The REVERT Trial is Evaluating STAT3 Inhibitor, TTI-101, Added to Palbociclib and an Aromatase Inhibitor to Overcome Resistance and Improve Clinical Outcomes for Metastatic Breast Cancer Patients

Tvardi Therapeutics, Inc., a privately held, clinical-stage biopharmaceutical company focused on the development of STAT3 inhibitors, announced that the first breast cancer patients have been dosed in the Phase 1b/2 REVERT trial of TTI-101 added to palbociclib and aromatase inhibitor (AI) therapy in adult patients with HR⁺/HER2^- palbociclib-resistant metastatic breast cancer. The first patients were dosed at the Washington University School of Medicine Siteman Cancer Center by Cynthia Ma, MD, PhD, Professor of Medicine, Clinical Director of the Breast Cancer Program, Section of Medical Oncology.

In the US, approximately 74,000 patients per year are diagnosed with HR⁺/HER2^- metastatic breast cancer. These patients are generally treated with CDK4/6 inhibitors (such as palbociclib) and an AI. Unfortunately, the vast majority of these patients acquire resistance to palbociclib and AI therapy and their tumors continue to metastasize. Recent research has demonstrated that this resistance is driven by the activation of a protein in tumors known as STAT3. Tvardi has developed a STAT3 inhibitor, TTI-101, that has been well tolerated and has clinical activity across a broad range of tumors. The REVERT trial has been designed to add TTI-101 to palbociclib and AI therapy when breast cancer patients acquire resistance to standard therapy.

“I am excited the Washington University School of Medicine Siteman Cancer Center was the first to enroll patients to this important trial. The addition of TTI-101 to palbociclib and AI directly addresses the mechanism which leads to patients becoming resistant to the standard of care. TTI-101 has the potential to improve clinical outcomes for HR⁺/HER2^- metastatic breast cancer patients,” said Cynthia Ma, MD, PhD.

“STAT3 is a well-known driver of tumor resistance. Based on Phase 1 trial data, TTI-101 specifically targets STAT3, and is well-positioned to reverse the resistance pathway for metastatic breast cancer,” said Imran Alibhai, PhD, CEO of Tvardi. “This is the first of three Phase 2 trials in metastatic breast cancer, advanced liver cancer, and idiopathic pulmonary fibrosis that Tvardi has initiated to address diseases driven by STAT3.”

For more information about the REVERT breast cancer trial that is enrolling at sites throughout the US, please visit ClinicalTrials.gov (NCT05384119).

About Tvardi Therapeutics

Tvardi is a privately held, clinical-stage biopharmaceutical company developing small molecule inhibitors of STAT3, a key regulatory protein positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells. STAT3 also plays a central role in the pathogenesis of many inflammatory and fibrotic diseases. The company’s lead product, TTI-101, completed enrollment in its first-in-man Phase 1 trial of relapsed/refractory patients with advanced solid tumors. To date, TTI-101 monotherapy has been well-tolerated and has clinical activity across a broad range of tumors including multiple durable radiographic objective responses. The company has now initiated three Phase 2 clinical programs in hepatocellular carcinoma (NCT05440708), metastatic breast cancer (NCT05384119), and idiopathic pulmonary fibrosis (NCT05671835). To learn more, please visit https://tvarditherapeutics.com/.

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“TTI-101 has the potential to improve clinical outcomes for metastatic breast cancer patients because the addition of TTI-101 to palbociclib and AI directly addresses the mechanism which leads to resistance to the standard of care,” said Cynthia Ma MD, PhD