Shelton-based Intensity Therapeutics is preparing to resume patient enrollment in a late-stage cancer drug trial it paused last year because of funding constraints, although the biotech company says a broader restart remains dependent on raising additional capital.
Intensity said it began work in April to resume enrollment at a limited number of U.S. locations in its Phase 3 study of an experimental drug that is injected directly into tumors. The study is testing the treatment in patients with certain types of soft-tissue sarcoma, a rare form of cancer.
The experimental treatment combines two cancer-killing drugs with a compound designed to help them penetrate tumor tissue. Rather than delivering chemotherapy throughout the body, the treatment is injected directly into a tumor, with the goal of killing cancer cells locally while also stimulating an immune response against the cancer.
Patient enrollment is expected to resume during the third quarter, according to a regulatory filing. Intensity said it plans to expand enrollment and add study locations once it secures sufficient additional funding. The company paused new enrollment in March 2025 after signing up 21 patients, although it continued treating those already participating in the study.
Founder and CEO Lewis Bender told the Hartford Business Journal in December that Intensity estimated it would need about $30 million to enroll and treat another 300 patients to complete the study.
Intensity’s latest regulatory filing shows that funding remains a significant challenge. The company said it will need substantial additional funding and could be forced to delay, scale back or eliminate drug-development programs if it cannot raise enough capital or secure other financing arrangements.
Intensity had $9.5 million in cash as of June 30 and has raised another $1.3 million since then through stock sales.
The company reported a $3 million second-quarter net loss, compared with a $2.5 million loss a year earlier. Research and development spending increased to $1.8 million from $1.5 million, driven primarily by higher costs related to preparations to resume enrollment in the Phase 3 study.
The company has also restarted patient treatment in a separate study involving triple-negative breast cancer, an aggressive form of the disease. In that Phase 2 trial, researchers are studying the tumor-injected treatment given before patients receive standard immunotherapy and chemotherapy, compared with standard treatment alone.
Intensity paused new enrollment last September after some patients experienced skin irritation near the injection site, prompting the company to revise the dosing regimen. Patient treatment restarted in July, and Intensity opened its first study site in France for enrollment in August. The company is targeting completion of enrollment by the end of 2027.
Intensity also said it met with potential strategic partners at the BIO International Convention in late June and expects those discussions to continue during the second half of the year.
