{"id":17987,"date":"2023-06-12T00:09:00","date_gmt":"2023-06-11T16:09:00","guid":{"rendered":"https:\/\/flcube.com\/?p=17987"},"modified":"2024-12-15T00:12:33","modified_gmt":"2024-12-14T16:12:33","slug":"keymed-biosciences-cm313-monoclonal-antibody-shows-promise-in-phase-i-study-for-multiple-myeloma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=17987","title":{"rendered":"Keymed Biosciences’ CM313 Monoclonal Antibody Shows Promise in Phase I Study for Multiple Myeloma"},"content":{"rendered":"\n

China-based Keymed Biosciences Inc., (HKG: 2162<\/a>) has announced that the latest results from a Phase I clinical study for its Category 1 drug CM313, a monoclonal antibody (mAb) targeting CD38, have been presented at the 28th European Hematology Association (EHA) annual meeting. The trial focuses on the molecule’s potential use in treating recurrent\/refractory (R\/R) multiple myeloma (MM) and lymphoma.<\/p>\n\n\n\n

Design and Findings of the Phase I Study<\/strong>
The Phase I study (NCT04818372) is designed to assess the safety and initial efficacy of CM313 in patients with R\/R MM and R\/R lymphoma, including Waldenstr\u00f6m macroglobulinemia (WM) and marginal zone lymphoma (MZL). As of October 10, 2022, 34 patients were enrolled in the study, with 31 having R\/R MM and 3 having MZL. The safety assessment indicates that CM313 is well-tolerated, with the dose successfully escalated to 16.0 mg\/kg without reaching the maximum tolerable dose or encountering dose-limiting toxicity. The most common drug-related adverse events are infusion-related reactions and decreases in lymphocyte, white blood cell, and neutrophil counts, all of which are grade 1 or 2 and occurred during the first two medication sessions.<\/p>\n\n\n\n

Efficacy Evaluation and Future Prospects<\/strong>
Of the 29 R\/R MM patients who underwent at least one post-baseline efficacy evaluation, an overall objective response rate (ORR) of 34.5% was observed, with a median progression-free survival (PFS) of 132 days. The median overall survival (OS) has not been achieved. The Phase I study results suggest that CM313 demonstrates good overall safety and shows preliminary efficacy in treating R\/R MM at a dose level of \u2265 2.0 mg\/kg, indicating potential as a treatment option for patients with these conditions.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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

China-based Keymed Biosciences Inc., (HKG: 2162) has announced that the latest results from a Phase…<\/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":[106,16,17,974,179],"class_list":["post-17987","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-academic-conference","tag-cancer","tag-clinical-trial-results","tag-hkg-2162","tag-keymed-biosciences"],"yoast_head":"\nKeymed Biosciences' CM313 Monoclonal Antibody Shows Promise in Phase I Study for Multiple Myeloma - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Keymed Biosciences Inc., (HKG: 2162) has announced that the latest results from a Phase I clinical study for its Category 1 drug CM313, a monoclonal antibody (mAb) targeting CD38, have been presented at the 28th European Hematology Association (EHA) annual meeting. 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