Invion’s INV043 candidate demonstrates positive results in Phase II prostate cancer trial

Life sciences group Invion (ASX: IVX) has announced that its photodynamic technology (PDT) partner RMW Cho Group has completed a Phase II prostate cancer trial using its active pharmaceutical ingredient and lead cancer candidate INV043.

The trial used six treatment cycles of INV043 as a monotherapy and a laser probe to apply red light to the prostate and prostate bed via transurethral or transrectal intraluminal techniques.

It showed that INV043 has a solid safety profile when administered under the tongue, with promising efficacy signals three months after treatment and only mild side effects experienced by patients.

Phase II results

Approximately 40% of participants in the Phase II trial showed a positive response to the treatment, with 10% demonstrating complete regression as measured by the industry-standard Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 framework.

Another 44% of participants — all of whom had positive prostate-specific membrane antigen-positron emission tomography (PSMA-PET) prior to the trial — registered negative PSMA-PET results three months after treatment with INV043.

A clinical study summary report collated by pharmaceutical consultancy group Scendea concluded that “the favourable safety profile and the preliminary efficacy results are promising and warrant further investigation of INV043.”

‘Effective treatment’

Invion chief executive officer Thian Chew welcomed the results.

“They show that INV043 can be safely administered via sublingual or intravenous routes and activated with light to treat prostate cancer,” he said.

“This points to the potential of this candidate to become an effective treatment for prostate cancer without the devastating side effects that can be associated with conventional treatments.”

Common cancer

Industry research shows prostate cancer to be the second most common cancer in men and presents a large addressable market that is expected to grow to around US$27.5 billion by 2032.

Radiotherapy, chemotherapy and surgery are the most common mainstream treatment options but carry risks of significant side effects such as urinary incontinence, bowel dysfunction, erectile dysfunction and infertility.

The current standard of care is to monitor the cancer until it progresses to a point where the benefits of these treatments outweigh the risks.

Next-gen technology

Invion’s patented INV043 employs next-generation PDT using non-toxic photosensitisers and light to selectively kill cancer cells and promote an anti-cancer immune response.

Less invasive than surgery and with minimal side effects, PDT offers an alternative treatment option aimed at achieving complete tumour regression and long-lasting remission.

It has also demonstrated broad-spectrum activity across multiple infectious diseases, including bacteria, fungi and viruses.