🔒Shelton cancer-drug startup looks to Big Pharma after clinical trial pause

A small Shelton biotechnology company testing a new way to attack cancer has been forced to halt a clinical trial after running low on cash. Intensity Therapeutics, founded in 2012 by chemical engineer Lewis Bender, is developing an injectable cancer drug designed to kill tumors from the inside out. Unlike traditional chemotherapy, which circulates through the bloodstream and affects the whole body, Intensity’s lead drug candidate — INT230-6 — is injected directly into tumors. The drug uses a chemical “penetration enhancer” to push cancer-killing agents deep into the tumor and help trigger the body’s immune system to attack the disease. But advancing a cancer drug is expensive, and Intensity says it needs to raise more money to keep its largest study running. Earlier this year, the seven-employee company paused new patient enrollment in its Phase 3 Invincible-3 trial, which was testing whether INT230-6 could outperform standard treatments for certain soft-tissue sarcomas — a rare and aggressive cancer. Intensity said it has spent about $5 million treating roughly 30 patients so far, but estimates it will need another $30 million to enroll and treat 300 more in order to finish the study. “It’s a tragedy that I had to stop the enrollment on the Phase three because the drug seems to be helping people,” Bender said in a recent interview with the Hartford Business Journal. The company, in September, also paused enrollment in its Phase 2 Invincible-4 trial. That study is testing INT230-6 in patients with early-stage triple-negative breast cancer, an especially difficult-to-treat form of the disease. Intensity suspended enrollment after some patients experienced localized skin irritation near the injection site — a known risk of the drug. The company is adjusting the dosing regimen and plans to restart enrollment in early 2026, Bender said. Since its founding, Intensity has raised $82.6 million through stock sales, including $19.5 million from its 2023 initial public offering. It has also invested $75.4 million in research and other operating costs. It reported $7.1 million in cash at the end of September. In October, the company announced it raised an additional $6.1 million that extended its cash runway through early 2027 — but doesn’t provide enough funds to restart the soft-tissue sarcomas clinical trial.

Wanted: A large pharma partner

Bender said he is open to selling the company to a larger drugmaker with the resources to continue clinical testing and pursue wider uses for INT230-6. “We reach out to them all the time,” he said. “I have no idea what’s going to flip the switch in these guys’ and gals’ minds to finally recognize what we have.” He previously thought Intensity would have been acquired by now, but has since learned that markets are fickle and big drugmakers often move slowly when considering early-stage treatments. The fundraising climate has been difficult in recent years for early-stage biotech firms as investors pulled back during a period of high interest rates and inflation, said Matt Storeygard, director of investments at Connecticut Innovations, the state’s quasi-public venture investment arm. But he said conditions are beginning to improve. “We are now starting to see positive momentum,” he said. “We fully expect this shift to translate into rising activity levels for early-stage companies.” Storeygard said Connecticut Innovations is preparing to launch a bio-accelerator to support emerging pharmaceutical and biotech startups. “Pharma’s capital intensity requires deep, patient investment partnerships and bold thinking,” he said.

A possible way to kill cancer

For Bender, Intensity’s recent funding troubles are just the latest obstacle in a two-decade effort he believes could reshape how some cancers are treated. The idea behind INT230-6 dates back to his earlier work in the pharmaceutical industry, where he learned about a little-known compound called SHAO. The molecule acts as a “penetration enhancer” — essentially a chemical helper that allows drugs to break through tough biological barriers, including the dense structure of solid tumors. Bender began to wonder whether SHAO could help deliver chemotherapy directly into tumors, concentrating cancer-killing drugs where they’re most needed instead of circulating them throughout the body. “I thought I had an idea that the rest of the world was not going to get because I knew how to work with this SHAO molecule,” he said. At 52, with two children heading toward college, he left his job as CEO of Interleukin Technologies in 2012 and began developing INT230-6 — a combination of SHAO and two chemotherapy agents (cisplatin and visblastine) — in his basement. After a few months, he sent the formulation to Charles River Laboratories for preclinical testing required by the Food and Drug Administration. “I said, if I don’t do this and it works, I will have too much regret right at the end of my life,” he said. The drug spent three years in animal studies before receiving FDA approval in late 2016 to begin human testing. The first Invincible-1 trial, which ran from 2016 to 2023, treated 110 patients with various advanced cancers. A second study, Invincible-2, tested the drug in 91 breast cancer patients between 2020 and 2024. In October, a peer-reviewed paper in Lancet Discovery Science, a publication of the well-known medical journal The Lancet, reported that INT230-6 produced a high rate of tumor control and shrinkage in patients with metastatic cancers, according to Bender. “That’s a big deal,” he said. Throughout this period, Intensity’s headquarters shifted from Norwalk to Westport and, most recently, to Shelton in 2023. But Bender said the company’s mission never changed: finding a new way to help cancer patients. “That is my strategy, and the best way to do that is more money, more money, more money.” he said. “Who has money? Pharma companies. I would love to have them help us.”