Tvardi Therapeutics, an upstart biotech from the brains of MD Anderson Cancer Center leaders, has raised $74 million to prep for a phase 2 trial of an oral, small-molecule inhibitor signal transducer and activator of transcription 3 (STAT3).
After adding two members to its board earlier this year, and with “inflection points” in clinical data from a phase 1 trial, Tvardi now has the financial resources from a slate of long-term hedge fund investors to move forward with multiple trials next year.
The clinical-stage biopharma unveiled the $74 million series B financing Wednesday, brought in from new investors Slate Path Capital, Palkon Capital, ArrowMark Partners and 683 Capital on top of existing backers like Sporos Bioventures.
With this roster of investors, Tvardi has the flexibility to "do any number of things," said CEO Imran Alibhai, Ph.D., in an interview. Future financing activities could include going public with this group, conducting a crossover round with existing and new investors, partnership deals or other avenues that will get Tvardi's candidates "into as many patients as humanly possible," the CEO said.
Houston-based Tvardi is wrapping up a phase 1 trial of its lead asset, a small-molecule inhibitor of STAT3, in patients with advanced solid tumors who have failed all lines of therapy.
Early safety and efficacy data have "prompted people to come out of the woodworks very quickly” to invest in the company, Alibhai said.
The company's candidate prevents the activation of STAT3, which means the small molecule acts across all levels of the tumor to prevent cells from growing, according to Alibhai. With STAT3, the protein is involved in both the microenvironment and the tumor.
Alibhai, who joined the company as CEO in December 2018, three months after a $9 million series A raise, analogized tumors to weeds.
“Think about tumors as a weed, an invasive weed, for example. Weeds grow either because they have strong roots or because the environment around them is fertile for them to grow, the same thing with tumors. Previously, people had focused on proteins that either are in the microenvironment of the tumor, or they focus on the tumor itself,” the CEO said.
The financing will be used to “dive into phase 2 trials," in cancer and fibrosis in the first half of next year. A second-generation molecule is also being prepped for the clinic. Tvardi plans to submit a regulatory filing in the second half of 2022 for its second generation asset, also an oral small-molecule STAT3 inhibitor, Alibhai added.
The company is working with the MD Anderson Cancer Center on the phase 1 clinical trial for the lead candidate. Former MD Anderson President Ron DePinho, M.D., and the cancer center’s internal medicine division head, David Tweardy, M.D., founded Tvardi. Both sit on the scientific advisory board with Nobel laureate James Allison, Ph.D., who chairs MD Anderson’s immunology department, along with three Harvard and Baylor professors.
Tvardi’s collaborators have received approximately $25 million in grant funding to date to support the development and clinical trials of the lead compound, TTI-101, Alibhai said. Grants have come from the National Cancer Institute, the National Institutes of Health, the V Foundation and the Cancer Prevention and Research Institute of Texas.
Wednesday’s financing will also go toward rounding out the Tvardi team, Alibhai said. The company will bulk up on the clinical side as well as hire for roles in chemistry, manufacturing and controls.
In conjunction with the financing, Slate Path Partner Jamie McNab joins the Tvardi board, which also recently added former Genzyme CFO Michael Wyzga and CymaBay Therapeutics CEO Sujal Shah.