Company: INTS
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001567264-25-000010
Chunk: 83

Company: INTENSITY THERAPEUTICS, INC.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 83
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 from a breast cancer patient confirm that this effect also occurs in humans. Applying a special set of stains to the biopsied tissue enables the measurement of immune cells inside the tumor. We observe infiltrating immune cells in the tumor. In Figure 13 (below) the first panel (Image A) shows extensive cancer (blue color) (DAPI) and a marker of live and proliferating cancer. The green and yellow colors represent immune cells. The second panel (Image B) shows that 28 days after two doses there is a markedly reduced amount of live cancer (less blue stain). In addition, the green/yellow stained cells, representing CD4 and CD8 T-cells, are increased throughout the entire tissue. 

Figure 13 — IHC Staining of breast cancer tissue for immune cell infiltration pre- and post-dosing of INT230-6

Necrosis Results in Sarcoma

Several patients with metastatic soft tissue sarcomas were enrolled in the IT-01 Study. As was seen with breast cancer and multiple other tumor types, there were substantial reductions of cancer in the biopsies pre- and post-dosing. As shown in Figure 14. Image A is the stained tissue sample (pre-dose) that shows significant cancer (dark purple cells) throughout the tissue sample. Image B is the stained tissue sample taken on day 28 after two doses of INT230-6 (day 0 and day 14) that shows significant reduction in the live cancer (Magnification 3.7x).

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Figure 14 — Images from match pair biopsied soft tissue sarcoma subject 010-001 pre- and post-two INT230-6 injections

Image AImage B

Immune Response in Sarcoma

We also measured DAPI and activated T-cells from a sarcoma tumor. The results again confirm that for this non-immunogenic tumor type, there is also a substantial reduction of cancer cells as seen by the decrease in the marker post INT230-6 treatment. Figure 15 shows the influx into the tumor of CD4 and CD8 T-cells at 28 days following the first dose.

Figure 15 — Staining of biopsied sarcoma tumor tissue pre and post dosing of INT230-6

           Image A - Pre-dose        Image B - Post-dose

The results of the H&E analysis and the multiplex IHC staining show substantial cancer cell reduction, decreases in proliferation, and increased