Ghent University Hospital

LYON, France I November 14, 2024 I Osivax , a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses, today announced that the first participant has been vaccinated in a Phase 2a clinical trial ( NCT06582277 ) evaluating OVX836, its broad-spectrum influenza vaccine candidate as a booster in participants previously administered with OVX836. Based on the encouraging data gathered so far, Osivax launched this study to further assess the safety and immunogenicity of a booster dose of OVX836. The booster dose will be administered to participants who were vaccinated three to five years ago in earlier Osivax studies at the same clinical site. The study is taking place at the Center for Vaccinology (CEVAC) at Ghent University Hospital. The topline results from the trial are expected by the end of 2025. “ We are pleased to support the ongoing evaluation of OVX836 through this Phase 2a influenza booster study ,” commented Prof. Isabel Leroux-Roels, Principal Investigator at CEVAC and Associate Professor at Ghent University . “We anticipate important insights that could significantly impact long-term influenza prevention.” “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,” said Dr. Nicola Groth, CMO of Osivax . “Osivax is committed to leveraging innovative science to develop vaccines that protect individuals and help reduce the global healthcare burden associated with seasonal flu epidemics and potential pandemics.” The single-center trial is a randomized, double-blind, Phase 2a clinical study evaluating the immunogenicity and safety of one single dose of OVX836 administered intramuscularly (IM) at either 180μg or 480μg. The study includes healthy participants ages 20-64 who previously received OVX836 (180μg to 480μg), Influvac ® Tetra or placebo in the OVX836-002 ( NCT04192500 ) and OVX836-003 ( NCT05060887 ) studies. About OVX836 OVX836 is a first-in-class influenza A vaccine candidate that targets the nucleoprotein (NP), a highly conserved internal antigen. Unlike surface antigens, the NP is much less likely to mutate, providing a broader and more universal immune response. Osivax’ oligoDOM™ technology enables the design and production of a recombinant version of the NP which self-assembles into a nanoparticle, thus triggering powerful T- and B-cell immune responses. OVX836 has been tested in 5 clinical trials with 1,200 participants so far, and has shown promising safety, immunogenicity, and efficacy read-outs. About Osivax Osivax is a clinical-stage biopharmaceutical company leveraging its novel, self-assembling nanoparticle platform technology, oligoDOM TM , to develop transformative, first-in-class pan-respiratory virus vaccines generating superior T-cell responses in addition to strong and sustained B-cell responses. The company is establishing proof of concept with its broad-spectrum “universal” influenza candidate, OVX836, which is currently in Phase 2 clinical trials with over 1,200 volunteers tested and encouraging efficacy proof of concept data. Osivax’ ambition is to develop a pan-respiratory virus vaccine to prevent all strains of influenza and all variants of Covid-19 in one single shot. The company will expand into other infectious disease indications through combinations and collaborations worldwide. For further information: www.osivax.com SOURCE: Osivax

LYON, France--( BUSINESS WIRE )-- Osivax , a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses, today announced that the first participant has been vaccinated in a Phase 2a clinical trial ( NCT06582277 ) evaluating OVX836, its broad-spectrum influenza vaccine candidate as a booster in participants previously administered with OVX836. Based on the encouraging data gathered so far, Osivax launched this study to further assess the safety and immunogenicity of a booster dose of OVX836. The booster dose will be administered to participants who were vaccinated three to five years ago in earlier Osivax studies at the same clinical site. The study is taking place at the Center for Vaccinology (CEVAC) at Ghent University Hospital. The topline results from the trial are expected by the end of 2025. “ We are pleased to support the ongoing evaluation of OVX836 through this Phase 2a influenza booster study ,” commented Prof. Isabel Leroux-Roels, Principal Investigator at CEVAC and Associate Professor at Ghent University . “We anticipate important insights that could significantly impact long-term influenza prevention.” “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,” said Dr. Nicola Groth, CMO of Osivax . “Osivax is committed to leveraging innovative science to develop vaccines that protect individuals and help reduce the global healthcare burden associated with seasonal flu epidemics and potential pandemics.” The single-center trial is a randomized, double-blind, Phase 2a clinical study evaluating the immunogenicity and safety of one single dose of OVX836 administered intramuscularly (IM) at either 180μg or 480μg. The study includes healthy participants ages 20-64 who previously received OVX836 (180μg to 480μg), Influvac ® Tetra or placebo in the OVX836-002 ( NCT04192500 ) and OVX836-003 ( NCT05060887 ) studies. About OVX836 OVX836 is a first-in-class influenza A vaccine candidate that targets the nucleoprotein (NP), a highly conserved internal antigen. Unlike surface antigens, the NP is much less likely to mutate, providing a broader and more universal immune response. Osivax’ oligoDOM™ technology enables the design and production of a recombinant version of the NP which self-assembles into a nanoparticle, thus triggering powerful T- and B-cell immune responses. OVX836 has been tested in 5 clinical trials with 1,200 participants so far, and has shown promising safety, immunogenicity, and efficacy read-outs. About Osivax Osivax is a clinical-stage biopharmaceutical company leveraging its novel, self-assembling nanoparticle platform technology, oligoDOM TM , to develop transformative, first-in-class pan-respiratory virus vaccines generating superior T-cell responses in addition to strong and sustained B-cell responses. The company is establishing proof of concept with its broad-spectrum “universal” influenza candidate, OVX836, which is currently in Phase 2 clinical trials with over 1,200 volunteers tested and encouraging efficacy proof of concept data. Osivax’ ambition is to develop a pan-respiratory virus vaccine to prevent all strains of influenza and all variants of Covid-19 in one single shot. The company will expand into other infectious disease indications through combinations and collaborations worldwide. For further information: www.osivax.com

In the context of Autoimmune Awareness Month, the coalition of patients suffering from Myasthenia Gravis (MG) "All United for MG" urges citizens throughout Europe to unite in instigating positive change and enhancing Myasthenia Gravis management. All United for MG is officially launching a European petition to advocate for better rights for patients and their caregivers, improved access to healthcare and enhanced conditions. All United for MG was founded in 2023 to raise awareness about gMG and strengthen patients and their caregivers' rights for improved quality of life, better care and access to resources on the disease. The petition aims to bring changes in the gMG and broader Rare Disease community, calling for a renewed Rare Disease Plan under the next European Commission. BRUSSELS, March 6, 2024 /PRNewswire/ -- Following Rare Disease Day and in anticipation of the European elections, All United for MG has undertaken the initiative to mobilize society, initiating transformative changes for the patient community. Since its establishment in 2023, All United for MG has been amplifying the generalised Myasthenia Gravis (gMG) patient voice across Europe. A Call for Action, launched with European parliamentarians Tomislav Sokol and Istvan Ujhelyi in June 2023 during the first-ever Myasthenia Gravis Day, contains six actionable policy recommendations for the improvement of the visibility, recognition and treatment of Myasthenia Gravis (MG) and other rare diseases. These recommendations were supported by over 30 stakeholders, including 11 members of the European Parliament, healthcare professionals and Patient Advocacy Groups (PAGs). All United for MG is now intensifying its efforts and seeks the support of all citizens across Europe by launching a petition on change.org, to encourage the civil society to support and advocate for changes in the management of rare diseases care,especially in generalized Myasthenia Gravis (gMG). The ambition is to collect between 5.000 - 10.000 signatures in the lead-up to the second Myasthenia Gravis Awareness Day on June 2nd and the European elections. gMG is recognized as a rare chronic autoimmune disease that imposes substantial challenges on the majority of individuals affected. It causes complex and chronic physical symptoms that weaken the body's muscles and can be potentially life-threatening. Affecting facial expressions, vision, speech, chewing, swallowing, and breathing, it makes daily movements exhausting and challenging. As a rare disease, it remains difficult and time-consuming to diagnose. "Taking action at European Union level is extremely important to raise awareness and increase interconnectivity among all Member States. This enables rare disease patients and healthcare professionals from different countries to exchange data, ensuring better understanding for the disease and better social support. It is thus crucial to collectively support All United for MG initiative to underline the significant impact of MG on patients' daily lives, as well as to their loved ones. I would also like to encourage all EU citizens to sign the petition, stressing the importance of raising awareness of MG and defending the rights of those affected, and bringing positive change to the rare disease environment in Europe" said Stelios Kympouropoulos, Member of the European Parliament. "gMG is a debilitating neuromuscular disease with complex physical symptoms that, for the most severely affected patients, even necessitate the assistance of a caregiver," added Prof. dr. Jan De Bleecker, Ghent University Hospital and Ghent University. "There remain unmet needs in rare disease, and as healthcare professionals, it is crucial for us to ensure that the broader healthcare community comprehends the intricacies of the disease for improved management." "The burden of the gMG is not universally well-understood or recognised across Europe. Raising awareness and elevating the patient voice can make a meaningful difference in driving change. The aim of the petition is thus to mobilise each citizen to lend their support to patients and the broader rare disease community. By uniting individuals in this collective effort, we can foster a greater understanding, stand up for improved resources, and ultimately enhance the overall quality of life for those affected" said Lutgarde Allard, Board Member at EUMGA. "Rare diseases often struggle for visibility in political discourse, making the All United for MG petition all the more important. This Call to Action urges citizens to join hands in encouraging positive change. In the current political environment, this petition serves as a powerful tool to highlight the necessity of prioritizing Myasthenia Gravis, neuromuscular disorders and more broadly rare diseases in the policy agenda" added Jean-Philippe Plançon, President of EPODIN. If you want to express your support by adding your signature, you can access the online petition via this link: . About Generalized Myasthenia Gravis Generalized myasthenia gravis (gMG) is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. Approximately 85% of people with MG progress to gMG within 24 months, where muscles throughout the body may be affected. Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population. SOURCE All United for MG