Next Generation PDT Program

• Breast cancer is the most common cancer in women in Australia, and the second most common cancer to cause death in women, after lung cancer.
• 1 in 7 women and 1 in 700 men will be diagnosed with breast cancer in their lifetime.
• Every year over 3,300 people in Australian (including 33 men) will die from breast cancer.
• Approximately one woman under the age of 40 is expected to die each week from breast cancer.
• In the last 10 years, breast cancer diagnosis has increased by 24%.

Cell based trials

NG-PDT was optimised and used during preclinical cell-based studies, triple negative breast cancer patient derived cell lines.

Cancer cells were seen to respond strongly to treatment with activation light while remaining unaffected in the presence of compound without activating light treatment.

Preclinical trials

NG-PDT was used to treat preclinical models and 16 hours later were illuminated using activating light. No adverse effects were identified.

One week later, preclinical models underwent a second identical treatment.

Preclinical Trial Results

Treatment using NG-PDT (INV043) resulted in complete regression of the breast cancer in preclinical trials.

No evidence of metastatic disease noted, suggesting INV043 treatment had induced a systemic immune response.

Most excitingly when previously treated models were rechallenged with secondary tumour implant, no tumours could be grown. This confirms that NG-PDT treatment established protective immunity in these models, a key requirement to maintain long-term remission.

Next Steps

We have further optimised NG-PDT compounds for breast cancer and plan to carry out further trials.

We will use immune checkpoint inhibitor in combination in NG-PDT treatment. These have shown significant increase in tumour reduction in combination with NG-PDT in our other trials.

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• It is estimated that there were 26,368 cases of prostate cancer diagnosed in 2024. The average age at diagnosis is 70 years old.
• Prostate cancer is the most commonly diagnosed cancer in Australia, and it is estimated that one in six males will be diagnosed by the time they are 85.
• Early (localised) prostate cancer refers to cancer cells that have grown but do not appear to have spread beyond the prostate.

Clinical Trial

16 male patients aged between 50-80 years.

Clinical trial participants underwent a total of six (6) cycles of NG-PDT treatments over a nine (9) week period, administered in rounds of two (2) cycles on sequential days with a 4-week interval before the subsequent rounds.

The study’s primary endpoint objective was to assess PDT treatment effectiveness using Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Secondary endpoint objectives aimed to assess PDT safety and tolerability as well as further assess PDT effectiveness using standard outcome measures.

Mild side effects | NG-PDT (INV043) appeared to be safe and well-tolerated when administrated sublingually to patients over the six cycles of PDT treatments.

There were no serious adverse events (SAEs), life-threatening treatment emergent adverse events (TEAEs), or TEAEs leading to death reported in the study. All adverse events reported were mild and included fever, fatigue, headache and soreness.

Clinical Trial Results

The trial results showed that INV043 has a solid safety profile and demonstrated promising efficacy signals three months post treatment:

A regime of 6 cycles of INV043 treatments was very well tolerated by patients.

No serious adverse events were experienced and all side effects reported were mild.

40% of patients showed a positive response as measured by the RECIST 1.1 standard (10% had complete response).

44% of patients had negative PSMA-PET results 3 months post treatment.

Next Steps

The positive safety and efficacy signals for NG-PDT (INV043) opens the potential for treatment of prostate cancer without the serious side effects associated with conventional treatment. We are planning to use optimised NG-PDT compounds for prostate cancer on further clinical trials.

We will use immune checkpoint inhibitor in combination in NG-PDT treatment in trials. These have shown significant increase in tumour reduction in combination with NG-PDT in our other trials.

Read more | ASX Announcement 1

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Skin cancer is one of the world’s most common cancers and non-melanoma skin cancer (NMSC) makes up over 98% of all skin cancers. The global treatment market is set to hit US$21.1 billion by 2032.

The prevalence of the disease highlights the urgent need for effective and affordable treatments with minimal side effects.

Currently, the mainstream treatment for NMSC’s such as Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC) include surgery, which can lead to permanent scarring.

Preclinical Trial Results

Preclinical studies undertaken at Hudson Institute of Medical Research showed the potential for INV043 to regress cancers without scarring and with minimal pain.

Our research led to the development of a topical gel cream that contains NG-PDT drug that can be applied safely to non-melanoma skin cancer lesions and treated with light.

We then carried out a Phase I/II Human trial with six patients diagnosed with NMSC.

Clinical Trial Results

No adverse events identified by the Safety Review Committee (SRC) following the treatment of the first six patients in Phase I/II NMSC trial. Patients did not experience any pain during the treatment, which compares favourably to currently approved PDT treatments.

Early indications show an observable reduction in the NMSC lesion size after a single treatment cycle.

The early results also highlighted INV043’s potential as a diagnostic with suspected cancers fluorescing under violet light.

Now proceeding to Part 2 of the adaptive trial that will enable further dose optimisation permitted under the protocol.

Next Steps

The Phase I/II NMSC trial is an adaptive trial, which provides flexibility to adjust the treatment protocol to optimise outcomes.

Now progressing to Part 2 of the study, which will include adjusting dose-light interval (time between treatment of NG-PDT (INV043) to the lesion and subsequent activation by light).

The adaptive trial also enables other dose optimisation dimensions allowed under the protocol.

Read more | Announcement 1

Pancreatic cancer in Australia is a significant health concern, with increasing incidence and high mortality rates.

Pancreatic cancer is currently the fourth leading cause of cancer death in Australia, and is projected to become the third.

The five-year survival rate is only around 10%, highlighting the aggressive nature of this cancer and urgent need for new treatment options.

Cell based Trials

NG-PDT was optimised and used during preclinical cell-based studies, pancreatic cancer patient derived cell lines.

Cancer cells were seen to respond strongly to treatment with activation light while remaining unaffected in the presence of compound without activating light treatment.

Preclinical Trials

Preclinical models were implanted with pancreatic cancer to establish solid tumours. NG-PDT was used to treat the preclinical models and 16 hours later, were illuminated using activating light.

Showed no adverse effects.

One-week later the preclinical models underwent a second identical treatment.

Preclinical Trial Results

Treatment using NG-PDT resulted in complete regression of pancreatic cancer in preclinical models.

No evidence of metastatic disease noted, suggesting INV043 treatment had induced a systemic immune response.

Most excitingly when previously treated models were rechallenged with secondary tumour implant, no tumours could be grown. This confirms that NG-PDT treatment established protective immunity, a key requirement to maintain long-term remission.

Pancreatic Cancer and NG-PDT

NG-PDT (INV043) has shown to be very effective at killing pancreatic cancer cell models (PANC1, PANC2)

NG-PDT (INV043) was safely used to treat preclinical models with pancreatic tumours, with little to no side effects.

NG-PDT (INV043) strongly localised to tumour mass and margins in pancreatic tumours

Pancreatic tumours were regressed following treatment, determined by a decrease in measurable volume.

Immune Checkpoint Inhibitor (ICI) therapies have limited effectiveness against several cancer types as a monotherapy despite its widespread clinical use.

Collaborative work from Peter Mac and Hudson Institute where a reduction in tumour size of approximately 65% was achieved in preclinical models implanted with triple negative breast cancer tumours and treated with INV043 intratumorally when compared to an ICI alone.

Combining NG-PDT with ICI demonstrates enhanced clinical response in “cold” tumours (a tumour that is unlikely to trigger a strong immune response).

NG-PDT presents an attractive opportunity to pharmaceutical groups that own ICI drugs to develop new combination therapies to improve clinical outcomes, develop new intellectual property, and extend the patent life of their blockbuster ICI therapies.

Preclinical Trial

The study aimed to explore the role of the immune system in preclinical models bearing squamous cell carcinoma when treated with NG-PDT (INV043) with and without check point inhibition blockade.

Preclinical models with squamous cell carcinoma lines were separated into 4 treatment groups:

1. Treated with single therapy anti-PD-1 alone
2. Treated with INV043 alone
3. Treated with the combination of both
4. Control group

Tumours were treated with INV043 or vehicle control then exposed to activating light. This was repeated 48 hours later. ICIs were injected every four days up to four rounds of treatment.

No effect on preclinical model wellbeing or weight gain over time was observed. As with other treatments with INV043, no visible scarring was observed where complete tumour control was achieved.

Preclinical Trial Results

INV043 in combination with an immune checkpoint inhibitor (ICI) resulted in ~80% of subjects being tumour-free. The study was conducted by Peter Mac using immune competent anal squamous cell carcinoma (ASCC) in vivo models.

Results support previous findings by Hudson Institute using intratumorally administered INV043 in combination with ICIs on another cancer type (triple negative breast cancer).

Opens additional treatment options for upcoming clinical trial programs that span multiple cancers.

Next Steps

We have ethics and undertaking NG-PDT / ICI clinical trials on anal squamous cell carcinoma (ASCC) patients.

The combined use of immune checkpoint inhibitors and NG-PDT treatment has proven safe and very effective.

Read more | ASX Announcement 1

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