With $4.2 million in funding from the Henry Jackson Foundation and a new partnership with the U.S. Naval Medical Research Center (NMRC), Centivax Inc. intends to pursue phase one clinical development of Centi-B9, a broad-spectrum injectable for treating SARS-CoV-2.
Unlike other vaccines and therapeutics currently out there, Centi-B9 was developed to neutralize the pandemic-causing virus’s many emerging variants. So far, the company touts, it has demonstrated 99.5 percent reactivity against all coronavirus variants in the U.S. and 98 percent of those globally, from those originally found in the U.K. to the deadly South African variant and more.
“Broad-spectrum. High-concentration. Enhanced safety,” Dr. Jacob Glanville, CEO of Centivax, said. “The Centi-B9 biosuperior represents the first clinical example from the Centivax portfolio of next-generation antibody therapeutics bespoke engineered to specific needs of patient populations and the diseases that they confront. With discovery research supported by Medical Technology Enterprise Consortium, and now clinical development supported by our remarkable collaboration with the Naval Medical Research Center, this biotech-government partnership is proud to advance this molecule into clinical development and closer to the patients and doctors that need a better medicine to end the pandemic.”
Notably, the treatment does not require an IV infusion but can instead be utilized as a prophylactic or single injection dose therapeutic, even in non-hospital settings. Centivax hopes to see it fill gaps in protection that vaccines cannot fill, particularly as mutations make them less effective. This is of particular importance to the Navy since servicemembers on long deployments could come into contact with variants overseas.
“Our highly concentrated, thermostable, neutralizing antibody fits the needs of the Navy, and DOD in general, in that it can be administered intramuscularly to warfighters in cramped quarters or austere environments to boost and extend protection already afforded by vaccination,” Dr. David Gangemi, Chief Government Relations Officer for Centivax, said.
For the clinical study, Centivax and NMRC will each provide a Principal Investigator. NMRC will also host the phase one trial site for intramuscular and subcutaneous delivery of Centi-B9, in addition to providing support for protocol development and medical oversight. This trial will focus on safety and pharmacokinetics in healthy volunteers, with a start date planned for July. Potentially, a phase two/three adaptive trial could then begin later this year.