Special Report: Tvardi Therapeutics Fierce Biotech’s Fierce 15 2021

Tvardi is focused on STAT3 inhibitors, a regulatory protein involved in a number of signaling pathways key to the survival and invasion of cancer cells

CEO: Imran Alibhai, Ph.D.
Founded: 2018
Based: Houston, Texas
Clinical focus: Coming up with better ways to treat solid tumors, fibrosis, inflammation.

The scoop: There’s plenty of early-stage biotechs out there—maybe too many if you listen to some analysts. But what sets Tvardi apart is that it actually has the data to back up its science.

The company’s first asset is TTI-101, which is wrapping up a phase 1 clinical trial in advanced solid tumors and will soon be moving into phase 2. The therapy was found to induce cancer cell death and reduce activated STAT3 proteins in treatment-resistant breast cancers.

What makes Tvardi fierce: They say everything is bigger in Texas, and for Tvardi Therapeutics that translates into cash. The Houston-based biotech—now a 2021 Fierce 15 winner—raked in the largest private financing in Houston’s history when it closed a $74 million Series B in June.

Tvardi is focused on one target: STAT3.

STAT3 is a regulatory protein involved in a number of signaling pathways key to the survival and invasion of cancer cells. TTI-101 is a small molecule oral pill that inhibits STAT3 and has been shown to shrink tumors in early human testing.

The funding round was a huge leap from its September 2018 series A, which raised a meager $9 million to help the company find its footing.

CEO Imran Alibhai, Ph.D., said the reason investors flocked to the second round is simple: “It’s data and people.”

The molecule that has become Tvardi’s focus came from scientists at MD Anderson Cancer Center, specifically physician and “biochemist at heart” David Tweardy, M.D., and Ron DePinho, M.D. Both are co-founders of the company.

Tweardy and his team took the STAT3 molecule to the doorsteps of clinical trials and then with the addition of DePinho, Tvardi was born.

“It’s truly the holy grail target,” Alibhai said of STAT3. “It has been the one thing that people have been trying to drug for a couple decades now.”

Tvardi is not a cancer company, Alibhai stresses. The initial focus is on solid tumors, but the biotech is also conducting pre-clinical work in fibrosis and inflammation.

The company has the data to back up the first indications and will soon move a second, more potent STAT3 inhibitor into the clinic.

“You’re talking about a company that has clinical data. So much of what we see in the public markets is pre-clinical or the promise of something,” Alibhai said. “We’ve actually now delivered.”

He’s right—the public markets are being flooded with new biotechs that barely have a megabyte of data to their name. Alibhai is not ready to say what the company might do next in terms of financing, but everything from a crossover round to a SPAC deal to an IPO is on the table.

“The world’s our oyster,” he said.

These are, of course, things CEOs would say if they were looking to do an IPO. But Alibhai insists he’s in no hurry while acknowledging that at some point Tvardi is going to need another cash infusion.

He also knows the nearest STAT3 competitors are far behind. Vividion, which was recently acquired by Bayer, has a STAT3 molecule that is still about 18 months out from hitting the clinic. Similarly, Kymera has about six months to go.

Investors: Slate Path Capital, Palkon Capital, Arrowmark Partners, 683 Capital, Sporos Bioventures.

Tvardi Press Release

Fierce Biotech Article

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