial which will compare Intercept RBC safety and efficacy against conventional RBCs in Puerto Rico, which is currently impacted by Zika. It will also be put toward in vitro studies to pave the way for Phase III clinical trials in the U.S.
Cerus' contract with BARDA has a base period with committed funding up to $30,750,939. However, throughout the 5-year contract are option periods which, if completed, could bring the total nondilutive funding to over $180 million. These trials are all working toward U.S. commercial launch of the tech, Corash said.
Funding from subsequent options could be put toward "broader implementation in areas of Zika virus risk, clinical and regulatory development programs in support of licensure, and development, manufacturing and scale-up activities," the announcement said. Cerus and its partners are responsible for co-investing $14.5 million for manufacturing. Also included in this contract is the possibility of funding to support the deployment of previously licensed Intercept-treated platelet and plasma components, which will be used in Hawaii in the event of a Zika outbreak in that region.
The announcement of this agreement comes hand-in-hand with a boost on the Nasdaq today, where Cerus moved up 10%.
- here is the release