CVBT-141H / Venturis Therapeutics - LARVOL DELTA

Preliminary results from a phase 1/2 study of INCB054828, a highly selective fibroblast growth factor receptor (FGFR) inhibitor, in patients with advanced malignancies (AACR 2017) - P1/2; "INCB054828 is a selective FGFR1, 2, and 3 inhibitor (AACR 2015; Abstract 771). INCB054828 was generally well tolerated; hyperphosphatemia was the most common TEAE. Preliminary efficacy in patients with FGFR pathway activation was also observed. PK/PD data support once-daily dosing and sustained inhibition of FGFR signaling at doses >9 mg."

Clinical • P1 data • P1/2 data • Biliary Cancer • Biosimilar • Cardiovascular • Gastrointestinal Cancer • Heart Failure • Immunology • Myelodysplastic Syndrome • Oncology • Renal Disease

Use of tumor mRNA expression for patient selection in a phase I study of the pan-fibroblast growth factor receptor inhibitor BAY 1163877 (AACR 2017) - P1; "This population includes patients with and without genetic aberrations of FGFR1-3 encoding genes. In summary, an mRNA expression-based selection approach may identify a broader patient population with potential benefit from BAY 1163877, including tumor types not previously associated with altered FGFR signaling."

P1 data • Biosimilar • Bladder Cancer • Esophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Urothelial Cancer

Galectin3 Mediates Alcoholic Liver Injury via the Inhibition of the Aryl Hydrocarbon Receptor (AASLD 2017) - "Alcoholic liver injury was attenuated in galectin3-/but exacerbated in AhR-/- mice. Galectin3-/- mice had improved AhR/FGF21 signaling sugesting galectin3 may mediate ALD via the inhibition of AhR/FGF21 axis. Therefore, galectin3 inhibition and AhR physiologic induction can be potential therapies."

Biosimilar • Immunology

Preliminary results from a phase 1/2 study of INCB054828, a highly selective fibroblast growth factor receptor (FGFR) inhibitor, in patients (pts) with advanced malignancies (EORTC-NCI-AACR 2017) - P1/2; "INCB054828 is a selective inhibitor of FGFR1, 2 and 3. INCB054828 was generally well tolerated; hyperphosphatemia was the most common TEAE. PK/PD data support once-daily dosing (2-wk on/1-wk off) and sustained inhibition of FGFR signaling at doses >9 mg. Preliminary efficacy in pts with FGFR pathway activation was observed."

Clinical • P1/2 data • Biliary Cancer • Breast Cancer • Gastrointestinal Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor