Ancient Material Promises To Solve Drug Delivery “Pain”
Vaxess is a venture capital and Gates Foundation-backed company that is developing vaccine patches. Their mission is to significantly increase access to vaccines — instead of vaccines having to be shipped in cold storage and administered via a shot, these patches can be shipped in the mail and used from the comfort of people's homes. In order to accomplish this mission, the company is developing novel vaccine formulations and delivery technologies based on its proprietary silk platform.
To learn more about how the team at Vaxess managed to utilize the knowledge about silk to improve the area of drug development, we sat down with Michael Schrader, CEO and co-founder of the biotech.
What is the current state of therapeutics and vaccines delivery? Can you outline existing approaches, their features and drawbacks?
— Today, the majority of vaccines are administered by injection, which has a number of drawbacks:
First, vaccines injected into non-barrier tissue are typically cleared from the body in less than two days. This is not enough time for immune cells to mount an optimal, broad humoral or T-cell response, similar to what occurs through sustained, natural exposure to infection.
Second, many vaccines must be kept in cold storage until shortly before they are administered. This means that vaccines require incredibly complex supply chain logistics to distribute around the world — and these logistics only increase in complexity when delivering vaccines to areas of the world without reliable refrigeration.
On a related note, administering a vaccine requires significant logistical hurdles for both the person receiving the vaccine, and the provider. Today, a person has to visit a pharmacy, doctor’s office, or clinic to receive a vaccine, and the site must have staff that is trained in administering vaccines — such as a pharmacist, nurse, or doctor. They also have to safely dispose of the syringe to avoid reuse or accidental needle-sticks.
Finally, an estimated 25% of adults fear needles. This fear contributes to vaccine hesitancy. In fact, an estimated 16% of adults do not get a vaccine because of their needle phobia.
How did COVID change people's perceptions of and interest in home-based healthcare?
— The COVID-19 pandemic rapidly accelerated the adoption of home-based care.
The rise of telehealth during COVID has been well documented. Up until March 2020, people would likely go to a local doctor or urgent care facility if they were feeling unwell. Now, people are much more likely to have an initial visit with a medical professional via a video consultation, phone call, or even text message exchange.
COVID-19 has also made people much more comfortable with at-home diagnostics. At the beginning of the pandemic, people had to visit a clinic to receive a COVID test. Now, people in the US and around the world use an at-home rapid test to see if they have the virus. These tests are often shipped directly to their door from their healthcare provider, pharmacy, or an e-commerce site like Amazon or Target.
Much like we’ve seen COVID-19 tests come out of the clinic and into peoples homes, we expect vaccines will do the same in the coming years.
Can you explain how such a well-known material as silk suddenly emerges at the far-front of drug delivery research? What makes it so unique in this sense?
— Prized for its unique properties including stiffness and high tensile strength, silk has been used for millennia to make textiles. Vaxess has adapted this ancient material to a new context, harnessing a key structural component of silk — fibroin proteins — to create advanced biomaterials that are strong, stable, and compatible with life-saving pharmacological compounds.
Silk fibroin is inherently stable, simplifying the shipping and storage of sensitive treatments and able to protect sensitive compounds during extended release at body temperature. At Vaxess, we fine-tune these properties to achieve the most effective delivery profiles of various medicines and vaccines.
The MIMIX patch delivers vaccines through silk microneedles that dissolve slowly in the skin, releasing the treatment over the most effective length of time.
How do you protect your idea from competition? Does the company have a patent portfolio for vaccine patches?
— Vaxess has a key patent on the MiMIX patch technology. The patent is specifically for, “Microneedle and microneedle devices including implantable silk-based tips for sustained dermal delivery of a vaccine, kits, as well as methods of manufacturing and using the same are described herein. In other embodiments, compositions and methods for controlled- or sustained- administration of a vaccine (e.g., an influenza vaccine) to provide improved immunogenicity and/or broad- spectrum immunity to a subject are also described.” Beyond that, the company has ten other patent families, either in-house or in-licensed from Tufts and MIT that protect the technology from competition.
How do you plan to collaborate with vaccine/therapeutics makers? What is your business model in a nutshell?
— The concept of home-based vaccine delivery is so transformative that the company did not simply want to offer our platform to partners to develop products on. Instead, Vaxess actively pursued international partners with great products who were willing to outlicense them to us for internal development. Our lead program, MIMIX-Flu, is a joint collaboration with GC Pharma, a Korean vaccine powerhouse. They provide the vaccine as well as technical and regulatory support. We develop the final product and move it through the regulatory and clinical development process. In the end, they have rights to the final product in Korea. We have a similar arrangement with another partner for our COVID program.
Just this year, we did open the platform to other partners that want to use it to develop next generation products under their brand, but we are being very selective in choosing partners that appreciate the full disruptive opportunity that MIMIX unlocks.
In October 2021, your company announced the opening of a GMP facility for vaccine patch clinical trials. Where are you now with that planning? When do you foresee the launch of clinical trials, and what are your plans for this year and the next one?
— In March of 2022, Vaxess produced the first human clinical batches for the company’s lead program, a seasonal influenza vaccine called MIMIX-Flu, which will enter clinical trials for the first time in the summer of 2022.
While our first GMP facility is an important step, it is only designed to support Phase I and Phase II clinical trials. In parallel, we’ve completed much of the engineering work for the next phase of manufacturing, scaling up to the hundreds of millions of patches necessary to make an impact in the next pandemic.
Thank you for your time!
