Invion Limited (ASX: IVX), a life-science company leading the global research and development of the Photosoft™ technology for the treatment of a range of cancers, atherosclerosis and infectious diseases, has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead drug candidate, INV043, for the treatment of anal cancer. This designation marks a significant milestone for Invion, providing several key benefits to accelerate the development and commercialisation of INV043.
The FDA’s Orphan Drug Designation is awarded to drugs intended to treat rare diseases, offering incentives to encourage their development. These incentives include seven-year exclusive marketing rights in the US post drug approval, potential financial incentives such as tax credits for clinical trials, and waivers of certain fees. Moreover, the designation may facilitate a faster path to market through fast-tracked approvals and potentially smaller clinical trials.
INV043 has demonstrated promising preclinical efficacy, achieving approximately 80% tumour control in mice when used in combination with immune checkpoint inhibitors. Invion is collaborating with the Peter MacCallum Cancer Centre to plan an anogenital cancer clinical trial using INV043 in combination with immune checkpoint inhibitors. Anogenital cancers include anal, vulvar, and penile cancers, which are often challenging to treat with mainstream treatments often causing severe side effects.
Professor Thian Chew, Invion’s Executive Chairman and CEO, stated that this regulatory milestone enhances the company’s ability to bring INV043 forward more quickly and cost-efficiently. The Orphan Drug Designation may also increase Invion’s appeal to strategic partners, given the potentially accelerated pathway to leverage intellectual property combining their immune checkpoint inhibitors with Invion’s technology. Early results from ongoing trials also indicate INV043 is well tolerated, with encouraging signs of efficacy.
