The University of Queensland

BRISBANE, Australia & CAMBRIDGE, MA, USA I October 28, 2024 I Vaxxas , a clinical-stage biotechnology company commercializing a novel high-density microarray patch (HD-MAP) vaccination platform , today announced that the United States National Institutes of Health (NIH) has granted the company a license to a next-generation vaccine antigen (DS2), designed for use in prophylactic vaccines against Respiratory Syncytial Virus (RSV). Vaxxas’ worldwide license from the NIH enables the company to create the first needle-free, room-temperature stable RSV vaccine to enter clinical studies. The next-generation DS2 RSV vaccine antigen licensed by Vaxxas was developed by scientists at the NIH’s Vaccine Research Center and the National Institute of Allergy and Infectious Diseases to prompt a more robust and durable immune response against RSV compared to the antigen used in currently approved vaccines (DS-Cav1). “ Published preclinical results show the potential immunogenic advantages of this next-generation antigen as the basis for an RSV vaccine that could offer more robust and durable protection against the virus, compared to vaccines already on the market,” David L. Hoey, President and CEO of Vaxxas, said. “These advantages, coupled with our needle-free technology’s potential to eliminate the need for refrigerated distribution and enable self-administration, could offer a vaccine that makes a significant impact on the way we protect populations against this serious respiratory infection in the future.” Vaxxas’ HD-MAP vaccine delivery platform is advancing toward commercialization, with five successful Phase I clinical trials involving more than 500 participants completed, including a second-generation COVID-19 vaccine candidate, a HD-MAP delivered flu vaccine showing greater immunogenicity than the approved injectable vaccine comparator, and a measles and rubella vaccine. With funding from the United States Biomedical Advanced Research and Development Authority (BARDA), the company is currently conducting its first U.S. IND-enabled Phase I clinical study for a pre-pandemic influenza vaccine involving 258 participants. Vaxxas plans to progress its needle-free HD-MAP/RSV vaccine to a Phase I clinical study after completing preclinical development of the product. About Respiratory Syncytial Virus (RSV) RSV is a common contagious virus affecting the lungs and breathing passages. The global burden of RSV is substantial, causing an estimated 33 million acute lower respiratory infection episodes per year, resulting in an estimated 3.6 million RSV-related hospitalizations and over 101,400 RSV-related deaths annually. RSV contributes substantially to morbidity and mortality burden globally in children aged 0-60 months, especially during the first six (6) months of life. Adults can be at increased risk for RSV disease due to comorbidities, immune compromised status, or advanced age. RSV can exacerbate conditions, including COPD, asthma, and chronic heart failure which can lead to severe outcomes, such as pneumonia, hospitalization, and death. The 2023 approval of the world’s first RSV vaccines in the US and Europe, GSK’s AREXVY and Pfizer’s ABRYSVO, was a significant milestone in addressing the grave unmet medical needs associated with RSV. About HD-MAP needle-free vaccines The Vaxxas HD-MAP is comprised of thousands of microscopic projections molded into a small patch. Each microprojection is coated with a small dose of vaccine in a dried formulation. When applied to the skin using a proprietary, easy to use applicator, the patch delivers the vaccine to the abundant immune cells that naturally reside immediately below the skin surface. HD-MAP vaccine delivery offers many potential benefits over more traditional ways of administering vaccines. For example, the dried form of the vaccine is more stable at higher temperatures than vaccines in liquid formulations, therefore potentially reducing the need for cold-chain storage and distribution. Vaxxas’ HD-MAPs have proven safe and tolerable in hundreds of trial participants to date , and have been shown to induce equal or greater immune responses to injected vaccines at lower doses. Compared with needle and syringe systems, HD-MAP vaccines are also much easier to administer and are likely to have greater acceptability by healthcare workers and patients/subjects. Ultimately, HD-MAPs could enable a future in which vaccine patches could be shipped directly to peoples’ homes, workplaces, and schools, avoiding the delay, inconvenience, and safety challenges associated with traditional needle-and-syringe vaccine scheduling and administration. About Vaxxas Vaxxas is a privately held biotechnology company focused on enhancing the performance of existing and next-generation vaccines with its proprietary HD-MAP. Vaxxas is targeting initial applications in infectious diseases and oncology. With success in several completed human clinical trials involving more than 500 participants; additional ongoing Phase I clinical studies for seasonal influenza and COVID-19; and other vaccine studies targeting pandemic influenza, funded by the United States Biomedical Advanced Research and Development Authority (BARDA), Vaxxas’ HD-MAP vaccine delivery platform is advancing toward commercialization. Vaxxas’ core technology was initially developed at The University of Queensland (UQ), and the company was established as a start-up in 2011 by UQ’s commercialization group UniQuest. The company was founded with the completion of an initial equity financing led by OneVentures Innovation Fund I with co-investors Brandon Capital Partners and US-based HealthCare Ventures, followed by a further financing led by OneVentures with UQ joining the most recent financing. OneVentures Innovation Fund I and Brandon BioCatalyst are supported by the Australian Government’s Innovation Investment Fund (IIF) program. The IIF is an Australian Government venture capital initiative that provides investment capital and managerial expertise through licensed venture capital fund managers to investee companies. Learn more at OneVentures and Brandon Capital . SOURCE: Vaxxas

Financing led by new investor TCGX, alongside Goldman Sachs Alternatives, Avoro Ventures and venBio Funding will support and accelerate development of next-generation multivalent respiratory virus vaccines using proprietary Molecular Clamp technology Commenced Phase I clinical study of bivalent vaccine targeting both Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (hMPV) LONDON, Sept. 23, 2024 /PRNewswire/ -- Vicebio Ltd ("Vicebio"), a biopharmaceutical company developing novel vaccines against life-threatening respiratory viral infections, today announces a $100 million Series B financing led by TCGX with investment from Goldman Sachs Alternatives, Avoro Ventures, venBio, and participation from UniQuest and founding investor Medicxi. Vicebio is developing next-generation vaccines for respiratory viruses utilising its proprietary Molecular Clamp technology, discovered at The University of Queensland. This novel technology uniquely stabilises viral glycoproteins in their highly immunogenic 'prefusion' conformation, crucial for eliciting strong protective immune responses. This innovative approach enables the production of highly effective vaccines that are easy to manufacture and will be available in ready-to-use prefilled syringes. The Molecular Clamp technology is applicable to a wide range of viruses including Respiratory Syncytial Virus (RSV), Human Metapneumovirus (hMPV), Parainfluenza virus, Influenza and Coronaviruses, as confirmed by promising preclinical and clinical studies. Vicebio has recently initiated a Phase I clinical trial with VXB-241, its bivalent vaccine targeting both RSV and hMPV viruses that cause a significant burden of disease in elderly patients and those with a weakened immune system. There is currently no commercially available vaccine targeting RSV and hMPV. Initial clinical readouts of the Phase 1 study are expected mid 2025. This financing will also support the acceleration and expand further development of Vicebio's multivalent pipeline including VXB-251, a trivalent vaccine targeting RSV, hMPV and Parainfluenza Virus 3 (PIV3), a further valency that addresses a significant remaining medical burden in the elderly. Dr Emmanuel Hanon, Chief Executive Officer of Vicebio, said: "The support from these high-calibre investors underscores the robust data package we have generated for VXB-241, highlighting the significant potential of our proprietary Molecular Clamp technology to develop next-generation vaccines against respiratory viruses." Cariad Chester, Managing Partner at TCGX, said: "At TCGX, we are dedicated to supporting the translation of cutting-edge science into transformative medicines and we are thrilled to partner with Vicebio. This is a highly experienced team with a breakthrough technology to address a critical public health need. Vicebio has a unique capability to advance vaccine products that simultaneously provide robust immune responses against multiple respiratory pathogens. We look forward to working closely with the team to bring these important vaccines to the market." Dr Giovanni Mariggi, Chairman of Vicebio and Partner at Medicxi, said: "Vicebio has made significant progress in developing its Molecular Clamp platform and successfully advanced VXB-241 which offers unmatched vaccine coverage against respiratory viruses. We are pleased to welcome TCGX, Goldman Sachs, Avoro Ventures and venBio to the syndicate to support the fight against life-threatening respiratory viral infections." In connection with the financing, the Vicebio Board of Directors will expand to include Cariad Chester, Managing Partner at TCGX, Colin Walsh, Managing Director at Goldman Sachs and Mark Chin, Partner at Avoro Ventures. 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: 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: 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: uniquest.com.au 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 About Goldman Sachs Alternatives Goldman Sachs 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: 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 . SOURCE Vicebio WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Both VXB-241 and VXB-251 have been developed with Vicebio’s so-called “molecular clamp” tech. The respiratory syncytial virus (RSV) space may have filled up over the past year, but that isn’t deterring Vicebio or its investors.The British biotech has secured $100 million in series B funds as it continues a phase 1 trial of its bivalent vaccine targeting both RSV and human metapneumovirus (hMPV). A readout for the vaccine, dubbed VXB-241, is expected next year.Further, the company will use some of the cash to push ahead with VXB-251, a trivalent vaccine targeting RSV, hMPV and parainfluenza virus 3.Both VXB-241 and VXB-251 have been developed with Vicebio’s so-called “molecular clamp” tech, which is designed to better stabilize viral proteins and thus make the biotech’s vaccines easy to administer and store. It was developed by a team led by professors Paul Young, Ph.D., Daniel Watterson, Ph.D., and Keith Chappell, Ph.D., at the University of Queensland in Australia before being licensed out to Vicebio by the university’s commercialization arm.“This innovative approach enables the production of highly effective vaccines that are easy to manufacture and will be available in ready-to-use prefilled syringes,” the biotech explained in a Sept. 24 release. The financing was led by TCGX and featured founding investor Medicxi alongside Goldman Sachs Alternatives, Avoro Ventures, venBio and UniQuest."The support from these high-calibre investors underscores the robust data package we have generated for VXB-241, highlighting the significant potential of our proprietary Molecular Clamp technology to develop next-generation vaccines against respiratory viruses,” Vicebio CEO Emmanuel Hanon, Ph.D., said in the release.Hanon joined Vicebio from GSK, which secured the first approval for an adult RSV vaccine last year in the form of Arexvy. Pfizer now has its rival Abrysvo on the market, which was joined in May by Moderna's mRESVIA. Merck & Co. is following close behind, while AstraZeneca—which manufactures the approved RSV antibody Beyfortus—threw its hat in the ring late last year by buying RSV vaccine developer Icosavax.There are currently no approved vaccines targeting both RSV and hMPV, meaning Vicebio could still carve out its own niche in an increasingly crowded arena. However, Vicebio's prospect will be going up against IVX-A12, the RSV and hMPV combo vaccine that AstraZeneca acquired as part of its Icosavax buyout. AstraZeneca was touting IVX-A12 as being “phase 3 ready” as far back as December.