VAXESS 2023 YEAR IN REVIEW

Michael Schrader, CEO and co-founder

When I heard in November that Vaxess was named the “2023 Vaccine Innovation of the Year” by the Biotech Breakthrough Awards, I reflected on all the incredible work our team has done over the last year.

At Vaxess, we’re developing the only vaccine patch featuring dissolvable, sustained-release micro tips that can ‘mimic’ the pace of natural infection, helping the body produce a slow, strong, and enduring ramp-up of immune response. Looking back at Vaxess’s history, our path towards commercialization 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. 

Below, I’ve detailed a few of Vaxess’s many notable accomplishments from 2023. If you’d like to learn more about the work we’re doing, please don’t hesitate to reach out. I will also be at the J.P. Morgan Healthcare Conference in January. 

Collaborating with AstraZeneca on evaluation of RNA-based pandemic influenza prototype vaccine in patch format 

Pandemic influenza is a major biosecurity threat due to its ability to rapidly spread through respiratory droplets, causing severe illnesses that could overwhelm healthcare systems around the world. The potential for the virus to mutate further adds to the complexity, making it harder to develop effective vaccines and treatments. Developing an mRNA flu vaccine that could be distributed globally is a key step in effectively preparing for pandemic influenza.

In the summer 2023, Vaxess announced a collaboration with AstraZeneca to evaluate novel patch delivery technology for an RNA-based pandemic influenza prototype vaccine. Through this collaboration, Vaxess could receive up to $10.3 million from AstraZeneca as part of a broader agreement of up to $80 million with the U.S. Government. 

Completing mRNA stability tests assessing the potential for room temperature storage

One of the biggest challenges associated with mRNA vaccines is the need to store them at very low temperatures. Vaxess is working towards a world where mRNA vaccines can be stored and distributed without the need for refrigeration.

The tests Vaxess conducted with Emory University and The Georgia Institute of Technology demonstrate that using Vaxess’s proprietary silk fibroin as a novel biomaterial for stabilization and delivery of mRNA LNPs can address storage and distribution limitations of current mRNA vaccines. The Defense Advanced Research Projects Agency (DARPA), a branch of the US Department of Defense, funded the mRNA testing.

In 2023, Vaxess announced that functional activity of mRNA LNPs stored in silk fibroin matrices at elevated temperatures was confirmed when injected into mice. 24 hours after injection, strong nanoluciferase expression as measured by IVIS imaging was observed in quads, lymph nodes, and liver. No statistical difference in expression was observed in any organ between mRNA LNPs recovered from silk matrices stored at 4°C, 25°C, and 37°C versus liquid mRNA LNP control — a significant improvement over existing products which require frozen storage.

Publishing phase 1 trial results of the MIMIX-flu vaccine patch

In 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 GC Biopharma Corp., delivered via the Vaxess MIMIX™ Patch. Vaxess enrolled healthy adult volunteers ages 18-39 to evaluate the safety, reactogenicity, tolerability, and immunogenicity profiles for two influenza vaccine dose levels, fractional H1 vaccine dose level 7.5 μg and standard H1 vaccine dose level 15 μg vs placebo. Vaxess also evaluated the durability of the immune response for each vaccine dose level, and assessed the breadth of the influenza A H1 antigen responses.

One of the most promising findings from our 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.

Raising venture capital funding

Over the last year, Vaxess has been honored to receive the backing of incredible VCs who continue to invest in the company’s vaccine patch development. 

In Q1 2023, Vaxess closed the final $10 million tranche of its $37 million in Series B funding, with investors including RA Capital, The Engine, and Mission BioCapital, and Global Health Investment Corporation (GHIC). More recently, Vaxess announced an additional $9 million to accelerate mRNA vaccine patch development. With this additional funding, Ulu Ventures joined as a first time investor in the company. 

"Imagine a world where vaccines don't require trips to the clinic, cold chain transport, or needle and syringe injection — this would meaningfully expand access to preventative care," said Kathy Chen, Partner at Ulu Ventures. “With proven distribution advantages and enhanced efficacy of protection, Vaxess's unique approach could play a pivotal role in improving public health globally. We're excited to work with the company as it commercializes its first patches.” 

Hiring a former global head of new products from Sanofi to lead Vaxess’s business and product development strategy

With the progress Vaxess made in recent years around opening a GMP manufacturing facility, producing clinical trial-grade vaccine patches, and signing partnerships with the world’s largest biopharma companies — Vaxess attracted Steve Bende, a titan in the biopharma world, to join Vaxess as chief strategy officer in 2023. Prior to joining Vaxess, Bende served as global head of new products at Sanofi Pasteur. There, he led international multifunctional teams to assess commercial viability of potential new products for internal pipeline projects or potential business development deals. Previously, Bende was a senior policy advisor for the US Department of Health and Human Services’ National Vaccine Program Office.