Intensity Therapeutics reports 2025 milestones and 2026 plans

Intensity Therapeutics Inc. (NASDAQ: INTS) reported developments from its 2025 clinical trials and outlined strategic priorities for 2026, according to a company statement.

The biotechnology company's INVINCIBLE-4 study, a Phase 2 trial testing INT230-6 in early-stage triple-negative breast cancer, achieved a pathological complete response in its first evaluated patient in September 2025. The study was temporarily paused due to localized skin irritation in some patients, prompting protocol modifications to reduce dosing volumes. The company plans to file a protocol amendment in the first quarter of 2026 and expects to resume enrollment for the 61-patient study during the same period.

Early data from the INVINCIBLE-4 study presented at the San Antonio Breast Cancer Symposium in December 2025 showed 50% fewer grade 3 or higher adverse events in the INT230-6 cohort compared to standard chemotherapy alone. The study has treated 14 patients, with 7 in each cohort.

The company's Phase 3 INVINCIBLE-3 study in soft tissue sarcoma was paused in March 2025 due to funding constraints after enrolling 21 patients. Intensity continues treating enrolled patients while maintaining reduced study activities.

In October 2025, Intensity published Phase 1/2 clinical study results in eBioMedicine, a Lancet Discovery Science journal. The publication reported a 75% disease control rate and median overall survival of 11.9 months in patients with advanced solid tumors, with 21.3 months observed in sarcoma patients.

The company raised over $20 million in gross proceeds during 2025 through multiple offerings, extending its operating runway into the second quarter of 2027. CEO Lewis Bender stated the company will maintain disciplined operations while seeking additional capital to reinitiate the INVINCIBLE-3 study and potentially launch a new Phase 3 breast cancer trial.

You May Also Be Interested In

• Nomura/Instinet Upgrades Genting Singapore (GENS:SP) (GIGNY) to Neutral
• Apple In Coming Months To Launch Suite Of AI Tools In China-sources - Reuters
• Western Union's Intermex deal gets NY approval, California suspended