CA-IMAGO-BIOSCIENCES
30.7.2020 14:02:16 CEST | Business Wire | Press release
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 .
View source version on businesswire.com: https://www.businesswire.com/news/home/20200730005280/en/
About 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
Incyte Announces New Positive 54-Week Late-Breaking Data for Povorcitinib in Hidradenitis Suppurativa at the 2026 American Academy of Dermatology (AAD) Annual Meeting28.3.2026 20:00:00 CET | Press release
Phase 3 data from the STOP-HS program demonstrate povorcitinib’s substantial and durable clinical efficacy through Week 54 in patients with moderate to severe hidradenitis suppurativa (HS). Through Week 54, clinically meaningful and durable responses were observed across all groups in both STOP-HS1 and STOP-HS2, with up to 71.4% of patients achieving HiSCR50. Improvements in clinical responses across high stringent thresholds were observed, with up to 57% of participants achieving HiSCR75 and up to 29% of participants achieving HiSCR100. Povorcitinib treatment led to consistent reductions across key inflammatory lesion types, with full resolution (ANdT=0) achieved in up to 20% of patients. Additionally, clinically meaningful improvements in quality-of-life measures, including skin pain and fatigue, were observed at Week 54. The overall safety profile of povorcitinib through 54 weeks is consistent with previously reported data, and both doses were well tolerated. Incyte (Nasdaq:INCY) to
Takeda’s Zasocitinib Delivered Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill, Affirming Promise to Reshape Psoriasis Care28.3.2026 20:00:00 CET | Press release
About 70% of patients treated with zasocitinib achieved clear or almost clear skin (sPGA 0/1) at week 16 in Phase 3 plaque psoriasis studies A significantly greater PASI 75 response rate versus placebo was observed as early as week 4 Safety profile consistent with Phase 2b studies with no new safety signals identified Takeda(TSE:4502/NYSE:TAK)today announced new data from the two pivotal Phase 3studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).1 Presented as a late-breaking abstract at the 2026 American Academy of Dermatology (AAD) Annual Meeting, these data show that convenient once-daily oral zasocitinib demonstrated rapid and durable skin clearance with a safety profile consistent with Phase 2b studies.1,2 “Our goal in psoriasis treatment is clear or almost clear skin, and previously this has been achieved primarily with injectable therapies,” said Melinda Gooderham,
AAD 2026: Late-Breaking Nemolizumab Data Demonstrate Clinically Meaningful Benefits for Children Aged 2 to 11 With Moderate-to-Severe Atopic Dermatitis28.3.2026 16:00:00 CET | Press release
Pharmacokinetics, safety and efficacy clinical study data show that nemolizumab achieved clinically meaningful reductions in skin lesions and itch through Week 16, which were sustained up to a year in children aged 2 to 11 with moderate-to-severe atopic dermatitis1 These findings reinforce the previously established safety and efficacy of nemolizumab in adults and adolescents with moderate-to-severe atopic dermatitis, for which it is approved by multiple global regulatory authorities2,3 Up to 25% of children are affected by atopic dermatitis, and currently there are limited approved treatment options for children living with moderate-to-severe atopic dermatitis4,5 Galderma (SIX: GALD) today announced new phase II data showing that nemolizumab was well tolerated and effective in children (aged 2 to 11 years) with moderate-to-severe atopic dermatitis, with a clinically meaningful and sustained reduction in skin lesions and itch for up to a year.1 Results will be presented in a late-break
Angelalign Technology (6699.HK)Releases 2025 Results: Passion for Clinical Excellence Drives Worldwide Growth27.3.2026 20:56:00 CET | Press release
Angelalign Technology Inc. (6699.HK) (“Angel” or the “Company”) released its financial results for fiscal year 2025. During the reporting period, the Company continued to do well in both the global and China markets. Total case volume was 532,400, which increased 48.1%, revenue was USD 370.3 million, which increased 37.8%, and adjusted net profit was USD 43.8 million, which increased 63.0%. The results were driven by Angel’s passion for clinical excellence and its open and inclusive culture that empowers talented people to work together to meet customer needs, the Company said. Fox Hu, CEO of Angel, stated: “The clear aligner industry is complex and multidisciplinary. It requires top-tier technical and operational talent along with seamless collaboration among professionals from diverse geographies. Angel’s open and inclusive culture attracts professionals who share a passion for clinical excellence and a dedication to bringing outstanding products and services to customers. This melti
Axway Positioned as a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment27.3.2026 18:46:00 CET | Press release
Axway, a 74Software company (Euronext: 74SW) and global leader in federated API management and enterprise integration, has been named a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment.1 Axway Amplify securely connects, orchestrates, and automates data integration. Organizations in financial services, manufacturing, healthcare, and other industries rely on Amplify to modernize integrations and confidently unlock data to deliver superior digital services faster. The report notes: “The platform benefits from Axway’s long-standing experience in B2B integration, secure file transfer, and legacy connectivity, providing differentiated capabilities for organizations that need to expose and control APIs around core systems that are not cloud-native.”1 This multi-pattern expertise in security, integration, and federated governance — built during the early phases of the API-driven digital transformation — becomes especially critical as enterprises seek to govern dat
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