Ferronova – Transforming Colorectal Cancer Outcomes With More Accurate Micro-metastases Identification : MTPConnect

23 Oct 2023
/ Case Study

Ferronova’s unique patented technology, FerroTrace®, is a new-generation, polymer-coated magnetic nanoparticle.

Colorectal (bowel) cancer is the third most common cancer worldwide. In 2020, more than 1.9 million new cases were diagnosed and over 930,000 deaths were attributed globally to this disease¹. In Australia, colorectal cancer causes the second highest number of cancer deaths per annum and has its greatest impact on those aged between 60 and 79 years of age. While early screening programs have significantly improved outcomes with a 71 per cent five-year survival rate, challenges remain.

Colorectal surgery involves removing the primary tumour and a large block of surrounding tissue containing lymph nodes, which are then analysed by pathology. If no cancer is found in the sampled lymph nodes, the patient is considered cured, yet up to 31 per cent of Stage II patients have recurrence of the cancer in less than five years and up to 10 per cent die².

The problem with this current standard of care is that pathologists may miss an important lymph node – and due to the large number of nodes they find, they only undertake a limited assessment. Several researchers have shown that when pathologists do a more thorough analysis of lymph nodes, approximately 25 per cent of patients have undetected cancer cells. Past research suggests these patients have a poor prognosis, yet patients that truly have no cancer in their lymph nodes are cured.

Mapping the lymph system

A solution to overcome the limitations of this existing process is to map the lymph system from the primary tumour to the direct draining lymph node (the sentinel lymph node or SLN) and perform a detailed assessment of this node only.

Supported by BioMedTech Horizons (BMTH) program funding, South Australian biotechnology company Ferronova set out to develop and test in a clinical trial a surgical oncology tracer system – designed to improve the treatment guidance and staging of complex cancers and help increase survival rates.

Pictured: The Ferronova team.

Ferronova’s unique patented technology, FerroTrace®, is a new-generation, polymer-coated magnetic nanoparticle. This nanoparticle is detected on MRI for radiotherapy and surgical planning. It also drives a magnetically guided imaging system to precisely identify the SLNs, to assist surgeons and pathologists to more accurately stage solid tumours and locate and address micro-metastases that may otherwise go undetected.

Preclinical activity including optimisation of the FerroTrace composition, development, and refinement of the surgical procedures, testing of the localisation of the imaging markers to lymph nodes, and optimisation of the MRI parameters, created the foundation for the design and setup of the first-in-human clinical study.

Despite the challenges of conducting a clinical trial during the COVID-19 pandemic, the safety and feasibility of the system was demonstrated in 16 patients. The trial has since been expanded and will continue to enrol up to 40 patients.

Well positioned for next stage of manufacturing development

Excitingly, Ferronova has transferred nanoparticle synthesis from an academic environment at The University of Sydney to Ferronova’s premises, developed new analytical methods for nanoparticles, and is well positioned for the next stage of manufacturing development in 2023–24, up-scaling of the manufacturing process.

With a detailed assessment of the regulatory and reimbursement pathways completed and establishing highly efficient in-house manufacturing capability under GMP conditions, and under the control of a quality management system, Ferronova has made significant progress toward setting up for larger scale trials,regulatory approval, and eventual commercialisation.

The BMTH program delivered significant value to Ferronova, helping it progress its innovative system along its journey towards commercialisation, said the company’s CEO Stewart Bartlett.

“This project has supported the establishment of infrastructure and systems required to transfer outstanding academic research in nanoparticles to a commercial setting and a first-in-human gastrointestinal clinical trial,” he explained.

The project was a collaborative effort involving Ferronova, scientists from The University of Sydney and University of South Australia (UniSA), as well as clinicians from the Ingham Institute for Applied Medical Research and surgeons/researchers from the Royal Adelaide Hospital. The preclinical testing was conducted at the SAHMRI Preclinical, Imaging and Research Laboratories (PIRL), with support through the loan of equipment from industry, including KARL STORZ Endoscopy Australia, Stryker, and Device Technologies (Intuitive Surgical).

New research and clinical collaborations

The impact of these relationships has already been felt, with Ferronova and UniSA establishing new research and clinical collaborations with other partners including the Australian Bragg Centre for Proton Therapy and Research, Siemens, and the Olivia Newton-John Cancer Wellness and Research Centre.

These collaborations have resulted in Ferronova, UniSA and the new partners receiving grant funding of approximately $5 million to bring to the clinic a second variation of the FerroTrace technology, for use in brain and pancreatic cancer.

Director of the Key Centre for Polymers and Colloids at The University of Sydney, Associate Professor Brian Hawkett, said that the collaborations established through the BMTH project have proved beneficial for all parties.

“The University of Sydney has been developing unique polymer chemistry for nanoparticles for over 20 years and investigating the application in medicine for almost as long,” he said. “The collaboration with Ferronova, UniSA and the Ingham Institute has been one we are proud to be associated with and is the first time our technology has been applied in human trials. We look forward to continuing our collaboration into the future.”

Promising pipeline of projects and further funding

With the progress made in the first-in-human trial, new IP, and a promising pipeline of projects, Ferronova recently secured an equity investment of $8 million led by industry partner Renew Pharmaceuticals: the leader in infrared dyes for image-guided surgery.

Over time, the project will lead to larger trials, where anticipated success is expected to create lasting impact and change for patients with early-stage gastrointestinal cancers – increasing their odds of becoming truly cancer free.

Nanoparticles and nanomedicines are part of a growing industry with broad potential. Ferronova’s experience in this project is identifying pathways for other researchers to transition their own academic research to the clinic and commercialisation.