This press release was originally published by Island Pharmaceuticals Ltd.
- Master Service Agreement (MSA) secured with Texas Biomedical Research Institute (Texas Biomed) — a leading BSL-4 research facility in the United States
- Texas Biomed is the only independent, non-profit infectious disease institute with integrated National Primate Research Centre capabilities
- Agreement provides for potential non-human primate studies to support Galidesivir’s FDA Animal Rule development pathway
- Texas Biomed is one of multiple institutes in negotiations with the Company to assist in Galidesivir’s development
- Follows recent positive FDA engagement confirming Animal Rule eligibility and Priority Review Voucher (PRV) potential post-approval
- Further FDA feedback expected early January 2026, guiding study design ahead of a planned Q1 CY26 clinical program, subject to approval
- MSA aligns with ILA’s focus on US government preparedness priorities targeting high-consequence viral threats with no approved treatments
MELBOURNE Australia, 17 December 2025: Australian antiviral drug development company, Island Pharmaceuticals Ltd (ASX: ILA; Island or the Company) is pleased to advise it has secured a Master Service Agreement (‘MSA’) with Texas Biomedical Research Institute (‘Texas Biomed’), a leading biosafety level 4 (‘BSL-4’) facility in the USA.
Texas Biomed is one of four BSL-4 facilities in the US that can conduct preclinical infectious disease research using non-human primates, which will be required to advance Galidesivir via the Animal Rule path. Of those four, however, Texas Biomed is the only private sector BSL-4 facility. BSL-4 is the highest level of biosecurity precaution, and the highly regulated setting is required for work with highly lethal pathogens that can easily be transmitted and cause severe to fatal disease in humans for which there are no available vaccines or treatments.
The Institute was established in 1941 and is based in San Antonio, Texas. It is the only independent, non-profit infectious disease research institute in the US to combine the highest-level biocontainment labs for infectious disease and biodefense research; a federally designated National Primate Research Centre; and over 80 years of discoveries advancing vaccines and therapies and specific expertise in the regulated science required for US Food & Drug Administration (FDA) approval.
Securing the MSA follows extensive due diligence on Texas Biomed’s demonstrated track record in infectious disease research, including prior non-human primate studies addressing highly lethal viral pathogens involving haemorrhagic-fever viruses. Island believes the Institute’s unique infrastructure, encompassing BSL-4 containment, non-human primate resources, and deep regulatory expertise required for FDA approval will provide exceptional optionality for the planned development of Galidesivir.
The agreement follows a recent response to the FDA regarding Galidesivir’s development pathway, which confirmed that a countermeasure for Marburg is eligible for the FDA’s Animal Rule pathway, and a Priority Review Voucher post-approval (refer ASX announcements 17 November 2025 and 4 December 2025). Island expects further feedback from the FDA around 2 January 2026 (US time), which will inform the proposed study design ahead of a planned clinical program in Q1 CY2026, subject to FDA program approval.
Management commentary:
CEO and Managing Director, Dr David Foster said: “Securing an agreement with Texas Biomed represents an important strategic step in the development of Galidesivir. Texas Biomed’s world-class expertise in high-containment infectious disease research, including deep experience conducting non-human primate studies under rigorous regulatory standards, provides Island with an optimal potential partner to progress our antiviral candidate toward FDA approval.”
“While negotiations with a range of other facilities is ongoing, Texas Biomed’s unique BSL-4 capabilities and access to a federally designated National Primate Research Centre have the potential to efficiently generate data to underpin approval under the FDA’s Animal Rule pathway, once a clinical trial program has been finalised.”
“The Company will continue to advance its discussions with other potential research partners, in its ongoing push to attract a best-in-class partner for the next phase of Galidesivir’s development. Concurrently, we remain focused on aligning our program with US government preparedness priorities to deliver a globally relevant antiviral solution.”
About Island Pharmaceuticals
Island (ASX: ILA) is focused on areas of unmet need for drugs that can address urgent viral diseases, public health or biosecurity threats. The Company is executing a dual development strategy for its assets, ISLA-101 and Galidesivir.
ISLA-101 has a well-established safety profile, being repurposed for the prevention and treatment of dengue fever and other mosquito (or vector) borne diseases. Galidesivir is a clinical-stage antiviral molecule with a broad spectrum of activity in over 20 RNA viruses, including high-priority threats such as Ebola, Marburg, MERS, Zika and yellow fever – viruses with significant unmet medical needs and that may contribute to national security threats.