Osivax, a biopharmaceutical company developing vaccines for broad-spectrum protection against infectious viruses, has vaccinated the first participant in its phase 2a clinical trial of OVX836.

This broad-spectrum influenza vaccine candidate is being evaluated as a booster for participants who received OVX836 three to five years ago.

The trial is being conducted at the Center for Vaccinology (CEVAC) at Ghent University Hospital, Belgium, and aims to enrol over 150 participants.

Professor Isabel Leroux-Roels, Principal Investigator at CEVAC and Associate Professor at Ghent University, commented, “We are pleased to support the ongoing evaluation of OVX836 through this phase 2a influenza booster study. We anticipate important insights that could significantly impact long-term influenza prevention.”
Dr Nicola Groth, CMO of Osivax, added, “This milestone is a significant step forward in our mission to develop a truly broad-spectrum, lasting flu vaccine capable of addressing the ever-evolving threat of influenza. By studying the effects of a booster dose, we aim to deepen our understanding of OVX836’s potential to provide robust and sustained immune protection.”

The single-centre trial is a randomised, double-blind study evaluating the immunogenicity and safety of a single dose of OVX836 administered intramuscularly at either 180μg or 480μg.

Participants aged 20-64 who previously received OVX836, Influvac Tetra, or placebo in prior studies will be included. Topline results from the trial are expected by the end of 2025.

OVX836 is a first-in-class influenza A vaccine candidate that targets the nucleoprotein (NP), a highly conserved internal antigen.

Unlike surface antigens, NP is less likely to mutate, providing a broader immune response.

Osivax’s oligoDOM technology enables the design and production of a recombinant version of NP that self-assembles into a nanoparticle, triggering powerful T- and B-cell immune responses.

So far, OVX836 has been tested in five clinical trials with 1,200 participants, showing promising safety, immunogenicity, and efficacy results.

The Scottish Medicines Consortium (SMC) has approved Kite’s CAR-T cell therapy, Yescarta (axi-cel), for treating adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).

This marks the first time a CAR-T cell therapy has been accepted for second-line treatment in Scotland.

“Blood cancer survival rates in the UK lag behind countries of similar wealth and health and the blood cancer community deserves better. It’s great that people with DLBCL in Scotland now have access to the drug axi-cel on the NHS in this setting, where it is already available in England and Wales,” said Josh Hill, Scottish Policy Officer at Blood Cancer UK.

He added, “CAR-T therapies offer hope to people who are often living with the most aggressive forms of blood cancer, and having earlier access to this innovative drug across the UK is an important step in improving outcomes for patients.”

DLBCL, an aggressive form of non-Hodgkin lymphoma, affects approximately 450 new patients in Scotland each year. While 50 to 60% of patients respond to initial treatment, a significant portion experience relapse or have refractory disease, necessitating alternative treatment options.

Peter Wickersham, Vice President and General Manager, Gilead Sciences UK & Ireland, expressed pride in the approval, “From the first clinical trials, we have been committed to ensuring equitable access to our cell therapies. We are proud to now offer the first cell therapy treatment for patients in a second-line setting in Scotland, including both those eligible and ineligible for stem cell transplant. This news marks a significant step forward for the blood cancer community.”

The approval was based on two clinical trials, ZUMA-7 and ALYCANTE, showing axi-cel’s superiority over standard treatments in relapsed/refractory DLBCL, with improved survival rates and progression-free survival.