Enesi Pharma & BARDA Drive Enter Public-Private Partnership to Develop Solid Dose Vaccine Delivery Technology

Enesi Pharma recently announced it has entered a public-private partnership with the US Biomedical Advanced Research and Development Authority’s (BARDA) DRIVe (Division of Research, Innovation, and Ventures) initiative to develop new vaccines against influenza enabled by Enesi’s ImplaVax device and formulation technology.

ImplaVax is a novel formulation and needle-free device technology that enables solid dose vaccine implants to be delivered quickly under the skin. The aim of this technology is for healthcare providers or individuals themselves to administer the vaccine using this simple, convenient, and reusable needle-free device. ImplaVax also has the potential to generate improved immune responses, along with reduced storage and distribution costs.

This new program aims to provide a cost-effective technological innovation that improves vaccination uptake, coverage, compliance, and preparedness and is part of DRIVe’s innovative health security technologies portfolio. DRIVe is seeking and funding extremely bold, radical, and disruptive innovative solutions that have the ability to transform health security. Relevant projects in this portfolio may create new technologies or leverage existing technologies in an innovative, disruptive way.

Under the program, Enesi will leverage its ImplaVax platform, combining a protective influenza vaccine with its simple and robust needle-free vaccine delivery system, enhancing the vaccine’s efficacy, thermal stability and rapid administration to a target population. ImplaVax could become a potentially disruptive technology not only for pandemic influenza, but for multiple vaccines, vaccination protocols, infectious diseases, and biological threats.

“We are extremely proud to have been selected by BARDA DRIVe for this partnership. The team at DRIVe has been incredibly supportive of Enesi and clearly recognize the need to revolutionize vaccine delivery as part of their mission to advance research and development of medical countermeasures against serious health security threats. This is the latest in a series of key strategic partnerships and represents the next step in our journey to make a tangible difference to global healthcare,” said David Hipkiss, Enesi CEO.

This DRIVe project will involve analytical and pre-clinical evaluation of novel ImplaVax-enabled solid dose implant formulations of marketed influenza vaccines in validated models. In vitro tests will include confirmation of titer generation, mechanical strength, and surety of implantation. In vivo testing will assess comparative efficacy and dosing regimens. Performance of solid dose implants versus placebo and active control delivered by needle and syringe will also be measured. The overall aim is to generate compelling evidence to support the use of solid dose presentations as the preferred method of vaccination in a future pandemic influenza event.

BARDA (Biomedical Advanced Research and Development Authority) is a key component of the US Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR). DRIVe (Division of Research, Innovation, and Ventures) is an initiative of BARDA that supports the development of innovative products and approaches that aim to solve major health security challenges through innovative products and approaches.

DRIVe was established in June 2018 to transform health security innovation to protect Americans from 21st century health security threats. DRIVe’s business-friendly EZ-BAA application process streamlines the way government partners with industry. www.phe.gov/about/barda/ .

Enesi Pharma is an innovative pharmaceutical company developing new products with potential to transform performance and delivery of vaccines and make a material impact on global healthcare. The company’s primary focus is the development of novel solid dose vaccines against a range of infectious and other select diseases, working in partnership with global companies, government agencies, and non-governmental organisations.

Enesi’s ImplaVax formulation and device technologies offer significant potential benefits for patients, care givers, healthcare professionals, and payers through enhanced effectiveness, safety, ease of use, reliability, and stability, and are supported by a strong patient preference over a standard needle and syringe.

The company has established multiple collaborations to evaluate opportunities for ImplaVax-enabled vaccines for a range of infectious diseases and allergies, including with BARDA DRIVe, the University of Oxford, the Walter Reed Army Institute of Research, Public Health England, Sementis and GeoVax.

Enesi’s experienced leadership team has a proven track record in the successful development and commercialisation of innovative products delivering high value outcomes for all stakeholders. For more information visit www.enesipharma.com or follow Enesi on Twitter at www.twitter.com/enesi_pharma.