Westport biotech firm Intensity Therapeutics Inc. has received fast track designation from the U.S. Food and Drug Administration (FDA) for the development of a treatment for relapsed or metastatic triple negative breast cancer.
INT230-6 is comprised of two proven, potent anti-cancer agents and a penetration enhancer molecule that helps disperse the drugs throughout tumors and diffuse into cancer cells. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor kill and recruitment of dendritic cells to the tumor micro-environment that induced anti-cancer T-cell activation. Other encouraging signs have been recorded via injections of the treatment in animals.
“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,” said Lewis H. Bender, president and CEO of Intensity Therapeutics.
Approximately 15 to 20% of breast cancers test negative for estrogen receptors, progesterone receptors and excess HER2 protein, qualifying them as triple negative. The condition is considered to be more aggressive and have a poorer prognosis than other types of breast cancer, mainly because there are fewer targeted medicines. According to a study published in the Journal of Clinical Oncology, patients who fail two lines of therapy for TNBC typically progress within nine weeks. Those who have failed three lines progress within four weeks.
“This important regulatory designation is based on the promising data observed to date from use of INT230-6 in our breast cancer research,” said Dr. Ian B. Walters, 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.”
The FDA’s fast track program facilitates development and expedites the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. A fast track drug must show some advantage over available therapy.
Fast track designation allows early and frequent communication between the FDA and a drug company, often leading to earlier drug approval and access by patients. In addition, the fast track program allows for eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.