C-188-9

HOUSTON--(BUSINESS WIRE)-- Tvardi Therapeutics, Inc., a privately held, clinical-stage biopharmaceutical company focused on the development of STAT3 inhibitors, announced it will present a trials in progress poster at the upcoming 2024 ASCO Gastrointestinal Cancers Symposium on Friday, January 19, 2024, in San Francisco, CA. The poster will highlight the design of the ongoing REVERT LIVER CANCER study, a Phase 1b/2 trial evaluating safety and clinical activity of TTI-101, a novel STAT3 inhibitor, as monotherapy and in combination with standard of care in patients with locally advanced or metastatic, and unresectable hepatocellular carcinoma (HCC). Presentation Details: Date: Friday, January 19, 2024 Time: 12:30 p.m. PST Location: Moscone West, San Francisco, CA Session Type: Trials in Progress Poster Session Abstract Title: A Phase 1b/2 Study to Evaluate the Safety and Efficacy of TTI-101 as Monotherapy and in Combination in Advanced Hepatocellular Carcinoma Abstract #: TPS577 Poster Bd #: P6 The REVERT LIVER CANCER trial is currently enrolling HCC patients at top US cancer research institutes and is designed to evaluate TTI-101 across multiple lines of therapy: TTI-101 alone for patients previously treated with up to three prior lines of systemic therapy TTI-101 in combination with pembrolizumab (Keytruda®) for patients previously treated with immunotherapy TTI-101 in combination with atezolizumab (Tecentriq®) and bevacizumab (Avastin®) for treatment-naïve patients HCC is the most common form of liver cancer; however, treatment options for the disease are limited and overall prognosis is poor, with a 5-year survival rate of 18%. TTI-101’s target, STAT3, is a key regulatory protein which plays a critical role in the pathogenesis of HCC by initiating tumorigenesis as well as promoting an immunosuppressive tumor microenvironment. TTI-101 is an orally delivered, small molecule, direct inhibitor of STAT3. “We are excited to present this unique trial design that allows us to evaluate the potential of TTI-101 to enhance outcomes across 1st, 2nd, and last line HCC patients, where the current standard of care is insufficient,” said Imran Alibhai, PhD, CEO of Tvardi Therapeutics. For more information about the REVERT LIVER CANCER trial, please visit ClinicalTrials.gov (NCT05440708). 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 has now initiated three Phase 2 clinical programs in STAT3-driven diseases: hepatocellular carcinoma (NCT05440708), metastatic breast cancer (NCT05384119), and idiopathic pulmonary fibrosis (NCT05671835). To learn more, please visit tvardi.com or follow us on LinkedIn and X (Twitter).

HOUSTON--(BUSINESS WIRE)-- Tvardi Therapeutics, Inc., a privately held, clinical-stage biopharmaceutical company focused on the development of STAT3 inhibitors, announced that the first patients have been dosed in its ongoing REVERTIPF trial. The trial is a 12-week, randomized, double-blind study evaluating both safety and clinical activity of TTI-101 at three different doses, alone or in combination with nintedanib (OFEV®), compared to placebo in patients with idiopathic pulmonary fibrosis (IPF). IPF is a chronic, progressive, and debilitating lung disease with unknown etiology. This disease has a poor prognosis, with most patients experiencing worsening respiratory symptoms, declining lung function, and functional impairment. Currently approved treatments have been shown to slow progression; however, fail to reverse clinical decline or restore lung function. Although several ongoing efforts are underway to discover novel ways to treat IPF, none have interrogated STAT3, a key regulatory protein, that is the central node in the development of pulmonary fibrosis. TTI-101 is an orally delivered, small molecule, direct inhibitor of STAT3. “The REVERTIPF trial will expand our understanding of the impact of STAT3 inhibition beyond cancer into fibrotic diseases, which severely impair and burden hundreds of thousands of people globally. Interest in our IPF study continues to grow due to recently presented clinical data demonstrating TTI-101 was safe and effective in heavily pretreated cancer patients, published preclinical work highlighting TTI-101’s restorative effect in fibrosis, and the FDA’s Orphan Drug Designation for TTI-101 in IPF,” said Imran Alibhai, PhD, CEO of Tvardi Therapeutics. “This is the third of three Phase 2 trials Tvardi has initiated to address diseases driven by STAT3.” For more information about the REVERTIPF trial currently enrolling at sites throughout the US, please visit ClinicalTrials.gov (NCT05671835). 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 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 the website for Tvardi Therapeutics.