Microneedle Solutions (MNS): Improving the needle-free delivery of vaccines

Written by Ana Ivanus, Edited by Charles Leach and Natasha Barrow.

Microneedle Solutions (MNS) is on a quest to increase vaccines uptake by manufacturing affordable self-adhesive vaccine patches that patients can use themselves. The self-administration means that, ultimately, MNS’s product can reduce the strain on healthcare systems and increase vaccine uptake, thus reducing health inequality whilst improving access to vaccines globally.

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“Our mission is to democratise vaccinations so that those in rural, resource-limited settings no longer die from wholly preventable diseases.”

— Henry Dunne

We sat down with the CEO and co-founder of Microneedle Solutions (MNS), Henry Dunne, to discuss the product, the company’s history, and future perspectives.

The problem

While the last century saw a revolutionary development of vaccines that help prevent and control life-threatening infectious diseases, such as polio, measles, hepatitis, or HPV, to this day there are still huge issues faced by the public health. These include vaccine hesitancy, needle phobia, and equitable distribution, leading to health inequalities worldwide. With the need for vaccines to be transported and stored at low temperatures, this often poses problems when it comes to vaccine supply chain in low- and middle-income countries. Microneedle Solutions seeks to solve exactly this problem.

The technology behind Microneedle Solutions

Microneedle Solutions (MNS), as the name suggests, manufactures self-adhesive vaccine microneedle patches. Microneedles, arrow-shaped microscopic structures, are used to facilitate the delivery of water-soluble vaccines or therapeutics transdermally (through the skin). These solid silica-based or metal-based microneedles are small yet robust enough to penetrate the outermost layer of the skin (the stratum corneum). They are pre-coated with the active pharmaceutical ingredient (API) before application, allowing the drug of choice to be dissolved in the interstitial fluid and delivered in the body (Fig. 1) [1].

This approach is less invasive than traditional intramuscular/intravenous injections, as it presents less severe side effects localised at the site of administration (such as redness of the skin, or temporary skin irritation), thus avoiding systemic allergic reactions. Furthermore, transdermal delivery through microneedle patches is virtually painless, as these structures are too small to reach any nerve ending and produce a pain response. These drug-coated microneedle patches can also be manufactured whilst factoring in the varied skin elasticity among populations.

Wider implications and societal impact

The patches MNS have worked on as part of their R&D process are extremely cheap to manufacture both on a small and a larger industrial scale. As the chosen therapeutics have been previously approved by regulatory bodies, every component in the patches, including the APIs, are already cleared for safety, and any side effects and immune responses are well-characterised. Their technology is not limited to vaccines or therapeutics, but it can also be implemented for non-pharmaceutical applications, such as cosmetics.

What makes MNS unique is their ability to increase market access to a wider population, through a less invasive method that facilitates user compliance and self-administration. However, as CEO Henry Dunne points out, this technology has been established for five decades, and there are plenty of other companies working on microneedle delivery of vaccines and drugs. Therefore, their key goal lies in driving the commercialisation pipeline forward using inexpensive, FDA-approved precursors, and bringing the product to market following pre-clinical and clinical trials, and with the guidance of their advisors.

The answer may lie in the stringent regulations for vaccine patches. Whilst there are microneedle-based products on the market, none of those are currently sold for pharmaceutical delivery. In fact, the company raised their pre-seed funding using prototypes that were manufactured and tested in vitro using different cargo delivery methods, and they successfully proved the device pipeline is translatable to other pharmaceutical devices.

The infrastructure behind the manufacturing and supply of “traditional” injections is complex, requiring freeze drying and storage at low temperatures for the vaccines to still be viable. Vaccine microneedle patches can overcome this problem as they can be stored at room temperature for 30 days and still be efficient and safe to use. From a pharmaceutical perspective, microneedle patches need to have an immune response that is at least as good as, if not better than, the intravenous and intramuscular injections that are currently on the market.

With this in mind, a satisfactory immune response, as well as the ability to scale up the manufacturing as cheaply as possible, are both advantages the MNS team hold. These two selling points could persuade pharmaceutical stakeholders to adapt the current infrastructure to allow the implementation of microneedle vaccine delivery through a self-administration model, thus increasing accessibility.

In high-income countries, which receive the main benefits of innovative therapeutics, regulations behind self-administration of drugs are strict to prevent the population from “self-medicating” at home. However, this is not the case for low- and middle-income countries, where infectious diseases are also more prevalent, therefore representing a way for MNS to enter the market and democratise vaccine uptake. MNS is not only “winning” the technology selling point, but also the global societal impact they could bring after commercialisation.

The team behind MNS

Co-founders Henry Dunne and Ian Bartenev met at University of Leeds, where they were both BSc Biotechnology with Enterprise students. Equipped with biotech knowledge and newly acquired enterprise learnings, they founded MNS with the support of the university. They started working on their R&D pipeline and prototypes while they were still completing their undergraduate degrees, and so their research was undergone at the University of Leeds.

Henry Dunne recalls how the University of Leeds was a supportive environment for founding their own start-up. Following a successful pitch, built based on their enterprise modules knowledge, both Henry and Ian were recipients of the Spark Scholarship, which enabled them to run MNS as part of the Spark incubator and receive business advice and professional mentoring. They also had access to NEXUS, the University of Leeds hub that connects innovators, entrepreneurs, and business professionals. Henry describes how being part of these communities helped them in the early stages of the company, as they had the support needed to understand the problem addressed and the accessible market, and they benefitted from mutually beneficial collaborators with the other Spark incubator start-ups.

What’s next?

The sky’s the limit when it comes to Henry and Ian. Following the company’s incorporation in 2022, they were successful in securing places in different venture-building programmes such as Nucleate Catalyse and Pioneer Group Pre-Accelerator and Accelerator programmes. Now, as part of the SEC Innovators Club 2023 cohort, Henry recalls how it was truly beneficial for them to learn how to stand out as a company and gain new connections and industry insights.

With the pre-seed round they raised, and with an expanded team of postgraduate students, MNS is now aiming to finalise their in vivo and in vitro studies and compile a set of reliable, high quality data as well as build their IP portfolio. Their plan is to explore the scope of market for other opportunities they can apply their technology in, and ultimately prepare for raising seed funding within the next 12 months, funding which will allow them to employ professionals on the board team and progress to human trials.

A CEO’s advice to aspiring entrepreneurs

Henry and Ian were both undergraduates when MNS was born, and so their success story is something to take note of. The advice Henry has for current students and aspiring entrepreneurs is to prioritise their education first, but to fiercely pursue their ideas nonetheless.

“A key consideration is to gather information. Before doing any R&D, talk to the people in the industry and in your particular sector. You need to validate your assumptions and gather resources. Don’t be put off by negative comments and persevere regardless of the things that go wrong”

— Henry Dunne

References

Microneedle Solutions have so far proven they are definitely a company and team to watch. With their tenacious approach to commercialising vaccine microneedle patches and finally tackling health inequality through democratising vaccines, their spark might be just what the market needs.

[1] Kim, Y.C., Park, J.H., Prausnitz, M.R, Microneedles for drug and vaccine delivery, Advanced Drug Delivery Reviews, Volume 64, Issue 14, 2012, 1547-1568. https://doi.org/10.1016/j.addr.2012.04.005.

[2] Henry Dunne and Ian Bartenev, Case Studies, Centre for Enterprise and Entrepreneurship Studies, University of Leeds. (https://cees.leeds.ac.uk/casestudies/enterprise-students-develop-vaccine-administration-products-with-help-of-spark-funding/)

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