Company Overview of H3 Biomedicine Inc.
H3 Biomedicine Inc., a biopharmaceutical company, is engaged in the discovery and development of small-molecule drugs to treat cancer. It develops H3B-8800, a clinical compound for the treatment of patients with acute myelogenous leukemia and chronic myelomonocytic leukemia. H3 Biomedicine Inc. has a strategic collaboration with Selvita S.A. The company was founded in 2010 and is based in Cambridge, Massachusetts. H3 Biomedicine Inc. operates as a subsidiary of Eisai Inc.
300 Technology Square
Cambridge, MA 02139
Founded in 2010
Key Executives for H3 Biomedicine Inc.
Chief Executive Officer and President
Senior Vice President of Planning and Operations
Chief Data Sciences Officer
Compensation as of Fiscal Year 2017.
H3 Biomedicine Inc. Key Developments
H3 Biomedicine Inc. Announces First Patient Dosed with H3B-6545 in Phase 1 Study in Breast Cancer
Sep 5 17
H3 Biomedicine Inc. announced dose administration for the first patient in a Phase 1, open-label, dose-escalation and expansion study of single agent H3B-6545, an orally bioavailable, potent and selective small molecule antagonist of wild-type and mutant Estrogen Receptor (ERa). Preclinical data indicates H3B-6545 inhibits the growth of cell line and patient-derived xenograft models of wild-type and mutant ERa. H3B-6545 represents a new class of ERa antagonists discovered by H3 Biomedicine scientists called ‘Selective Estrogen Receptor Covalent Antagonists’ (SERCAs). The purpose of the Phase 1 multi-center, open-label study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of H3B-6545 in women with ER-positive, Her2-negative breast cancer. H3B-6545 will be administered daily as a single agent dosed orally on a 28-day cycle. The first portion of the study includes a dose-escalation phase, in which cohorts of patients will receive ascending oral doses of H3B-6545 to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose based on safety and tolerability. The second portion of the study is a dose expansion phase where patients will receive H3B-6545 to further evaluate the safety, tolerability and clinical activity of the recommended Phase 2 dose.
U.S. Food and Drug Administration Grants Orphan Drug Designation of H3B-8800 to H3 Biomedicine Inc. for Treatment of Acute Myelogenous Leukemia and Chronic Myelomonocytic Leukemia
Aug 14 17
H3 Biomedicine Inc. announced that the U.S. Food and Drug Administration (FDA) has granted the company an orphan drug designation for H3B-8800, its lead clinical compound for the treatment of patients with Acute Myelogenous Leukemia (AML) and Chronic Myelomonocytic Leukemia (CMML). H3B-8800, which is a potent, selective and orally bioavailable small molecule modulator of wild-type and mutant SF3b complexes, is currently in Phase 1 clinical trials. The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for rare diseases or conditions that affect fewer than 200,000 people in the U.S. The orphan drug designation provides H3 Biomedicine with certain benefits, including market exclusivity upon regulatory approval if received, exemption of FDA application fees and tax credits for qualified clinical trials.
H3 Biomedicine Inc. Report Preclinical Data Describing Immune Evasion Mechanism in Muscle-Invasive Bladder Cancer
Jul 24 17
H3 Biomedicine Inc. announced that data on one of H3’s pre-clinical programs focusing on muscle-invasive bladder cancer, has been published in the current issue of Nature Communications. Muscle-invasive bladder cancer is an aggressive form of cancer with limited therapeutic options available to patients. In the past year, agents designed to target the immune system have been approved for bladder cancer; however, the median survival in patients with second-line disease remains less than a year, and less than a third of first-line patients respond to treatment. Based on this unmet need, researchers at H3 Biomedicine took a novel approach to understanding how tumors can overcome the debilitating effects of the immune system. The publication in Nature Communications reports that a significant proportion of bladder tumors showing focal amplification of PPAR? and hotspot mutations in RXRa, lead to hyperactivity of the peroxisome proliferator-activated receptor gamma (PPAR?) pathway. Deep molecular characterization in cell lines and clinical samples also showed that tumors increased the activity of this pathway to prevent immune cells from infiltrating the tumors increasing the survival of the tumor cells. In collaboration with a team of Drs. Mads Daugaard and Peter Black at the University of British Columbia, the Vancouver Prostate Centre and VCHRI, the scientists further confirmed the association of PPAR? pathway activity with immune evasion in additional cohorts of bladder tumors.
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