Enesi ImplaVax - Enabled Vaccination Technology

The ImplaVax technology comprises three main components:

• A single precision-engineered solid dose Universal Vaccine Implant (UVI) containing the monovalent or multivalent vaccine, antigen, or vector construct together with its associated excipient matrix that confers its mechanical strength and stability
• A separate, disposable unit dose cassette pre-loaded with the single solid UVI
• A handheld spring-powered actuator (single or reusable up to 1,000 times)

Our proprietary technologies are approved for human clinical trial use having successfully completed thorough feasibility tests.

Data delivered to date provide compelling evidence for the potential of ImplaVax products to transform the performance and delivery of vaccines and make a significant positive impact on global healthcare.

You can watch the process of creating an ImplaVax UVI and see the ImplaVax in action here

Our ImplaVax^® platform is built upon our advanced formulation capabilities, evidenced by the breadth of UVIs made to date and their applicability to all current vaccine formats, including sub-units, toxoids, conjugates, peptides, proteins, virus-like particles, recombinant products, live attenuated viruses, vector-based systems, and DNA-based vaccines.

Current projects include but are not limited to Influenza, measles-Rubella, HPV, HIV, Shigella, Anti-microbial resistance, TCV, and a number of emergent threat pathogens and Medical Counter Measures.

The Universal Vaccine Implant (UVI) is a novel, proprietary, precision engineered unit solid dose vaccine formulation. Each UVI consists of the vaccine(s) and approved excipients that are utilised in traditional lyophilised vaccine or biological formulations. All benefit from enhanced thermal stability, which both aids administration, extends shelf-life and optimises stockpiling.

Each UVI is 0.85mm in diameter and 4mm in length with a solid volume of injection of approximately 2.5 microlitres, or about 250 times less than a typical intramuscular liquid delivery. It has a sharp tip and mechanical strength designed to ensure 100% skin penetration each and every time.

The physicochemical properties of the UVI can be fine-tuned so that the dissolution of the vaccine into the dermis layer of the skin is rapid (minutes) or slow (weeks), or even pulsatile. This can optimize the interaction and recruitment of immune cells and antibodies to generate a long-lived immune response with potential for regimen sparing.

Enesi Pharma can employ one of three manufacturing processes, namely extrusion, micro-tableting, and polymer moulding, to match the required robustness of the vaccine in development. All three processes have the capability for high-throughput scaleup, and ImplaVax^® can offer local, global and portable approach to commercial-scale vaccine manufacture.

The Universal Vaccine Implant (UVI), which is pre-loaded during manufacturing in a sterile single use disposable cassette, is delivered using Enesi Pharma’s proprietary needle-free, multi-use (up to 1,000 times), spring-loaded actuator to facilitate reliable needle-free delivery in a pain-free manner. In our first human factors study, we found that the ImplaVax platform was preferred (93%) by all groups of administrators, recipients and parents in comparison to a standard needle and syringe injection.

Additionally, a single use disposable system is in development where all three components are self-contained and could enable self-administration in the home setting. Both repeat use and single use systems do not require the use of glass vials, separate diluent or multiple needles and syringes.

Each UVI is delivered transcutaneously 2.5 – 7mm into the dermis, which has been shown in pre-clinical studies to be as least as effective as intramuscular or subcutaneous delivery routes. This is because the dermal and the sub-cutaneous region of the skin are rich in dendritic cells which are responsible for presenting antigens to the immune system.

Enesi’s ImplaVax enabled products have transformational potential for patients, users and suppliers, including:

• Multiple products formulated with excellent stability profiles – up to two-years’ stability demonstrated
• Enhanced immune response for vaccines demonstrated compared to standard injection
• Direct needle-free solid dose delivery – rapid administration, easy and intuitive to use for one-off and repeat-use regimens
• Strong patient preference for ImplaVax® over needle and syringe
• Single-use disposable cassettes – eliminating risk of disease transmission between individuals from shared needles
• No need to dispose of hazardous needles, syringes or vials eliminating needle stick injuries for patients and care givers, and reducing costs associated with disposal
• No need for additional diluents or water for reconstitution at point of care
• Single unitary dose – 100% dosing assured each time
• Reducing/eliminating need for cold-chain requirements