Company: INTS
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001567264-25-000010
Chunk: 82

Company: INTENSITY THERAPEUTICS, INC.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 82
---
 the potent killing agents to diffuse into the cancer cell without damage to the cell membrane. When the tumor’s cancer cells are dying or no longer alive, the ability of the immune system to identify the cancer and mount a response can be increased.

In our prior studies, we collected tumor tissue before and after dosing of our drug candidate from patients injected tumors. We analyze for live and dead cancer cells (referred to as necrotic cells). Our data shows that our drug candidate can kill cancer cells over a few days to a few weeks and activate an immune response. We have observed these effects in multiple cancer types.

Methods used

In the IT-01 Study, INT230-6 injections were conducted on the first treatment cycle’s first day (“C1D0”) and on the fourteenth day (“C1D14”). Pre and post-dose biopsies from the same injected tumor were obtained on C1D0 and again 28 days later just prior to the 3rd dose on the first day of the second treatment cycle (“C2D0”). To determine the percentage of viable tumor cells and necrotic (dead) cancer cells pre and post two treatments, we conducted analysis on the collected tissue following hemotoxylin and eosin (“H&E”) staining. H&E tissue analysis helps identify different types of cells and provides important information about the pattern, shape, and structure of cells in a tissue sample.

19

For many patients, we observed substantial reductions of cancer following the two injections of INT230-6 alone. Below are data on cell killing and immune activation from the two cancer types, breast cancer and sarcoma. We also use immunohistochemistry (“IHC”) staining to help assess cancer and various immune cell populations, as well as the degree of cancer cell proliferation in the treated tumors.

Necrosis Results in Breast Cancer

Figure 12 shows tissue taken from a metastatic breast cancer patient from the IT-01 Study. The pre-dose C1D0 samples stained positive (dark purple) indicating significant amounts of cancer throughout the sample. However, 28 days later C2D0, there was almost no cancer observed in the collected tissue. Magnification is 400µ.

Figure 12 — Images from match pair biopsied tissue samples pre and post two INT230-6 injections:

Immune Response in Breast Cancer

In preclinical studies, our technology reduces cancer levels substantially and causes an influx of immune cells into the tumor. The below images