Business Wire

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

Share

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.

Contact information

Steve Kunszabo 
Canale Communications 
steve@canalecomm.com 
(619) 849-5388 

About Business Wire

Business Wire
Business Wire



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

Andersen Global Initiates Expansion into Albania28.10.2020 14:30:00 CETPress release

Andersen Global continues to focus on its expansion strategy in the European region with the addition of KALO & ASSOCIATES in Albania. The firm, founded in 1994 by Managing Partner Perparim Kalo, is a leading law firm in Albania. With a team of eight Partners and 30 professionals, the firm has proven capabilities in banking and finance, corporate, commercial litigation and arbitration, employment, tax, infrastructure, intellectual property, and real estate. In addition to working with large projects and investors and IFIs, including a number of Fortune 500 companies, the firm has contributed to the development of a modern commercial legislation and regulatory framework through involvement in the drafting of laws on secured transactions, financial leasing, pension funds, collective investment funds, telecommunications, concessions, renewable energy and energy efficiency. Additionally, the firm is highly ranked by IFLR1000,Chambers and Legal 500. “As the business environment continues to

Sevan Completes 28,000 Surveys, Reaches Major Milestone28.10.2020 14:00:00 CETPress release

Sevan Multi-Site Solutions, Inc. (Sevan) — a global leader in innovative design, program management, construction services and data analytics — has reached a significant milestone. The company has completed 28,000surveys, adding up to more than 700 million square feet since Sevan’s inception in 2011. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201028005437/en/ Sevan completes 28,000 surveys, reaches major milestone. More than 700 million square feet surveyed. (Graphic: Business Wire) “Sevan’s surveys have become a thread that runs through many of our program management offerings,” President and CEO Jim Evans said. “One of our strongest traits as a company is that we tailor to the needs of our clients, customize innovative solutions and deliver excellence. It has been incredible to see the growth of our surveys and technology offerings in the past years, and we are grateful we have the opportunity to contribute to the succ

Synergis Adept Named #1 in 21 Rankings on G2’s 2020 Fall Grid Reports28.10.2020 13:21:00 CETPress release

Synergis Software, a global leader in engineering information management and product data management (PDM), today announced that its flagship product, Adept, has earned 21 top placements in G2 Crowd’s Fall 2020 Grid Reports. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201028005422/en/ Synergis Adept earns 21 top honors on G2 Crowd's 2020 Fall Grid Reports. (Graphic: Business Wire) The reports, which are based on real customer reviews, highlight Adept’s leadership in ease of use, ease of setup, fastest implementation, best support and best relationship as some of the key differentiators compared to other products on the market. Adept earned Leader status in Product Data Management (PDM) and Enterprise Content Management (ECM), and High Performer status in Construction Drawing Management. “We're committed to helping clients become more efficient, secure and collaborative, and reports like this help us understand what we're

Boehringer Ingelheim Begins Phase 2 Clinical Trial of a Targeted Therapy to Help People with Severe Respiratory Illness from COVID-1928.10.2020 13:20:00 CETPress release

Boehringer Ingelheim today announced the initiation of a Phase 2 clinical trial of BI 764198, an inhibitor of TRPC6, a receptor-operated cation channel. This potent and selective inhibitor of TRPC6 may alleviate the damage to the lung and decrease the risk or severity of acute respiratory complications in patients hospitalized for COVID-19. The aim of therapy with BI 764198 is to reduce the need for ventilator support, to improve patient recovery rate and ultimately to save lives. Boehringer Ingelheim is committed to fighting COVID-19 and contributing with its expertise and resources to develop new therapeutic options for patients suffering from the virus’ severe complications. “COVID-19 can cause serious lung complications, such as viral pneumonia, and in severe cases can lead to acute respiratory distress syndrome (ARDS) and lung failure,” said Dr. Lorraine B. Ware, Ralph and Lulu Oven Endowed Chair and Professor of Medicine, and Pathology, Microbiology and Immunology, Vanderbilt Uni

First Patients Treated with the World’s Smallest Heart Pump, the 9Fr Impella ECP28.10.2020 13:03:00 CETPress release

Abiomed (NASDAQ: ABMD) announces the first two patients have been treated with the Impella ECP expandable percutaneous heart pump. Impella ECP is the smallest heart pump in the world. It measures 9 French (Fr) (3 millimeters) in diameter upon insertion and removal from the body. While in the heart, it expands while supporting the heart’s pumping function, providing peak flows greater than 3.5 L/min. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201028005398/en/ Impella ECP is the world’s smallest heart pump. (Graphic: Business Wire) The first Impella ECP patient was treated by Amir Kaki, MD, an interventional cardiologist and director of mechanical circulatory support at Ascension St. John Hospital in Detroit, part of Ascension Michigan. The patient had severe narrowing of his coronary arteries. Dr. Kaki successfully opened the patient’s arteries by performing several percutaneous interventions with support from Impella ECP

Alira Health and Embleema Announce Partnership to Deploy Next-Generation Real-World Data Solutions for Life Sciences28.10.2020 13:00:00 CETPress release

Alira Health, a leading international healthcare and life sciences advisory firm, and Embleema, the innovative software provider for patient-driven healthcare data platforms, today announced a strategic partnership to develop next-generation real-world data solutions aimed at accelerating clinical innovation and improving patient outcomes. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201028005026/en/ "Our partnership with Embleema is a critical step in the further development of our real-world evidence capabilities, which connects clinical research, hospital care, and the patient experience,” says Gabriele Brambilla, Chief Executive Officer of Alira Health. Romain Finas, VP of Real World Evidence at Alira Health, adds, “We are excited to offer our clients new solutions for real-world data, which will empower them to better evaluate their treatments and deliver new innovations to patients more quickly.” Robert Chu, Chief Ex

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