Ghent University

GHENT, Belgium--( BUSINESS WIRE )--RheaVita, a pioneer in controlled, continuous freeze-drying technology for biopharmaceuticals, is pleased to announce a strategic partnership with IMA Life , one of the three pharma divisions of IMA Group and global leader in advanced, aseptic pharmaceutical process and production solutions. This partnership includes both a financial investment in RheaVita by IMA Life and ongoing support to expand the development and commercialization of RheaVita’s cutting-edge technology for the global market. “Our partnership with IMA Life represents a major opportunity to accelerate our technology and expand its market reach,” said Prof. Dr. Thomas De Beer, CEO and co-founder of RheaVita. “Collaborating with an industry leader like IMA Life in aseptic pharmaceutical production technology not only strengthens our development and equipment manufacturing capabilities but also provides confidence to our end-users with respect to the robustness and reliability of our solutions. With IMA Life’s extensive expertise and global footprint, we’re well-positioned to bring our continuous freeze-drying solution to biopharmaceutical manufacturers worldwide, providing a fast, flexible, and reliable alternative to conventional batch freeze-drying.” This collaboration marks a significant milestone in RheaVita’s mission to transform biopharmaceutical freeze-drying processes with a continuous approach. RheaVita’s patented technology integrates all traditional freeze-drying steps into a single continuous and controlled production line, delivering faster process development, enhanced flexibility, and consistent guaranteed product quality at the single vial level. This innovative solution meets the specific needs of biopharmaceutical production, particularly for high-value, low-volume products such as gene and RNA therapies, monoclonal antibodies, antibody-drug conjugates, vaccines, and precision medicines for rare diseases. Michele Arduini, Managing Director at IMA Life, said: “RheaVita’s continuous freeze-drying technology is a future-proof solution for the flexible and extremely well-controlled production of increasingly complex biopharmaceutical drugs. We anticipate a growing need for low-volume, high-value production, and RheaVita’s technology is ideally suited for this demand. Each unit produced with RheaVita’s system is subject to rigorous, individual product quality control, ensuring that every single dose meets the highest standards. This level of control makes the RheaVita solution an invaluable asset for biopharmaceutical companies looking to guarantee consistent product quality in the most efficient way possible.” IMA Life’s commitment to technological innovation and excellence aligns closely with RheaVita’s objectives, and the two companies are focused on driving impactful advancements in the freeze-drying market. This partnership aligns with IMA Life’s mission to support innovative technologies that enhance production efficiency and ensure consistent quality in life-saving therapies. The common aim is to create new standards in freeze-drying to benefit the global pharmaceutical industry and patients worldwide. About IMA Life IMA Life, part of the IMA Group, is a leading provider of advanced freeze-drying and aseptic processing solutions for the pharmaceutical sector. The company’s comprehensive range of products and services supports pharmaceutical companies in achieving high-quality, efficient, and reliable manufacturing processes on a global scale. With decades of expertise, IMA Life remains at the forefront of innovation in pharmaceutical production, offering tailored solutions that meet the unique needs of each client. For more information, please visit: https://ima.it/pharma/brands/ima-life/ . About RheaVita Founded in 2018 as a spin-off from Ghent University, RheaVita is dedicated to transforming the freeze-drying process in biopharmaceutical production. The company’s continuous freeze-drying technology addresses the challenges of traditional methods by integrating all process steps into one streamlined, efficient system. RheaVita’s technology enables rapid product and process development, flexible production capabilities, and superior product quality, making it ideally suited to produce precision medicines and other high-value therapies. With strong partnerships, RheaVita is committed to scaling its innovative technology for the global pharmaceutical industry. For more information, please visit: www.rheavita.com .

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