Enesi Pharma (“Enesi”), an innovative biotechnology company developing next-generation vaccination products targeting infectious diseases and emergent threat pathogens enabled by its ImplaVax® technologies.
Enese Pharma today announced it has achieved a key milestone in its project to develop needle-free thermostable unit solid-dose live vaccines with retained activity against Measles and Rubella. The project, which started in October 2019, received funding from the Bill & Melinda Gates Foundation.
The project established important proof-of-concept for ImplaVax®-enabled unit solid-dose presentations of both vaccines, demonstrating that each was thermally stable at temperatures of 40°C for three days and at 25°C for at least one month, and met key criteria for retained activity. Further longer-term stability studies are underway, and the Company is planning the immunogenicity studies needed to determine the next development steps to progress the novel vaccine formulations towards clinical trials.
Measles and Rubella vaccines are typically maintained in a lyophilized (freeze-dried) form that requires reconstitution in solution prior to injection using a needle and syringe. Once reconstituted, however, the vaccines exhibit very poor thermal stability and rapidly lose effectiveness if not refrigerated. This is an important consideration in low- and middle-income countries (LMIC) where cold-chain issues and access to target populations for vaccinations can be challenging.
By eliminating the need for reconstitution and improving thermal stability, ImplaVax®-enabled Measles and Rubella vaccines could improve the cost-effectiveness of supply and robustness of vaccine deployment and delivery in these regions. Additionally, ImplaVax®-enabled Measles and Rubella vaccines may provide further benefits that improve vaccination uptake and coverage based on needle-free delivery of a unit dose minimizing vaccine wastage, elimination of needlestick, and cross-contamination hazards and waste and requirement for minimal training.
David Hipkiss, Enesi Pharma CEO, commented: “We are extremely grateful for the support we have received from the Bill & Melinda Gates Foundation to undertake this project. It is very exciting to see the results emerging from this and the many other collaborations we initiated over the past few years with leading partners, including those announced recently in pandemic flu and in significant animal health indications. These results are establishing preclinical proof-of-concept for ImplaVax®-enabled solid dose forms of vaccines based on many of the major current formats in use today. As we successfully achieve key milestones in these collaborations, we are building a firm foundation of evidence supporting our belief that our ImplaVax® solid-dose technology could be a potentially transformational approach to improving vaccination against significant health threats globally.”