Invion Doses First Patient in Phase I/II Non-Melanoma Skin Cancer Trial with INV043
Key Insights
Invion (search) has dosed the first patient in its Phase I/II trial evaluating topical INV043 for non-melanoma skin cancer (search) (NMSC).
The open-label, adaptive trial will assess the safety and efficacy of INV043 in cutaneous Squamous Cell Carcinoma (search) and superficial Basal Cell Carcinoma (search).
Preclinical data suggests INV043 may offer advantages over current NMSC treatments, such as efficacy without scarring and minimal pain.
Invion (search) Limited has announced the dosing of the first patient in its Phase I/II non-melanoma skin cancer (search) (NMSC) trial at Veracity Clinical Research in Brisbane, Australia. This trial aims to evaluate the safety and efficacy of INV043, a novel photosensitizer, for photodynamic therapy (PDT) in treating various cancers.
Trial Design and Objectives
The open-label, adaptive trial is designed to assess the safety profile of topically applied INV043 in non-metastatic cutaneous Squamous Cell Carcinoma (search) (cSCC). Subsequent phases will focus on dose optimization, including dose-light interval and light intensity, and identifying efficacy signals. The trial will expand to include superficial Basal Cell Carcinoma (search) (sBCC) in its third part.
The adaptive design allows for modifications based on interim results, enhancing the trial's efficiency. The study will enroll a minimum of 18 patients, with the possibility of increasing the number based on the data obtained. Participants will include male and female patients over 18 years of age with non-metastatic cSCC and sBCC. Other NMSCs may be considered on a case-by-case basis, considering lesion size and location.
Significance of NMSC and INV043's Potential
Skin cancer is a prevalent global cancer, with NMSC accounting for over 98% of all skin cancers. The global treatment market is projected to reach US$21.1 billion by 2032, highlighting the need for effective and affordable treatments with minimal side effects. Current mainstream treatments, such as surgery, can lead to permanent scarring.
Preclinical studies at the Hudson Institute of Medical Research have indicated that INV043 has the potential to regress cancers without scarring and with minimal pain, offering a significant advantage over existing treatments.
Future Plans
This NMSC trial follows promising Phase II prostate cancer (search) trial results using INV043. Invion (search) plans to use the data from the NMSC trial to support a planned Phase II anogenital cancer trial using topical INV043, potentially incorporating immune checkpoint inhibitors (search) (ICIs). Preclinical data from the Peter MacCallum Cancer Centre showed 80% complete pathological control of anal squamous skin cancers (search) with INV043, compared to a 12% response rate with ICI treatments alone.
Thian Chew, Executive Chair and CEO of Invion (search), stated, "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."
Chew added, "On the back of the recently announced prostate cancer (search) 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 adhere to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) good clinical practice (GCP) and ISO 14155 standards.