Vaxess Technologies is a venture capital and Gates Foundation-backed life science company that is developing novel vaccine patches. The company is committed to improving access to vaccines with its shelf-stable patches that can be self-applied and delivered all over the world. Pulse 2.0 interviewed Vaxess Technologies co-founder and CEO Michael Schrader to learn more.
Michael Schrader’s Background
Schrader spent his career transforming complex technologies into transformational products. And Schrader said:
“Prior to Vaxess, I spent time at Google and Honda, where I helped bring a range of products to market and earned more than fifteen patents. I received my B.S. in Mechanical engineering from Purdue University and my MBA from Harvard University.”
Formation Of Vaxess Technologies
(Livio Valenti, Co-founder, Senior VP of Strategy, Operations and Business Development; Michael Schrader, Co-founder, CEO; Kathryn Kosuda, PhD, Co-Founder, Chief Scientific Officer)
How did the idea for the company come together? Schrader shared:
“As a Harvard Business School student in Professor Vicki Sato’s Commercializing Science class, I wanted to tackle an unmet global healthcare need by applying my engineering and business skills to a critical problem. Working with my co-founders, we saw an opportunity to supply much-needed vaccines worldwide without refrigeration or cold storage using an ancient material, silk.”
“While silk has been used for millennia to make textiles, it offers unique opportunities in the medical space for its unique properties, including stiffness and high tensile strength. Vaxess’s pioneering utilization of silk fibroin proteins creates advanced biomaterials that are strong, stable, and biocompatible.”
Core Products
What are the company’s core products and features? Schrader explained:
“Vaxess is developing and manufacturing the MIMIX patch, designed to be the easiest and most effective way to deliver vaccines and therapeutics.”
“With only a few minutes of wear time, the MIMIX patch releases treatments to the body at their most beneficial rate and duration. For vaccines, the controlled release simulates the pace of a natural infection, helping the body produce a slow, strong, and enduring ramp-up of immune response, ultimately boosting a vaccine’s effectiveness.”
“Engineered for stability, the MIMIX patch does not require refrigeration and can be shipped to and applied in low resource settings. It is virtually painless and resembles an adhesive bandage. After the minutes-long prescribed wear time, the MIMIX patch is simply removed and discarded — without the need for sharps storage.”
Favorite Memory
What has been your favorite memory working for the company so far? Schrader reflected:
“For me, it was working in the cleanroom in 2021 to produce the clinical materials alongside my teammates on the manufacturing line. Nine years after we started Vaxess, knowing that these would be the first products that would go into patients was an amazing feeling. It was even more exciting to see the strong results from those first human studies.”
Challenges Faced
Has Schrader faced any specific bottlenecks in his sector of work recently? Schrader noted:
“For vaccine patches specifically, one of the biggest challenges facing our industry is there is not a contract manufacturer that companies can go to and say “please make this for us.” Since there aren’t feasible options for outsourcing, a company developing vaccine patches has to build its own manufacturing facility at a relatively early stage in the company’s lifecycle, which is a highly capital-intensive endeavor.”
Evolution Of Vaxess’ Technology
How has the company’s technology evolved since launching? Schrader noted:
“Over the last decade, Vaxess has adapted and innovated our business model. COVID-19 showed us that to be prepared for the next global pandemic, we need to make a fundamental paradigm shift in the method of vaccine delivery in two major ways, administration of and access to vaccines. Vaxess has moved to a platform vaccine delivery company for at-home administration, owning a new method and instrument of delivery.”
Significant Milestones
What have been some of the company’s most significant milestones? Schrader cited:
“Looking back at Vaxess’s history, our path towards commercialization of vaccine patches for at-home use accelerated significantly in 2021 when we opened our GMP manufacturing facility in Woburn. This enabled us to prepare for our first phase 1 trial, and lay the groundwork for a number of exciting studies, partnerships, investments, and executive hires.”
“A couple of milestones that came after the opening of our manufacturing facility are:
1.) mRNA collaboration with AstraZeneca: In August 2023, Vaxess announced a collaboration with AstraZeneca to evaluate novel patch delivery technology for an RNA-based pandemic influenza vaccine. Through this collaboration, Vaxess could receive up to $10.3 million from AstraZeneca as part of a broader agreement with the U.S. Government. mRNA shows significant promise for improving the speed at which pandemic influenza vaccines can be developed. However, the current need for cold storage is a limiting factor to deploy vaccines where they are most needed. Earlier in 2023, Vaxess announced mRNA stability results from tests assessing the potential for room-temperature storage. The testing found that Vaxess’s silk fibroin formulations protect mRNA lipid nanoparticles (LNPs) through drying and maintain in vivo potency after storage at 37°C for two weeks, a significant improvement over existing products that require frozen storage.
2.) The MIMIX-Flu Vaccine Patch: In June 2023, Vaxess became the first company in the world to complete a phase 1 trial of a vaccine patch with sustained release, dissolvable microneedles — providing more precise dosing and potentially increasing the effectiveness of the vaccine. The trial, conducted in 45 healthy patients, evaluated delivery of an H1N1 influenza antigen from Vaxess’s partner, GC Biopharma Corp., delivered via the Vaxess MIMIX Patch. One of the most promising findings from the 180-day data is the immune response durability coupled with the potential for the VX-103 patch to protect against drifted strains. This means that receiving a ‘flu shot’ via a Vaxess MIMIX patch has the potential to improve a flu vaccine’s effectiveness relative to administering the vaccine via needle and syringe — in addition to a patch being far more comfortable than a traditional injection.”
Customer Success Stories
Can you share any specific customer success stories? Schrader cited:
“Vaxess’s biggest ‘customer success’ story is from the 45 healthy patients ages 18-39 that enrolled in our phase 1 vaccine flu patch clinical trial. The trial followed subjects for 180 days, and the results were very encouraging. The MIMIX-Flu vaccine patch elicited robust, durable and broadly protective immune responses. MIMIX-Flu vaccine patch was also well tolerated systemically and locally — no pain, no bruising, and limited tenderness were reported.”
Funding/Revenue
After asking Schrader about the company’s funding and revenue information, he revealed:
“Vaxess has raised more than $80 million in equity and non-dilutive funding. Most recently, in September Vaxess announced $9 million in additional capital. Our investors include RA Capital, The Engine, GHIC, Ulu Ventures, BARDA, DARPA, NIH, NSF, and the Gates Foundation.”
Total Addressable Market
What total addressable market (TAM) size is the company pursuing? Schrader assessed:
“First, let’s consider vaccines: The global vaccine market is well over $70 billion, and I estimate it will exceed $100 billion in the coming decade. Within this market, the TAM for vaccine delivery services is over $6 billion.”
“Second, Vaxess’s MIMIX platform has the potential to be used for a range of therapeutics, with combined TAMs in the hundreds of billions of dollars.”
Differentiation From The Competition
What differentiates the company from its competition? Schrader affirmed:
“The Vaxess MIMIX patch is the only vaccine patch featuring dissolvable, sustained-release microarrays that can “mimic” the pace of natural infection, helping the body produce a slow, strong, and enduring ramp-up of the immune response.”
“One significant advantage of a dissolvable microarray, like what Vaxess is developing, is that the tips gradually dissolve into the body after the patch is removed, releasing their payload of vaccines over time. In contrast, many of the other vaccine patches in development feature coated microarrays, with hundreds or thousands of tips on the microarray patch made of a solid material. The vaccine or therapeutic is then ‘coated’ over the patch.”
“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.”
Future Company Goals
What are some of the company’s future company goals? Schrader concluded:
“First, we look forward to developing a rapid response vaccine platform that combines the speed of mRNA with the stability and accessibility of MIMIX. We’ll be pushing this forward with AstraZeneca, and also internally.”
“Second, we will explore applications of the MIMIX platform beyond vaccines. Now that we’ve validated the platform in the clinic with a very challenging vaccine, we’re actively looking at other therapeutics that would be good candidates for the MIMIX patch.”
