Revolutionary vaccines to prevent pandemic and seasonal outbreaks of respiratory viral infections: The best-in-class UNIVERSAL multi-season influenza vaccine

Project Information

OSIRIX

Grant agreement ID: 961112

DOI

10.3030/961112

Project closed

EC signature date 16 July 2020

Start date 1 April 2020

End date 30 September 2022

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 3 515 889,25

EU contribution

€ 2 461 122,48

Coordinated by

OSIVAX SAS
France

Periodic Reporting for period 2 - OSIRIX (Revolutionary vaccines to prevent pandemic and seasonal outbreaks of respiratory viral infections: The best-in-class UNIVERSAL multi-season influenza vaccine)

Reporting period: 2021-04-01 to 2022-09-30

Summary of the context and overall objectives of the project

Symptomatic flu, another respiratory RNA viral infection, affects ~10% of global population every year and is subject to frequent mutations and variants development as well as to regular pandemic outbreaks. Because of the rapid mutation rate of surface viral proteins that are targeted by the current vaccines, existing prophylactic vaccination requires updates each flu season or pandemic outbreak and has a strikingly limited efficacy (40% on average, as low as 9% in elderly). Governments, institutions, and vaccine community urgently seek for a universal flu vaccine that would provide a multi-season protection against all seasonal and emerging pandemic viral strains. OSIVAX, a French clinical stage innovative biotech, strives to develop vaccines able to prevent respiratory viral infections across multiple seasons and outbreak. OSIVAX has developed OVX836, a best-in-class, game-changing universal flu vaccine candidate.

OVX836 is based on oligoDOM®, a proprietary immune-boosting technology that triggers powerful, targeted, and durable immune responses involving activation of specific immune response killing infected cells. OVX836 circumvents the need for annual vaccination updates by targeting an intraviral protein that is highly conserved across all influenza strains. OVX836 has a potential to disrupt the flu vaccine market currently dominated by single-season vaccines. The revolutionary universal flu vaccine is predicted to have a blockbuster potential (>€2.5 billion). OSIVAX’s experienced team aims to get OVX836 ready for the clinical proof-of-efficacy milestone (Phase IIb) that will position the company for a premium licensing deal with a Big Pharma the coming years.

While variants of COVID-19 are negatively impacting the efficacy of 1st generation vaccines, a quest for effective vaccination against all variants of COVID-19 becomes of unprecedented importance to save lives and economies globally. OSIVAX leverages this revolutionary clinical-stage technology to develop a universal vaccine against all variants of COVID-19 with a phase 1 clinical trial expected to start in mid-2023.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Phase 2a clinical trial was finalized
• Primary objective was successfully achieved with a significant increase at Day 8 vs Day 1 in the total T-cell response measured by ELISpot for the subjects vaccinated with OVX836.
• Safety was excellent, similar to the seasonal influenza vaccine which is known to be a vaccine with excellent safety profile;
• Directional evidence of efficacy was demonstrated, with an observed decrease of the influenza-like symptoms two months after vaccination in the 180µg group vs the 90µg group;
• Dose-dependent NP-specific immune response was observed in both total T-cell and CD4 T-cell responses, as well as in IgG responses (trend).

Preparation of the next phase 2b is ongoing
• Process has been adapted to larger scale, and a GMP batch was produced in 2021;
• Phase 2b is in active preparation: the full regulatory package was submitted to relevant health authorities, and European CRO has been selected;
• Site Selection in France, Belgium and Germany is currently on-going.

Preclinical mice studies have been performed with the Covid-19 universal vaccine candidate.
• Lead-candidate construct has been chosen;
• Preclinical experiments in mice have been conducted (and other preclinical work ongoing);
• Preparatory work for clinical trial is in progress (not funded by the OSIRIX project).

Business Development and fundraising:
• The IP for both the product and the technology was expanded in strategic geographies;
• Dissemination activities have been conducted with publication in scientific journals, participation in scientific conferences, press releases, medias and social medias activities;
• Significant funds from private investors and local non-dilutive funds were raised;
• The company is preparing for a strong outreach to secure series B funding round.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Most of the scientific results have been obtained in this first year of the project. The second year was more focused on disseminating and preparing for the next stage of the project (additional phase 2 trial).

Broader impact
The impact of a universal influenza vaccine on the global disease burden will be substantial. In the EU, current vaccination programs are recommended for elderly, children, pregnant women and chronically ill. Despite the suboptimal 40% efficacy the current vaccination programs are estimated to prevent an annual average of 2.1 million cases of influenza, 37,200 deaths, and €332 million of direct disease-related costs. In an epidemiologic model, an increase of the flu vaccine efficacy to 80% in the EU would prevent 1.7 million additional cases of influenza, 14,342 additional deaths, and €226 million of total additional direct disease-related costs. These numbers are an underestimation, as they do not consider the increased acceptance of such highly efficient vaccine (increased vaccination coverage rate) and a significant effect on herd immunity.

Market opportunity
OSIVAX’s universal vaccine has a blockbuster potential of global multi-billion-euro sales, as the best-in-class universal influenza vaccine bringing sustained protection over any stain of influenza.
• Initial target population: Elderly >65y for the prevention of seasonal influenza (market entry 2027 in US and 2028 in other high-income countries);
• Second target population: Adults for immediate response in case of a pandemic influenza outbreak (market entry 2026 in US and 2027 in other high-income countries).

General approach of the Osivax vaccine (OVX836), targeting an internal part of the virus. This inter

Expected impact of the Osivax vaccine upon commercialization