Encouraging SRC Findings on Ph I/II Skin Cancer Trial
Released
Released
Announcement PDF
ASX ANNOUNCEMENT
ENCOURAGING SAFETY REVIEW COMMITTEE FINDINGS ON SKIN CANCER TRIAL
FOR INITIAL PATIENT GROUP
Highlights:
No adverse events identified by the Safety Review Committee (SRC) following the
treatment of the first six patients in Invion’s Phase I/II non-melanoma skin cancer
(NMSC) trial
Early indications show an observable reduction in the NMSC lesion size after a single
treatment cycle
Clinician feedback indicated that patients did not experience any pain during the
treatment, which compares favourably to currently approved PDT treatments
The early results also highlighted INV043’s potential as a diagnostic with suspected
cancers fluorescing under violet light
Proceeding to Part 2 of the adaptive trial that will enable further dose optimisation
permitted under the protocol
The safety data is also an important input into the upcoming Ph I/II anogenital trial done
in partnership with the Peter MacCallum Cancer Centre
MELBOURNE (AUSTRALIA) 29 May 2025: Invion Limited (ASX: IVX) (“Invion” or the “Company”)
is pleased to announce the conclusions from the Safety Review Committee (SRC) after the
treatment of the first six patients in its Phase I/II non-melanoma skin cancer (NMSC) trial in
Queensland.
The SRC did not identify any adverse events associated with the application and use of INV043
(Invion’s lead drug candidate for the treatment of cancers) in ointment form. All data suggests
that the treatment was well tolerated and feedback from clinicians indicated there were no
signs of pain associated with the treatment, which is a significant benefit over other
Photodynamic Therapy (PDT) treatments for NMSC.
Further, there were early indications of patients responding positively to the treatment with an
observable reduction in the NMSC lesion size after a single treatment cycle at 15- and 30- days
post treatment, while on average, untreated patient-matched lesions increased slightly in
diameter over the same corresponding periods post treatment.
Change in size of NMSC lesions – treated and untreated lesions*
Untreated Lesions
Treated Lesions
SEM = Standard Error of the Mean
*Based on SRC review of available data to date.
Further analysis will be conducted at the next
stage of the trial.
Invion Limited ABN 76 094 730 417
100 Albert Road, South Melbourne, VIC 3205
P: +61 3 9692 7222 W: www.inviongroup.com
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Preliminary data analysis indicates a trend towards reduced lesion diameter following one
round of INV-043 treatment.
INV043’s Potential as a Theragnostic (Therapy and Diagnostic)
Additionally, the potential to use INV043 as a diagnostic tool was further demonstrated during
trial. While red light of 660nm would activate INV043 to generate Reactive Oxygen Species
(ROS) to kill the cancer, violet light of 405nm causes cancer cells to fluoresce.
Having an effective diagnostic tool may help surgeons more accurately identify and remove
cancers to minimise the risk of either missing some of the cancer margin or cutting too much
of the healthy tissue.
Fig 1: Patient 101-002 at Day 1 of the treatment (INV043 ointment)
Natural light,
no INV043
Violet light,
no INV043
Violet light,
INV043
Fig 2: Photos from three different patients in the trial
INV043 appears to localise in the lesion site, which is consistent with preclinical data that showed
accumulation in the tumour cells.
Invion Limited ABN 76 094 730 417
100 Albert Road, South Melbourne, VIC 3205
P: +61 3 9692 7222 W: www.inviongroup.com
ASX ANNOUNCEMENT
Next Steps
The Phase I/II NMSC trial is an adaptive trial, which provides flexibility to adjust the treatment
protocol to optimise outcomes. Following the SRC meeting, it was determined that the
maximum light dose allowed under the protocol would be used, and that the trial would
progress to Part 2 of the study, which will include adjusting dose-light interval (time between
the topical application of INV043 to the lesion and subsequent activation by light). The
adaptive trial also enables other dose optimisation dimensions allowed under the protocol.
The safety data is also an important input into the upcoming Phase I/II anogenital trial that
Invion will undertake in partnership with the Peter MacCallum Cancer Centre (Peter Mac). The
anogenital trial aims to include a study on the impact of INV043 when used in combination
with immune checkpoint inhibitors (ICIs), such as PD-1.
Preclinical studies undertaken at Peter Mac and Hudson Institute of Medical Research have
shown INV043’s potential to significantly improve the efficacy of ICIs.
The Executive Chair and CEO of Invion, Prof Thian Chew, said:
“We are very pleased with the safety profile of INV043 and look forward to exploring
other elements that may help optimise the dose regime. It is also exciting to see
how clearly and easily INV043 can ‘illuminate’ the cancers.
“The results set us up for the next stages of our clinical program, including the
planned Phase I/II anogenital trial as well as the next part of the NMNC trial, where
we are seeking to further demonstrate the safety of INV043 and to better optimise
the treatment regime in the next group of patients.”
Skin cancer is one of the world’s most common cancers and NMSC makes up over 98% of all
skin cancers1 with the global treatment market to hit US$21.1 billion by 20322. The prevalence
of the disease highlights the urgent need for effective and affordable treatments with minimal
side effects.
Currently, the mainstream treatment for SCC and BCC includes surgery, which can lead to
permanent scarring. Preclinical studies undertaken at the Hudson Institute of Medical Research
showed the potential for INV043 to regress cancers without scarring and with minimal pain.
More details on the Phase I/II NMSC trial design can be found at:
https://investors.inviongroup.com/announcements/6690510.
This announcement was approved for release by the Board of Directors.
____________________________________________
Sign up at Invion’s Investor Hub to receive regular updates, provide feedback and participate
in discussions: https://investors.inviongroup.com/
Investor and Media enquiries:
Thian Chew (Chairman & CEO)
T: +61 3 9692 7222
E: investor@inviongroup.com
1
2
Brendon Lau (Investor & Media Relations)
M: +61 409 341 613
E: brendon.lau@inviongroup.com
https://www.cancercouncil.com.au/skin-cancer/about-skin-cancer/
https://www.fortunebusinessinsights.com/skin-cancer-treatment-market-102806
Invion Limited ABN 76 094 730 417
100 Albert Road, South Melbourne, VIC 3205
P: +61 3 9692 7222 W: www.inviongroup.com
ASX ANNOUNCEMENT
About Invion
Invion is a life-science company that is leading the global research and development of the
Photosoft™ technology for the treatment of a range of cancers, atherosclerosis and infectious
diseases. Invion holds the exclusive Australia and New Zealand license rights and exclusive
distribution rights to Hong Kong and the rest of Asia Pacific, excluding China, Macau, Taiwan
and Japan, to the Photosoft technology for all cancer indications. It also holds the exclusive
rights to the technology in Asia and Oceania, excluding China, Hong Kong, Taiwan, Macau,
the Middle East and Russia for atherosclerosis and infectious diseases, and subsequently
acquired the rights to the United States, Canada and Hong Kong for infectious diseases.
Research and clinical cancer trials are funded by the technology licensor, RMW Cho Group
Limited. Invion is listed on the ASX (ASX: IVX).
About Photodynamic Therapy (PDT)
Invion is developing PhotosoftTM technology as a novel next generation Photodynamic
Therapy (PDT). PDT uses 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. PDT has also demonstrated broad-spectrum activity
across multiple infectious diseases, including bacteria, fungi and viruses. Photosoft has the
potential to address the global challenge of antibiotic-resistant “superbugs”.
Invion Limited ABN 76 094 730 417
100 Albert Road, South Melbourne, VIC 3205
P: +61 3 9692 7222 W: www.inviongroup.com
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