Next-Generation COVID-19 Antibody to Neutralize SARS-CoV-2 Mutated Variants and Allow Injectable Dosing

Centivax Inc. (South San Francisco, CA, USA) has entered into a strategic partnership with the US Naval Medical Research Center (NMRC) for Phase I clinical development of Centi-B9, its broad-spectrum injectable for COVID-19. 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.

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 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. 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.

"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," said Dr. Jacob Glanville, CEO of Centivax.

"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."

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