Bench2Bedside:
Tell us about Micron Biomedical and the rationale behind the dissolvable microarray patch platform. 

Steven Damon, CEO of Micron Biomedical:
Micron Biomedical’s technology is designed to replace injections. There’s a lot of nuance to that, but by replacing them, we can improve access to therapeutics and vaccines worldwide. And importantly, we can improve them in different ways for different populations around the world.

This includes allowing greater access into low-resource countries that don’t currently get certain access to vaccines or therapeutics as well as our own healthcare system, where we can help improve access in potential emergency situations like epidemics or pandemics or to prepare our country for biosecurity situations. One recent example of this, we recently announced that we signed new government contracts pertaining to defending against nuclear radiation exposure.

B2B:
Can you discuss how a dissolvable microarray patch delivers a vaccine or therapeutic, and why the skin is such an effective and underutilized route of administration?

Steven Damon:
Our technology replaces the injection with what I like to call “a little button”, about the size of a nickel that can be placed on the wrist, pressed until you hear a little click. You don’t feel anything, but the indicator on the button tells you that you’ve pushed hard enough and given yourself a dose, which is equivalent to the dose that you would receive with the needle. You can give this dose to yourself or could be applied by a lower-skilled caregiver. We work with partners worldwide to utilize their therapies and their vaccines that are already on the market, and some that are in development, to be combined with our technology.

Our microarray patch makes this possible with what are sometimes called microneedles. When you push the button, you are inserting one hundred-plus tiny microdoses, equivalent to the dose you would have received with the needle into your intradermal skin layer.

B2B:
How does this compare to current, standard needle-based injections?

Steven Damon:
Typical injections are either intramuscular or subcutaneous; that’s just the way needles work. But intradermal delivery is actually preferable. There you have Langerhans cells, which are the immune cells in the skin, which help support the efficacy of the vaccine or therapeutic. Overall, it’s a better place to insert these treatments. We are optimistic that efficacy will be better than dosing with a needle, and it potentially could allow us to reduce doses and still get the same efficacy as needed.

The skin’s outer layers consist of fatty layers and dead cells, which are lipid-soluble, and the drug or vaccine needs to bypass that. There are certain drugs and hormones that can get sucked through that layer, with nicotine being one of the first clear examples, i.e. nicotine patches. In order to deliver vaccines or other therapeutics that normally have to be injected, we need to bypass that outer layer. We are able to do that in a way that’s pain-free, safe, effective, simple to administer, and provides greater access everywhere.

We’ve studied our product with seasonal flu as well as with measles-rubella, and in both cases, we were equal to or better than either an intramuscular injection for flu or a subcutaneous injection for measles-rubella.

Also important when we consider the global impact, is that these treatments are stable and dry, so they don’t need the cold chain that typically a lot of vaccines and drugs need. They can be shipped or mailed, and delivery does not require a doctor, no sharps containers are needed, so we can really overcome a lot of the barriers to broader access around the globe.

B2B:
Tell us more about the results in Measles-Rubella.

Steven Damon:
So, I can’t talk about Measles-Rubella without talking about the Gates Foundation. The foundation, first Bill & Melinda Gates Foundation and now the Gates Foundation, have been huge supporters of our company and our technology for this project specifically. The idea was that Bill and Melinda hoped to eradicate measles. In order to eradicate measles, you have to get into these small areas in the world, these villages in Africa for example, that normally will not get vaccinated. And in those places in the world, you have children dying, and I mean hundreds, thousands, of children dying of measles that just because they’re not vaccinated. Measles is the most contagious disease out there, and the vaccine is the best out there. They should not be dying just because we can’t get a vaccine to them because the doctors don’t get there, they don’t have refrigeration, all of the issues that we talked about earlier.

So, with the goal to vaccinate children who otherwise wouldn’t have been vaccinated, we need to rethink delivery and that means remove the needle and all the barriers to delivery that go with it.

We initiated the study in adults for safety, obviously—then were able to move into in toddlers where these groups have had exposure, and you can’t really get a clear, naive patient population to test how well you delivered that that vaccine. The next step is to go to the 6-month-old, where we showed that the device was as effective, and in some cases more effective than the subcutaneous shot. Because of the ease of the delivery, we can provide access to these vaccines traveling to villages on mopeds, in a backpack. Arguably, we’ve already started to save lives, even in that early-stage clinical trial, as these kids might not have been vaccinated otherwise.

Working with the CDC, we’re taking on a similar challenge on rotavirus vaccine. This is a disease that kills children all around the world but has a large impact in low-resource countries due to diet and access to healthcare. 150,000 kids are dying a year of rotavirus where we have a vaccine, so the CDC has issued a goal to develop a new vaccine that’s going to be much more effective and reach those populations. The new rotavirus vaccine is very effective so far in early-stage trials, but again, it’s going to be injected, and it still won’t get to those populations. So, Micron has been working with them, and we just completed a Phase 1 study at the Emory Clinic with the CDC. Those results will be rolling out towards the end of this year, and we’re very excited.

B2B:
How is Micron Biomedical funded?

 Steven Damon:
We get funding from two main avenues. We’ve raised $33 million from investors; our investors have a culture and mission that aligns well with ours. While we will strive to make money for our investors, we also have a global impact focus. The largest investor in Micron right now is the Global Health Investment Corporation, which partners with BARDA, which means that I work for you and the U.S. taxpayer.

Separate from that, we have non-dilutive funds, which come from partners, foundations and agencies, such the Gates Foundation, the CDC, and others which totals close to $70 million.

B2B:
What else is Micron Biomedical working on?

Steven Damon:
Our development pipeline is about 50% vaccines and 50% therapeutics. The vaccines are public information considering the organizations that we work with, but on the therapeutic side, we work extensively with private industry and pharma. Without going into specifics, we have major pharma in our pipeline as well. Our work is quite broad across different therapeutic areas as we’re simply limited by how much dose we can deliver. And as Micron is evolving, we will even be developing some of our own products into later stages.