Intensity Therapeutics Updates Breast Cancer Trial, Files To Resume Enrollment Following Study Pause

Intensity Therapeutics Inc. (NASDAQ:INTS) on Thursday provided an update on the INVINCIBLE-4 Study.

The INVINCIBLE-4 study is a Phase 2 study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the standard of care (SOC) immunochemotherapy treatment in patients with early-stage, operable triple-negative breast cancer and SOC alone.

Intensity Therapeutics’ Interim Data

The company on Thursday revealed that 14 patients have been treated so far, with a total enrollment expected to reach 61.

Preliminary observations showed that five out of seven patients (71.4%) who received INT230-6 before SOC achieved a pathological complete response (pCR)

Two out of six (33%) patients in the SOC arm alone achieved a pCR, with one patient still to be evaluated.

Preliminary observations indicate that safety data for patients receiving INT230-6 plus SOC remain favorable compared to SOC alone.

Intensity Therapeutics Paused Enrollment

In September 2025, the company paused enrollment due to skin irritations observed in the group INT230-6 before SoC.

In early March 2026, a protocol amendment was submitted to Swissmedic and the Swiss Ethics Committee to resume enrollment using a lower drug volume per tumor volume ratio and a single injection of INT230-6.

The update highlighted that in the previous presurgical study, skin issues were rare, and surgeries were performed without complications.

Management Commentary

“Reducing the total number of grade 3 or higher adverse events by 44%, especially immune-related adverse events, and the potential for a higher pCR rate with INT230-6 prior to SOC, could be life-saving for patients. With the amendment now filed with Swissmedic, we look forward to dosing the next patient,” Lewis Bender, Founder, President & CEO, said on Thursday.

Recently, Intensity Therapeutics announced a 1-for-25 reverse stock split to increase the per-share trading price and comply with Nasdaq listing requirements.

Intensity Therapeutics Benzinga Edge Rankings

Below is the Benzinga Edge scorecard for Intensity Therapeutics, highlighting its strengths and weaknesses compared to the broader market:

• Momentum: Weak (Score: 6.98) — Stock is underperforming the broader market.

The Verdict: Intensity Therapeutics’ Benzinga Edge Momentum score indicates underperformance; the company’s ongoing clinical trials present potential growth opportunities that investors should monitor closely.

INTS Stock Price Activity: Intensity Therapeutics shares were down 6.70% at $7.50 at the time of publication on Thursday, according to Benzinga Pro data.

Image via Shutterstock