Imago BioSciences Announces First Participant Dosed in Investigator-Sponsored Phase 1 Study of Bomedemstat in Combination with Venetoclax in Relapsed/Refractory Acute Myeloid Leukemia

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The Phase 1 open-label study is being conducted at the University of Miami, led by Terrence J. Bradley, M.D.

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Wednesday, November 30, 2022
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Ruxolitinib, Good manufacturing practice, Venetoclax, AML, MF, Bone marrow, Priority, Food, University, EMA, Acute myeloid leukemia, Safety, LSD1, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ET, Hematological Cancer Research Investment and Education Act, Annual report, Sumathi Best Television Current Reporting Award, Standard of care, Blood, HIV disease progression rates, Sale, Cancer, Fast track (FDA), Intellectual property, Pancreatic serous cystadenoma, European Medicines Agency, Trial of the century, FDA, Pharmaceutical industry, Imago
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SAN FRANCISCO, CA, US, CALIFORNIA, UNITED STATES
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IMAGO BIOSCIENCES, IMAGO BIOSCIENCES, INC.
Summary
Key Points: 
  • The Phase 1 open-label study is being conducted at the University of Miami, led by Terrence J. Bradley, M.D.
  • We are very pleased that such an experienced team as that at the University of Miami has initiated this trial.
  • In ongoing Phase 2 studies, bomedemstat has been generally well-tolerated and has demonstrated significant symptom improvement for patients with myelofibrosis and essential thrombocythemia .
  • Imago is evaluating Bomedemstat as a potentially disease-modifying therapy in two Phase 2 clinical trials for the treatment of essential thrombocythemia (NCT04254978) and myelofibrosis (NCT03136185).



REDWOOD CITY, Calif., Nov. 30, 2022 (GLOBE NEWSWIRE) -- Imago BioSciences, Inc. (“Imago”) (Nasdaq: IMGO), a clinical-stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, today announced that the first participant has been dosed in an investigator-sponsored Phase 1 study of bomedemstat, an investigational oral lysine-specific demethylase 1 (LSD1) inhibitor, in combination with venetoclax (Venclexa®) in patients with relapsed or refractory acute myeloid leukemia (AML). Venetoclax is a BCL-2 inhibitor approved by the U.S. Food and Drug Administration (FDA) for treatment of several hematologic cancers, including in combination with azacytidine for elderly patients with AML unable to tolerate the standard of care.

The Phase 1 open-label study is being conducted at the University of Miami, led by Terrence J. Bradley, M.D. It will enroll approximately 18 adult participants diagnosed with AML who have failed at least one standard, front-line therapy and will assess the safety and efficacy of bomedemstat in combination with venetoclax (VenBom therapy). This combination regimen consists of once daily, oral administration of both bomedemstat and venetoclax. Participants will receive three cycles of the treatment, and may continue to receive treatment as long as they experience clinical benefit or until disease progression.

“This study is the first clinical study grounded on the pre-clinical work by Dr. Sheng Cai demonstrating that this combination had the potential to offer a unique benefit to patients with AML who have limited treatment options,” said Hugh Young Rienhoff, Jr., M.D., Chief Executive Officer of Imago BioSciences. “We are very pleased that such an experienced team as that at the University of Miami has initiated this trial.”

In ongoing Phase 2 studies, bomedemstat has been generally well-tolerated and has demonstrated significant symptom improvement for patients with myelofibrosis and essential thrombocythemia. Additional information about the study can be found at www.clinicaltrials.gov using the identifier NCT05597306.

About Imago BioSciences
Imago BioSciences is a clinical-stage biopharmaceutical company discovering and developing novel small molecule product candidates that target lysine-specific demethylase 1 (LSD1), an enzyme that plays a central role in the production of blood cells in the bone marrow. Imago is focused on improving the quality and length of life for patients with cancer and bone marrow diseases. Bomedemstat, an orally available, small molecule inhibitor of LSD1, is the lead product candidate discovered by Imago for the treatment of certain myeloproliferative neoplasms (MPNs), a family of related, chronic cancers of the bone marrow. Imago is evaluating Bomedemstat as a potentially disease-modifying therapy in two Phase 2 clinical trials for the treatment of essential thrombocythemia (NCT04254978) and myelofibrosis (NCT03136185). Bomedemstat has U.S. FDA Orphan Drug and Fast Track Designation for the treatment of ET and MF, European Medicines Agency (EMA) Orphan Designation for the treatment of ET and MF, and PRIority MEdicines (PRIME) Designation by the EMA for the treatment of MF. Imago is based in Redwood City, California. To learn more, visit www.imagobio.com, www.myelofibrosisclinicalstudy.com, www.etclinicalstudy.com and follow us on Twitter @imagobiorx, Facebook and LinkedIn.

Forward Looking Statements
All statements, other than statements of historical facts, contained in this press release, including statements regarding the results, conduct, progress and timing of Imago clinical trials, the regulatory approval path for Bomedemstat, and plans for future operations and information related to Imago, are forward-looking statements. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, Imago’s limited operating history and lack of products for commercial sale; Imago’s dependence on development, regulatory approval and commercialization of its product candidates; difficulties in enrolling patients and risks of substantial delays in its clinical trials; Imago’s minimal control over product candidates in investigator-initiated clinical trials; uncertainties in the cost and outcomes of its clinical studies and the acceptance for presentation at medical meetings of data from such clinical studies; uncertainties in the regulatory review and approval of Imago’s product candidates if its pivotal studies are positive; potentially material changes to the interim, top-line and preliminary data from its clinical trials; potential undesirable effects of Imago’s product candidates and safety or supply issues, in each case with respect to its product candidates alone or in combination with other compounds or products; Imago’s potential inability to obtain and maintain orphan drug designation and delays in approvals despite FDA Fast Track designation for expedited review; risks related to clinical trials outside of the United States; Imago’s need to manufacture adequate supplies, including multiple batches of Bomedemstat, using a commercial current Good Manufacturing Practice; risks related to information technology system and cybersecurity; risks related to misconduct of Imago’s employees and independent contractors; risks related to hazardous materials and Imago’s compliance with environmental laws and regulations; risks related to litigation and other claims; risks related to reliance on third parties to conduct and support preclinical studies and clinical trials, and to manufacture Imago’s product candidates; risks related to third-party intellectual property infringement claims and Imago’s ability to protect its own intellectual property; risks related to governmental policies and regulations, including with respect to drug prices and reimbursement, and changes thereof.

Further descriptions of risks and uncertainties relating to Imago can be found in Imago’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, its Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Current Reports on Form 8-K, all of which are filed with the SEC and available at www.sec.gov and https://ir.imagobio.com/financial-information/sec-filings.

You should not place undue reliance on any forward-looking statements. Forward looking statements should not be read as a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved, if at all. Except as required by law, Imago does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

Contacts:

Media Contact:
Will Zasadny
Evoke Canale
[email protected]

Investor Contact:
Laurence Watts
Gilmartin Group, LLC.
[email protected]

 


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