Company: TVRD
Filing Date: 2025-10-07
Form Type: S-1/A
Source: 0001104659-25-097519
Chunk: 185

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-10-07
Form: S-1/A
Chunk 185
---
 1 or 2. TTI-101 showed linear PK from dose level 1 – 3 plateauing at dose level 3 which was selected as the RP2D. The exposures of patients treated with TTI-101 at its trough exceeded the expected concentration required for 90% inhibition of STAT3-dependent growth, or the IC90. PD values were available from ten patients who agreed to pre- and on-treatment paired tumor biopsies. Eight of these patients had elevated pre-treatment pY-STAT3. Each of these patients demonstrated a decrease in their pY-STAT3 levels at the follow-up biopsy (approximately six weeks after initiating treatment), with a median decrease of 55% in pY-STAT3 levels. Among the three patients who demonstrated a clinical benefit, the median decrease was 79% in pY-STAT3 levels. The biologic effect of TTI-101 monotherapy in patients with advanced diseases, who had previously been treated with a median of over three prior systemic therapies and evaluable for tumor response is outlined in the table below. Overall, 41 patients were evaluable for response, and we observed a disease control rate of 54%, as measured by RECIST v1.1, among all tumor types, including confirmed partial responses in HCC, ovarian and gastric tumor types. Among the 17 patients with HCC, we observed a disease control rate of 53%, as measured by RECIST v1.1.

| ​                             | ​ |                 ​ | ​ |                   ​ | ​ |
| ​                             |   |                 ​ |   |   All Patients with |   |
| ​                             | ​ | Patients with HCC | ​ |      Advanced Solid |   |
| ​                             | ​ |       -N=17) n (% | ​ | Tumors (N=41) n (%) |   |
| Confirmed partial response(1) |   |            3 (18) | ​ |             5 (12)* | ​ |
| Stable disease(2)             |   |            6 (35) | ​ |             17 (41) | ​ |
| Progressive disease(3)        |   |            8 (47) | ​ |             19 (46) | ​ |
| Disease Control Rate(4)       |   |               53% |   |                 54% |   |
| Median Number of Therapies    |   |                 2 |   |