Vaccination simplified: Ceramic patches to replace painful jabs!

Imagine if taking a vaccine would have been as easy as eating an ice cream. Sounds childish? Not anymore, as soon we might have the technology in India that allows smooth delivery of vaccines instead of a painful jab. Yes, we are talking about small ceramic skin patches that can load and release many different vaccines into the skin, delivering vaccines in a much better way than the traditional jabs that use syringe-and-needle injecting vaccines into muscles.

Developed by Dutch company, MyLife Technologies, the ceramic skin patches are approximately 1 cm in diameter, and 1 mm thick and contain 100+ minute protrusions or shafts, each with a small but distinct tip. They are also called micro needle arrays, but have nothing in common with normal hypodermic needles. Designed to penetrate only the upper skin layers, they reach into the epidermis and dermis, in full contact with the abundant lymph fluids, yet never touching the blood vessels and never touching the nerves which lie deeper at approx. 500 – 600 micrometer and further down. No pain, no contaminated blood, no needle anxiety.

The standard pore size of 80 nanometers of the ceramic material is large enough for small drugs, peptides and small proteins to be loaded inside the pore volume and to diffuse out of the array via needle tips and shaft into the skin. Larger macro-molecules, complexes of peptides or proteins and virus like particles are conveniently located at the pitted surface of the ceramic tips and shafts and stabilized by using certain excipients in our formulation. Any liquid vaccine formulation is rapidly absorbed by the ceramic nano structure and dries quickly, much like a ceramic sponge or filter.

Explaining further, Mike de Leeuw, CEO, MyLife Technologies says, “Unlike all other types of micro needle arrays, our ceramic material consists of tough ceramic material interspersed with nano-pores. These nano-pores are inter-connected throughout the complete array, with nano pores of an average diameter of 80 nanometers. The ceramic arrays are completely inert, meaning the ceramic material cannot react with the loaded cargo, nor with the surrounding skin, limiting any kind of ‘skin reaction’ to the absolute minimum of minute mechanical penetration.”

On being asked how Indian vaccine industry could benefit from ceramic skin patch platform, Mike says, “The fact that we can enable vaccine companies to deliver the same protection as intramuscular injections with 5-20 times less vaccine and no need for adjuvants will make its acceptability by the public far better, and allow these companies to differentiate themselves from the run-of-the-mill vaccine products.”

What’s wrong with current form of vaccine delivery?

Estimated 25% of all vaccines and biologicals that require cold chain distribution are lost due to disruption the logistical cold chain. In 2019 that meant losing 28 bln US$ of valuable and much needed vaccines. Then the first populations to miss out are living in Low and Middle Income Countries and rural areas. Imagine what that looks like these days with Covid-19 Pandemic and Ebola in war-torn African regions.

Another challenge is that anti-vaxxers can communicate strong, rational views concerning side-effects, conspiracy theories and safety concerns, but often have a deep-felt needle anxiety driving their opinions and positions. In EU and USA that means that 40-60% of the adolescents don’t show up for HPV-vaccination campaigns, free of charge, primarily driven by needle anxiety and group think. Realizing that up to 7% of all cancers are caused by this viral communal disease. HPV is completely preventable, life long, with 2 or 3 vaccinations, with the age group 12-15 to be most effective in breaking the infection cycles. That is why the WHO and other NGO’s are stepping up their efforts for HPV.

“Jabs in muscles is the traditional way of vaccination for the past 100 years, with great merits worldwide. But often ignored is the fact that muscles typically don’t have the required immune cells (antigen-presenting cells, dendritic cells) that can handle a vaccine. To attract the correct type of immune cells, vaccine developers add chemicals to the liquid formulation, called adjuvants, and that in itself leads to unnecessary side effects. Opposite to that, by presenting vaccines inside thin skin layers where the correct immune cells reside abundantly, 5x-20x times less antigen is required to trigger the same immunization and protection levels against pathogens. In most cases no form of adjuvant is needed to get this desired reaction,” explains Mike.

The foundational story

MyLife Technologies was founded in 2012 at the Technical University Twente in the city of Enschede, the Netherlands. In the early years (2012-2015) the company was virtual and had shown very promising initial development with Influenza-A Vaccine, Diphtheria and Tetanus. As of 2016, the company embarked on a mission to develop its own products based on generic drugs for chronic disease management like Alzheimer, Osteoporosis and Hemophilia, but didn’t manage to secure the necessary funding as the development risks for these chronic diseases are very high and the development lines very long, while the initial investors and founders would have been diluted out to negligible positions.

MyLife doesn’t call itself a device company as its ceramic skin patches are part of a vaccine product that will register in US and EU as a combined product. During November 2019, Mike de Leeuw, CEO, MyLife Technologies was invited by the shareholders to take-over and turn-around the company. He quickly convinced the board to go back to the original platform technology that was focused on the delivery of vaccines in the skin, but then do it in partnerships with vaccine developers. They also agreed that scaling-up the production of the ceramic skin patches would be core for raising new capital.

Mike explains: “We license out the technology based on our granted patents, and we supply the ceramic skin patches. But before reaching that mark, we perform paid feasibility studies to demonstrate to customers the competitive value of the proposition for their business. Initially in November 2019 we were aiming at the high value/ small volume cancer vaccines, but little did we know what was about to unleash at a global level,” says Mike. He stresses on the fact that customers are very keen about what they want with their vaccine candidates in their respective markets, while his company develops unique competitive advantages for these customers based on his in-house formulation IP, scale-up abilities and secure supply for them.”

One of two lead projects of the company is its HPV-skin patch that is aimed at improving vaccination against Human Papilloma Virus in Low-and Middle-Income Countries. The other main project is mRNA nano-particle delivery encoding for vaccine antigens.

“We are working on intradermal delivery of mRNA polymeric nanoparticles with an innovative partner here in Leiden, the Netherlands. Although initially aimed as demonstrating the intradermal delivery with Influenza, the mRNA can be aimed at cancer eradication and at other infectious diseases like COVID-19 etc. The fact that we combine polymeric nanoparticles with ceramic skin patches makes the product ambient stable and without need for Cold Chain distribution. For cancer-vaccine therapy we can enable patient specific patches, with minute quantities of mRNA or vaccine particles required since we target the most efficient target in the body for this type of vaccination: the skin”.

“Next to the two above projects, we have a SARS-CoV-2 spike protein project running with good results in vitro, and we have recently been invited by a famous academic hospital to test our ceramic skin patches in a clinical trial study using a commercially available mRNA COVID-19 vaccine aiming to reduce the current dosing levels by a factor 5-10 times. We have done first-in-human studies before with peptides on chronic disease management, and we have just finalized the feasibility with the commercial mRNA COVID-19 vaccine in our labs showing sufficient release, so now the proposal goes to our national Medical Ethical Committee for approval to perform the First-in-Human studies.

India plans: Banking big on JVs

“Currently we are a small sized start-up in Leiden-NL, but in my previous start-up and turn around experiences abroad and at home, I see no reason why we should be shy of rapid expansion and multi-facetted growth through JV’s and collaborations,” says Mike.

Mike thinks it is certainly feasible that the company sets up a JV-collaboration in vaccine R&D or a manufacturing JV in India. He is hopeful that vaccine companies in India would be exploring MyLife’s technology platform for their innovation drive.

“Having set-up an Indian JV in the 1990’s and having worked and lived in China and Indonesia, it is clear to me that the Indian entrepreneurial spirit and the sound technology acquired and innovated has matured and developed to world class levels yet bypassing unsustainable prices, which we increasingly endure here in the EU. Over the past three decades India has firmly rooted its products and innovation in many global markets for pharma and vaccines. In that sense India (and China as well) has taken its rightful share in the world markets and is leading the badly needed paradigm shift to keep global healthcare accessible, affordable for all in need. For us as vaccine delivery innovator we hope to partner with Indian vaccine developers and oncology companies as we expect their development to accelerate even further and drive our innovation to excel,” Mike mentions.

The company’s current partners in India are two-fold so far: a supplier of HPV-antigens and a small yet specialized consulting firm from Hyderabad helping it to map the regulatory and legal aspects of introducing its ceramic skin patches for the Indian vaccine opportunities. In addition, MyLife is partnering with a USA-based company originating from the Indian vaccine industry as well.

Way forward

MyLife plans to expand business activities to the USA, especially for the development of cancer vaccines, and into Indian markets via JV’s.

“For the coming 3-4 years we need to collaborate with multiple vaccine companies to introduce and license out our ceramic skin patches to multiple users. We have started to scale-up production of the ceramic skin patches stepwise up to pilot plant level, so that we can supply expanding clinical trials led by our customers, and to supply early commercialization levels. To that end we are preparing our Series A investment round of US$17 million,” informs Mike de Leeuw.

“From year 3-4 onwards, we will raise a series B round to pick up our own in-house product development into advanced clinical trials and sell those projects to vaccine companies once successful. I myself don’t yet target that we will become a full-blown vaccine company. We rather focus on better delivery, while our partners focus on the biology of the vaccine, the clinical development, production and commercialization. That includes both established vaccines to reduce dose and eliminate cold-chain costs, and novel vaccines like mRNA-nano particles” he adds.

“Our company’s and my personal drive stands by our Triple-A-Product objective:
We develop products which are Affordable, and Accessible for All,” Mike signs off.