Centivax Inc. announced today that it has entered into a strategic partnership with the U.S. Naval Medical Research Center (NMRC) for Phase I clinical development of Centi-B9, Centivax's SARS-CoV-2 broad-spectrum injectable antibody therapeutic and prophylactic.
Centi-B9 has been engineered to broadly neutralize the mutated emerging coronavirus variants, with demonstrated broad-spectrum reactivity against 99.5% of all coronavirus variants in the U.S.A, and over 98% of coronavirus variants globally, including critical mutations found in the UK B.1.1.7, South African B.1.351, Brazilian P.1, New York B.1.526 and California B.1.429 strains.
Rather than requiring an IV infusion, Centi-B9 has been bioengineered for high stability, low viscosity high concentration (250mg/ml) delivery, enabling a prophylactic or therapeutic dose of Centi-B9 to be delivered in a non-hospital setting through a single injection. Centi-B9 has been further engineered for enhanced safety and enhanced half-life, using Xencor Xtend technology.
Broad-spectrum. High-concentration. Enhanced safety. 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."
Dr Jacob Glanville, CEO, Centivax
In the strategic partnership Centivax and NMRC will each contribute a Principal Investigator to the clinical study, and NMRC will host the Phase I clinical trial site for intramuscular and subcutaneous delivery of Centi-B9, as well as providing support for protocol development and medical oversight. The Henry Jackson Foundation is providing $4.2M US in non-dilutive funding support for the trial. The Phase I trial will demonstrate safety and pharmacokinetics of the Centivax monoclonal in healthy volunteers and is planned to begin in July of this year. These Phase I studies will enable a Phase II/III adaptive trial to begin later this year. The Phase II/III trial will study efficacy in several patient populations, including hospitalized COVID-19 patients, pre-hospitalized COVID-19 cases, post-exposure prophylaxis and pre-exposure prophylaxis. Given the unmet need for a broad-spectrum injectable, Centivax will seek Emergency Use Authorization during interim analysis.
While vaccines appear to be very effective against some strains of the virus, they known to provide reduced protection against many of the emerging variant strains, with further reductions in protection anticipated to continue as the virus continues to mutate. This is particularly important to the Navy, since individuals on long deployments may come into contact with these variants at international ports of calls.
"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," said Dr. David Gangemi, Ph.D., Chief Government Relations Officer for Centivax. "Our antibody is highly effective against over 98% of the currently circulating variants and is a good fit for use in prolonged deployments when prophylaxis and/or post-exposure treatment is needed."
Centi-B9 can be used either prophylactically to protect against COVID-19, or as an adjunct to vaccines to provide complete protection, or as an early interventional therapy for those who chose not to be vaccinated and subsequently became infected with SARS-CoV-2. Centi-B9 is a highly stable product that can be stored for extended periods in standard refrigeration conditions and can be administered ship-board prophylactically to prevent the risk of transmission.