{"id":13522,"date":"2022-11-14T00:00:00","date_gmt":"2022-11-14T00:00:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/3934879_CN34879_0"},"modified":"2022-11-14T00:00:00","modified_gmt":"2022-11-14T00:00:00","slug":"akesos-ivonescimab-pd-1-vegf-bispecific-antibody-ak112-granted-breakthrough-therapy-designation-for-i-o-resistance-nsclc-patients-in-china","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=13522","title":{"rendered":"Akeso&#8217;s Ivonescimab (PD-1\/VEGF Bispecific Antibody, AK112) Granted Breakthrough Therapy Designation for I-O Resistance NSCLC Patients in China"},"content":{"rendered":"<div id=\"dvContent\" readability=\"84.298975811724\">\n<table name=\"logo_release\" border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/1797099\/logo_Logo.jpg?p=medium600\" border=\"0\" alt title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ul type=\"disc\">\n<li><i>AK112 has now been granted three Breakthrough Therapy Designations for NSCLC<\/i><\/li>\n<li><i>The only drug candidate granted Breakthrough Therapy Designation for I-O Resistance NSCLC in <span class=\"xn-location\">China<\/span><\/i><\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">HONG KONG<\/span>, Nov. 14, 2022 \/PRNewswire\/ &#8212; Akeso, Biopharma (9926. HK) (&#8220;Akeso&#8221;) announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for Ivonescimab (PD-1\/VEGF bispecific antibody, AK112) combined with docetaxel for the treatment of locally advanced or metastatic Non-Small-Cell Lung Carcinoma (NSCLC) patients who failed to respond to prior PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy. This is the third BTD for AK112 for use with NSCLC patients, and AK112 is the only drug candidate granted BTD for PD-(L)1 resistant lung cancer treatment in <span class=\"xn-location\">China<\/span>.<\/span><\/p>\n<p>The three BTDs of AK112 comprise:<\/p>\n<ul type=\"disc\">\n<li>AK112 combined with chemotherapy for the treatment of EGFR-mutated locally advanced or metastatic NSCLC patients who have failed to respond to EGFR-TKI treatment, which has completed Phase III clinical trials patient enrollment.<\/li>\n<li>AK112 as the first-line treatment for locally advanced or metastatic NSCLC patients with positive PD-L1 expression, which has entered into Phase III clinical trials.<\/li>\n<li>AK112 combined with docetaxel for the treatment of locally advanced or metastatic NSCLC patients who failed to respond to prior PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy, which is the only drug candidate granted BTD for PD-(L)1 resistant lung cancer treatment in <span class=\"xn-location\">China<\/span>.<\/li>\n<\/ul>\n<p>Breakthrough Therapy Designations aim to accelerate development and regulatory review of new drugs to treat severe diseases which show encouraging preliminary clinical results. These drugs need to demonstrate a significant improvement in clinical endpoints over existing therapies, or fulfill unmet medical needs. Akeso believes that these three designations of AK112 for NSCLC will accelerate the R&amp;D and marketing progress of AK112 in <span class=\"xn-location\">China<\/span>.<\/p>\n<p>PD-1\/L1 monoclonal antibody combined with platinum-based chemotherapy is the standard of care for first-line therapy for patients with advanced NSCLC. However, the majority of patients do not benefit from the treatment or may relapse after a period of response, highlighting the need for more effective treatment. However, there are currently no immunotherapy regimens approved for NSCLC patients who failed to respond to prior PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy.<\/p>\n<p>Immunotherapy plus anti-angiogenesis therapy has proven its combined advantages in previous studies worldwide. Lung cancer is one of the mainstream exploration areas of this therapy. AK112 can potentially simultaneously block PD-1 and VEGF targets, and has demonstrated a favorable safety profile and promising anti-tumor efficacy in recent studies conducted by the Company. AK112 is expected to provide a valuable option for NSCLC patients to overcome immunotherapy resistance antibody therapy.<\/p>\n<p><b>ABOUT IVONESCIMAB (PD-1\/VEGF BI-SPECIFIC ANTIBODY, AK112)<\/b><\/p>\n<p>Ivonescimab is a first-in-class and the first to enter phase III clinical trial PD-1\/VEGF bi-specific antibody independently developed by Akeso Biopharma. Engineered with our unique Tetrabody technology, Ivonescimab blocks PD-1 binding to PD-L1 and PD-L2, and blocks VEGF binding to VEGF receptors. PD-1 antibody combined with VEGF blocking agents have shown robust efficacy in various tumor types (including renal cell carcinoma, non-small cell lung cancer and hepatocellular carcinoma). In view of the co-expression of VEGF and PD-1 in the tumor microenvironment, Ivonescimab, as a single agent to block these two targets, may block these two pathways more effectively and enhance the antitumor activity, as compared to combination therapy.<\/p>\n<p>Currently, Akeso is conducting a phase III clinical trial of AK112 monotherapy versus Pembrolizumab monotherapy as the first-line treatment for NSCLC patients with positive PD-L1 expression. In addition, a phase III clinical trial of AK112 plus chemotherapy versus chemotherapy in EGFR mutated advanced non-squamous NSCLC that failed in prior EGFR-TKI therapy is ongoing. AK112 has started multiple clinical trials for various stages treatment of indications including non-small cell lung cancer and small cell lung cancer.<\/p>\n<p id=\"PURL\"><img loading=\"lazy\" decoding=\"async\" title=\"Cision\" width=\"12\" height=\"12\" alt=\"Cision\" src=\"https:\/\/c212.net\/c\/img\/favicon.png?sn=CN34879&amp;sd=2022-11-13\"> View original content to download multimedia:<a id=\"PRNURL\" rel=\"nofollow noopener\" href=\"https:\/\/www.prnewswire.com\/news-releases\/akesos-ivonescimab-pd-1vegf-bispecific-antibody-ak112-granted-breakthrough-therapy-designation-for-i-o-resistance-nsclc-patients-in-china-301676355.html\" target=\"_blank\">https:\/\/www.prnewswire.com\/news-releases\/akesos-ivonescimab-pd-1vegf-bispecific-antibody-ak112-granted-breakthrough-therapy-designation-for-i-o-resistance-nsclc-patients-in-china-301676355.html<\/a><\/p>\n<\/p><\/div>\n<p>Source: Akeso, Inc.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>AK112 has now been granted three Breakthrough Therapy Designations for NSCLC The only drug candidate granted Breakthrough Therapy Designation for I-O Resistance NSCLC in China HONG KONG, Nov. 14, 2022 \/PRNewswire\/ &#8212; Akeso, Biopharma (9926. HK) (&#8220;Akeso&#8221;) announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has granted [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-13522","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Akeso&#039;s Ivonescimab (PD-1\/VEGF Bispecific Antibody, AK112) Granted Breakthrough Therapy Designation for I-O Resistance NSCLC Patients in China - My Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/transmediavictoria.net.au\/?p=13522\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Akeso&#039;s Ivonescimab (PD-1\/VEGF Bispecific Antibody, AK112) Granted Breakthrough Therapy Designation for I-O Resistance NSCLC Patients in China - My Blog\" \/>\n<meta property=\"og:description\" content=\"AK112 has now been granted three Breakthrough Therapy Designations for NSCLC The only drug candidate granted Breakthrough Therapy Designation for I-O Resistance NSCLC in China HONG KONG, Nov. 14, 2022 \/PRNewswire\/ &#8212; Akeso, Biopharma (9926. 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