We have been successful in securing multiple collaborations with leading international partners to develop novel solid dose ImplaVax®-enabled vaccines designed to prevent and treat a wide range of infectious diseases, allergies and other diseases. This demonstrates the broad potential of our ImplaVax® formulations against many diseases across all vaccine formats.
Infectious disease – improved versions of existing vaccines
A public-private partnership* between Enesi and the U.S. Biomedical Advanced Research and Development Authority’s (BARDA) DRIVe (Division of Research, Innovation, and Ventures) initiative to develop new influenza vaccines enabled by ImplaVax® technology. DRIVe is an initiative of BARDA that supports the development of innovative products and approaches aiming to solve major health security challenges.
The partnership aims to generate evidence to support the use of solid dose presentations as the preferred method of vaccination in a future pandemic influenza event, with the potential of enhancing the immune response, while improving logistics (manufacture, stockpiling) and reducing storage and distribution costs.
*This project has been funded in whole or in part with US Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, DRIVe, under this contract.
Enesi has entered a collaboration with an undisclosed international partner to develop a solid dose version of the Typhoid Conjugate Vaccine, bringing improvements to the existing manufacturing and supply chain of the vaccine.
Enesi was awarded grant funding from the Bill & Melinda Gates Foundation* in October 2019 to evaluate the ImplaVax® technology for enabling the development and delivery of solid dose vaccines for Measles and Rubella. The project aims to generate compelling data to confirm if the ImplaVax platform can impart significant advantages to the delivery of vaccines for these diseases, such as bringing user improvements, enhancements to the existing manufacturing and supply chain of the vaccine, together with the potential for regimen sparing.
*’Bill & Melinda Gates Foundation’ is a registered trademark of the Bill & Melinda Gates Foundation in the United States and is used with permission.
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.
Allergies & antimicrobial resistance – Applying ImplaVax® to non-traditional vaccine applications
Enesi and Sementis are collaborating to develop and evaluate a solid dose version of Sementis’ lead peanut hypoallergy vaccine, which has the potential to offer a permanent cure for peanut allergy.
Serious allergies to peanuts represent a large unmet medical need across the world, with a high cost to healthcare systems. An ImplaVax®-enabled vaccine could provide a simple and effective means to address peanut allergy on a large scale, particularly for younger sufferers who may have an aversion to needles and traditional injections.
Enesi and an undisclosed partner are collaborating to develop a solid dose vaccine to fight Staphylococcal infection, a bacterial infection with rapidly increasing incidence, which shows resistance levels between 20% and 40% against methicillin.
Oncology via therapeutic vaccines
Enesi is collaborating with undisclosed partners to develop solid dose vector-based DNA vaccines against cancer. A collaboration with an undisclosed immunotherapy company focuses on the administration of target antigen DNA via a plasmid-based vector, whilst a partnership with an academic institution addresses a form of cancer associated with a high level of mortality and morbidity.