Updated with comments from Terumo.
Cerus (NSDQ: CERS) and Terumo Corp. (TYO:4543) won grants from a U.S. Health & Human Services Dept. agency worth a collective $48 million to study their respective devices for eliminating blood pathogens like the Zika virus.
Zika, which the World Health Organization declared a global emergency in February, has been linked to microcephaly, a birth defect characterized by an unusually small head and potential developmental problems.
Last week U.S. officials said 3 babies were born here with defects that were most likely caused when their mothers contracted the mosquito-borne virus during pregnancy. More than 1,400 Zika-related microcephaly cases have been confirmed in Brazil, which is preparing to host the Olympic games in August. The WHO said last week that the risk of Zika infection for athletes and attendees is very low.
The 5-year, $180.5 million pact with Cerus calls for the Concord, Calif.-based company to test its Intercept device in Puerto Rican Zika patients. HHS’s Biomedical Advanced Research & Development Authority will put up $30.8 million initially, including $10.7 million for the trial on La Isla del Encanto.
“The funding for this program shows how important blood safety and availability are for agencies like Barda that are charged with providing support to technologies that have major health care impact and importance for the United States constituency. Terumo BCT’s selection as a partner for this program of work reflects on our position in the industry as a leader and innovator, and the Mirasol PRT platform is a truly innovative solution to blood safety needs. Terumo BCT is committed to unlocking the potential of blood and improving the safety of the world’s blood supply with Mirasol,” chief scientific officer of pathogen reduction technologies Ray Goodrich
The BARDA agreement with Terumo’s Lakewood, Colo.-based BCT Technologies business aims to evaluate Terumo’s Mirasol device in preventing viruses from infecting blood platelets. The 6-year, $151.8 million deal includes a 2½-year provision for $17.5 million to cover the trial.
“We are working to make needed products available as quickly as possible to protect our nation’s blood supply against a variety of threats that could endanger public health,” BARDA acting director Dr. Richard Hatchett said in prepared remarks. “These technologies are of particular interest given their potential use against multiple diseases. By focusing on products that can reduce the risk of various transfusion-transmitted infections, we can provide emergency products sooner in a sustainable, cost-effective way.”
The Cerus treatment uses amotosalen, a photo-activated compound that targets nucleic acids in DNA and RNA, creating “docks” between the strands. Ultra-violet light is then used to activate the amotosalen, causing permanent cross-linking that prevents the the pathogen or leukocyte from replicating. Cerus said the BARDA deal will also fund in vitro studies ahead of a possible U.S. pivotal trial. The company said it’s also on the hook for a $14.5 million co-investment in the project to cover manufacturing costs.
“This contract offers the potential to fund activities related to anticipated Phase III clinical studies for the Intercept red blood cell system in the U.S. and the required manufacturing and development activities needed to pursue a potential U.S. commercial launch,” Cerus chief scientific officer Dr. Laurence Corash said in a press release. “We believe that T-cell inactivation levels with Intercept provide the opportunity for future replacement of gamma irradiation, which would also align with the Homeland Security Dept.’s initiative to eliminate nuclear source irradiators in the U.S. through the introduction of non-nuclear technologies.”
Terumo’s Mirasol device, similarly, uses riboflavin (vitamin B2) and ultraviolet light to kill pathogens’ ability to replicate. Riboflavin molecules link to guanine-based nucleic acids; under UV light the vitamin chemically alters the nucleic acid, making pathogens unable to replicate.