Vaxxas Expands Global Intellectual Property Portfolio for Exclusive Manufacture and Sale of Needle-Free Vaccination Technology

BRISBANE, Australia & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Vaxxas, a clinical-stage biotechnology company, has expanded its global intellectual property portfolio to 42 patents, supporting its exclusive claim to manufacture and sell its proprietary vaccination technology, the high-density microarray patch (HD-MAP), in the United States, Europe, Asia and Australia.

Vaxxas’ patent portfolio covers all significant proprietary aspects of the company’s vaccine delivery platform and products, including the manufacture and use of the HD-MAP technology and novel applicator device; vaccine formulations; and methods for formulating, loading and coating vaccines on HD-MAP technology.

The latest patent issued to Vaxxas in November 2024 covers the specific design and use of the HD-MAP and applicator technology for vaccine delivery to the skin in the United States.

Following issuance of the company’s latest US patent, Vaxxas CEO and President David Hoey said, “Vaxxas is aiming to transform the vaccine market by improving the performance of vaccines and reducing the economic and logistical challenges typically associated with needle-and-syringe vaccination.

“The growing breadth of our patent portfolio protects our exclusive use of the technologies necessary to achieve this goal, as well as freely manufacture and sell our products at commercial scale and in a safe and regulatory compliant manner.”

Vaxxas Chief Technology Officer Dr Angus Forster said the company has been very intentional in building its global intellectual property portfolio.

“The coverage of Vaxxas’ issued patents, both geographically and technologically, sets us apart as we continue to mature our vaccination platform and expand our range of products,” said Dr Forster.

“In the past 24 months alone, we have filed seven new patent applications covering new aspects of our technology platform, including HD-MAP delivery of mRNA vaccines, the fastest growing segment of the vaccine market. These patent applications, if granted, would extend our cover through to 2045.”

Vaxxas is scaling up to manufacture and distribute the world’s first commercially available vaccine patches from its global headquarters and state of the art biomedical facility in Brisbane.

Vaxxas Chief Operating Officer Scott Fry added, “Because we’re developing a combination product that includes a vaccine or medicine component with a medical device, we have broad patenting opportunities.

“We not only file patents around the vaccines we formulate and deliver, but also the systems and processes to manufacture the HD-MAPs and applicators at scale. This latest US patent is further evidence of the value our team of engineers brings to technology that could transform the vaccine industry.”

Vaxxas’ HD-MAP technology has completed five successful Phase I clinical trials involving over 500 participants with vaccines that address some of the world’s biggest health challenges including COVID-19, flu, and measles and rubella.

Vaxxas is currently conducting its first US IND-enabled Phase I clinical study for a pre-pandemic influenza vaccine involving 258 participants, with funding from the United States Biomedical Advanced Research and Development Authority (BARDA).

About Vaxxas

Vaxxas is a privately held biotechnology company focused on enhancing the performance of existing and next-generation vaccines with its proprietary high-density microarray patch (HD-MAP). Vaxxas is targeting initial applications in infectious diseases and oncology.

With success in several completed human clinical trials, Vaxxas’ HD-MAP vaccine delivery platform is advancing toward commercialisation. The company has completed Phase I clinical trials for COVID-19, seasonal influenza, and measles and rubella vaccine patches involving more than 500 participants; and conducted other vaccine studies targeting pandemic influenza with funding from the Biomedical Advanced Research and Development Authority (BARDA) – part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services.

Vaxxas’ core technology was initially developed at The University of Queensland (UQ), and the company was established as a start-up in 2011 by UQ’s commercialisation group UniQuest. The company was founded with the completion of an initial equity financing led by OneVentures Innovation Fund I with co-investors Brandon Capital Partners and US-based HealthCare Ventures, followed by further financing led by OneVentures, joined by UQ.

OneVentures Innovation Fund I and Brandon BioCatalyst are supported by the Australian Government’s Innovation Investment Fund (IIF) program. The IIF is an Australian Government venture capital initiative that provides investment capital and managerial expertise through licensed venture capital fund managers to investee companies. Learn more at OneVentures and Brandon Capital.

About HD-MAP needle-free vaccines

The Vaxxas high-density microarray patch (HD-MAP) is comprised of thousands of microscopic projections moulded into a small patch. Each microprojection is ‘printed’ with a small dose of vaccine in a dried formulation. When applied to the skin, the patch delivers the vaccine to the abundant immune cells that naturally reside immediately below the skin surface.

HD-MAP vaccine delivery has the potential to overcome challenges faced by traditional needle and syringe delivery of vaccines. For example, the dried form of the vaccine has been shown in early clinical studies to be more stable at higher temperatures than vaccines in liquid formulations, potentially reducing the need for cold-chain storage and distribution.1

Previous studies have also shown the safety and tolerability of Vaxxas’ HD-MAP for use in vaccine delivery and inducing equal or greater immune responses to injected vaccines at lower doses.1 Compared with needle and syringe systems, HD-MAP vaccines are designed to be easier to administer and have potential use in future pandemic responses.1

Caution

The Vaxxas HD-MAP delivered vaccines are under investigation and available only for investigational uses. They are not available anywhere in the world for sale or purchase. As such, Vaxxas makes no claim that the vaccines are reliable, durable, dependable, safe, or effective, and makes no claim that it is superior to any other vaccine or vaccine delivery technology.

References

1 Baker, B., Hacker, E., Siller, G., Lee, M., Mursaliyev, N., & Forster, A. (2023). Evaluation of the self-administration potential of high-density microarray patches to human skin: A preliminary study. Human Vaccines & Immunotherapeutics, 19(1). https://doi.org/10.1080/21645515.2023.2189409

Contacts

Australia
Amy Miller

WE Communications

+61 431 072 422

amymi@we-worldwide.com

United States
Kathryn Morris

The Yates Network

+1 914 204 6412

kathryn@theyatesnetwork.com

ENA Respiratory Receives USPTO Notice of Allowance for Key Patent Covering INNA-051, a First-in-Class Antiviral Innate Immunomodulator

MELBOURNE, Australia, May 08, 2024 (GLOBE NEWSWIRE) — ENA Respiratory, a clinical-stage pharmaceutical company developing innate immune modulators for the prevention of complications associated with respiratory viral infections in at-risk populations, announces today that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application US 18/112091 entitled “Novel molecules” covering claims for its lead program, INNA-051 and its composition.

A virus-agnostic intranasal antiviral host defence immunomodulator, INNA-051 is a potent first-in-class agonist of toll-like receptor 2/6 (TLR2/6) which plays a key role in recognizing pathogens and triggering the innate immune response.

This USPTO allowance further strengthens ENA Respiratory’s strong IP portfolio related to INNA-051, with 30 granted patents and allowed applications in the major markets, including the US, Europe, the United Kingdom, Japan and China. The portfolio covers seven distinct patent families, with claims directed to the composition of matter for INNA-051 and various backup molecules, formulations and method of use protection, as part of a comprehensive lifecycle management strategy. ENA Respiratory has an additional 39 pending applications in various jurisdictions.

ENA Respiratory’s CEO, Christophe Demaison, PhD said: “Our IP portfolio provides robust and long-lasting protection with potential exclusivity for INNA-051 out to at least 2042 and likely for five years post that date. This gives us great confidence in the future global commercial value of our innate immune modulators as we continue to drive forwards in clinical development.”

Having demonstrated accelerated viral clearance and local stimulation of antiviral host defences for INNA-051 in a Phase IIa proof-of-principle study using a liquid formulation in an influenza-challenge model, ENA Respiratory has developed an improved dry powder formulation to take into further clinical development. This formulation recently received FDA IND clearance and the Company has submitted ethics approval for a Phase 1b study in Australia. This study is expected to be initiated in mid-2024 with the aim to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of the dry powder formulation of INNA-051 in older adults.

About ENA Respiratory

ENA Respiratory is a clinical-stage pharmaceutical company tackling serious respiratory viral infections through the development of host defence immune modulators which locally prime and boost the body’s innate immune response – the natural first line of defence. Being virus-agnostic, immune modulators are complementary to often virus-specific vaccines and existing direct-acting antivirals.

The company’s lead product, INNA-051, is a potent agonist of toll-like receptor 2/6 (TLR2/6) which plays a key role in recognising pathogens and triggering the innate immune response. With a safe profile supporting prophylaxis use, it has demonstrated accelerated viral clearance and stimulation of antiviral host defences, including IFN Type I & III responses, in a Phase IIa proof-of-principle study using an influenza-challenge model. INNA-051 is being developed as a convenient, once-a-week nasal dry powder product to prevent complications associated with respiratory viral infections in at-risk populations, including the elderly, those with an underlying medical condition (including chronic lung conditions, diabetes, kidney disease, and cardiovascular disease) and individuals with occupational risk (e.g. first responders, military or essential services personnel).

Headquartered in Melbourne, Australia, the company has raised US$26M (AU$44million) in equity financing from Brandon Capital, The Minderoo Foundation and Uniseed. It is partnered with the COPD Foundation to support the clinical development of INNA-051 in COPD and has been awarded a US$8.18million contract from the U.S. Department of Defence. It is a member BLUE KNIGHT™, a joint initiative between Johnson & Johnson Innovation and BARDA designed to accelerate next-gen potential solutions for future pandemics.

For more information, please visit https://enarespiratory.com

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Ferronova – Nanoparticle Trial Begins in Patients With Gastric and Oesophageal Cancers

ADELAIDE, Australia–(BUSINESS WIRE)–Australian biotech company Ferronova has announced the initiation of a clinical trial of the company’s FerroTrace® nanoparticle technology in patients with gastric and oesophageal cancers. It follows the completion of a first-in-human trial in 2020-2022 in oral cancer patients.

The MAGMAP trial will enrol 60 patients and commenced today with the first patient at the Royal Adelaide Hospital, to be followed by Flinders Medical Centre and Queen Elizabeth Hospital in South Australia, and then expanding to the Peter MacCallum Cancer Centre and Austin Hospital/Olivia Newton John Cancer Centre in Victoria. Trial imaging is supported by the South Australian Health and Medical Research Institute (SAHMRI) and the National Imaging Facility.

The MAGMAP trial (Clinicaltrials.gov ID: NCT05899985) is a multi-centre, partially blinded, side-by-side comparator study to assess the safety and tolerability, feasibility, and potential added diagnostic and clinical value of FerroTrace® for mapping high-risk lymph nodes in subjects.

Ferronova Chief Executive Officer Mr Stewart Bartlett said it is potentially an important study offering the promise of an innovative approach for identifying and assessing lymph nodes at high risk of containing cancer.

“Gastric, gastric-oesophageal junction, and oesophageal cancers have very poor outcomes, even where the tumour is localised to a primary location and surrounding lymph nodes where surgery is intended to be curative, and this trial is an important step to test whether our novel technology can improve outcomes in this group of patients.”

Studies show following surgery, the 5-year relative survival rates for localised gastric and oesophageal cancers are approximately 74.7% and 48.5% respectively. Where the cancer has also spread to lymph nodes, the 5-year relative survival is only 34.6% and 27.7% [1][2].

Ferronova’s FerroTrace® product is a super-paramagnetic iron oxide nanoparticle targeting CD206 receptors found in lymph nodes. It offers a unique targeting mechanism designed to enable a longer lymph node retention time allowing the use of MRI and a handheld surgical magnetic detector to identify and assess lymph nodes containing FerroTrace®.”

Principal Investigator, Dr Markus Trochsler said the trial will investigate the feasibility of mapping lymph nodes directly draining a primary tumour which theoretically have the highest risk of containing metastasis.

“Gastric and oesophageal cancers are difficult to treat due to unpredictable and extensive lymphatic drainage network in this area of the body, which means lymph nodes containing cancer could potentially be found anywhere from the neck down to the abdomen. At present, when these metastases are very small, they cannot be detected with current imaging technology” Dr Trochsler said.

“This pilot study may lead to providing us with another alternative, being a more informed treatment plan. We are testing whether nanoparticles can identify lymph nodes which are at high-risk of containing cancer cells.  It will support us to progress to larger randomised trials where we will investigate tailoring our treatment approach based on the identification and position of these nodes.”

Mr Bartlett said the study enrolment is predicted to take 12-15 months, and he hoped the results will lead to new methods of treating patients facing uncertain outcomes.

“The enrolment of the first patient is an important milestone for Ferronova,” Mr Bartlett said.

“We are incredibly thankful for the investigators and their support teams, led by Dr Trochsler, as well as Associate Professor Kanhere at the RAH, Professor Watson and Dr Bright at Flinders, Dr Liu at the Austin and Peter Mac, and Dr Dwyer at SAHMRI. They have all put in an incredible amount of work and planning to design and initiate this trial. We look forward to seeing the results when the trial is complete.”

About Ferronova

Ferronova is an Australian biotechnology company headquartered in Adelaide, South Australia. Shareholders include Renew Pharmaceuticals Limited, Uniseed, the University of South Australia, Artesian Venture Partners and the South Australian Venture Capital Fund (SAVCF), Powerhouse Ventures, the University of Wellington in New Zealand, the University of Sydney, PAN Ventures, Australian Unity, and ex-Macquarie Bank executive Allan Moss. Grant assistance has been provided by the SA Government since 2016 and the Federal Government’s BioMedTech Horizons Program, operated by MTPConnect. In 2023, Ferronova was awarded an Australian Government CRC-P grant to progress a nanoparticle formulation through to a Phase 1b brain cancer clinical trial. For more information go to: www.ferronova.com.au

1 Cancer of the oesophagus – cancer stat facts, National Cancer Institute SEER. Available at: https://seer.cancer.gov/statfacts/html/esoph.html (Accessed: 5 April 2024).

2 Cancer of the stomach – cancer stat facts, National Cancer Institute SEER. Available at: https://seer.cancer.gov/statfacts/html/stomach.html (Accessed: 5 April 2024).

Contacts

For more information:

Ferronova
Stewart Bartlett, CEO

Email: marketing@ferronova.com.au

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