The COVID-19 global health emergency has highlighted the need for vaccines to address novel infections, as its rapid spread has made vaccine development an urgent worldwide priority. While speed is of the essence, both scientific considerations for generation of effective and safe vaccines, and ease of deployment and administration en-masse are of paramount importance, especially given the huge scale at which such vaccines will be required to meet global demand.
SARS-CoV-2 is the latest in a series of viral threats to have emerged in the last 20 years, others of which include Ebola, MERS, Zika and Anthrax. Similarly, there are also a number of other emerging biological threats and priority pathogens that may affect the public or military personnel against which our ImplaVax® technology is uniquely positioned to address in partnership with global partners.
Infectious diseases – New threats; addressing biodefence and global priority pathogens
Enesi and Public Health England (PHE), an executive agency of the UK Government’s Department of Health and Social Care, are working together to develop and evaluate a novel solid dose formulation of a number of PHE’s proprietary vaccine candidates against emergent threat pathogens for delivery using ImplaVax®, including Anthrax recombinant Protective Antigen (rPA) and Crimean-Congo Haemorrhagic Fever (CCHF).
ImplaVax®-enabled vaccines could simplify the dosing schedule, reducing the number of doses and time to reach threshold immunity in both a pre- and post-exposure setting. They also benefit from extended thermal stability, making a significant contribution to reducing the end-to-end cold chain logistical challenges, cost, and will greatly assist in optimising the cost-effectiveness of the national strategic stockpile.
Enesi is collaborating with the world-renowned Oxford Vaccine Group (OVG) at the University of Oxford to create and test a solid dose vaccine against plague, a Category A priority pathogen for which there is currently no approved vaccine.
The collaboration aims to create a stable and easy-to-use solid dose plague vaccine for use in areas around the world where outbreaks occur as well as for building strategic stockpiles as part of government preparedness for rapid deployment in the event of a bioterrorism incident. It leverages ImplaVax® and a proprietary vaccine against the bacteria causing plague (Yersinia pestis) developed by OVG, based on a ChAdOx adenovirus vector.
Enesi has entered a Cooperative Research and Development Agreement (CRADA) with the Walter Reed Army Institute of Research (WRAIR), a United States Department of Defense Laboratory, focusing on the development of a robust and stable solid dose formulation of WRAIR’s Shigella flexneri 2a artificial Invaplex (Sfl2a InvaplexAR) vaccine for delivery using ImplaVax®.
A vaccine able to protect against Shigella is a high-priority objective for the US Army and is an equally high-priority for vaccine developers targeting paediatric populations in endemic areas of the world.
Enesi is collaborating with Sementis to develop and evaluate a solid dose version of Sementis’ single vectored chikungunya/Zika dual combination vaccine candidate. An ImplaVax®-enabled product using the Sementis proprietary SCV (Sementis Copenhagen Vector) chikungunya/Zika vaccine offers the potential to provide long-lasting immunity and retain potency across a wide range of storage conditions for prolonged periods. These represent high-priority objectives for governments and health authorities around the world.
Enesi is collaborating with the University of Adelaide to develop a thermostable solid dose DNA vaccine targeting Zika virus to prevent infection of pregnant women and the resultant congenital effects in the unborn child. The innovative combination of this ImplaVax® formulation and needle-free delivery system with the novel DNA vaccine construct developed by researchers at the University of Adelaide is expected to enhance the vaccine’s efficacy, thermal stability and allow for safe and rapid vaccination of target populations that are otherwise geographically and economically disadvantaged.
Enesi and Imperial College London are collaborating to evaluate ImplaVax® solid dose, needle-free vaccines against RNA vaccines, including SARS-CoV-2, that are stable at ambient temperatures and up to 40o Celsius (104o Fahrenheit).
Enesi, supported by Innovate UK, is undertaking a major new project to develop a scalable aseptic manufacturing process for live or live-attenuated viral vectors for use with ImplaVax®. Viral vector vaccines represent a rapidly growing area of interest as they form the foundation of new vaccines being developed by many companies to target defined and high-value opportunities in infectious diseases, emergent threat pathogens, allergies and oncology among others.
The Innovate UK grant will support the advancement of Enesi’s existing collaborative programmes and will also pave the way for the company to capture future opportunities to develop viral vector vaccines for delivery using ImplaVax® using other viral vectors and addressing a wide range of public health concerns.