Therapeutic Innovation Australia’s (TIA) voucher program has supported early-stage work that helped enable the new spin-out, Ibnova Therapeutics, which is advancing a stem cell–based treatment for heart failure towards human clinical trials within the next three to five years. The company builds on a strong foundation of early-stage research and translational support across the Australian and international research ecosystem.

This research, led by Prof. Enzo Porrello from Murdoch Children’s Research Institute and Prof. James Hudson from QIMR Berghofer, in collaboration with clinicians at The Royal Children’s Hospital and The Alfred Hospital in Melbourne, has demonstrated that lab-grown human heart muscle can restore heart function after a heart attack, with safety and efficacy shown in preclinical models.

As part of the translation pathway, Prof. Porrello was awarded a Technical Feasibility Assessment voucher supported through NCRIS. This engagement enables researchers to address key technical and manufacturing questions at an earlier stage, strengthening the overall development pathway and positioning projects for subsequent investment and clinical translation.

The voucher was delivered through the Centre of Excellence in Cellular Immunotherapy at the Peter MacCallum Cancer Centre and provided an early-stage assessment of the technical feasibility of producing large, vascularised heart patches, including evaluation of the Good Manufacturing Practice (GMP) manufacturing requirements for clinical translation. This is a critical step in de-risking promising technologies, helping to determine whether they can be scaled and manufactured under conditions suitable for human use.

Since this initial work, the technology has progressed significantly. The large vascularised heart patch has demonstrated proof of concept and is now transitioning toward GMP manufacturing, a key requirement for advancing into clinical trials. This progression reflects a successful pathway from early feasibility assessment through to translational development, supported by coordinated infrastructure and expertise.

By leveraging both Australian and international partnerships, the research is now positioned to accelerate toward first-in-human clinical trials.

Ibnova Therapeutics is based in Denmark and supported by the BioInnovation Institute and the Novo Nordisk Foundation Cellerator, which provide expertise in manufacturing, regulatory strategy and early-stage company development. The broader research program has also benefited from sustained investment from organisations including the Novo Nordisk Foundation’s reNEW initiative, as well as Australian funding bodies such as the Australian Research Council, the Medical Research Future Fund and the National Health and Medical Research Council.

Addressing a significant global health need

Heart failure affects more than 60 million people globally, with limited treatment options available for end-stage disease. While heart transplantation remains the only definitive treatment, donor shortages continue to present a significant challenge.

Cellular therapies, such as those being developed by Ibnova Therapeutics, aim to address this gap by repairing or regenerating damaged heart tissue. The progression of this technology from early-stage feasibility through to GMP readiness highlights the importance of sustained investment in translational research and access to enabling infrastructure within the NCRIS ecosystem.

Front Photo credit: An animal model of heart failure treated with a vEHT. Photo: Hayley Pointer and Rebecca Sutton, research assistants, Porrello lab and Elliott Lab, reNEW Melbourne.