Recruitment Conclusion for Ph 1 NMSC Trial & Advance to Ph 2
Released
Released
Announcement PDF
ASX ANNOUNCEMENT
Invion Limited ABN 76 094 730 417
Suite 2, Level 11, 385 Bourke Street Melbourne, VIC 3000
P: +61 3 9692 7222 W: www.inviongroup.com
INVION CONCLUDES RECRUITMENT IN NON-MELANOMA SKIN CANCER PHASE 1 TRIAL
WITH PRELIM DATA SUPPORTING ADVANCEMENT TO PHASE 2
Highlights:
• Phase I Non-Melanoma Skin Cancer (NMSC) recruitment concluded, based on findings
by Safety Review Committee (SRC).
• SRC found consistently strong safety readouts including with more recently treated BCC
patients. No serious adverse events, dose‑limiting toxicities or pain across 14 patient
readouts – reinforcing INV043’s attractive safety profile.
• Encouraging efficacy signals observed across SCCs and BCCs, including a 79% disease
control rate with one complete response.
• Findings support advancing INV043 into a Phase II trial, which will incorporate dose
optimisation and may target advanced skin cancer indications, including rare
cancers, with significant unmet clinical need.
MELBOURNE (AUSTRALIA) 19 October 2026: Invion Limited (ASX: IVX) (“Invion” or the
“Company”) is pleased to announce it has successfully completed patient treatments and has
closed patient recruitment for the Phase I Non-Melanoma Skin Cancer (NMSC) trial.
While the results for the trial will be finalised only after the 12-month patient follow-up and
independent audit, Invion believes the preliminary findings from treated patients are sufficient
to meet primary safety endpoints and demonstrate encouraging efficacy signals.
The preliminary data, which has been reviewed by the Safety Review Committee (SRC),
supports Invion’s decision to advance the NMSC study to a Phase II trial.
Invion’s Executive Chair and CEO, Prof Thian Chew, said:
“INV043 has delivered what we hoped to see in a first-in-human study for skin cancer:
a strong safety profile and promising early efficacy signals across multiple
non-melanoma skin cancer types, including in both Squamous Cell Carcinoma
(SCC) and Basal Cell Carcinoma (BCC) lesions, reinforcing the potential of
Photosoft™ as a differentiated photodynamic therapy platform.”
Preliminary Results
The primary end-points for the Phase 1 trial focus on safety. The preliminary unaudited findings
from this study taken from 14 patient treatment readouts showed no serious adverse events
and dose-limiting toxicities (DLTs).
There were eight cases of mild to moderate adverse events (e.g. mild headache, urinary tract
infection, and skin abrasion) but all were assessed by the SRC to be “not related” or “unlikely
related” to the treatment.
Tumour responses were assessed using calliper measurements consistent with RECIST 1.1
principles (longest diameter, percentage change from baseline). Across SCC and BCC lesions,
there was a 79% positive disease control response rate, including one complete response.
ASX ANNOUNCEMENT
Invion Limited ABN 76 094 730 417
Suite 2, Level 11, 385 Bourke Street Melbourne, VIC 3000
P: +61 3 9692 7222 W: www.inviongroup.com
Next Steps
Invion has started planning a Phase II clinical trial that looks to incorporate dose optimisation
and may target advanced skin cancers, including rare cancers, with pressing unmet needs.
More details will be provided at the appropriate juncture.
This announcement was approved for release by the Board of Directors.
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Investor and Media enquiries:
Thian Chew (Chairman & CEO)
T: +61 3 9692 7222
E: investor@inviongroup.com
Brendon Lau (Investor & Media Relations)
M: +61 409 341 613
E: brendon.lau@inviongroup.com
Forward-Looking Statements
This announcement contains or may contain forward-looking statements that are based on
Invion’s beliefs, assumptions, and expectations and on information currently available to
Invion.
All statements that address operating performance, events, funding or developments that
Invion or its directors expect or anticipate will occur in the future are forward-looking
statements, including, without limitation, statements as to the expectations of Invion or the
market it operates in.
Invion believes that these forward-looking statements are reasonable as and when made.
You should not place undue reliance on forward-looking statements because they speak
only as of the date when made. Invion does not assume any obligation to publicly update or
revise any forward-looking statements, whether as a result of new information, future events
or otherwise. No assurance or guarantee is, or should be taken to be, given in relation to,
and no reliance should be placed on, the future business performance or results of Invion or
the likelihood that the current assumptions, estimates or outcomes will be achieved. Actual
results, developments or events could differ materially from those disclosed in the forward-
looking statements.
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, ophthalmic and infectious
diseases. Invion holds the global exclusive license to the Photosoft technology for multiple
cancer and non-cancer disease indications. Invion is listed on the ASX (ASX: IVX). Find out more
at www.Inviongroup.com.
ASX ANNOUNCEMENT
Invion Limited ABN 76 094 730 417
Suite 2, Level 11, 385 Bourke Street Melbourne, VIC 3000
P: +61 3 9692 7222 W: www.inviongroup.com
About Next Generation Photodynamic Therapy (NGPDT)
Invion is developing its PhotosoftTM platform technology as a novel Next Generation
Photodynamic Therapy (NGPDT). NGPDT 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, NGPDT offers an alternative treatment option aimed at achieving
complete tumour regression and long-lasting remission. NGPDT has also demonstrated
potential in ophthalmic applications as well as broad-spectrum antimicrobial activity across
pathogens including bacteria, fungi and viruses.
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