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

Amazon Project Zero Launches in Seven New Countries11.8.2020 06:00:00 CESTPress release

Today, Amazon (NASDAQ: AMZN) announced the expansion of Project Zero to seven new countries - Australia, Brazil, Netherlands, Saudi Arabia, Singapore, Turkey, and the UAE - making it available in 17 countries where Amazon has a store. Project Zero combines Amazon’s advanced technology, machine learning, and innovation with the sophisticated knowledge that brands have of their own intellectual property so we can together drive counterfeits to zero. Launched in 2019, Project Zero builds on Amazon’s long-standing work and investments to ensure that customers always receive authentic goods when shopping on Amazon. Over 10,000 brands – from large, global brands to emerging entrepreneurs including Arduino, BMW, ChessCentral, LifeProof, OtterBox, Salvatore Ferragamo, and Veet – have already enrolled in Project Zero. “Amazon is committed to protecting our customers and the brands we collaborate with worldwide,” said Dharmesh Mehta, Vice President of Worldwide Customer Trust and Partner Support

FINEOS Acquires Limelight Health11.8.2020 02:07:00 CESTPress release

FINEOS Corporation (ASX:FCL), the global market leader in core systems for life, accident and health insurance, has entered into an agreement to acquire Limelight Health, a leading North American provider of quoting, rating and underwriting solutions for group and voluntary employee benefits, for $75M US. The union will provide an end-to-end SaaS core product suite from quote, rate and underwrite through to billing, policy administration, absence and claims management for the global life, accident, and health industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200810005814/en/ Michael Kelly, CEO of FINEOS, said: “We’re delighted to welcome the Limelight Health team and their clients to FINEOS, and we look forward to accelerating our combined growth for the benefit of all of our clients, people and partners. This acquisition delivers more product options for our clients as they accelerate their digital transformations an

IFF Reports Second Quarter 2020 Results; Increases Quarterly Dividend10.8.2020 22:05:00 CESTPress release

International Flavors & Fragrances Inc. (NYSE: IFF) (Euronext Paris: IFF) (TASE: IFF) reported financial results for the second quarter ended June 30, 2020. Management Commentary "Throughout the COVID-19 pandemic, we have continued to serve the needs of our customers and our communities around the world,” said Andreas Fibig, IFF Chairman and CEO. “Our unwavering dedication and commitment through this challenging set of circumstances are indicative of the passion and perseverance of our employees and the resiliency of our business. "The second quarter coincided with peak COVID-19 regulatory actions to date around the world – presenting both opportunities and challenges for our business. We are fortunate that a large portion of our business is in end-markets such as packaged food, beverage, hygiene and disinfection products, all of which have performed well. As we communicated in early June, the categories most exposed to COVID-19 restrictions – Fine Fragrance and Food Service – did expe

CyberArk Named a Leader in Gartner 2020 Magic Quadrant for Privileged Access Management10.8.2020 17:09:00 CESTPress release

CyberArk (NASDAQ:CYBR), today announced it was named a Leader in the Gartner 2020 Magic Quadrant for Privileged Access Management1, positioned both highest in ability to execute and furthest in completeness of vision for the second time in a row. CyberArk delivers the most comprehensive solution for protecting privileged accounts, credentials and secrets associated with humans, applications and machines across cloud and hybrid environments. As the global leader in privileged access management, CyberArk enables organizations of all sizes to reduce risk, improve operational efficiency and securely adopt modern technologies and infrastructure, including cloud, DevOps and process automation, to transform their business. “This report reinforces that the privileged access management market continues to mature with accelerated adoption,” said Marianne Budnik, CMO, CyberArk. “With privileged access management as its foundation, CyberArk’s Identity Security strategy delivers innovative solution

Silicon Mitus Starts Mass-Producing Automotive OLED PMIC10.8.2020 16:00:00 CESTPress release

Silicon Mitus, Inc. (Silicon Mitus), an advanced specialist in Power Management Integrated Circuit (PMIC), announced that it has completed the development of automotive OLED PMIC and starts supplying the new products in the global automotive market. Silicon Mitus develops and supplies OLED PMIC with a Korean OLED display manufacturer, which are applied to OLED displays, smartphones, tablets, and laptop computers. Through the addition of the new automotive OLED PMIC, the company is expanding the scope of its business. The automotive OLED PMIC, which Silicon Mitus has started mass-production, is certified with AEC Q100, a standard for automotive semiconductor reliability assessment. Silicon Mitus supplies the OLED PMIC for Virtual Mirror that consists of a camera and an OLED screen to German automakers through global module manufacturers. It also supplies the product for Center Information Display (CID), a screen showing vehicle information inside an automobile, to Japanese automakers. O

Prumo, bp and Siemens Enter Into Partnership With SPIC on Energy Projects in Brazil10.8.2020 15:00:00 CESTPress release

Prumo, a private Brazilian company controlled by EIG Global Energy Partners, bp and Siemens signed a binding agreement with SPIC Brasil. Under the agreement, SPIC will initially acquire 33% of the GNA I and GNA II LNG-to-power projects, located in Port of Açu, Rio de Janeiro. SPIC has also entered into an agreement to participate in the future expansion projects GNA III and GNA IV, which are expected to be fueled by a combination of LNG and domestic gas from Brazil’s vast pre-salt reserves. The closing of the agreement, scheduled for the fourth quarter of 2020, is subject to the fulfillment of certain conditions precedent usual to this type of transaction, among others. GNA I and GNA II is the largest gas-to-power project in Latin America, with 3 GW of installed capacity — enough to supply energy for up to 14 million households. The complex also includes an LNG terminal with a total capacity of 21 million m3/ day. GNA I, which has an installed capacity of 1.3 GW, is expected to commenc

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