Author: aVaxzipen

aVaxziPen Revolutionizes Vaccine Delivery for Enhanced Accessibility and Distribution

Posted on by aVaxzipen

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.”

Needle-free vaccine delivery platform aims to end frozen storage needs and improve access

Posted on by aVaxzipen

June 6, 2023; OSLO, Norway and OXFORD, UK: CEPI, the Coalition for Epidemic Preparedness Innovations, and 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 protein-based vaccines developed using aVaxziPen’s platform.

The potential of needle-free vaccines to end frozen storage

Advances in vaccine technology have been critical to the global response to COVID-19, but one of the challenges the world faced in getting these lifesaving vaccines to vulnerable populations—particularly those people in poorer countries—was the need to store them at low or very low temperatures.

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. Its 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 align with unmet vaccination needs in low- and middle-income countries) to take forward into Phase 1 clinical trials.

This project is the third to be announced as part of CEPI’s January 2022 Call for Proposals, aimed at improving thermostability of—and thereby improving equitable access to—a variety of new vaccine platforms. This Call forms part of CEPI’s wider strategic goal of harnessing innovative technologies to improve the speed, scale and access of vaccine development and manufacturing in response to epidemic and pandemic threats.

Enabling equitable access to vaccines

CEPI and aVaxziPen are committed to enabling global equitable access to vaccines developed through their partnership. Under the terms of the funding agreement, aVaxziPen has committed to ensuring supply for low- and middle-income countries (LMICs), production of vaccine volumes required to meet public health needs, affordable pricing for LMICs, and the potential technology transfer to LMIC manufacturers in line with CEPI’s Equitable Access Policy.

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.”

The world has long needed a better vaccine delivery system.” The time of the hollow needle is over – solid dose vaccines are the future

Posted on by aVaxzipen

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.

aVaxziPen’s needle-free vaccine yields positive data across multiple diseases

Posted on by aVaxzipen

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.

aVaxziPenTM solid dose vaccines are thermostable compared to liquid vaccines

Posted on by aVaxzipen

aVaxziPenTM Limited and Sementis Limited have completed a feasibility study formulating vaccinia-based Sementis Copenhagen Vector (SCV) system into aVaxziPen’s solid dose vaccine (SDV), which allows needle-free injection of vaccines using aVaxziPen’s Multi-use pen and disposable cartridge vaccine delivery platform.

The study demonstrated that the SDV formulation retained full vaccine titre for at least 12 months at 4oC and 22oC and higher titre retention at 37oC and 45oC compared to the liquid controls.

Methods

SCV liquid vaccine stock, provided in storage buffer, 10mM Tris, pH 8 was formulated using aVaxziPen’s proprietary formulation containing stabilising and bulking excipients prior to manufacture of solid dose vaccine (SDV). Each SDV containing 1.45×107 plaque forming units (PFU) per dose were packaged in sterile screw cap polypropylene tubes and were stored within secondary packaging (moisture barrier bags) under minimum humidity environmental conditions. Liquid controls were formulated in 10mM Tris pH 8/150mM NaCl targeting the measured titres of the solid doses (1.45×107 PFU/dose). Aliquots were made in sterile O-ring screw cap polypropylene tubes. SDVs and liquid controls were set on stability at different temperatures: 2-8oC, 22oC, 37oC, and 45oC based on ICH Quality Guideline for Stability Testing of New Drug Substances and Products Q1A(R2) with adjustment for available materials, equipment and the pilot nature of the study. Vaccine stability was assessed by measuring vaccine potency by plaque assay. The limit of detection (LoD) was designated as the lowest dilution factor assayed. Where no plaques were detected, a value of 10 was designated for graphical purposes.

Results

Solid dose vaccine formulation of SCV was manufactured using aVaxziPen’s microtableting technology and subjected to stability study for up to 12 months. The thermostability of the viral vaccine in the SDV formulation at the different time points (1, 3, 6, 9, and 12 months) was consistently greater than that of the liquid formulation.

At 2-8oC (Figure 1A), the SDV formulation showed full retention of potency of the viral vector vaccine. The difference in titre between the Day 0 and 12-month samples was minimal (0.06 log10 PFU) for the SDV formulation compared to 0.7 log10 PFU in the liquid control.

At room temperature, 22oC (Figure 1B), the loss of titre in the SDV formulation was less than 0.5 log10 PFU after 12 months compared to more than 3 log10 PFU in the liquid control.

Similarly, at 37oC and 45oC (Figure 1C and 1D), the liquid control lost more than 2 log10 PFU) after 30 days and 7 days of storage, respectively.  The vaccine formulated as a SDV had greater retention of titre at these temperatures.

Figure 1: Assessment of retention of infectivity titre of Sementis Copenhagen Virus (SCV) in aVaxziPen’s Solid Dose Vaccine (SDV) stored at, (A) 2-8oC, (B) 22oC, (C) 37oC, and (D) 45oC. Data are shown as PFU/dose where each data point represents the mean ± SEM of doses tested (n=2-3)

Discussion

aVaxziPenTM has produced a solid dose vaccine (SDV) formulation of Sementis’ recombinant vaccinia, SCV, vaccine, which have been shown to be stable at 22℃ for 12 months and have greater stability relative to a standard liquid formulation at 37℃ and 45℃. SCV is a live, attenuated viral vaccine platform that requires infectivity to function as a vaccine. Retention of infectivity is dependent on maintaining the integrity of all the biological components of the virus particle. The stability of vaccines is an important consideration in relation to how it is used and the overall cost-effectiveness of that vaccine.  Stability studies are an important aspect of the regulatory assessment. The use of thermostable SDV formulations of such vaccines will facilitate distribution by reducing cold chain requirements, while the additional benefits are provided by the needle-free delivery of the SDV by the reusable, self-actuating aVaxziPenTM device.

Conclusion

aVaxziPen’s solid dose vaccine technology can avoid many of the challenges associated with conventional liquid formulations of vaccines such as restrictive cold-chain requirements and vaccine hesitancy associated with needles. aVaxziPen’s thermo-stable, needle free technology offers the potential to enhance the cost effectiveness of vaccines through reduced resource utilization in their storage, handling and delivery. This study clearly demonstrates that aVaxziPen’s solid dose formulation successfully enhanced thermal stability compared to storage in a liquid formulation.

aVaxziPen Announces Positive Data in Multiple Diseases on Novel Needle-Free Vaccine, Thermally Stable Delivery Platform at World Vaccine Congress

Posted on by aVaxzipen

In vivo data demonstrates immune equivalence to traditional needle and syringe injection when using a needle-free solid dose formulation

Oxford, UK, 3 April 2023 – aVaxziPen, a biotech company developing a novel needle-free vaccine delivery platform, announces the presentation of data at the World Vaccine Congress (WVC) in Washington, USA. The company will present a poster entitled, “Needle-free, injectable solid dose vaccine delivery generates equivalent immune response with different antigens and animal models”.

The immunogenicity data from four in vivo models reinforces the value of the company’s 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.

Dr 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
  • 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.