{"id":31352,"date":"2025-04-08T14:11:28","date_gmt":"2025-04-08T06:11:28","guid":{"rendered":"https:\/\/flcube.com\/?p=31352"},"modified":"2025-04-08T14:11:29","modified_gmt":"2025-04-08T06:11:29","slug":"phanes-therapeutics-gains-cde-approval-for-peluntamig-phase-ii-trial-in-sclc-and-nec","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=31352","title":{"rendered":"Phanes Therapeutics Gains CDE Approval for Peluntamig Phase II Trial in SCLC and NEC"},"content":{"rendered":"\n

Sino-US biotech Phanes Therapeutics Inc. announced receiving approval from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) to initiate a Phase II study for its bispecific antibody (BsAb) peluntamig (PT217). This milestone marks significant progress in the development of peluntamig, a potential first-in-class therapy for patients with neuroendocrine cancers.<\/p>\n\n\n\n

Clinical Trial Details<\/strong>
The Phase II study will evaluate peluntamig’s safety, tolerability, pharmacokinetics, and anti-tumor activity when combined with chemotherapy and\/or a PD-L1 inhibitor. The trial will focus on patients with small cell lung cancer (SCLC) and other neuroendocrine cancers (NEC), including prostate neuroendocrine carcinoma (NEPC).<\/p>\n\n\n\n

Drug Profile<\/strong>
Peluntamig is a novel bispecific antibody targeting DLL3 and CD47. It has been granted two Orphan Drug Designations (ODDs) by the US FDA for SCLC and NEC, as well as two Fast Track designations for previously treated extensive-stage SCLC and primary and induced NEPC.<\/p>\n\n\n\n

Strategic Partnership<\/strong>
Phanes entered into a partnership with Roche in 2023 to explore the combination of peluntamig with Roche\u2019s anti-PD-L1 therapy, atezolizumab. This collaboration aims to enhance the therapeutic potential of peluntamig in the treatment of neuroendocrine cancers.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Sino-US biotech Phanes Therapeutics Inc. announced receiving approval from the Center for Drug Evaluation (CDE)…<\/p>\n","protected":false},"author":1,"featured_media":31353,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[7,11],"tags":[62,29,28,1517],"class_list":["post-31352","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-clinical-trial-approval-initiation","tag-combination-therapy","tag-multi-specific-antibodies","tag-phanes-therapeutics"],"yoast_head":"\nPhanes Therapeutics Gains CDE Approval for Peluntamig Phase II Trial in SCLC and NEC - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Sino-US biotech Phanes Therapeutics Inc. announced receiving approval from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) to initiate a Phase II study for its bispecific antibody (BsAb) peluntamig (PT217). 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