Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted)

Vicebio enters the second stage of its Phase 1 Clinical Study of its lead candidate VXB-241 The Clinical Study, an actively controlled Proof of Concept Phase 1 conducted in target population aged 60+, is progressing as planned with initial data expected by mid-2025 Moncef Slaoui, former Chief Scientific Advisor of Operation Warp Speed & former Chair of R&D at GlaxoSmithKline and Khurem Farooq, previously CEO of Aiolos, join Board of Directors London, UK, 21 November 2024: Vicebio Ltd (“Vicebio”), a biopharmaceutical company pioneering next-generation vaccines for life-threatening respiratory viruses, today announces its progress in the ongoing VXB-241 bivalent RSV-hMPV Phase 1 (P1) study as well as the appointment of Moncef Slaoui, PhD, and Khurem Farooq to its Board of Directors. Vicebio is progressing into the second stage of its clinical study of VXB-241 and is now enrolling individuals aged 60 years of age and above to evaluate the candidate vaccine’s safety in this vulnerable population. Early data from the study are expected by mid-2025. Vicebio anticipates these data will represent a significant milestone in the clinical validation of its platform. More information on the P1 study can be found on clinicaltrials.gov (NCT06556147). Moncef Slaoui, PhD, and Khurem Farooq join the Board of Directors, effective immediately. Both bring vast experience in vaccine development and biopharmaceutical leadership. Emmanuel Hanon, Chief Executive Officer of Vicebio, said: “In connection with our significant Series B financing, we are building upon our world-class leadership team with the addition of Moncef and Khurem to the Board. Their expertise not only further supports our innovation but will be essential as we continue to advance the Company’s vision to deliver the next generation of respiratory viral vaccines.” At the heart of Vicebio’s innovation is its proprietary Molecular Clamp technology, designed to stabilise viral antigens and enhance protective immunity across multiple respiratory pathogens. This transformative technology supports the development of multivalent respiratory viral vaccines that are ready-to-use, cost-effective, and capable of addressing critical needs in global respiratory health. Moncef Slaoui, PhD, newly appointed Independent Board Member at Vicebio, commented: “Vicebio’s Molecular Clamp technology marks a transformative advancement in vaccine development. It is fantastic to be joining the Board of a company where the technology and novel approach holds the potential to expedite delivery of highly effective and stable vaccines in ready-to-use prefilled syringes.” Khurem Farooq, newly appointed Independent Board Member at Vicebio, added: “Vicebio is at an exciting phase of growth as it looks to advance its pipeline of multivalent vaccines with the potential to prevent a wide range of diseases in a single vaccine.” Moncef Slaoui, PhD, has extensive experience in drug development and commercialisation. He currently serves as an advisor to Medicxi and is on the Board of Directors of several companies including Arcturus Therapeutics, Altesa, and Zephyr AI. Under his leadership as Chief Scientific Advisor to Operation Warp Speed, he played a critical role in the rapid development and deployment of multiple of COVID-19 vaccines in the US. Prior to this Moncef’s career at GlaxoSmithKline (GSK) spanned nearly three decades, where he held several senior leadership roles, including being a member of the Board of Directors. He spearheaded GSK’s Pharmaceutical R&D restructuring to improve focus on innovation and productivity, and was instrumental in the development of 14 new vaccines, including Shingrix, to prevent shingles; Cervarix, to prevent cervical cancer and Mosquirix, to prevent malaria. Moncef earned a PhD in Molecular Biology and Immunology from the Université Libre de Bruxelles and completed postdoctoral studies at Harvard Medical School and Tufts University. He also holds an accelerated MBA from IMD in Switzerland. Khurem Farooq is an avid biotech entrepreneur with over 20 years of experience in drug development. Khurem was co-founder and CEO of Aiolos Bio, which was acquired by GSK for $1.4bn in February 2024. Prior to this, Khurem served as CEO of Gyroscope, which was acquired by Novartis in 2021 for up to $1.5bn. Khurem was Senior Vice President of the Immunology and Ophthalmology business unit at Genentech, a member of the Roche Group, where he played a key role in the commercialisation and launch strategies of several medicines and contributed to the development of numerous pipeline products. He holds an MBA and a BSc in Biological Sciences, with honours, from Aston University and University of Wolverhampton, respectively. For further information, please contact: Optimum Strategic Communications Mary Clark, Hana Malik, Vareen Outhonesack Tel: +44 (0) 203 922 0889 Email: vicebio@optimumcomms.com Vicebio is backed by a global syndicate of life science investors including Medicxi, UniQuest, TCGX, Goldman Sachs Alternatives, Avoro Ventures and venBio. For more information, please visit: www.vicebio.com About Vicebio Vicebio is focused on developing next-generation respiratory virus vaccines using the Molecular Clamp Technology. The company was founded with investment from Medicxi and acquired the rights to the Molecular Clamp technology through a license from UniQuest, the commercialization arm of The University of Queensland, Australia. This proprietary technology was developed by Prof. Paul Young, Prof. Daniel Watterson, and Prof. Keith Chappell at UQ. For more information, please visit: https://www.vicebio.com About Medicxi Medicxi is a healthcare-focused investment firm with the mission to create and invest in companies across the full drug development continuum. Leveraging deep expertise in drug development and company creation spanning over two decades, Medicxi invests in early and late-stage therapeutics with a product vision that can fulfil a clear unmet medical need. For more information, please visit: https://www.medicxi.com About UniQuest UniQuest is the commercialisation company of The University of Queensland (UQ). In partnership with UQ researchers, UniQuest creates impact through the commercialisation of UQ intellectual property. Established in 1984, UniQuest’s commercialisation track record positions UQ as the leader of research commercialisation in Australasia. Notable successes include the blockbuster cervical cancer vaccine Gardasil® and start-up companies Spinifex Pharmaceuticals Inc and Inflazome Ltd, which were acquired in two of the largest university start-ups exits in Australian history. UniQuest has also established the Queensland Emory Drug Discovery Initiative (QEDDI), a world-class small molecule drug discovery and development group, dedicated to translating academic biomedical research into drug candidates for partnering. In 2024, UniQuest launched its AUD$32 million UniQuest Extension Fund, an investment fund dedicated to supporting the start-up eco-system at The University of Queensland. For more information, please visit: https://uniquest.com.au/about/ About TCGX TCGX is a healthcare investment firm dedicated to advancing disruptive medicines and supporting companies that can improve the lives of patients. TCGX invests in pioneering healthcare companies led by exceptional entrepreneurs focused on developing better treatment options for patients. TCGX has investment teams in San Francisco, Palo Alto, and New York City. For more information, please visit: www.tcgcrossover.com Goldman Sachs (NYSE: GS) is one of the leading investors in alternatives globally, with over $450 billion in assets and more than 30 years of experience. The business invests in the full spectrum of alternatives including private equity, growth equity, life sciences, private credit, real estate, infrastructure, hedge funds, and sustainability. Clients access these solutions through direct strategies, customized partnerships, and open-architecture programs. The business is driven by a focus on partnership and shared success with its clients, seeking to deliver long-term investment performance drawing on its global network and deep expertise across industries and markets. The alternative investments platform is part of Goldman Sachs Asset Management, which delivers investment and advisory services across public and private markets for the world’s leading institutions, financial advisors, and individuals. Goldman Sachs has over $2.8 trillion in assets under supervision globally as of March 31, 2024. About Avoro Ventures Avoro Ventures is a global life sciences investment firm, and an affiliated company of Avoro Capital Advisors, an SEC-registered investment manager based in New York City, with over $6.5 billion in capital primarily focused on supporting emerging life sciences and biotechnology companies. For more information, please visit: www.avorocapital.com About venBio venBio is a life sciences investment firm that partners with industry leaders to build innovative medicines and technologies, with a focus on novel therapeutics for unmet medical needs. For more information, please visit: www.venbio.com

Recently, the journal Nature Reviews Microbiology published a research report that thoroughly analyzed the development process of malaria vaccines and their effectiveness and challenges. Nearly half of the global population faces the threat of malaria, with pregnant women and young children being particularly vulnerable. Over time, women and children gradually develop partial resistance, providing possibilities for vaccine development. The clinical presentation of malaria is often misdiagnosed as non-specific influenza-like symptoms, leading to delayed treatment. The symptoms range from mild to severe complications, and the mortality rate for untreated cases remains high.   In 2022, malaria caused more than 600,000 deaths, and the mortality rate has not shown significant improvement since 2015. Five species of Plasmodium parasites can cause human malaria, with Plasmodium falciparum responsible for the most cases and deaths. The continued existence of malaria is partly attributed to parasite drug resistance and mosquito vector resistance to insecticides. Furthermore, climate factors such as temperature, humidity, and increased rainfall have exacerbated vector breeding, expanding the risk areas, particularly due to population movements driven by food and economic insecurity, which may increase the risk of malaria transmission.   The 2023 World Malaria Report states that R21 and RTS,S vaccines have become the first approved malaria vaccines, primarily targeting the circumsporozoite protein (CSP) of the parasite, with the potential to significantly reduce child mortality. RTS,S has shown a 36% reduction in clinical malaria in high to moderate transmission areas, while R21 has demonstrated a 75% (seasonal) or 68% (standard) reduction in clinical malaria in subsequent doses. However, the protective efficacy of these vaccines wanes over time, requiring annual booster doses, and their effectiveness may vary depending on transmission intensity and timing of administration. Additionally, the supply of saponin extracts used in the vaccine components is limited, and the current vaccines are mainly targeted at young children.   Pre-erythrocytic vaccines and blood-stage vaccines target different stages of the parasite, aiming to prevent infection and clinical symptoms. While some progress has been made in liver-stage vaccines, the development of blood-stage vaccines, particularly those targeting the complex variations of the PfEMP1 family, still faces significant challenges. The development of VAR2CSA as a leading candidate for pregnancy-specific malaria vaccines and the advancement of transmission-blocking vaccines provide new research directions for malaria control.   Although the R21 and RTS,S vaccines have achieved breakthroughs, their limitations indicate the need for continuous development of new strategies, including improving existing vaccines, developing vaccines for different age groups, and integrating genomics technology to strengthen public health responses, effectively monitor, prevent, and control infectious diseases.