December 15, 2017

Cambridge, MA — H3 Biomedicine Inc., a clinical stage biopharmaceutical company specializing in the discovery and development of precision medicines for oncology and a member of Eisai’s global Oncology Business Group, today announced that data on one of its clinical programs has been published in the current issue of Cancer Research. The title of the paper, “H3B-6527 is a Potent and Selective Inhibitor of FGFR4 in FGF19-driven Hepatocellular Carcinoma,” was composed by H3 scientists with Anand Selvaraj, PhD, Senior Investigator as lead scientist on the study.

“We are encouraged by the pre-clinical data of H3B-6527 and the article published in Cancer Research highlights the strength of H3’s unique drug discovery platform that successfully targets specific drivers of hepatocellular carcinoma,” said Markus Warmuth, M.D., President and CEO of H3 Biomedicine. “We feel this new research continues to underscore our commitment to FGFR4 inhibition as a novel treatment approach in this therapeutic area and we look forward to advancing this program.”

The data were recently presented at the International Liver Cancer Association annual meeting held in Seoul, Republic of Korea.

The publication reports that an oral dosing of H3B-6527 in mice led to dose-dependent pharmacodynamic modulation of FGFR4 signaling and tumor regression in FGF19 altered HCC xenograft models. These data served as proof-of-concept for the approach and led to the clinical introduction of H3B-6527.

The data published in Cancer Research show promising pre-clinical activity of H3B-6527 in hepatocellular carincoma models," said Pete Smith, Ph.D., Chief Scientific Officer, H3 Biomedicine. "H3B-6527 is currently in a Phase I clinical trial and we look forward to discussing the progress of the trial in the coming months.”

About H3B-6527

H3B-6527 is a selective, orally bioavailable, and potent inhibitor of fibroblast growth factor receptor 4 (FGFR4) that is being investigated for the treatment of advanced hepatocellular carcinoma (HCC). Aberrant signaling through the FGF19-FGFR4 axis has been shown to drive tumor development and dependency in pre-clinical models of HCC. H3B-6527 has shown sustained tumor regressions in several preclinical models of HCC where FGF19-FGFR4 signaling is aberrantly activated. The safety and preliminary efficacy of H3B-6527 will be explored in patients that are selected using a companion diagnostic that identifies HCC with activated FGF19-FGFR4 pathway activity. H3B-6527 is currently in Phase 1 clinical trials. For more information on the clinical trial, please click here.

About H3 Biomedicine Inc.

H3 Biomedicine is a Cambridge, Massachusetts-based biopharmaceutical company specializing in the discovery and development of precision oncology treatments, and was established as a subsidiary of Eisai's U.S. pharmaceutical operation, Eisai Inc. Leveraging this collaboration with Eisai Co., Ltd., who through this partnership provides essential research funding and access to the capabilities and resources of this global pharmaceutical company, H3 Biomedicine combines long-term vision with operational independence. Using modern synthetic chemistry, chemical biology, and human genetics, H3 Biomedicine seeks to bring the next generation of cancer treatments to market with the goal of improving the lives of patients. For more information, please visit

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