Recombinant polio virus vaccine (Istari Oncology)

GOLDEN, Colo.--( BUSINESS WIRE )-- PharmaJet ® , a company that has developed and commercialized a needle-free platform to more effectively administer drugs and biologics, today announced they received an $800,000+ direct to Phase II grant from the National Institutes of Health (NIH), to evaluate the immunogenicity of intradermal administration of human papillomavirus virus (HPV) vaccine using their Tropis intradermal (ID) Needle-free Injection System (NFIS). The study will compare Tropis intradermal delivery against traditional needle and syringe (N/S) intramuscular administration. The study, in collaboration with Padjadjaran University (UNPAD) in Indonesia, will begin recruiting approximately 900 girls, aged 9 to 14 years of age in early 2023. This follows PharmaJet’s preliminary studies evaluating intradermal delivery for HPV vaccines. 1 Intradermal administration is already widely used for polio vaccine delivery and has been found to be safe, effective, and immunogenic. Intradermal needle-free delivery of polio vaccine using the Tropis NFIS has also been shown to be a preferred approach by healthcare workers and patients. 2 Worldwide, cervical cancer is the fourth most frequent cancer in women with an estimated 604,000 new cases in 2020, and a large majority of them (more than 95%) are due to HPV. Of the estimated 342,000 deaths from cervical cancer in 2020, about 90% of these occur in low- and middle-income countries where there is limited access to preventative measures and cervical cancer is often not identified until it has further advanced, and symptoms develop. Additionally, access to treatment of cancerous lesions (for example, cancer surgery, radiotherapy and chemotherapy) may be limited, resulting in a higher rate of death from cervical cancer in these countries. 3 “We are pleased to receive this grant from the NIH to evaluate the feasibility of needle-free intradermal vaccine delivery for HPV,” said Erin Spiegel, Vice President of Clinical & Regulatory Affairs for PharmaJet. “Intradermal administration of vaccines can provide benefits for low resource settings including lower costs, increased coverage, and increased acceptability.” For more information about PharmaJet visit https://pharmajet.com . Refer to Instructions for Use to ensure safe injections and to review risks. Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under Award Number R44CA261326. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. 1 Nelson, E. et al, A pilot randomized study to assess immunogenicity, reactogenicity, safety and tolerability of two human papillomavirus vaccines administered intramuscularly and intradermally to females aged 18-26 years , Vaccine, 25 July 2013, pages 3452-3460. 2 Daly, C. et al, Needle-free injectors for mass administration of fractional dose inactivated poliovirus vaccine in Karachi, Pakistan: A survey of caregiver and vaccinator acceptability , Vaccine, 18 February 2020, pages 1893-1898. 3 Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021:71:209–49. doi:10.3322/caac.21660. About PharmaJet PharmaJet’s mission is to enable greater access to life improving pharmaceuticals. We are committed to helping our partners realize their research and commercialization goals while making an impact on public health. PharmaJet Needle-free Systems provide increased vaccine effectiveness, a preferred patient and caregiver experience, and a proven path to commercialization. They are also safe, fast, and easy-to-use. The Stratis ® System has U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously. The Tropis ® System has CE Mark and WHO PQS certification for intradermal injections. For more information visit https://pharmajet.com . Follow us on LinkedIn .

The polio vaccine. Surgical treatment for macular degeneration. The potential of paraplegics to walk again. Treatment for Parkinson’s disease. Antivirals to treat or prevent HIV. Covid-19 vaccines. Each of these lifesaving medical advancements is rooted in research involving nonhuman primates, most often monkeys. Yet scientists conducting this critical work have faced harassment and threats. We endure calls for primate research to be limited or even banned, which would have dire scientific consequences. These voices are few, but they are loud, and the potential costs of listening to them are high. Nonhuman primates will be critical to our efforts to understand the long-term effects of Covid-19. Estimates suggest that 10-30% of individuals may experience long Covid following initial recovery. The National Institutes of Health must fund research that seeks to explain the neurological impacts of long Covid, and this needs to include projects using nonhuman primate models. In the frightening early days of the pandemic, infectious disease experts turned to primate research to understand how the disease attacked the body and then to develop the Covid-19 vaccine. As early as May 2020, studies were published showing primates could develop immunity against Covid-19, establishing in a record-setting time that vaccines could be an effective tool to control the spread of SARS-CoV2. More than a dozen vaccine candidates were tested on monkeys to determine their safety and effectiveness, critically, scientists drew on previous research that showed an mRNA vaccine provided primates protection from Zika virus. This past experience helped lay the foundation for the development of Covid-19 mRNA vaccines, the fastest vaccines ever created. Going forward, primate research will help us understand if specific groups, such as the elderly, are more prone to develop long Covid. My team and others have early research suggesting the virus can travel to the brain through a person’s nose and potentially cause lasting neurological issues, such as brain fog, lost or distorted senses of smell, anxiety, depression, difficulty focusing and headaches, as has been reported in patients. Even more concerning is the risk that the pandemic will lead to a surge in cases of Alzheimer’s or Parkinson’s. Powerful monkey models of Covid-19 will be required to sort out such a potential link. We’re only at the very beginning of understanding long Covid, and we need to put all our tools — including increased federal funding — to work to unlock its mysteries. Providing additional federal funding for nonhuman primate research will help to speed up this critical research, getting us much-needed answers about long Covid faster. My colleagues and I are committed to conducting our research ethically and humanely. In the four decades I’ve been conducting research on primates, our protocols have continually evolved to improve the monkeys’ well-being. They live in social housing conditions, except in the rare occasions when scientific protocol demands isolation. We take care to respect and sustain the colonies’ natural hierarchies. We provide them dietary supplements and dental and eye care, and we work to keep their stress levels down. Furthermore, before any research on nonhuman primates can occur, it must be approved by an Institutional Animal Care and Utilization Committee, a committee of veterinarians, scientists and lay members of the community. What hasn’t changed since I started my career in primate research? Monkeys’ similarities to humans continue to make them essential partners in our quest for new discoveries of direct relevance to human health. More than 100,000 Parkinson’s patients have benefited from deep brain stimulation, a therapy developed through research on monkeys. Furthermore, researchers have even implanted electrodes in the brains and spines of paralyzed monkeys, allowing them to walk again. This research is already being applied to humans, potentially allowing paraplegics to walk. What was once thought of as impossible might become a standard medical procedure. For us to achieve that bright future, we need to recruit the best young scientists to join the field, and not fear they will be vilified for conducting vital research. We need the support of lawmakers who rightly herald medical advances that save lives every day. Anything else risks missing out on lifesaving advances that could benefit millions of people worldwide.