Company: INTS
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001567264-25-000010
Chunk: 86

Company: INTENSITY THERAPEUTICS, INC.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 86
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 soft tissue sarcoma (Subbiah data)

We were able to estimate the RMHI score in our study for each patient receiving only INT230-6. Subjects in our study primarily had a RMHI score of 1 (33%) or 2 (40%). To be more confident that we are matching the population when 

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comparing our drug to the Subbiah population, we created a synthetic Kaplan-Meier control curve from the Subbiah dataset that approximated our patients’ RMHI score distribution (Figure 17 below). We chose Subbiah as the dataset, because it was the study that reported the longest survival of the three Sarcoma studies, and would be the most conservative data to serve as the basis for a synthetic control.

We calculated the Kaplan-Meier synthetic control derived from the Subbiah basket trial matched to the IT-01 Study sarcoma population’s RMHI scores for all INT230-6 monotherapy patients that predicted our sarcoma patients should have had a median survival of 6.7 months.

Figure 17 — Survival of INT230-6 monotherapy sarcoma patients

Estimates of sarcoma subject survival using INT230-6 based on dose per TTB from the IT-01 Study compared to a synthetic control are shown in the table below.

INT230-6 Dosed <40% of TTB (months)Synthetic Control of sarcoma patients (2 prior lines) (months)INT230-6 all subjects (months)INT230-6 Dosed >40% of TTB MonthsMedian overall survival, CI4.06.721.3Not reached with 400 days of median follow-up

Phase 2 Presurgical Breast Cancer Study (“INVINCIBLE-2 Study”)

In March 2021, we began a Phase 2 Randomized, Window of Opportunity trial evaluating clinical and biological effects of intratumoral INT230-6 against no treatment (the SOC) in early-stage breast cancer patients awaiting surgery. The study completed enrollment and the database was locked in November 2023. The key efficacy endpoints were to (i) compare necrosis levels in tumors based on size and dose compared to saline control, (ii) the percentage of subjects having a greater than 50% reduction of viable cancer cells in their tumor compared to control, and (iii) the percentage of subjects who achieve a cell cycle arrest, defined as a reduction in the proportion of cells staining positive for Ki67, a widely used marker of cancer cell