Intensity Therapeutics Secures US Patent No. 12,496,345, Expands IP to 41 Countries
Intensity Therapeutics obtained US Patent No. 12,496,345 on December 16, 2025, for its intratumoral cancer treatment, bringing its total to four US patents and 19 issued patents globally. The company holds enforceable IP protection in 41 countries and orphan drug status grants seven years of market exclusivity for INT230-6 components.
1. Patent Portfolio Expansion
Intensity Therapeutics’ newly issued US Patent No. 12,496,345, granted December 16, 2025, covers its proprietary intratumoral formulation method. This brings the company’s total to four US patents, 19 patents worldwide, and enforceable claims in 41 countries, including validation across 27 European nations.
2. Orphan Drug Exclusivity
The company’s three main components of INT230-6 have orphan drug designation, providing seven years of market exclusivity post regulatory approval in the US. This status enhances the commercial potential of its lead compound by insulating it from generic competition.
3. Clinical Pipeline Impact
INT230-6, developed on the DfuseRx℠ platform, combines cisplatin, vinblastine sulfate, and a penetration enhancer for direct tumor injection. Ongoing Phase 3 soft tissue sarcoma and Phase 2/3 triple-negative breast cancer trials could leverage the strengthened IP to support future regulatory submissions and partnerships.