Company: INTS
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001567264-25-000010
Chunk: 91

Company: INTENSITY THERAPEUTICS, INC.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 91
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ular carcinoma. There was also an increase in immune activation. Both of these study findings support the hypothesis that IT INT230-6 prior to SOC neoadjuvant therapy could increase pCR rates in high-risk patients.

Phase 3 Metastatic Soft Tissue Sarcoma Study (“INVINCIBLE-3 Study”)

In July 2024, we initiated and dosed our first patient in the INVINCIBLE-3 Study, a phase 3 study in 2nd/3rd line treatment for locally advanced, recurrent, inoperable, or metastatic non-diffuse soft tissue sarcoma with overall survival as the primary endpoint in a subset of advanced soft tissue sarcoma patients (leiomyosarcoma, liposarcoma and undifferentiated pleomorphic sarcoma).  These subtypes comprise over 80% of the sarcoma populations. This study has been authorized by the FDA, Health Canada, the European Medicines Authority, and Australia's Therapeutics Goods Administration. The trial is enrolling patients and is being conducted in eight countries: the US, Australia, Canada, France, Germany, Italy, Poland, and Spain. Up to 60 sarcoma-focused hospitals and other centers are expected to participate from these countries.

The INVINCIBLE-3 Study will randomize patients 2 to 1 to either INT230-6 for 5 doses Q2 weeks with maintenance dosing every 9 weeks for 2 years or the SOC. The three drugs most used for soft tissue sarcoma will be the control SOC at the investigator’s choice depending on the type of sarcoma. Our Phase 3 study is designed to be 90% powered to detect a difference hazard value of 0.65 in overall survival between the INT230-6 treatment group and the control group with 333 patients enrolled (2:1 randomization to either INT230-6 treatment or control therapy). The study will have 3 interim data reviews. The first at 20% of events (deaths) for futility only, the second at 40% of events, and the third at 60% of events.  The final analysis will be based on 80% of events (266 deaths). See Figure 21 below for INVINCIBLE-3 Study schema.

Figure 21 — The INVINCIBLE-3 Study schema comparing INT230-6 to the approved 2nd or 3rd line standard of care drugs

Figure 22 shows the survival curves from five recent Phase