Invion’s Funding and Trial Progress Highlight Risks and Opportunities Ahead
Invion Limited has marked significant progress in its cancer treatment pipeline, dosing the first patient in a pivotal skin cancer trial and reporting encouraging prostate cancer results, while securing fresh funding to support ongoing development.
- First patient dosed in Phase I/II non-melanoma skin cancer trial
- Promising safety and efficacy signals from Phase II prostate cancer trial
- Strategic partnerships advancing in South Korea with Hanlim Pharm and Dr.inB
- Appointment of Prof Rob Ramsay as Scientific Advisor
- Completion of 1-for-100 share consolidation and receipt of $350K funding
Clinical Progress Marks a Turning Point
Invion Limited (ASX: IVX) has reported a series of pivotal developments in its cancer therapy pipeline during the December 2024 quarter. The company achieved a critical milestone by dosing the first patient in its Phase I/II non-melanoma skin cancer (NMSC) trial in Brisbane, a key step in evaluating its lead drug candidate INV043. This novel photosensitiser, developed for Photodynamic Therapy (PDT), aims to offer a less invasive and targeted cancer treatment option.
The open-label, adaptive design of the NMSC trial allows Invion to optimize dosing parameters and assess early efficacy signals, with plans to expand patient enrolment based on interim results. This flexibility could accelerate the path to identifying the most effective treatment regimen for superficial Basal Cell Carcinoma (sBCC).
Encouraging Prostate Cancer Trial Outcomes
Complementing the skin cancer trial, Invion released promising data from a Phase II prostate cancer trial. The results demonstrated a strong safety profile for INV043 and encouraging efficacy signals, with 40% of patients showing a positive response three months post-treatment. Notably, 10% of patients achieved complete tumour regression, and 44% had negative PSMA-PET scans, indicating a significant reduction in cancer activity.
These findings bolster confidence in INV043’s potential as a therapeutic agent and provide a foundation for further clinical exploration.
Strategic Partnerships and Scientific Leadership
Invion’s collaborations with South Korean pharmaceutical companies Hanlim Pharm and Dr.inB are progressing well. Hanlim is funding preclinical studies targeting glioblastoma multiforme, a challenging brain cancer, while Dr.inB advances research toward human papillomavirus (HPV) treatment using the Photosoft technology. Both partnerships retain Invion’s rights to the technology, underscoring its global commercial potential.
Adding to its scientific expertise, Invion appointed Professor Robert Ramsay as Scientific Advisor. Prof Ramsay, an Honorary Professor at the Peter MacCallum Cancer Centre and a globally recognised cancer researcher, previously led preclinical studies demonstrating the efficacy of INV043 in combination with immune checkpoint inhibitors. His involvement is expected to guide Invion’s clinical strategy and accelerate trial development, particularly for anogenital cancers.
Financial Position and Capital Structure
On the financial front, Invion ended the quarter with $736,000 in cash reserves and secured an additional $350,000 in January 2025 from The Lind Partners under a share purchase agreement. This funding arrangement provides a minimum monthly instalment of $100,000, with potential increases up to $500,000, offering a runway to support ongoing R&D and corporate activities.
The company also completed a 1-for-100 share consolidation, reducing the total shares on issue to approximately 70.4 million. This move aims to enhance capital structure efficiency and shareholder value as Invion advances its clinical programs.
Looking Ahead
Invion’s recent achievements position it at a critical inflection point in its mission to develop innovative cancer therapies. The upcoming months will be crucial as data from the NMSC trial matures and preparations for the anogenital cancer trial progress in partnership with the Peter MacCallum Cancer Centre. Investors and analysts will be watching closely for further clinical readouts and the impact of strategic collaborations on Invion’s growth trajectory.
Bottom Line?
Invion’s clinical and financial strides set the stage for pivotal data releases that could redefine its market potential.
Questions in the middle?
- How will interim results from the Phase I/II skin cancer trial influence trial expansion and regulatory strategy?
- What are the timelines and milestones expected from the anogenital cancer trial leveraging the Photosoft formulation?
- How might the partnerships with Hanlim Pharm and Dr.inB translate into commercial opportunities or further clinical programs?