On June 12, 2020 Imago BioSciences reported the presentation of data at the 2020 Virtual European Hematology Association (EHA) (Free EHA Whitepaper) meeting relating to the clinical trial of bomedemstat (IMG-7289) for the treatment of advanced myelofibrosis (Press release, Imago BioSciences, JUN 12, 2020, View Source [SID1234561031]). The abstract published online in May included an analysis of data from 34 patients. The presentation today as a poster reflects a more extensive analysis of a larger patient population based on a later data cutoff.

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"The poster enumerates spleen volume reductions and improvements in Total Symptom Scores in a majority of patients. Additionally, there were improvements in hemoglobin with patients transitioning from transfusion-dependence to transfusion-independence and bone marrow fibrosis improvements," said Kristen Petitt, MD, Assistant Professor of Medicine at the University of Michigan, Rogel Cancer Center, in Ann Arbor. "In this ongoing study, the preliminary data indicate that bomedemstat has significant clinical activity as monotherapy in a myelofibrosis patient population with advanced disease and no therapeutic alternatives."

Data Highlights

Bomedemstat (IMG-7289) monotherapy in intermediate-2 /high-risk patients with myelofibrosis who have become intolerant or resistant to a JAK inhibitor

Of evaluable patients at 24 weeks:
83% had spleen volume reductions
86% demonstrated reductions in Total Symptom Scores (TSS)
70% of patients had stable or improved hemoglobin
71% of patients had a stable or improved BM fibrosis score
>90% of patients with elevated circulating inflammatory cytokines showed significant reductions
Safety

Bomedemstat (IMG-7289) in patients with myelofibrosis was generally well tolerated. No dose-limiting toxicities were observed, and a maximum tolerated dose was not identified.

There were 723 adverse events (AEs) reported, of which 215 were attributed to bomedemstat. Only four SAEs — painful splenomegaly, heart failure, headache, rectal bleeding (all Grade 3) — were deemed by the Investigator to be related to bomedemstat. There were no Grade 5 events related to bomedemstat.

The most common treatment-emergent AEs deemed related to bomedemstat was dysgeusia (33%).

For further details, please see the 2020 EHA (Free EHA Whitepaper) abstract and poster on Imago’s website at www.imagobio.com.

Poster Presentation

TITLE: A PHASE 2 STUDY OF BOMEDEMSTAT (IMG-7289), A LYSINE-SPECIFIC DEMETHYLASE-1 (LSD1) INHIBITOR, FOR THE TREATMENT OF MYELOFIBROSIS (MF)

Session: Myeloproliferative Neoplasms—Clinical

Date and Time: June 12, 2020, 8:30 AM CEST/2:30 AM EDT

About Bomedemstat (IMG-7289)

Bomedemstat is being evaluated in an open-label Phase 2 clinical trial (www.myelofibrosisclinicalstudy.com) for the treatment of myelofibrosis (MF), a bone marrow cancer that interferes with the production of blood cells. The endpoints include spleen volume reduction and symptom improvement at 12 and 24 weeks of treatment. Bomedemstat is used as monotherapy in patients who are resistant to, intolerant of, or ineligible for ruxolitinib.

Bomedemstat is a small molecule developed by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme shown to be vital in cancer stem/progenitor cells, particularly neoplastic bone marrow cells. In non-clinical studies, IMG-7289 demonstrated robust in vivo anti-tumor efficacy across a range of myeloid malignancies as a single agent and in combination with other chemotherapeutic agents. Bomedemstat (IMG-7289) is an investigational agent currently being evaluated in ongoing clinical trials (ClinicalTrials.gov Identifier: NCT03136185 and NCT04254978). Bomedemstat has FDA Orphan Drug and Fast Track Designation for the treatment of myelofibrosis, essential thrombocythemia and acute myeloid leukemia.