Cerus Corp., of Concord, Calif., is teaming up with several collaborators in its home state, with an eye toward optimizing convalescent plasma therapy for COVID-19 patients.
“Convalescent plasma is one of few interventions that can be made available rapidly following the emergence of a new epidemic, and globally a number of investigators are already initiating this promising therapy,” explained Laurence Corash, Cerus’ chief scientific officer. He added that because of the emergent conditions during which convalescent plasma is used, there isn’t much of an opportunity to fully characterize each plasma unit. Doing so, however, could provide insight into responses observed in patients.
To help in this regard, the company will work with the California Department of Public Health, University of California, Irvine’s Vaccine Development Research Laboratory, Vitalant Research Institute, California National Primate Research Center and Enable Biosciences. For its part, Cerus already has its Intercept blood system, which works to reduce the risk of transfusion-transmitted infections by inactivating pathogens – including viruses, bacteria and parasites – that may be present in donated blood.
The U.S. FDA already has expressed its interest in convalescent plasma. Indeed, it highlighted therapies such as convalescent plasma and hyperimmune globulin in a March 31 update on COVID-19 that also detailed the agency’s new Coronavirus Treatment Acceleration Program, which is intended to speed the development of potentially safe and effective life-saving treatments. It previously released a FAQ document on the topic.
The focus on convalescent plasma is not new. Indeed, Corash told BioWorld that work on this front dates back at least to the Spanish Flu pandemic of 1918.
In addition to his work at Cerus, Corash is a hematologist and a professor of laboratory medicine at the University of California, San Francisco. He told BioWorld that he came to that city in 1982 to take over one of the hematology services and ultimately had 300 patients who got HIV via blood transfusion. This experience drove his interest in preventing transfusion-transmitted infections. To that end, he teamed up with other experts, and that ultimately led to the development of the technology behind Cerus.
“I’ve been working with some of these people since the mid-1980s,” he said of how this group had come together to work on COVID-19. He specifically highlighted Michael Busch, who heads the Vitalant Research Institute, as a close collaborator.
“We had a prior experience working on convalescent plasma for Ebola in a project funded by the [Bill and Melinda] Gates Foundation,” he said of the group. “And when COVID hit, we started talking and put the group together.”
In terms of turnaround, Corash explained that the FDA has been encouraging organizations to work as fast as possible. He also noted that the company has been in contact with the agency “almost daily” in terms of helping patients.
“Intercept plasma is a licensed product in the U.S.,” he noted. “We have kits available to collect and make this plasma. So, we have assays with the various participants in this consortium that are working today to titer antibodies, determine neutralizing capacity [and] identify epitope specificity. And we’re now working with various blood centers that are closely aligned with hospitals to recruit recovered COVID-19 patients.” To that end, the company can do its work “very rapidly.”
And there is evidence in China that this approach is helpful to patients. For example, one paper reported on the experience of 10 COVID-19 patients in that country. Specifically, researchers found that convalescent plasma treated with a pathogen inactivation technology that is not currently licensed in the U.S. helped in recovery – even for those on a ventilator.
These findings could prove helpful, as Cerus’ technology is marketed on a global basis. The company has been in contact with regulators worldwide, with Corash specifically highlighting discussions with officials in Kuwait, Saudi Arabia, France, Switzerland and Germany.
Confidence in product
At least one analyst has expressed confidence in the technology’s ability to help patients during this pandemic. Cowen’s Josh Jennings discussed this new group in a note, as well as the potential for Intercept during this time. “We think this could support adoption momentum as a focus on emerging pathogens may guide centers to Intercept,” he wrote. “Intercept currently has label approval for SARS-CoV inactivation in the EU and US, while the causative agent of COVID-19, SARS-CoV-2, has a genetic sequence that is at least 70% similar to SARS-CoV.” As a result of the risk posed by COVID-19, “we think there could be an increased urgency on behalf of blood centers and hospitals to adopt a mitigation strategy for their transfusions that has the capability to safeguard their blood supply from emerging pathogens.”