- First EMA PRIME designation for Imago BioSciences.
- Access granted on positive primary analysis of the ongoing Phase 2 trial to evaluate the safety and efficacy of IMG-7289 (bomedemstat).
South San Francisco, July 30, 2020 – Imago BioSciences, Inc. (“Imago”), a private clinical stage biopharmaceutical company developing innovative treatments for myeloid diseases, today announced that the European Medicines Agency (EMA) granted access to its PRIME (PRIority MEdicines) scheme for IMG-7289 (bomedemstat), a lysine-specific demethylase-1 (LSD1) inhibitor, for the treatment of intermediate-2 and high-risk patients with myelofibrosis who have become intolerant of, resistant to, or are ineligible for a Janus Kinase (JAK) inhibitor. IMG-7289 is being evaluated in an open- label Phase 2 clinical trial (www.myelofibrosisclinicalstudy.com) for the treatment of advanced myelofibrosis, a bone marrow cancer that interferes with the production of blood cells.
The PRIME initiative was launched by the EMA in 2016 to provide proactive and enhanced support to the developers of promising medicines with the view of accelerating their evaluation to reach patients faster. To be eligible for PRIME, a medicine must address an unmet medical need and show potential clinical benefit based on early trial data. Myelofibrosis is a progressive cancer in which bone marrow is gradually replaced by fibrous, scar-like tissue impairing the production of blood cells for which treatment options are limited.
“We are excited to receive PRIME designation for IMG-7289, our first LSD1 inhibitor in the clinic,” said Hugh Young Rienhoff, Jr., M.D., CEO of Imago BioSciences. “We intend to work closely with the EMA to optimize our development plans and help bring IMG-7289 to patients as quickly as possible. Myelofibrosis remains a major unmet medical need and IMG-7289 represents a potential new option for patients who don’t benefit from the current standard of care.”
The EMA reviewed IMG-7289 non-clinical and clinical data from the ongoing Phase 2 study, which demonstrated improvements in symptom scores, spleen volumes, anemia and bone marrow fibrosis. Data presented at the 25th European Hematology Association (EHA) Annual Congress demonstrated that IMG-7289 was well tolerated with no dose-limiting toxicities or safety signals. The Phase 2b study is actively enrolling in the U.S., U.K., and E.U.
About IMG-7289 (Bomedemstat)
IMG-7289 is a small molecule invented and developed by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme shown to be essential for maturation of blood cells and vital to neoplastic stem/progenitor bone marrow cells. In non-clinical studies, IMG-7289 demonstrated robust in vivo anti-tumor efficacy as a single agent and in combination with other chemotherapeutic agents across a range of myeloid malignancies including leukemia and myeloproliferative neoplasms such as myelofibrosis. IMG-7289 is an investigational agent currently being evaluated in several ongoing clinical trials (ClinicalTrials.gov Identifier: NCT03136185, NCT04254978, NCT04262141, NCT04081220). IMG-7289 has FDA Orphan Drug and Fast Track Designation for both the treatment of myelofibrosis and essential thrombocythemia, and Orphan Drug Designation for treatment of acute myeloid leukemia.
About Imago BioSciences
Imago BioSciences is a private clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics targeting epigenetic enzymes. Imago has developed a series of compounds that alter the activity and function of LSD1, an epigenetic enzyme critical for cancer stem cell function and blood cell maturation and function. Imago is advancing the clinical development of its first LSD1 inhibitor, IMG-7289, for the treatment of myeloid neoplasms including myelofibrosis, essential thrombocythemia and polycythemia vera. Imago BioSciences is backed by leading strategic and venture investors including a fund managed by Blackstone Life Sciences, Frazier Healthcare Partners, Omega Funds, Amgen Ventures, MRL Ventures Fund, HighLight Capital, Pharmaron, Greenspring Associates and Xeraya Capital. The company is based in South San Francisco, California. To learn more, visit www.imagobio.com and follow us on Twitter @ImagoBioRx, Facebook and LinkedIn.
