{"id":25945,"date":"2022-09-14T23:33:00","date_gmt":"2022-09-14T15:33:00","guid":{"rendered":"https:\/\/flcube.com\/?p=25945"},"modified":"2025-02-08T23:36:52","modified_gmt":"2025-02-08T15:36:52","slug":"i-mabs-lemzoparlimab-gains-cde-approval-for-hr-mds-phase-iii-trial","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=25945","title":{"rendered":"I-Mab’s Lemzoparlimab Gains CDE Approval for HR-MDS Phase III Trial"},"content":{"rendered":"\n

China-based I-Mab (NASDAQ: IMAB<\/a>) announced that it has successfully completed an End-of-Phase 2 (EoP2) meeting with the Center for Drug Evaluation (CDE) in China and obtained approval to initiate a Phase III registrational trial assessing lemzoparlimab, a novel CD47 antibody, in combination with azacitidine (AZA) as a first-line treatment for patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS).<\/p>\n\n\n\n

Encouraging Phase II Results<\/strong>
The EoP2 meeting was supported by encouraging results from the Phase II clinical trial evaluating the lemzoparlimab\/AZA combination in patients with newly diagnosed HR-MDS (NCT04202003). Top-line efficacy data demonstrated that the combination showed encouraging clinical response in HR-MDS patients. Results also showed that the combination can be safely administered without the need for a priming dose. The full results were reported in a proffered paper presentation at the European Society for Medical Oncology (ESMO) Congress 2022 on September 10, 2022.<\/p>\n\n\n\n

Mechanism of Action and Development<\/strong>
CD47 is a cell surface protein over-expressed in a wide variety of cancers, and can act to protect tumors by delivering a “don’t eat me” signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells. However, development of the CD47 antibody as a cancer therapy has been hampered by its hematologic side effects, such as severe anemia caused by the natural binding of CD47 antibody to red blood cells. Lemzoparlimab is designed to target tumor cells while exerting a minimal untoward effect on red blood cells.<\/p>\n\n\n\n

AbbVie Licensing Deal and Strategic Shift<\/strong>
AbbVie Inc. (NYSE: ABBV<\/a>) entered into a USD 1.04 billion licensing deal with I-Mab in September 2020, taking development and commercialization rights to lemzoparlimab outside of Greater China. However, last month the US major decided to end development of the drug, while forming another USD 1.295 billion deal for co-development of other CD47 mAbs in I-Mab’s pipeline.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

China-based I-Mab (NASDAQ: IMAB) announced that it has successfully completed an End-of-Phase 2 (EoP2) meeting…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[234,62,29,182,976,853],"class_list":["post-25945","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-abbvie","tag-clinical-trial-approval-initiation","tag-combination-therapy","tag-i-mab-biopharma","tag-nasdaq-imab","tag-nyse-abbv"],"yoast_head":"\nI-Mab's Lemzoparlimab Gains CDE Approval for HR-MDS Phase III Trial - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based I-Mab (NASDAQ: IMAB) announced that it has successfully completed an End-of-Phase 2 (EoP2) meeting with the Center for Drug Evaluation (CDE) in China and obtained approval to initiate a Phase III registrational trial assessing lemzoparlimab, a novel CD47 antibody, in combination with azacitidine (AZA) as a first-line treatment for patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS).\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=25945\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"I-Mab's Lemzoparlimab Gains CDE Approval for HR-MDS Phase III Trial\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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