Intensity Therapeutics said today that the 1st patient was treated in a Phase I/II trial of its intratumorally-administered cancer therapy, INT230-6.

The company’s plans to evaluate the safety of its cancer-killing agent in patients with tumors that are treated at the surface of the skin, including breast cancer and melanoma. Intensity Therapeutics also plans to study INT230-6 in patients with deep tumors.

Using image guidance, the Westport, Conn.-based company said the study’s investigators will directly inject INT230-6 into the patients’ tumors.

“Bringing our novel product, INT230-6, into human testing is a major milestone for Intensity Therapeutics,” president & CEO Lewis Bender said in prepared remarks. “Over the past few years our company has demonstrated impressive tumor shrinkage in several murine models of cancers. INT230-6 eradicated large tumors, activated a systemic immune response and improved survival. Animals having a complete response acquired the capability to spontaneous clear re-challenges of the same cancer throughout the remainder of their lives, suggesting a protective effect similar to that of a vaccine. We are therefore excited to have initiated human testing. Our staff, investigators and clinical centers are enthusiastic about bringing patients our potentially life-saving product.”

“Our studies with INT230-6 have shown the ability to stimulate a strong T-cell response as a monotherapy. There is considerably enhanced activity using INT230-6 in combination with checkpoint inhibitors such as anti-PD-1 antibodies, while maintaining a favorable safety profile,” chief medical officer Dr. Ian Walters added. “We are optimistic that our novel trial design can quickly detect evidence of direct tumor killing and immune system activation. Physicians desperately need improved treatments for patients with advanced cancers that are not responding to approved immunotherapies. Intensity Therapeutics is grateful to the volunteers participating in our study and looks forward to collecting data on INT230-6 in different cancer types.”