{"id":10890,"date":"2024-11-02T14:23:17","date_gmt":"2024-11-02T06:23:17","guid":{"rendered":"https:\/\/flcube.com\/?p=10890"},"modified":"2024-11-03T20:53:32","modified_gmt":"2024-11-03T12:53:32","slug":"novartis-trispecific-antibody-pit565-secures-nmpa-approval-for-clinical-trial","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=10890","title":{"rendered":"Novartis&#8217; Trispecific Antibody PIT565 Secures NMPA Approval for Clinical Trial"},"content":{"rendered":"\n<p>Swiss pharmaceutical giant Novartis (<a href=\"https:\/\/www.google.com\/finance\/quote\/NVS:NYSE\">NYSE: NVS<\/a>) has received acceptance for its clinical trial application for the investigational drug PIT565 from the China National Medical Products Administration (NMPA). PIT565 is a potential &#8220;first-in-class&#8221; trispecific antibody targeting CD3, CD19, and CD2, which Novartis is developing to treat B-cell malignancies.<\/p>\n\n\n\n<p>Preclinical research results for PIT565 were published in the journal Blood in 2022. The robust expression of the CD19 antigen in acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL) has driven the development of T cell redirecting therapies targeting CD19, including bispecific T cell engagers and CD19-targeting CAR-T therapies. However, T cell exhaustion often leads to treatment failure.<\/p>\n\n\n\n<p>To address this challenge, researchers have developed the IgG-like trispecific antibody PIT565, which targets CD19 on malignant B cells and engages both CD3 and CD2 on T cells, redirecting T cell cytotoxicity towards CD19-positive malignant B cells. Studies have shown that CD2 signaling is associated with a non-exhausted T cell phenotype. The interaction between CD2 and its ligand CD58 has been proven crucial for the efficacy of CD19 CAR-T cells in killing tumor cells, and the lack of CD58 expression on lymphoma cells is associated with resistance and relapse in patients treated with CD19 CAR-T therapy. Therefore, co-stimulation of CD2 by PIT565, compared to CD3 bispecifics, may overcome T cell exhaustion, increasing the depth and duration of patient responses.<\/p>\n\n\n\n<p>Preclinical studies have also indicated that PIT565 mediates more effective and sustained antitumor T cell responses compared to CD3 bispecifics, with greater T cell proliferation, cytokine production, and tumor cell lysis in vitro.<\/p>\n\n\n\n<p>Currently, PIT565 is being tested in an open-label, multicenter, Phase 1 study internationally to explore the preliminary efficacy and safety of the product in patients with relapsed or refractory B-NHL and R\/R CD19-positive B-ALL. The study involves dosing PIT565 either weekly (Q1W) or every two weeks (Q2W), with the route of administration (intravenous [IV] or subcutaneous [SC]) being explored during the dose-escalation phase. Patients initially receive PIT565 IV Q1W for a 28-day cycle, with the possibility of exploring Q2W treatment for 28-day cycles if preliminary pharmacokinetic (PK), pharmacodynamic, efficacy, and safety results are supportive.<\/p>\n\n\n\n<p>According to ClinicalTrials.gov, Novartis has also registered a Phase 1 clinical study to evaluate the safety, tolerability, and pharmacokinetics of PIT565 in patients with systemic lupus erythematosus (SLE), which has not yet begun recruiting participants.- <a href=\"https:\/\/flcube.com\">Flcube.com<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Swiss pharmaceutical giant Novartis (NYSE: NVS) has received acceptance for its clinical trial application for&#8230;<\/p>\n","protected":false},"author":1,"featured_media":10891,"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":[16,21,62,140,865,25],"class_list":["post-10890","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-car-t","tag-clinical-trial-approval-initiation","tag-novartis","tag-nyse-nvs","tag-potential-first-in-class"],"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>Novartis&#039; Trispecific Antibody PIT565 Secures NMPA Approval for Clinical Trial - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Swiss pharmaceutical giant Novartis (NYSE: NVS) has received acceptance for its clinical trial application for the investigational drug PIT565 from the China National Medical Products Administration (NMPA). 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