The Phase I Covid-19 trial of Centi-B9 is anticipated to start next month. Credit: torstensimon / Pixabay.

Centivax has signed a strategic collaboration with the US Naval Medical Research Center (NMRC) to conduct Phase I clinical development of its SARS-CoV-2 antibody, Centi-B9.

Centi-B9 is designed as a broad-spectrum therapeutic and prophylactic for administration through injections. It is also expected to act as an adjunct to vaccines to ensure broad protection.

The antibody is engineered to neutralise the emergent Covid-19 mutated variants and showed broad-spectrum reactivity against 99.5% of all variants in the US.

It also demonstrated reactivity against more than 98% of Covid-19 variants seen worldwide which includes UK B.1.1.7, South African B.1.351, Brazilian P.1, New York B.1.526 and California B.1.429 strains.

Bioengineered for greater stability, reduced viscosity high concentration (250mg/ml) delivery, the antibody facilitates a prophylactic or therapeutic dose that can be administrated in a non-hospital setting via a single injection.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

In addition, Centi-B9 was engineered using Xencor Xtend technology for improved safety and half-life.

Centivax CEO Dr David Gangemi said: “Our highly concentrated, thermostable, neutralising 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.

“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.”

As part of the collaboration, Centivax and NMRC will each provide a principal investigator for the clinical study.

NMRC will hold the Phase I clinical trial centre for intramuscular and subcutaneous administration of Centi-B9 and offer protocol development and medical management support.

Furthermore, the Henry Jackson Foundation is offering $4.2m non-dilutive funding for the trial.

The Phase I trial, which will validate Centi-B9’s safety and pharmacokinetics in healthy subjects, is anticipated to start next month.

These Phase I studies will facilitate a Phase II/III adaptive trial later this year.

The Phase II/III trial will analyse the antibody’s efficacy in various patient populations, such as hospitalised Covid-19 patients, pre-hospitalised individuals with the infection, post-exposure prophylaxis as well as pre-exposure prophylaxis.

Centivax intends to submit an application to obtain Emergency Use Authorization (EUA) during the interim analysis of the trial.