Highlights:
- First patient has been dosed in Invion’s open label Phase I/II non-melanoma skin cancer (NMSC) trial using topical INV043.
- The study is being conducted at Veracity Clinical Research’s facilities, based in Queensland Australia.
- Skin cancer is one of the world’s most common cancers and NMSC constitutes >98% of all skin cancers1 with the global treatment market to hit US$21.1 billion by 20322.
- Preclinical studies indicate INV043 may have distinct advantages over current NMSC treatments, such as efficacy without scarring and with minimal pain.
- The NMSC trial follows the release of promising Phase II prostate cancer trial results using INV043, and Invion plans to leverage the NMSC data into a planned Phase II anogenital cancer trial
The trial marks a significant milestone for Invion and is designed to evaluate the safety and efficacy of its lead drug candidate INV043, a novel photosensitiser developed in Australia for use in Photodynamic Therapy (PDT) for the treatment of multiple cancers.
Trial Design and Objectives
This open-label, adaptive trial provides flexibility to go beyond the testing and collection of human safety data of the topical formulation of INV043.
The initial part of the study aims to assess the safety profile of the topically applied INV043 in non-metastatic cutaneous Squamous Cell Carcinoma (cSCC). Subsequent parts aim to address dose optimisation (dose-light interval and light intensity) and the identification of efficacy signals. Part 3 will expand testing to include superficial Basal Cell Carcinoma (sBCC)
The adaptive design allows for modifications to the trial procedures based on interim results, enhancing the efficiency and effectiveness of the study. As such, the trial will enrol a minimum of 18 patients, which can be increased depending on the results.
Veracity will select male and female patients over the age of 18 with non-metastatic cSCC and sBCC, although other NMSCs may be approved on a case-by-case basis. Other screening criteria include size and location of the lesion.
Significance of NMSC
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 is 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.
Next Steps
The NMSC trial follows the release of promising results from a Phase II prostate cancer trial using the same active pharmaceutical ingredient, INV043. Once the trial results have been analysed, in addition to progressing the NMSC program, Invion plans to leverage this data into a planned Phase II anogenital cancer trial using topical INV043, and potentially including the use of immune checkpoint inhibitors (ICIs) on the back of solid in vivo data from the Peter MacCallum Cancer Centre.
This study showed 80% complete pathological control of anal squamous skin cancers versus a 12% response rate on ICI treatments on a standalone basis.
The Executive Chair and Chief Executive Officer of Invion, Thian Chew, said:
“Having the first patient dosed in our NMSC trial is a significant milestone for Invion in demonstrating the potential for the Photosoft technology to address limitations and undesirable side effects of current standard of care for NMSCs, including scarring and pain.”
“On the back of the recently announced prostate cancer results, this trial can also provide clinical evidence that INV043 can be safely used in more than one formulation to treat multiple cancers. This can then open up the potential for our next-generation PDT to become an important alternative modality for treating cancers.”
The NMSC trial will be conducted under International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) good clinical practice (GCP) and ISO 14155 standards.
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