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
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Piper Sandler Advises Momentive Performance Materials on the Sale of its Consumer Sealants Business to Henkel Corporation7.8.2020 21:55:00 EEST | Press release
Piper Sandler &Co., a leading investment bank and institutional securities firm, served as financial advisor to Momentive Performance Materials Inc. (Momentive) in the sale of its consumer sealants business to Henkel Corporation. The deal, which remains subject to customary closing conditions including regulatory clearances, is expected to close in 2020. Momentive’s consumer sealants business encompasses GE-branded consumer sealants sold under license from the General Electric Company and available through home-improvement centers, major retailers and hardware stores. Momentive will continue to manufacture consumer sealants through 2021 under a transition supply agreement. (Source: Momentive Performance Materials Inc.) “In the midst of a pandemic, we are delighted to have helped Momentive, reach this agreement and achieve the goals of the company and its shareholders,” said Telly Zachariades, managing director, chemicals and materials, at Piper Sandler. “We are looking forward to aidin
ENA Investment Capital Publishes Open Letter to Ontex Shareholders7.8.2020 14:00:00 EEST | Press release
ENA Investment Capital (“ENA”), a long-term, value-oriented investment firm and the second-largest shareholder in Ontex Group NV (“Ontex” or the “Company”) owning c.15% of the Company’s outstanding shares, today issued the following public letter to Ontex’s shareholders. Dear Fellow Ontex Shareholders, ENA Investment Capital, owning c.15% of the voting shares of Ontex, has devoted considerable time and resources to conduct a thorough analysis of Ontex. This includes acquiring a comprehensive understanding of the personal hygiene segment and, more importantly, of the Company’s turnaround potential which we are convinced, if effectively executed, can deliver significant value for shareholders. As part of this extensive 18-month due diligence effort, we have consulted with former executives from Ontex as well as its main competitors, industry experts, investment bankers, lawyers and specialist consultants on a wide range of topics critical to Ontex’s business such as raw material trends a
Novavax and Takeda Announce Collaboration for Novavax’ COVID-19 Vaccine Candidate in Japan7.8.2020 12:28:00 EEST | Press release
Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK), today announced a partnership for the development, manufacturing and commercialization of NVX‑CoV2373, Novavax’ COVID‑19 vaccine candidate, in Japan. NVX‑CoV2373 is a stable, prefusion protein made using Novavax’ recombinant protein nanoparticle technology and includes Novavax’ proprietary Matrix‑M™ adjuvant. Takeda will receive funding from the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) to support the technology transfer, establishment of infrastructure and scale-up of manufacturing. Takeda anticipates the capacity to manufacture over 250 million doses of the COVID-19 vaccine per year1. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200807005160/en/ “Takeda’s leading position in Japan, technical expertise,
SES S.A.: Half Year 2020 Results7.8.2020 08:30:00 EEST | Press release
SES S.A. announced financial results for the six months ended 30 June 2020. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200806006164/en/ SES S.A.: Half Year 2020 Results (Photo: Business Wire) Solid H1 performance in line with expectations and continued underlying growth in Networks of +7.1% year-on-year(1,2) Revenue of EUR 947.5 million, -1.5% as reported with underlying revenue 2.4%(1,2) lower than H1 2019 Adjusted EBITDA(3) of EUR 582.0 million, -2.3% as reported (-3.5% at constant FX(2)) compared with H1 2019 and representing an Adjusted EBITDA(3) margin of 61.4% including a 2.2% year-on-year reduction in recurring operating expenses Limited COVID-19 impact in H1 reflecting business resilience with measures in place to mitigate increased headwinds in H2 2020 Updated FY 2020 group revenue outlook to EUR 1,860 - 1,900 million(4) in view of expected COVID-19 related revenue development FY 2020 Adjusted EBITDA(3) outlook
Western Union Stands in Solidarity with Lebanon6.8.2020 23:47:00 EEST | Press release
Western Union, a leader in cross-border, cross-currency money movement and payments, today announced that it is offering zero-feei international money transfers paid out in U.S. dollars to Lebanon, as the country grapples with its recent tragedy amidst other economic and pandemic related threats. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200806006068/en/ Western Union Stands in Solidarity with Lebanon; Money Transfers to Lebanon Zero-Fee Paid out in US Dollars (Graphic: Business Wire) “We stand in solidarity with the people of Lebanon as they confront this latest tragedy following the horrific explosion in Beirut on August 4. Our thoughts and prayers are with families of those injured and have lost their lives,” said Jean Claude Farah, President, Global Network, Western Union. Farah said: “We know the people of Lebanon will stand strong as they grapple with this latest issue amidst other pressures of economic and COVID-
Pacific Drilling Announces Second-Quarter 2020 Results; Pacific Sharav Awarded a New 10-Well Contract in U.S. Gulf of Mexico6.8.2020 23:04:00 EEST | Press release
Pacific Drilling S.A. (NYSE: PACD) (“Pacific Drilling” or the “Company”) today reported results for the second quarter of 2020. Net loss for second-quarter 2020 was $87.4 million or $1.16 per diluted share, compared to net loss of $61.0 million or $0.81 per diluted share in first-quarter 2020. Pacific Drilling CEO Bernie Wolford commented, “In the second quarter, our crews and leadership continued to exemplify our commitment to safe and efficient operations, including adopting measures to manage risks associated with COVID-19 transmission, delivering exceptional results for our clients, efficiently preserving the value of our assets and significantly reducing overhead costs.” Mr. Wolford continued, “Although oil prices began to rebound during the second quarter, clients have generally reduced their drilling investments, as evidenced by Equinor’s decision to cancel the previously exercised third firm well for Pacific Khamsin, and Murphy’s decision to cancel the two well Mexico contract
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