Company: INTS
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001567264-25-000010
Chunk: 92

Company: INTENSITY THERAPEUTICS, INC.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 92
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3 studies using now approved SOC drugs for sarcoma, and also shows the expected Phase 3 survival for 1) the blended control based on the likely mix of sarcoma types (green curve) and 2) the INT230-6 survival curve based on the IT-01 Study results for sarcoma patients only (navy blue curve). The references showing the Phase 3 data for the SOC controls are; for trabectadin: Patel S, et. Cancer. 2019 Aug 1;125(15):2610-2620; for eribulin: Schöffski et. al. Lancet. 2016 Apr 16;387(10028):1629-37; and for pazopanib: van der Graaf et. al. Lancet. 2012 May 19;379(9829):1879-86.

It is notable that despite different regimens and sarcoma subtype distributions, the overall survival is consistent for the current SOC drugs. Our IT-01 Study enrolled sarcoma patients with mixed subtypes whose cancer progressed despite a median of 3 prior treatments. We plan to enroll a similar mix of sarcoma patients in the INVINCIBLE-3 Study, however, no patient will have progressed on more than 2 treatments. Thus, patients in the INVINCIBLE-3 Study should be healthier than those treated in our IT-01 Study, where over 25% of patients were well underdosed, and based on the tumor necrosis levels observed. 

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In the INVINCIBLE-3 Study, underdosing of patients will be less likely, given dosing of INT230-6 can be as high as 175mL from day 1, and patients will also receive long term maintenance treatment of INT230-6 every 12 weeks.

Figure 22 — Overall survival curves of standard of care drugs from phase 3 trials, and INT230-6 survival curve based on IT-01 Study sarcoma patient results.

The survival curves from five recent Phase 3 studies using now approved standard of care drugs for sarcoma. The figure also shows the expected Phase 3 survival for 1) the blended control based on the likely mix of sarcoma types (green curve) and 2) the  INT230-6 survival curve based on the IT-01 Study results for sarcoma patients only (navy blue curve), which was conducted in a less healthy sarcoma population.

Phase 2 Pre-surgical (