Company: INTS
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001567264-25-000010
Chunk: 78

Company: INTENSITY THERAPEUTICS, INC.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 78
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 the change in diameters of an individual patient’s group of tumors. In the right figure the same color represents that same patient’s change in tumor volumes.

Visualizing a change in 3 dimensions also shows the limitations of using RECIST methods for determining efficacy for intratumoral INT230-6. Figure 10 shows the scan of a sarcoma patient’s tumor pre- and post-dosing. The longest diameter declines by 15%, while the second longest diameter declines 42%. Using RECIST criteria, this patient would have been classified as having stable disease, whereas the World Health Organization, which uses the two longest diameters, would classify this patient as having had a partial response, which is a better outcome.

Figure 10 — Scan showing change in two longest diameters of an injected sarcoma tumor at the base of the spine.

We believe that RECIST measurements (longest diameter) are inappropriate to capture efficacy with INT230-6. As a result, overall survival, the FDA’s gold standard efficacy endpoint, is a better measure of INT230-6’s performance in metastatic cancer.

16

Disease Control Rate

Even though RECIST was deemed to be less accurate for measuring efficacy, a secondary objective of the IT-01 Study was to assess the preliminary efficacy of INT230-6 by measuring the disease control rate (shown below) based on the RECIST and immune RECIST (“iRECIST”) criteria. 

Monotherapy cohortsDisease Control RateTotal (all subjects) (N = 64), n (%)75.0 (62.6, 85.0; 48)Dosed ≥ 40% TTB (N = 48), n (%)83.3 (69.8, 92.5; 40)Dosed < 40% TTB (N = 16), n (%)50.0 (24.7, 75.3; 8)  Sarcoma only (N = 15), n (%)93.3 (68.1, 99.8; 14)Dosed ≥ 40% TTB (N = 11), n (%)90.9 (58.7, 99.8; 10)Dosed < 40% TTB (N = 4), n (%)100 (39.8, 100; 4)Prior treatment Yes (N = 31), n (%)74.2 (55.4, 88.1; 23)No (N