Category: In the News

Originally published in BioStartUps

aVaxziPen Ltd, a biotech company developing a novel needle-free vaccine delivery platform, have today announced a partnership to advance the development of two vaccines candidates (one protein and one mRNA-based) using aVaxziPen’s solid dose vaccine-delivery platform, which could help end the need for frozen storage of vaccines, thereby improving equitable access to vaccines. CEPI will initially provide up to US$1.6 million to establish proof-of-concept for aVaxziPen’s vaccine-delivery technology by evaluating stability, delivery and preclinical immunogenicity of both mRNA and proteinbased vaccines developed using aVaxziPen’s platform.

The current generation of mRNA vaccines require frozen storage due to the fragility of mRNA molecules. Once removed from the freezer, these vaccines usually have to be used within a short timeframe. Removing the need for frozen storage would make mRNA vaccines significantly easier, and cheaper, to ship, store and distribute in low-resource settings. While protein-based vaccines do not typically require frozen storage, they often need to be stored at temperatures between 2-8°C, so developing a protein vaccine platform capable of withstanding temperatures of up to 40°C for at least 1-2 months would help to simplify last-mile delivery of these vaccines, even in the most remote regions of the globe.

aVaxziPen’s solid-dose vaccine technology uses a pen applicator device and is designed to address these challenges by protecting the mRNA and proteins against degradation, potentially removing the need for frozen storage for mRNA vaccines, and the need for cold-chain storage altogether for protein-based vaccines. It does this through its proprietary solid-dose formulation technology, which uses precision engineering to produce a thermostable, guaranteed solid-dose formulation.

In addition to being thermostable, aVaxziPen’s applicator device offers other potential benefits, including ease of administration (requiring no specialised-medical training), and it can be reused for 1,000 doses, helping to minimise waste. It’s light and robust presentation also makes it ideal for shipment and storage.

If the initial preclinical proof-of-concept is successfully established, CEPI and aVaxziPen may agree to further the partnership by agreeing on vaccine candidates to take forward into Phase 1 clinical trials.

Anand Ekambaram, Executive Director of Manufacturing and Supply Chain, CEPI, said: “Equitable access is at the heart of CEPI’s mission. aVaxziPen’s innovative vaccine delivery technology requires little-to-no training to administer, while simultaneously reducing the need for expensive and burdensome cold-chain storage, allowing for easier distribution and administration. These innovations would ultimately help to enable greater access to potentially lifesaving vaccines in lower resource settings when a future outbreak or pandemic threat emerges.”

Robin Cohen, Chief Business Officer, aVaxziPen, said: “We’re delighted to be working with CEPI as an important strategic partner to demonstrate the great potential of our vaccine technology. Collaboratively we will bring our solid-dose vaccine formulations to two vaccines to demonstrate significantly improved and extended thermostability, as well as testing immunogenicity with plans to progress into Phase 1 clinical trials. This is a great step forward in our mission to disrupt the vaccine market, providing improved vaccine coverage around the world, reaching under-served populations and markets.”

Originally published by the Medicine Maker

I could easily argue that vaccines are the biggest success story of modern medicine; millions of lives are saved across the globe every year through vaccination programs that protect entire populations from a diverse and evolving range of pathogens. Vaccines were already contributing much before COVID-19, but the pandemic demanded an increase in the speed of vaccine innovation and development, with the pharma industry quick to respond with new approaches to vaccine design, testing, and manufacturing scale up.

Despite profound improvements in vaccine development, the predominant delivery device is still a hollow needle and syringe. And it’s worth noting that one of the biggest issues with needle-based delivery, is needle phobia, medically known as trypanophobia – a common issue that has detrimentally affected the uptake of vaccines. Moreover, most modern vaccines still rely on cold chain and trained personnel for delivery, which can prevent accessibility and uptake – especially in locations with unreliable infrastructure or staffing issues.

In other words, though vaccines have achieved a great deal, less emphasis has been placed on solving some basic challenges with their delivery – both across the world and into people’s arms. I’d argue that the world has long-needed a better vaccine delivery system – and one has been developed using a novel technology platform, called aVaxziPen.

First, aVaxziPen ditches the hollow needle in favor of an easy to use (reusable) pen-like applicator and a single-use (and non-reusable by design) cassette, which houses a solid dose vaccine (SDV) of just 0.98 mm in diameter. The pen is simply pressed onto the arm and delivers, with minimal pain sensation and minimal waste, the exact dose of vaccine, which dissolves under the skin in around 15 minutes. Human factor studies strongly indicate a preference for this form of delivery over traditional needle and syringe.

Second, the SDV formulation reduces or eliminates the need to store vaccines under cold-chain conditions, increasing accessibility and reducing the carbon footprint of each life-saving dose. In partnership with Sementis’ recombinant vaccinia, we showed that the SDV formulation retained full vaccine titer for at least 12 months at 40 °C and 22 °C, and higher titer retention at 37 °C and 45 °C compared with liquid controls that mimic traditional vaccines (please note that this data is held on file and is available under a confidential disclosure agreement). The platform has been used to successfully formulate almost all vaccine types – from proteinaceous to viral vector and mRNA vaccines.

We must remember that the total cost of immunizing a population includes the resources required to deliver the vaccines. By reducing storage, training, and equipment costs through modern vaccine delivery techniques, we can ensure that people everywhere have access to effective vaccines. I believe this technology will transform the delivery of vaccines – and deliver a (needle-free) shot in the arm for global health.

Originally published in LABIOTECH

aVaxziPen, a biotech company developing a novel needle-free vaccine delivery platform, presented data at the World Vaccine Congress (WVC) in Washington, U.S., recently. 

The company presented a poster entitled, “Needle-free, injectable solid dose vaccine delivery generates equivalent immune response with different antigens and animal models.”

The company said immunogenicity data from four in vivo models reinforced the value of its needle-free solid-dose vaccine platform as a novel way to effectively deliver vaccines for tetanus, anthrax, influenza, and peanut allergy.

As well as improving ease of administration and accessibility, the technology offers the potential to reduce vaccine hesitancy associated with needle-phobia.

The solid-dose formulation technology is designed to improve thermal stability of conventional vaccines, which may reduce the demand for cold-chain logistics during distribution.

aVaxziPen transforming vaccine delivery

Keith Howard, aVaxziPen’s CSO, said: “With our needle-free technology we’re on a mission to transform vaccine delivery for the benefit of communities around the world.  Our novel solid-dose formulation technology coupled with our ‘click-and-deliver’ pen device has the potential to improve the accessibility and cost-effectiveness of every-day vaccines. This latest in-vivo data, presented in Washington at the World Vaccine Congress, demonstrates how our technology generates comparable immune responses for several vaccines in a needle-free presentation.”

In the poster presented at WVC, in vivo data showed immunogenicity equivalence for aVaxziPen’s needle-free solid dose vaccine compared to existing vaccine presentation which employs needles and syringes, in four examples: a recombinant attenuated vaccinia virus expressing a peanut allergen; a tetanus toxoid vaccine with an alum adjuvant; a recombinant protective antigen anthrax vaccine; and a recombinant influenza H7 vaccine.

The company has completed construction of a manufacturing line using isolator technology capable of producing sterile products in preparation for human clinical trials.