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Intensity Therapeutics Reports INVINCIBLE-4, Presurgical Triple-Negative Breast Cancer Study Update

Key Takeaway: Intensity Therapeutics provided an update on the INVINCIBLE-4 trial, reporting a pathological complete response in the first patient of Cohort A. The trial involves administering two doses of INT230-6 followed by standard of care. While safety has been favorable, some patients experienced localized skin irritation, leading to a pause in new patient enrollment for data evaluation.
Price reaction · baseline $7.08 (2025-09-09 close) · hit pre-market · clean, no other INTS news in the window
day 0 close
-9.6%
day 1 · peak
-17.9%
day 3
-16.5%

Market Sentiment Analysis

POSITIVE FACTORS

  • First patient in Cohort A showed a pathological complete response.
  • Favorable safety profile reported in Cohort A.
  • Novel intratumoral cancer therapy shows promise.

CONCERNS & RISKS

  • Localized skin irritation was reported in some patients.
  • New patient enrollment has been paused for data evaluation.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Cash runway
~12 mo
Medium dilution risk
Lead asset
INT230-6
Phase 3 · Sarcoma,Soft Tissue

Full Press Release Details

• A pathological complete response ("pCR") has been observed in the first patient evaluated in Cohort A, where each patient receives two doses of INT230-6 eight days apart, followed by the standard of care immunochemotherapy ("SOC")
• Safety looks favorable in Cohort A
• Some INT230-6 patients begin to show localized skin irritation, and new patient enrollment has been paused to implement modifications to resolve the issue
• Patients being treated with INT230-6 continue to show significant necrosis after two doses of INT230-6 and prior to the initiation of the SOC, as shown in the photos below of a single patient's breast tumor scans
SHELTON, Conn.,Sept. 10, 2025/PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq:INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, today provided an update on the INVINCIBLE-4 trial. A pathological complete response ("pCR") has been observed in the first patient evaluated in Cohort A, where each patient receives two doses of INT230-6 eight days apart, followed by the SOC. To date, there has been favorable safety in cohort A. However, some patients in Cohort A experienced localized skin irritation near the tumor. As a result, new patient enrollment has been paused to evaluate the data collected and to implement necessary adjustments prior to reopening accrual.

Frequently Asked Questions

What is the INVINCIBLE-4 trial about?

The INVINCIBLE-4 trial evaluates the efficacy of INT230-6 in treating triple-negative breast cancer.

What were the results for the first patient in Cohort A?

The first patient in Cohort A achieved a pathological complete response.

What safety concerns were reported in the trial?

Some patients experienced localized skin irritation near the tumor.

Why was new patient enrollment paused?

Enrollment was paused to evaluate collected data and implement necessary adjustments.

Last updated: Sep 10, 2025