Business Wire

CA-IMAGO-BIOSCIENCES

Share
Imago BioSciences Granted Access by European Medicines Agency to PRIME Scheme for IMG-7289 (Bomedemstat) in Myelofibrosis

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 .

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Usercentrics Report Reveals: As Concern Over Data Use Grows, Transparency Becomes the Number One Driver for Building Trust1.7.2025 07:28:00 CEST | Press release

Consumer trust is waning as AI and data concerns rise — driving a shift toward Privacy-Led Marketing strategies 59% of consumers are uncomfortable with their data being used to train AI systems, according to a new report from privacy tech leader Usercentrics. But it isn’t AI itself that worries consumers - it’s the lack of clarity around how their data is used. Rather than rejecting innovation, people are demanding greater transparency and control. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630843237/en/ How much do consumers trust companies in various industries when it comes to data collection and use? According to the State of Digital Trust 2025report, based on insights from 10,000 frequent internet users across Europe and the United States, digital privacy has become a strategic imperative. “We’re not witnessing a breakdown in trust, but a reset in expectations,” says Adelina Peltea, CMO at Usercentrics. “In the a

Galderma Announces Departure of Its Chief Financial Officer1.7.2025 07:00:00 CEST | Press release

Ad hoc announcement pursuant to Art. 53 LR Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced that Thomas Dittrich, Chief Financial Officer, will be leaving the company to pursue another senior executive opportunity outside the organization. “We thank Thomas for his financial leadership and many contributions during his time at Galderma. He played a key role in establishing the financial discipline, operational readiness, and strategic clarity that will continue to guide us forward. We wish him every success in his next role and remain focused on further accelerating Galderma’s strong growth – from category leadership to becoming a true powerhouse in dermatology.” FLEMMING ØRNSKOV, M.D., MPH CHIEF EXECUTIVE OFFICER GALDERMA Thomas Dittrich will remain with the company as Chief Financial Officer through Q2 2026 to ensure a seamless transition through the close of the 2025 fiscal year. A successor will be announced in due course. “I want to thank Fle

Transition Industries Signs Strategic Agreements for the Pacifico Mexinol Project, the Largest Standalone Ultra-Low Carbon Chemical Production Facility in the World30.6.2025 20:30:00 CEST | Press release

Pacifico Mexinol project, a 6,130 MT per day ultra-low carbon methanol production facility worth more than US$3.3b will be located near Topolobampo, Ahome, Sinaloa. Once operational in 2029, Pacifico Mexinol is poised to be the largest standalone ultra-low carbon chemical production facility in the world. Transition Industries LLC, a developer of world-scale, net-zero carbon emissions methanol and green hydrogen projects in North America, held a signing event for an Engineering, Procurement, and Construction (EPC) contract with the consortium of Samsung E&A Co., Ltd. (Samsung E&A), Grupo Samsung E&A Mexico, S.A. de C.V., and Techint Engineering and Construction for the Pacifico Mexinol project located in Ahome, Sinaloa, Mexico, which is contingent upon the fulfillment of customary conditions precedent and obtainment of all required approvals. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630940954/en/ MAIRE group’s techn

Westinghouse and ITER Sign a $180M Contract to Advance Nuclear Fusion30.6.2025 15:45:00 CEST | Press release

The contract includes the assembly of the fusion reactor’s vacuum vessel, a key milestone which gets the project closer to replicating fusion energy on Earth Westinghouse Electric Company and ITER signed a contract for $180 million for the assembly of the vacuum vessel for the fusion reactor. This is a key milestone in the construction of the ITER reactor, leading the way toward the use of fusion as a practical future source of reliable carbon-free energy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630497810/en/ The ITER Tokamak pit with the two vacuum vessel sector modules installed. Westinghouse has participated in the fabrication of the sectors of the vacuum vessel, as part of the Fusion for Energy (F4E) Consortium with its partners Ansaldo Nucleare and Walter Tosto. Westinghouse will be responsible for completing the vacuum vessel which is ITER’s most critical component: a hermetically sealed, double-walled steel

Monetate Acquires SiteSpect to Deliver AI-Native Personalization and Testing at Enterprise Scale30.6.2025 15:00:00 CEST | Press release

Monetate’s Real-Time Personalization Unites with SiteSpect’s Zero-Flicker Testing to Optimize Digital Experiences with Unmatched Speed, Precision, and SecurityNow Global Ecommerce and Digital Experience Leaders Can Access a Best-in-Class, Enterprise-Grade Personalization, Testing, and Optimization Platform Monetate, the leading AI-driven personalization platform, today announced it has acquired SiteSpect, a leader in A/B testing, to drive next-generation digital experience optimization. This acquisition accelerates Monetate’s vision to deliver intelligent, intentional, and individualized experiences at scale, powered by agentic AI and backed by the industry’s most advanced, enterprise-grade infrastructure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630514541/en/ The combination of Monetate’s real-time personalization and SiteSpect’s zero-flicker testing will yield an industry-first solution for enterprise-grade person

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye