Vaxxas opens new advanced manufacturing facility in Brisbane. Carole Goldsmith reports.

Clinical-stage biotechnology company Vaxxas, in partnership with the Queensland Government, opened its global headquarters and state-of-the-art manufacturing facility this June in Brisbane.

The custom-built 5,500m² Vaxxas Biomedical Facility is a first-of-its-kind manufacturing site, designed to support the scale-up of Vaxxas’ needle-free vaccine technology platform, the high-density microarray patch (HD-MAP), for late-stage clinical trials and first commercial products.

AMT spoke to Vaxxas’ Chief Technology Officer, Dr. Angus Forster, the day after the new facility opened. “It’s been an exciting couple of weeks and it was an excellent day yesterday. Queensland’s Deputy Premier, Dr Steven Miles opened the facility and we had around 80 invited guests from industry in attendance.”

Vaxxas’ new facility is located in Brisbane’s Northshore and the company was previously based at the Translational Research Institute (TRI) at the Princess Alexandra Hospital Campus in Brisbane’s inner suburbs.

“We are still keeping a presence at the TRI for its pre-clinical infrastructure, while our new facility is focused on manufacturing our vaccine patches for late-stage clinical trials and commercial product. It’s great to still be connected with the vibrant TRI research community, as there are many immunology scientists and physicians working there. Vaxxas also had a small manufacturing engineering facility located further south of the city and this has been transferred to the new facility.”

Dr. Forster was Vaxxas’ first employee when he joined the company over 11 years ago as Vice President of R&D and he has been in his current role for 1.5 years. “Vaxxas now employs more than 130 staff. We’re also very excited that we’ve appointed industry veteran and Pfizer’s former senior medical leader, Dr. Rochelle Chaiken, as our new Chief Medical Officer (CMO). Previously she was CMO for Pfizer’s Biopharmaceutical Group for Emerging Markets, which included the rollout of the Pfizer Comirnaty mRNA COVID vaccine.

“Vaxxas has recruited a significant number of scientists, trained in biochemistry, biology and medicinal chemistry, to support our vaccine development programs. Engineers skilled in pharmaceutical and medical device industrialisation have also joined the company, along with experts in the pharmaceutical regulatory and quality areas which are critical to our progress through to commercialisation.”

The Vaxxas Biomedical Facility has office areas, laboratories for R&D and quality control testing as well as engineering development space for testing various aspects of the HD-MAP technology and the device components of the patch applicator.

“The major benefit of the facility is that it has space to do our manufacturing, both on the device side making patches and applicators, but also producing finished vaccine products in cleanrooms,” says Dr. Forster. “That’s very exciting as we will be able to make a product for Phase II and Phase III clinical trials and eventually for commercialisation here, although that is a few years away.”

“There’s two parts of the device technology. The patch itself is manufactured with thousands of micro projections that are ultimately printed with the vaccine. This then goes into an applicator device, which applies the patch with the vaccine to just under the surface of the skin. In our new facility, we can manufacture those individual components on a large scale. We need to be audited and certified with a licence from the Therapeutic Goods Administration (TGA) to manufacture in Australia.

“This facility will enable us to prepare for that first TGA audit and licence. Then we can supply products into Phase II and Phase III clinical trials. Down the track, with further regulatory approvals, we can move into commercial manufacturing. This facility is built to meet the TGA’s requirements as well as those of the US FDA and the European Medicines Agency (EMA).”

Vaxxas has six clinical programs underway with various vaccines and partners. Among these programs, the Vaxxas HD-MAP is currently being evaluated in Phase I human clinical trials for COVID-19 and seasonal influenza at the University of the Sunshine Coast’s Clinical Trial’s Centre. In addition, Vaxxas is preparing for clinical evaluation of a pandemic influenza vaccine under contract with the United States Biomedical Advanced Research and Development Authority (BARDA).

Keeping the funds rolling in to support ongoing operations, R&D and clinical trials is often difficult for early-stage biotechnology companies. “At Vaxxas however, we’re very well supported by our investors through different rounds of financing,” Dr Forster agrees, but, “we actually do bring in revenue through funded programs with partners and through grants.”

The Queensland Government provided funding and operational support to Vaxxas in developing the new manufacturing site. Vaxxas is renting the new facility from the Queensland Government. Additional funding has been provided by the Australian Federal Government through its Modern Manufacturing Initiative to support the installation of specialised manufacturing infrastructure. Vaxxas also receives the Australian Government R&D Tax Incentives each year.

In 2020, Vaxxas received a $26m grant from the US government’s Biomedical Advanced Research and Development Authority for pandemic influenza vaccination development. In the event of a global influenza pandemic, people could potentially self-dose using the HD-MAP once it is FDA-approved. “We also have an eight-year relationship with the Bill and Melinda Gates Foundation to work on a measles and rubella vaccine on our patch,” Dr Forster says.

“Vaxxas’ future plans are very bright,” adds Dr Forster. “We will keep progressing through our clinical studies, moving into Phase II studies by building up the safety and effectiveness data for a wide range of vaccines. Our aim is to grow the business and manufacture products for late-stage clinical studies and early-stage commercial distribution, working towards having a product to market in three to five years from now.”