Intensity Therapeutics Inc. announced that the U.S. FDA has granted Fast Track designation to the company’s development program evaluating INT230-6 for the treatment of patients with relapsed or metastatic triple negative breast cancer (TNBC) who have failed at least two prior lines of therapy.

“We are extremely pleased to receive this Fast Track designation, which validates the potential of INT230-6 to treat patients with relapsed or metastatic triple negative breast cancer as a single agent,” said Lewis H. Bender, President and Chief Executive Officer of Intensity Therapeutics. “Finding improved therapies for this disease is a critical unmet medical need, and we look forward to working closely with the FDA this year to initiate a Phase 2 clinical study for this indication.”

“This important regulatory designation is based on the promising data observed to date from use of INT230-6 in our breast cancer research,” said Ian B. Walters, M.D., Chief Medical Officer of Intensity Therapeutics. “The Fast Track designation will allow us to engage robustly with the Agency to most effectively and efficiently develop our new cancer treatment approach, as well as help us determine other potential indications to pursue for INT230-6. To date, our ongoing Phase 1/2 trial has treated patients with more than 14 different types of advanced solid tumors including TNBC, and we look forward to evaluating use of INT230-6 in other areas for potential registration-enabling studies.”