{"id":26054,"date":"2022-09-08T13:47:00","date_gmt":"2022-09-08T05:47:00","guid":{"rendered":"https:\/\/flcube.com\/?p=26054"},"modified":"2025-02-10T13:53:47","modified_gmt":"2025-02-10T05:53:47","slug":"laekna-therapeutics-doses-first-patient-in-lae001-lae002-study-for-prostate-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=26054","title":{"rendered":"Laekna Therapeutics Doses First Patient in LAE001\/LAE002 Study for Prostate Cancer"},"content":{"rendered":"\n<p>China-based Laekna Therapeutics Shanghai Co., Ltd announced that the first patient has been dosed in the Phase I\/II LAE201INT2101 study evaluating the combination of LAE001 and LAE002 (afuresertib) in South Korea. The multi-regional clinical trial (MRCT) now spans China, the United States, and South Korea.<\/p>\n\n\n\n<p><strong>Study Details<\/strong><br>LAE201INT2101 is a multi-center, open-label, Phase I\/II dose-escalation and efficacy study for LAE001 and LAE002 in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after or are intolerant to first-line standard treatment. Laekna has completed the dose-escalation phase and is now advancing to the proof-of-concept stage. The combination therapy aims to provide treatment benefits for patients who have progressed after therapies with new-generation androgen\/anti-androgen (A\/AR) drugs, including abiraterone and enzalutamide.<\/p>\n\n\n\n<p><strong>Drug Profiles<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>LAE001:<\/strong> In-licensed from Novartis, LAE001 is a next-generation anti-androgen inhibitor targeting both CYP17A1 and CYP11B2 (aldosterone synthase). This dual-targeted action eliminates the need for long-term prednisone use in patients under the abiraterone acetate regimen, reducing cardiovascular and hepatotoxicity risks. LAE001 has shown safety and preliminary anti-tumor efficacy in Phase I\/Ib studies for mCRPC.<\/li>\n\n\n\n<li><strong>LAE002 (Afuresertib):<\/strong> Also in-licensed from Novartis, LAE002 is a highly selective AKT kinase inhibitor under development for breast cancer, prostate cancer, ovarian cancer, and solid tumors resistant to PD-1\/PD-L1 inhibitors. Preclinical studies demonstrate its ability to restore platinum\/paclitaxel sensitivity in PROC cell lines, and a Phase Ib study has shown potential anti-tumor efficacy.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>China-based Laekna Therapeutics Shanghai Co., Ltd announced that the first patient has been dosed in&#8230;<\/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":[16,62,3592],"class_list":["post-26054","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-clinical-trial-approval-initiation","tag-laekna-therapeutics"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Laekna Therapeutics Doses First Patient in LAE001\/LAE002 Study for Prostate Cancer - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Laekna Therapeutics Shanghai Co., Ltd announced that the first patient has been dosed in the Phase I\/II LAE201INT2101 study evaluating the combination of LAE001 and LAE002 (afuresertib) in South Korea. 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