Diosynvax Ltd.

CAMBRIDGE, England, Oct. 7, 2024 /PRNewswire/ -- DIOSynVax, a pioneering clinical-stage biotechnology company specializing in revolutionary broadly protective vaccines, showcased its latest data on a broadly reactive bird-flu vaccine. This research offers significant hope for a vaccine that may safeguard against both current and future bird-flu infections. Bird flu, known as H5 influenza, has recently been detected in animal clusters, raising concerns about potential human-to-human transmission and the threat of a new pandemic. At the Options XII conference for Advancements in Influenza Control in Brisbane, Professor Jonathan Heeney, Chief Scientific Officer of DIOSynVax and a leading Infectious Disease expert at Cambridge University, presented compelling new data demonstrating strong neutralizing antibodies against a wide range of bird flu viruses Utilizing its proprietary "Digital Immune Optimized Synthetic Vaccine" (DIOSynVax) platform, the company has developed a single candidate vaccine designed to provide a broad protective net of neutralizing immune responses across the spectrum of very diverse H5 subtype of Influenza viruses, many of which could cause the next human pandemic. Professor Heeney remarked, "Our innovative approach, leverages advanced computational technologies with rigorous animal testing, has shown our ability to generate strong neutralizing antibodies effective against very different groups of H5 bird flu viruses (called clades) that have caused human infections around the world. This means countries will need only one DIOSynVax vaccine to combat them all, instead of current technologies based on selected strains of one particular clade that may not protect against the variety of H5 virus that ultimately causes the next pandemic in humans." Dr. Ronald Moss, CEO of DIOSynVax, added, "We have broadly protective vaccine candidates that are now ready for clinical trials that address the key problem of variability that both seasonal current influenza and bird-flu vaccines. Given the recent concern about potential human-to-human transmission of bird-flu, and not knowing what H5 virus strain that could be, is a powerful advantage that our unique vaccine platform offers. DIOSynVax vaccines provide powerful advantage for the prevention of another Influenza pandemic." For media inquiries or more information, please contact: [email protected] About H5N1 H5N1, or bird flu, continues to circulate widely among migrating wild birds, infecting domestic birds and livestock, with documented human infections occurring. Notably some human infections have occurred without direct contact with infected animals. Public health experts underscore the risk posed by H5N1 or it's re-assorted versions H5N2, H5N6, H5N8, that acquire mutations that can enhance its transmissibility between humans. "A possible cluster of bird-flu infections in Missouri has grown to include eight people, in what may be the first examples of person-to-person transmission in the United States, the Centers for Disease Control and Prevention reported on Friday." () About DIOSynVax DIOSynVax is a clinical-stage biotechnology company dedicated to developing universal vaccines through advanced computational biology technologies. Their mission is to create innovative solutions that provide broad protection against a wide range of infectious diseases, including emerging pandemics. SOURCE DIOSYNVAX LTD. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Successful vaccine candidate combining DIOSynVax's computational multi-virus vaccine antigen payload technology and Ethris’ proprietary non-immunogenic messenger RNA (SNIM mRNA) and lipidoid nanoparticle (SNaP LNP) platformsData demonstrates broad in vivo immune responses against multiple sarbecocoronaviruses and SARS-CoV-2 variants MUNICH, Germany and CAMBRIDGE, United Kingdom, Sept. 25, 2023 (GLOBE NEWSWIRE) -- Ethris GmbH, a leading biotechnology company pioneering next-generation messenger RNA (mRNA) therapeutics and vaccines, and DIOSynVax, a Cambridge UK based clinical stage biotech spinout specialized in the development of multi-valent vaccine antigen payloads (VAPs), announced today the publication of preclinical proof of concept results for each of their platform technologies in Nature Biomedical Engineering. The article titled “Single RBD-based antigen elicits broad humoral response against SARS-CoV-2 and related sarbecoviruses across different vaccine technologies” presents data supporting the broad applicability of both companies’ technologies in the discovery and development of robust vaccine candidates capable of generating broad immunogenicity based on digitally designed, immune-optimized antigens combined with advanced mRNA formulation and product stability characteristics. “Prior to the last pandemic, we had already experienced the serious threat of betacoronavirus outbreaks and grappled with the evolving variants that continually emerge. Today’s publication in collaboration with DIOSynVax serves as a strong validation and provides important preclinical evidence showcasing the efficacy of our mRNA modification and design technologies as well as our advanced stabilized nanoparticle delivery platform,” said Dr. Carsten Rudolph, CEO of Ethris. “Through our suite of in-house developed mRNA and LNP technology platforms, we are able to create candidates with superior thermostability and resistance to mechanical manipulation. This capability enables us to develop vaccines and therapeutics that can overcome limited stability and widespread biodistribution, which currently represent the biggest limitations for mRNA medicines.” “Publishing this study in Nature Biomedical Engineering, a renowned peer-reviewed journal, further indicates the value of our innovative technology for computationally selecting immune-optimized and structurally engineered antigens to create new vaccines,” said Dr. Jonathan Heeney, CEO of DIOSynVax. “These initial results are highly encouraging and demonstrate the great potential of in silico designed antigens to adapt to new virus variations and even pre-date variant emergence, which underscores our commitment to staying at the forefront of vaccine development.” The preclinical research published in Nature Biomedical Engineering employed DIOSynVax's innovative technology to design a core antigen sequence capable of fostering immune responses against a range of closely related viruses. DIOSynVax’s technology generated a panel of antigens (T2_13 to T2_17), with T2_17 proving most effective in stimulating broad immune responses to clinically relevant viruses. By adding the formulation into an mRNA vaccine candidate using the Ethris platform, the study confirmed the potential of T2_17 as a pan-sarbecovirus antigen, demonstrating its suitability as a booster and its effectiveness as an mRNA immunogen in a range of animal models with broad protection from sarbecoviruses as well as emerging variants of concern. Collectively, the findings from the study demonstrated that T2_17 is an efficacious single antigen for inducing immune responses against SARS-CoV, SARS-CoV-2, RaTG13, WIV16 and various SARS-CoV-2 variants, further validating the applicability of the vaccine technology employed by DIOSynVax as well as Ethris’ proprietary platforms. About DIOSynVaxDIOSynVax provides a solution to a significant unmet need in the vaccine industry. Despite the accelerated vaccine manufacturing timelines to meet the global needs of the COVID-19 pandemic, the risk of vaccine failure due to circulating variants of concern illustrates a major weakness in global vaccine technology. The crux of the problem with current vaccine technology is with vaccine antigens, the key information that vaccines use to precision-target the immune response. The wild-type Spike antigens used in current COVID-19 vaccines provide protection that is quite narrow and limited against future variants. To provide broader protection, a new approach to antigen creation is needed. In 2017 DIOSynVax (Digital Immune Optimised Synthetic Vaccines) was established as a spin-out of the University of Cambridge. Its technology brings together different areas of cutting edge science into a pipeline of candidates. The result is new VAPs with superior protection from highly variable pathogens, or viral variants across viral families. These computationally generated, synthetic genes represent vaccine antigens that are designed and immunologically selected to give the greatest possible breadth of protection from a variety of pathogens. About EthrisEthris has paved a new path from genes to therapeutic proteins, using its proprietary RNA and lipidoid nanoparticle technology platform to discover, design and develop innovative therapies. With more than a decade as an mRNA pioneer, Ethris is a global leader in delivering stabilized mRNAs directly to the respiratory system via optimised formulation and nebulisation technologies. The company is rapidly advancing its mRNA pipeline of immuno-modulation, protein replacement therapies, and differentiated vaccines, with the ultimate goal of improving patients’ lives. For more information, visit www.diosynvax.com or www.ethris.com For DIOSynVax, please contact:Jan Ruby+44 1223 766250contact@diosvax.com For Ethris, please contact: Dr. Philipp Schreppel+49 89 244 153 042schreppel@ethris.com Media contact:Madelin HawtinLifeSci Communicationsmhawtin@lifescicomms.com

Ethris to contribute its second-generation mRNA and Lipidoid Nanoparticle (LNP) stabilisation formulation technologies DIOSynVax to contribute its novel computational design-based multi-virus vaccine antigen payload (VAP) technology Programme is funded by up to $42 million investment from the Coalition for Epidemic Preparedness Innovations (CEPI) MUNICH--(BUSINESS WIRE)-- Ethris GmbH, a leading biotechnology company pioneering next-generation messenger RNA (mRNA) therapeutics and vaccines, announced today a collaboration with UK-based DIOSynVax to jointly develop a protective mRNA vaccine candidate against a broad range of Betacoronaviruses utilizing the company’s highly differentiated mRNA modification and design technologies as well as its lipidoid nanoparticle (LNP) and stabilisation platforms. The collaboration is founded on a $42 million award to DIOSynVax by the Coalition for Epidemic Preparedness Innovations (CEPI) to support the development of a broadly protective Betacoronavirus vaccine through to a Phase I/II clinical trial. Ethris will receive up to $20M to design and manufacture the mRNA vaccine candidate containing DIOSynVax’s broadly protective, multi-virus vaccine antigen payload designs. This vaccine approach aims to provide protection from SARS-CoV-2 - the virus which causes COVID-19 disease - as well as other members of this group of highly pathogenic coronaviruses. Ethris has developed a complete suite of proprietary technology platforms to overcome the limitations of existing mRNA medicines and enable future mRNA drug product distribution to all parts of the globe. The company has established its proprietary platforms to design and manufacture next-generation, well-tolerated, mRNA drug candidates with unparalleled LNP stability. Ethris’ stabilisation technology achieves best-in-class handling times of up to 4 days at room temperature, long-term storage potential at 2° to 8° Celsius due to lyophilisation and a first-in-class resistance to mechanical manipulation. “This collaboration underlines the potential of Ethris’ platform technologies combined with DIOSynVax’s highly immunogenic antigen design platform to produce a broadly protective mRNA vaccine, with best-in-class handling and distribution properties, to prevent severe disease caused by current SARS-CoV-2 variants of concern, Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS) and other members of the Betacoronavirus family,” said Dr. Carsten Rudolph, CEO of Ethris. “In the long-term, these combined technologies could produce vaccines that protect global populations against future pandemics.” Professor Jonathan Heeney, CEO of DIOSynVax added: “We are delighted to be working with Ethris and the company’s highly differentiated, potent, thermostable and mRNA and LNP platforms, which will complement DIOSynVax’s cutting-edge capability to create vaccine antigen payloads that are designed and immunologically selected to broadly protect individuals from multiple pathogens with high pandemic potential and ultimately develop vaccines with highly improved handling and distribution properties.” CEPI first announced its partnership with DIOSynVax in March 2022 following a funding call to support the development of vaccines that provide broad protection against SARS-CoV-2 variants and other Betacoronaviruses. The goal of the partnership is to establish clinical proof-of-concept for a novel and broadly applicable vaccine candidate against all Betacoronavirus members including Embecovirus, Merbecovirus, Nobecovirus and Sarbecovirus. “Over the last three years coronaviruses have proven their pandemic potential. The best way to control COVID-19 in the long term, and to prevent another coronavirus pandemic in the future, will be with vaccines that can protect us against newly emerging coronaviruses and against variants of this one,” commented Dr. Melanie Saville, Executive Director of R&D from CEPI. “We are excited to see the progress from this collaboration, which has the potential to bring a new generation of vaccines to people around the world.” About Ethris Ethris has paved a new path from genes to therapeutic proteins using its proprietary messenger RNA technology platform to discover, design and develop innovative therapies. With more than a decade as an mRNA pioneer, Ethris is a global leader in delivering stabilised mRNAs directly to the respiratory system via optimised formulation and nebulisation technologies. The company is rapidly advancing its mRNA pipeline of immuno-modulation, protein replacement therapies, and differentiated vaccines against viral infections, with the ultimate goal of improving patients’ lives. For more information, visit . View source version on businesswire.com: Contacts For Ethris, please contact: Dr. Carsten Rudolph +49 89 8955788 10 rudolph@ethris.com Media Relations Gretchen Schweitzer or Dr. Charlotte Spitz Trophic Communications +49 151 7441 6179 ethris@trophic.eu Source: Ethris GmbH View this news release online at: