PolyNovo’s technology proves critical in Beta Cell’s breakthrough transplant treatment for diabetics

Shares in Melbourne-based biotech PolyNovo (ASX: PNV) surged more than 15 per cent this afternoon after the company announced the success of a human trial featuring its Novosorb product in helping to treat and manage a critical problem that emerges for patients with Type 1 diabetes after kidney transplants.

PolyNovo, which is rapidly expanding into international markets with NovoSorb to treat severe burns, has been working with Adelaide-based biotech Beta Cell Technologies to explore other novel uses for the product which is also being applied for patients with diabetic foot ulcers.

The breakthrough trial which involved three patients with Type 1 diabetes has put the spotlight on PolyNovo’s potential to transform kidney transplant surgery for Type-1 diabetes patients.

Beta Cell director Professor Toby Coates presented the findings of the successful trial at the Joint Congress of ESPE and ESE, a major event for endocrinological health, in Copenhagen last night.

The proof-of-concept study by Beta Cell centred on the after-surgery survival of pancreatic islets during kidney transplants. Islets are clusters of endocrine cells that regulate blood glucose levels in the pancreas.

While the current standard of care in treating Type 1 diabetes involves the transplanting of human islet cells into the liver, researchers report that 75 per cent of cells are lost in the first 48 hours.

The trial by Beta Cell involved three participants, all long-term Type-1 diabetes (T1D) patients who received islet cells after kidney transplant.

After three years, these patients have reported the survival and function of human pancreatic islets that were transplanted into an alternative neovascularised site within the skin using Novosorb BTM to create a cell supporting vascular bed.

“This week we passed the third anniversary of the first human implant and remarkably the T1D patient’s sugar level has remained within a normal range at 5mmol/L with no requirement to top up cells over the journey,” says Coates.

“Our results are the culmination of the past 10 years of research and development using the NovoSorb technology and islet cells in rats and pigs and now in a ‘first in human study’.

“For the first time we report both three-year survival and function of human pancreatic islets transplanted within the NovoSorb BTM site outside of the liver. The results show an exciting new opportunity for the NovoSorb technology in cell therapies as a delivery vehicle.”

Beta Cell was co-founded by Professor Coates, Professor John Greenwood and Julian Burton to develop new ways of treating endocrine deficiency disorders, such as Type 1 diabetes, and it is in the early stages of designing, developing and implementing a novel Intracutaneous Ectopic Pancreas to treat Type 1 diabetes globally.

Coates says that the conventional method of transplant surgery presents barriers to ensuring the survival of islet cells.

“The problem with this treatment is that the transplant site cannot be easily biopsied and the islet cells can’t be monitored or retrieved so it is difficult to detect and remedy islet rejection,” he says.

“PolyNovo’s NovoSorb has some unique properties such as its ability to create a vascular bed capable of supporting the cells and, as the islet grafts are held within the NovoSorb matrix, the cells can be easily located and monitored in vivo.

“Additionally, the NovoSorb matrix properties enable the use of topical immune suppression which could potentially be ‘topped up’ easily if needed.”

Shares in PolyNovo surged to a high of $1.70, or more than 16 per cent, this afternoon following the announcement.

The company currently has two key products - NovoSorb MTX which offers a single-step procedure for soft tissue regeneration in the management of complex wounds; and Novosorb BTM, which is being embraced by surgeons to treat burns victims and increasingly diabetic foot ulcers.

PolyNovo says it is collaborating with Beta Cell to accelerate research and development pathways to ensure PolyNovo’s technology can play a major role in the cell therapy market space which is estimated to be US$34 billion ($53 billion) by 2034.

“I have been closely following the research undertaken by Beta Cell at the invitation of Professors Coates and Greenwood (who was instrumental in the invention of NovoSorb BTM) for the last three years,” says PolyNovo chairman David Williams.

“These are very exciting results, and a red-letter day potentially creating a new and distinct silo for the PolyNovo business - one in wound care and related uses, and another in cell delivery.”

Greenwood says when he was developing the BTM, he “always had a vision that the BTM platform, if successful in burns and wound care, would have the capability to be used in other cell areas”.

“The results of our trials confirms that the NovoSorb technology has the potential to be a game changer in the cell therapy space,” he says.

“As a bonus, we think because BTM and the cells are both approved, there are fewer regulatory hurdles.”

PolyNovo has been supplying NovoSorb BTM material to Beta Cell at no cost during its product development program while Beta Cell has established collaborations with major cell therapy players globally.

“It goes without saying we are extremely excited about the use of PolyNovo as a delivery device in cell therapies,” says Williams.

“Professors Coates and Greenwood have articulated the properties of our technology that should make it attractive to other cell therapy companies”.

PolyNovo, which currently generates most of its income from the US as surgeons have broadly adopted the NovoSorb technology for burns and foot ulcer treatments, posted a net profit after tax of $3.3 million in the first half of FY25 following a 28 per cent lift in sales to $54.1 million.

The company’s shares were trading at $1.665 at 2.56pm (AEST), up 20.5c for the day.