Centivax has entered into a strategic partnership with the US 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 US, and over 98% of coronavirus variants globally.
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,” said Dr. Jacob Glanville, CEO of Centivax.
“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.”
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 $4.2 million 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-hospitalised 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.