{"id":4641,"date":"2024-06-20T14:18:53","date_gmt":"2024-06-20T07:18:53","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=4641"},"modified":"2024-06-20T14:18:53","modified_gmt":"2024-06-20T07:18:53","slug":"keymed-biosciences-announces-safety-and-efficacy-results-of-cm313-for-primary-immune-thrombocytopenia-published-in-nejm","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=4641","title":{"rendered":"Keymed Biosciences Announces Safety and Efficacy Results of CM313 for Primary Immune Thrombocytopenia Published in NEJM"},"content":{"rendered":"

CHENGDU, China<\/span><\/span>, June 20,\u00a02024<\/span> \/PRNewswire\/ — Keymed Biosciences Inc. (HKEX: 02162) today announced that\u00a0Lei Zhang\/Renchi Yang’s team from the Institute of Hematology, Chinese Academy of Medical Sciences has recently published a research paper entitled “A Novel Anti-CD38 Monoclonal Antibody for Treating Immune Thrombocytopenia”\u00a0in the New England Journal of Medicine. This\u00a0is an investigator-initiated, single-arm, open-label\u00a0phase I\/II\u00a0study evaluating\u00a0the safety and preliminary efficacy of CM313 in adult patients with primary ITP.<\/p>\n

A total of 22\u00a0patients were enrolled in the study, with one\u00a0patient\u00a0dropping out after the first infusion.\u00a0The\u00a0remaining 21 patients completed both the 8-week treatment\u00a0and 16-week\u00a0follow-up periods. Results showed that\u00a095.5% of patients (21\/22)\u00a0achieved a platelet count of \u226550 \u00d7 109\/L during the 8-week treatment period, with a median cumulative response duration of 23 weeks (interquartile range, 17\u00a0to 24).\u00a0The\u00a0median time to first\u00a0platelet count\u00a0of\u00a0\u226550 \u00d7 109\/L was\u00a01\u00a0week (range:\u00a01-3), and the\u00a0median time to first\u00a0platelet count\u00a0of\u00a0\u226530 \u00d7 109\/L with a\u00a0\u22652-fold increase\u00a0from baseline\u00a0was 1\u00a0week. Additionally, the durable sustained platelet count response\u00a0rate (defined as a platelet count\u00a0of\u00a0\u226550 \u00d7 109\/L observed six or more times among the final eight platelet counts) was 63.6% (14\/22). Throughout\u00a0the entire study, overall response\u00a0(complete or partial response) was observed in 21 patients, with 20 patients achieving complete response.\u00a0\u00a0The proportion of patients with bleeding decreased from 68.2% (15\/22) at baseline to 4.8 (1\/21) at week 8.\u00a0Most patients discontinued concomitant medications\u00a0due to the restoration of platelet counts\u00a0to normal or safe levels with\u00a0CM313 treatment.\u00a0In summary, CM313 demonstrated rapid and sustained efficacy\u00a0in 95.5% of ITP patients who had previously received multiple therapies.\u00a0Safety analyses showed\u00a0that\u00a0CM313 was well-tolerated.<\/p>\n

CM313 is a humanized monoclonal antibody targeting CD38 and the first domestically-developed anti-CD38 antibody with IND approval by the NMPA in China<\/span>. Previous phase I\/II studies have demonstrated the favorable safety profile and encouraging efficacy of CM313 in patients with RRMM and primary ITP. In addition, the potential use of CM313 in SLE is currently under clinical development.<\/p>\n

About Keymed Biosciences Inc.<\/p>\n

Keymed Biosciences Inc. (HKEX: 02162) focuses on the urgent unmet clinical needs, and is committed to providing high-quality, affordable, innovative therapies for patients in China<\/span> and overseas. To accelerate the efficiency of our research and discovery, the Company has established a fully-integrated platform encompassing all of the key functions in the biological drug development which include target validation, lead molecule discovery and optimization, preclinical evaluation, process development, translational research, clinical development and manufacturing. This integrated platform has enabled us to rapidly and cost-effectively identify, build, expand and advance our diversified pipeline of innovative and differentiated antibody-based therapies, including monoclonal antibodies, antibody drug conjugates (ADCs) and bispecific antibodies.<\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n

CHENGDU, China<\/span><\/span>, June 20,\u00a02024<\/span> \/PRNewswire\/ — Keymed Biosciences Inc. (HKEX: 02162) today announced that\u00a0Lei Zhang\/Renchi Yang’s team from the Institute of Hematology, Chinese Academy of Medical Sciences has recently published a research paper entitled “A Novel Anti-CD38 Monoclonal Antibody for Treating Immune Thrombocytopenia”\u00a0in the New England Journal of Medicine. This\u00a0is an investigator-initiated, single-arm, open-label\u00a0phase I\/II\u00a0study evaluating\u00a0the safety and preliminary efficacy of CM313 in adult patients with primary ITP.<\/p>\n

A total of 22\u00a0patients were enrolled in the study, with one\u00a0patient\u00a0dropping out after the first infusion.\u00a0The\u00a0remaining 21 patients completed both the 8-week treatment\u00a0and 16-week\u00a0follow-up periods. Results showed that\u00a095.5% of patients (21\/22)\u00a0achieved a platelet count of \u226550 \u00d7 109\/L during the 8-week treatment period, with a median cumulative response duration of 23 weeks (interquartile range, 17\u00a0to 24).\u00a0The\u00a0median time to first\u00a0platelet count\u00a0of\u00a0\u226550 \u00d7 109\/L was\u00a01\u00a0week (range:\u00a01-3), and the\u00a0median time to first\u00a0platelet count\u00a0of\u00a0\u226530 \u00d7 109\/L with a\u00a0\u22652-fold increase\u00a0from baseline\u00a0was 1\u00a0week. Additionally, the durable sustained platelet count response\u00a0rate (defined as a platelet count\u00a0of\u00a0\u226550 \u00d7 109\/L observed six or more times among the final eight platelet counts) was 63.6% (14\/22). Throughout\u00a0the entire study, overall response\u00a0(complete or partial response) was observed in 21 patients, with 20 patients achieving complete response.\u00a0\u00a0The proportion of patients with bleeding decreased from 68.2% (15\/22) at baseline to 4.8 (1\/21) at week 8.\u00a0Most patients discontinued concomitant medications\u00a0due to the restoration of platelet counts\u00a0to normal or safe levels with\u00a0CM313 treatment.\u00a0In summary, CM313 demonstrated rapid and sustained efficacy\u00a0in 95.5% of ITP patients who had previously received multiple therapies.\u00a0Safety analyses showed\u00a0that\u00a0CM313 was well-tolerated.<\/p>\n

CM313 is a humanized monoclonal antibody targeting CD38 and the first domestically-developed anti-CD38 antibody with IND approval by the NMPA in China<\/span>. Previous phase I\/II studies have demonstrated the favorable safety profile and encouraging efficacy of CM313 in patients with RRMM and primary ITP. In addition, the potential use of CM313 in SLE is currently under clinical development.<\/p>\n

About Keymed Biosciences Inc.<\/p>\n

Keymed Biosciences Inc. (HKEX: 02162) focuses on the urgent unmet clinical needs, and is committed to providing high-quality, affordable, innovative therapies for patients in China<\/span> and overseas. To accelerate the efficiency of our research and discovery, the Company has established a fully-integrated platform encompassing all of the key functions in the biological drug development which include target validation, lead molecule discovery and optimization, preclinical evaluation, process development, translational research, clinical development and manufacturing. This integrated platform has enabled us to rapidly and cost-effectively identify, build, expand and advance our diversified pipeline of innovative and differentiated antibody-based therapies, including monoclonal antibodies, antibody drug conjugates (ADCs) and bispecific antibodies.<\/p>\n

<\/p>\n","protected":false},"author":0,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[5,7],"tags":[],"class_list":["post-4641","post","type-post","status-publish","format-standard","hentry","category-cision-pr-newswire","category-cision-pr-newswire-en"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/4641","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/types\/post"}],"replies":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=4641"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/4641\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4641"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4641"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4641"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}