Tundra Targeted Therapeutics prepares for human cancer trial

Milwaukee-based Tundra Targeted Therapeutics is advancing a homegrown cancer therapy toward Phase 1 clinical testing, marking a rare moment when a drug developed at a local research institution prepares to begin human trials in the same community where it started.

Founded in 2021, the company originated as a spin-off from the Medical College of Wisconsin. It received undisclosed funding in 2022 from BrightStar Wisconsin Foundation and Golden Angel Investors. The company has developed a platform that helps a patient’s own T-cells more efficiently attack and destroy cancer cells.

A targeted approach to cancer treatment

Tundra is developing a bispecific antibody designed to guide a patient’s T-cells directly to tumor cells. The goal is to help the immune system recognize and attack cancers that have stopped responding to existing treatments while reducing the side effects that often accompany broader therapies.

The technology builds on years of academic research conducted at the Medical College of Wisconsin in collaboration with academic innovators at the University of Virginia. CEO Jed White says the straightforward nature of the mechanism helps people understand the therapy. He added that the approach is familiar to anyone who has followed recent immune-engagement treatments.

“It is a really highly targeted therapy,” White said. “Our antibody attaches to a specific tumor protein. And as long as that tumor protein is present, our antibody will attach to it. That is how it works.”

Once fully commercialized, the therapy could be more effective, less toxic and lower in cost than current options for an estimated 30 percent of cancers.

Phase 1 planned in Milwaukee

The company expects its first-in-human clinical trial to begin in January. Phase 1 studies are designed to evaluate safety and observe how the therapy interacts with the human immune system.

“This is a product that the FDA has decided has met all of the safety criteria to be used in humans, but has never been used in humans before,” White said.

The initial trial is expected to include 12 patients over two years, with plans to reach at least 40 patients by the end of Phase 1. Participants will typically be individuals who have exhausted all approved cancer treatment options.

A long but meaningful timeline

Even with strong early data, White noted that drug development requires patience. After Phase 1, the company will move into a larger Phase 2 trial involving multiple clinical sites across the country.

“The average in our space is about 150 patients for a Phase 2,” he said. Because the treatment qualifies as a lifesaving medicine, the FDA may permit commercial use after Phase 2 while the company continues collecting data for comparison against existing therapies.

A Milwaukee-built innovation

Tundra’s founding team includes cancer researchers, clinicians and business leaders from the Medical College of Wisconsin, Children’s Wisconsin and Froedtert Hospital. White joined the company after years of leading and advising life sciences firms.

“I have done a number of life sciences startup companies and some larger life sciences companies as a business person,” he said. “We have our scientific experts, we have our clinical oncologist experts, we have our manufacturing experts and we have our business guy, and I am the business guy.”

He believes the company’s progress reflects the right mix of science, collaboration and persistence. “Startup companies fail for many different reasons. There are lots of ways things do not go well. But if you have a solid team and the cards are played correctly and you get the luck of the role of the dice when you have to take chances, those are the companies that stick around long enough to have a chance,” he said.

The role of academic research

White emphasized the importance of continued investment in university-based research.

“Innovations like this are most effectively developed by the private sector, but the innovations are not made most effectively by the private sector,” he said. “These innovations are most effectively made in these academic settings with federal funding.”

Looking ahead

For Milwaukee’s startup and scientific communities, Tundra’s progress highlights the region’s expanding biomedical capacity. A therapy conceived in local labs is now preparing for its first step into patient care, underscoring the potential of the collaborations and expertise that shaped its development.