Intensity Therapeutics restarts 61-patient breast cancer trial

• Intensity Therapeutics restarted patient treatment and administered the first new INT230-6 doses in Switzerland.
• Intensity Therapeutics shares were down 0.8% at $4.87 in premarket trading following the announcement.
• The company expects to recruit 47 additional patients in Switzerland and France under an amended single-injection protocol.

Intensity Therapeutics (NASDAQ:INTS) restarted dosing in its 61-patient INVINCIBLE-4 trial, testing INT230-6 before standard treatment for presurgical TNBC.

The study paused over skin irritation, prompting a March amendment that lowered the drug-to-tumor ratio and reduced dosing to one injection.

“We are excited to have restarted our Phase 2 study in presurgical triple-negative breast cancer,” said Intensity Therapeutics Founder, Chairman and CEO Lewis H. Bender.

The company expects 47 additional patients in Switzerland and France, with each cohort tested against a pCR null rate of 60% or less.

Among the first 14 patients, preliminary pCR rates were five of seven with INT230-6 before standard care and two of six evaluable controls.

Intensity is also restarting selected U.S. enrollment in Phase 3 INVINCIBLE-3, which compares INT230-6 with standard drugs in advanced soft-tissue sarcoma.