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Intensity Therapeutics Moves to Restart Phase 3 Sarcoma Trial

Intensity Therapeutics is preparing to resume enrollment in its Phase 3 INVINCIBLE-3 study for soft tissue sarcoma, marking a critical step toward reviving the company's clinical pipeline following a period of funding-related pauses. The firm reported a net loss of $3 million for the second quarter of 2026.

Intensity Therapeutics Moves to Restart Phase 3 Sarcoma Trial
Photo: Bio & News

The Shelton-based biotech firm, which ended the quarter with $9.5 million in cash and equivalents, is leveraging an FDA-reviewed amended protocol for its sarcoma study. This trial was previously stalled in March 2025 due to capital constraints. Management indicated that site activation and enrollment rates will scale as additional funding becomes available.

Meanwhile, the company has restarted patient treatment in the Phase 2 INVINCIBLE-4 study targeting triple-negative breast cancer. Preliminary data from 14 patients showed a 71% pathological complete response rate in the cohort receiving the company’s lead candidate, INT230-6, compared to 42% for the standard-of-care group. The company modified this study’s protocol earlier this year to address localized skin irritation reported by some participants. CEO Lewis H. Bender noted that the business is actively seeking strategic partnerships to advance its programs, following discussions held at the BIO International Conference in June.

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