Invion (ASX: IVX) has announced promising results from a Phase II trial of its lead cancer candidate, INV043, in treating prostate cancer. The trial, conducted by Invion's photodynamic technology (PDT) partner RMW Cho Group, evaluated INV043 as a monotherapy using red light activation via transurethral or transrectal intraluminal techniques.
The Phase II trial involved six treatment cycles and demonstrated a solid safety profile for INV043 when administered sublingually. Approximately 40% of participants showed a positive response to the treatment. Notably, 10% achieved complete regression as measured by the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 framework, the industry standard for assessing treatment response in solid tumors.
Efficacy and Safety Profile
In addition to the overall positive response rate, 44% of participants who had positive prostate-specific membrane antigen-positron emission tomography (PSMA-PET) scans prior to the trial registered negative PSMA-PET results three months after treatment with INV043. This suggests that INV043 may effectively target prostate cancer cells.
The safety profile of INV043 was a key highlight, with patients experiencing only mild side effects. This is particularly significant considering the debilitating side effects often associated with conventional prostate cancer treatments such as radiotherapy, chemotherapy, and surgery, which can include urinary incontinence, bowel dysfunction, erectile dysfunction, and infertility.
Expert Assessment
A clinical study summary report by Scendea, a pharmaceutical consultancy group, concluded that "the favourable safety profile and the preliminary efficacy results are promising and warrant further investigation of INV043." This endorsement from an independent consultancy further validates the potential of INV043 as a viable treatment option.
INV043: A Next-Generation Approach
INV043 utilizes next-generation PDT, employing non-toxic photosensitizers and light to selectively kill cancer cells while promoting an anti-cancer immune response. This approach offers a less invasive alternative to surgery with minimal side effects, aiming for complete tumor regression and long-lasting remission.
Invion CEO Thian Chew stated, "They show that INV043 can be safely administered via sublingual or intravenous routes and activated with light to treat prostate cancer. 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."
Market Context
Prostate cancer is the second most common cancer in men, representing a substantial and growing market. Industry research projects the prostate cancer treatment market to reach approximately US$27.5 billion by 2032. The current standard of care often involves monitoring the cancer until it progresses to a point where the benefits of aggressive treatments outweigh the risks, highlighting the need for safer and more effective therapies like INV043.
