Orphan Drug Designation for INV043 Marks Major Milestone for Invion

Invion Limited (ASX: IVX) announced that its lead oncology candidate, INV043, has received Orphan Drug Designation from the US Food and Drug Administration for use in treating anal cancer, marking a major advancement in the company’s development program. This designation provides several strategic benefits, including seven years of exclusive US marketing rights following approval, financial incentives such as potential tax credits and fee waivers, and an accelerated pathway to market through fast-tracked approvals and smaller clinical trials.

The recognition builds on promising preclinical results from the Peter MacCallum Cancer Centre, where INV043, in combination with immune checkpoint inhibitors (ICIs), achieved ~80% tumour control in mouse models, compared with ~12% for ICI alone, without adverse side effects. Invion is now preparing for an anogenital cancer clinical trial, targeting hard-to-treat cancers such as anal, vulvar, and penile cancer. According to CEO Prof Thian Chew, the ODD status enhances the company’s ability to advance INV043 efficiently while increasing its attractiveness to potential strategic partners.

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