RD-11.15-16.2022-Vaxess

KATHRYN KOSUDA: Good afternoon. My name is Kathryn Kosuda. I'm Co-founder and CSO at Vaxess Technologies, a clinical-stage company developing vaccines and therapeutics that are meant to move beyond the traditional healthcare setting. So our aim is really to improve access to these important medicines wherever they're needed.

Our core technology platform is a shelf-stable, self-applied patch that improves vaccination or treatment with a wide range of molecules. We have a lead program in influenza vaccination, for which we just initiated our first in-human trial this past summer. And we're a team of about 40 people, with R&D headquarters in Cambridge, Mass, and our own GMP pilot manufacturing line just north of Boston in Woburn, Mass. We are also fortunate to be an MIT Engine portfolio company.

So the MIMIX system is a drug device combination product consisting of a patch containing about a square centimeter array of micro projections and a Band-Aid-like backing. And this patch is preloaded into an applicare device, seen here in the white portion.

With application of this simple device to the skin, we can deliver vaccines and therapeutics to the skin-- which is, immunologically, a very active target-- immediately or over a sustained period of time, with only a few minutes of wear time. So if we look at the microarray under magnification, you can see here the blue tips is where the drug product is contained. And our formulation and manufacturing process has really been optimized to consolidate drug product into the tips of these micro projections. And this is really critical to achieving high-delivery efficiency.

Let's see if I can play the video. So the white portion is a dissolving-base polymer. So, upon exposure to the skin's moisture, begins rapidly dissolving. And this separates the biologically active tips, which enables removal of the backing. And the tips continue to dissolve in the skin over time.

So how does this work in practice? The patch can be applied to the patient's forearms using the simple applicator device, which is really meant to ensure consistent delivery no matter who is doing the application. The patch stays on the patient's arm for about five minutes, after which the patch backing can be removed and discarded into the normal trash, because there's no sharps hazard.

But ultimately, our goal is to be able to ship these patches anywhere they're needed. And with self-administration, one could imagine ordering vaccines and medicines needed online, and having them delivered to your doorsteps. But even beyond home-based vaccination or home-based health care, this technology can be easily deployed in many different settings where the need for a traditional trained health care worker often presents a barrier, such as in emergency response situations or in mass vaccination campaigns.

The MIMIX platform has really enabled by a novel biomaterial called fibroin, which is derived from natural silk fibers. And drug product formulation with fibroin in the tips of our microarray really enables stabilization of sensitive biological molecules, it lends structural integrity to the microneedle tips, and it enables the modulation of release kinetics-- anywhere from immediate release to sustained-release applications.

Our lead product is MIMIX-Flu, and this is a quadrivalent seasonal influenza vaccine intended for home-based use by adults. So in the US, only about 40% of adults get an annual influenza vaccine shot. And we believe we can improve vaccine coverage and grow the overall market through providing benefits, such as shelf stability, simple administration, and improved immunoresponse via dermal delivery.

So while our lead product is an influenza vaccine patch, we're also working with industry partners on both in-licensing, as well as partner development opportunities for pipeline expansion into new areas, new types of molecules-- such as mRNA-- as well as new indications both in infectious disease and beyond. I think we're interested in working with biotech and pharma partners on targets where delivery to the skin makes sense, and where self-administration would be an advantage. And happy to talk with anyone further at the booth afterwards. Thank you for your attention.