Intensity Therapeutics, Inc. provided a business update on January 10, 2025, detailing key achievements with its lead drug candidate, INT230-6. The company initiated and dosed its first patient in the Phase 3 INVINCIBLE-3 sarcoma study in July 2024, which has received regulatory authorizations from the US FDA, Health Canada, EMA, and Australia TGA. The trial is actively enrolling patients across eight countries, with 32 sites contracted and 25 patients screened.
In November 2024, Phase 1/2 data for INT230-6 in sarcoma was presented at CTOS, showing a median overall survival of 21.3 months versus a synthetic control of 6.7 months, along with increased T-cell activation. For breast cancer, the Phase 2 INVINCIBLE-4 study dosed its first patient in October 2024 in collaboration with SAKK, targeting localized triple-negative breast cancer. Phase 2 data from the completed INVINCIBLE-2 study, demonstrating tumor-killing and immune activation, was presented at SABCS in December 2024.
The INVINCIBLE-4 study is expected to enroll 54 patients in Switzerland and France, with seven sites activated and additional activations planned for the first half of 2025. The company is also engaged in discussions with multiple companies regarding potential strategic collaborations and licenses for INT230-6.
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