Tvardi Therapeutics, Inc. is a private biotechnology company developing a new class of breakthrough medicines for diverse cancers, chronic inflammatory diseases and fibrotic diseases. Tvardi is focused on the key signaling molecule, STAT3, which is positioned at the intersection of many signaling pathways controlling gene networks integral to the survival and immune sequestration of cancer cells as well as to the pathogenesis of many inflammatory and fibrotic conditions. Collectively, STAT3 driven diseases extract a significant societal and economic impact with over 50 million Americans afflicted. In cancer, greater than 50% of all cancers are STAT3-activated and compelling genetic data has established that extinction of STAT3 inhibits hepatocellular carcinoma, triple-negative breast cancer, lung cancer, among others. STAT3 knockout mice are healthy and profoundly resistant to development of inflammatory and fibrotic diseases.

Tvardi is executing a strategy to achieve rapid PoC in diverse cancers that will enable strategic development of its inhibitors across multiple indications. Accelerated clinical trials will be conducted at MD Anderson Cancer Center, the premier center for clinical trials in cancer, and such trials will be accelerated and de-risked with Tvardi’s CLIA-certified test for STAT3-activation which enables identification of STAT3-activated cancers for enlistment into clinical testing. Following clinical PoC, we will drive towards registration in specific cancer indications as well as conducting combination trials including immunotherapy drugs based on data showing that STAT3 plays a key role in supporting immune suppressive cells that thwart immune checkpoint blockade therapy

A total of 19 patents have been filed covering composition of matter and uses of C188-9. Four patents have issued (US, Canada, Europe, and Australia) that concern composition of matter and uses of C188-9 in cancer. Three additional sets of patents were filed in the US, Canada, Australia, Europe, and Hong Kong that concern composition of matter and use of C188-9 in muscle wasting (cachexia), fibrosis, and allergic reactions. Currently, no viable STAT3 inhibitor agents have been developed. There were three orally bioavailable, small-molecule inhibitors of STAT3 that were under development: Napabucasin (BBI-608; Boston Biomedical) and OPB-31121 and OPB-51602 (Otsuka Pharmaceutical Company). Evidence that BBI-608 targets STAT3 is lacking and it failed to improve responses in a Phase III clinical trial that compared paclitaxel plus BBI-608 vs. paclitaxel alone in gastric and GE junction cancers. In Phase I studies, OPB-31121 and OPB-51602 showed low tolerance, high incidence of side effects, and low efficacy. We have a clear mechanistic understanding of the basis for these molecules, which is not shared by C188-9. Thus, future development of these three competitors of C188-9 is unlikely.

Tvardi’s founding team of experienced entrepreneurs, drug developers, physician scientists seeks to secure $5 million Series A funding to recruit full time management and complete Phase I. This round will be followed by $30 million in Series B funding to achieve clinical PoC and develop its back-up drug series. Significant non-dilutive funding opportunities will also be pursued.