SOUTH SAN FRANCISCO, Calif., May 09, 2022 (GLOBE NEWSWIRE) — Imago BioSciences, Inc. (“Imago”) (Nasdaq: IMGO), a clinical-stage biopharmaceutical company discovering and developing novel drugs for the treatment of myeloproliferative neoplasms (NMP) and other bone marrow diseases, today announced that the first participant was treated in an investigator-sponsored Phase 1/2 study of bomedemstat in combination with the atezolizumab (Tencentriq®) during the maintenance phase of treatment in people newly diagnosed with extensive stage small cell lung cancer (ES-SCLC).
The study is conducted in Seattle and led by Rafael Santana-Davila, MD, associate professor at the University of Washington School of Medicine and Joseph Hiatt, MD, Ph.D., of the Fred Hutchinson Cancer Center (“Fred Hutch “), and in collaboration with the Fred Hutch Lung Research Excellence Specialty Project funded by the National Cancer Institute (NCI).
Bomedemstat is an inhibitor of lysine-specific demethylase 1 (LSD1), an enzyme that plays a central role in cell growth. Atezolizumab is an anti-PD-L1 monoclonal antibody approved by the United States Food and Drug Administration (FDA) in 2021 as an adjuvant treatment for non-small cell lung cancer. The open-label, Phase 1/2 study will enroll approximately 34 participants diagnosed with ES-SCLC to establish the safety and tolerability of combination therapy with bomedemstat and atezolizumab. Treatment cycles will be 21 days long, consisting of oral bomedemstat once daily and intravenous atezolizumab on day 1. Participants are monitored after 30 days and every 12 weeks thereafter.
“We are excited to work with UW Medicine and Fred Hutch to explore the expanded use of bomedemstat in solid tumors,” said Hugh Y. Rienhoff, Jr., MD, Chief Executive Officer of Imago. “A combination of bomedemstat, which in certain solid tumors improves their immunogenicity, and atezolizumab, an established checkpoint inhibitor, represents a promising clinical opportunity in the treatment of lung cancer. This new regimen may offer longer-term disease management options for patients with extensive-stage small cell lung cancer.
In ongoing Phase 2 studies in bone marrow cancers, bomedemstat was generally well tolerated and demonstrated significant symptom improvement in patients with essential thrombocythemia and advanced myelofibrosis.
Additional study information is available at www.clinicaltrials.gov using the identifier NCT05191797.
About Imago BioSciences
Imago BioSciences is a clinical-stage biopharmaceutical company that discovers and develops 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 focuses on improving the quality and length of life for patients with cancer and bone marrow diseases. Bomedemstat, an orally available small molecule LSD1 inhibitor, is Imago’s lead product candidate for the treatment of certain myeloproliferative neoplasms (MPNs), a family of related chronic bone marrow cancers. Imago is evaluating Bomedemstat as a potential disease-modifying treatment in two Phase 2 clinical trials for the treatment of essential thrombocythemia (NCT04254978) and myelofibrosis (NCT03136185). Bomedemstat has Orphan Drug and Fast Track Designation from the US FDA for the treatment of TE and MF, Orphan Drug Designation from the European Medicines Agency (EMA) for the treatment of TE and MF, and EMA PRIority MEdicines (PRIME) designation for the treatment of MF. The company is based in South San Francisco, California. To learn more, visit www.imagobio.com, www.myelofibrosisclinicalstudy.com, www.etclinicalstudy.com and follow us on Twitter @ImagoBioRx, Facebook and LinkedIn.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates”, “may”, “will”, “should”, “expect”, “believe and similar expressions (as well as other words or phrases that refer to future events, conditions or circumstances) are intended to identify forward-looking statements.
These statements may relate to, but are not limited to, the results, conduct, progress and timing of Imago’s clinical trials, bomedemstat’s regulatory approval pathway, and assumptions relating to the foregoing. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Important factors that could affect future results and cause them to differ materially from those expressed in the forward-looking statements include: our limited operating history and lack of products to sell; our material losses historically and for the foreseeable future; our need for substantial additional funding; our unpredictable operating results; our business’ dependence on the development, regulatory approval and commercialization of our product candidates; difficulties in recruiting patients and risks of significant delays in our clinical trials; our minimal control over product candidates in investigator-initiated clinical trials; uncertainties in the results of our clinical studies; uncertainties in the regulatory review and approval of our product candidates if our pivotal studies are positive; potentially material changes to interim, front-line and preliminary data from our clinical trials; potential adverse effects of our product candidates and safety or supply issues with combination use products; our potential inability to obtain and maintain orphan drug designation and delays in approvals despite Fast Track designation; risks associated with clinical trials outside the United States; our need to manufacture multiple batches of bomedemstat using a current good commercial manufacturing process; risks related to COVID-19 or other pandemics, natural disasters and wars; competition risks; difficulties in developing our organization and managing growth, attracting and retaining senior management and key scientific personnel, and establishing sales and other marketing functions; IT system and cybersecurity risks; risks relating to the misconduct of our employees and independent contractors; risks related to hazardous materials and our compliance with environmental laws and regulations; risks relating to litigation and other claims; risks related to reliance on third parties to conduct and support preclinical studies and clinical trials, and to manufacture our product candidates; risks relating to claims for infringement of third-party intellectual property and our ability to protect our own intellectual property; risks related to government policies and regulations, including with respect to drug pricing and reimbursement, and changes thereto; risks relating to our common stock; risks relating to our status as a public company, “emerging growth company” and “small reporting company”; risks related to internal control over financial information; and other risks and uncertainties, including those listed in the section titled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and our subsequent quarterly reports.
Except as required by law, Imago undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
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