Pharmaceutical Business review

Osivax and KM Biologics sign deal for influenza vaccine in Japan

KM Biologics will carry out the development, manufacturing, and commercialisation of Osivax's vaccine. Credit: CDC on Unsplash.

Under the terms of the agreement, KM Biologics will carry out the development, manufacturing, and commercialisation of Osivax’s vaccine.

KM Biologics will make an upfront payment to Osivax for the execution of the license option.

If KM Biologics decides to exercise this option, Osivax will receive an additional upfront payment, along with payments upon the achievement of several development and regulatory milestones, and tiered royalties for each candidate.

The financial specifics of the deal, however, remain undisclosed.

Osivax CEO and co-founder Alexandre Le Vert said: “We highly value the opportunity to collaborate with KM Biologics, an experienced and established influenza vaccine developer and manufacturer in Japan.

“This presents an exciting opportunity for us to expand the reach of our broad-spectrum ‘universal’ influenza vaccine candidates to a country that is at the forefront of seasonal and pandemic flu prevention.

“The license option agreement underscores the potential of our oligoDOM technology to generate T-Cell vaccines capable of providing universal protection against current and future influenza strains on a global scale.”

In June last year, Osivax began a Phase IIa trial administering the first dose of its vaccine candidate OVX836 to a participant in Australia.

This trial aims to recruit over 500 volunteers to receive OVX836 in combination with quadrivalent influenza vaccines (QIVs).

Osivax’s OVX836 has undergone testing in four completed clinical trials.

The company reported that a separate, recently concluded Phase IIa trial showed OVX836, when combined with QIVs, maintained a good safety profile without impairing the immune response elicited by the QIVs.

The ongoing trial in Australia seeks to evaluate the vaccine’s efficacy in a larger and more diverse population.