{"id":799087,"date":"2025-01-08T16:16:19","date_gmt":"2025-01-08T21:16:19","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/adicet-bio-provides-corporate-update-and-highlights-expected-2025-milestones\/"},"modified":"2025-01-08T16:16:19","modified_gmt":"2025-01-08T21:16:19","slug":"adicet-bio-provides-corporate-update-and-highlights-expected-2025-milestones","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/adicet-bio-provides-corporate-update-and-highlights-expected-2025-milestones\/","title":{"rendered":"Adicet Bio Provides Corporate Update and Highlights Expected 2025 Milestones"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }\n.bwlistdisc { list-style-type: disc }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>Adicet Bio Provides Corporate Update and Highlights Expected 2025 Milestones<\/b><\/p>\n<p class=\"bwalignc\"><i>Adicet made significant progress in 2024 and is well-positioned for success in 2025: Advancing Phase 1 clinical trial evaluating ADI-001 across six autoimmune diseases; preliminary data in lupus nephritis (LN) patients anticipated in 1H25, data from other patient cohorts expected in 2H25<\/i><\/p>\n<p class=\"bwalignc\"><i>Patient enrollment in systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS) expected to be initiated in 1Q25; initiation of patient enrollment in anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV) expected in 2H25<\/i><\/p>\n<p class=\"bwalignc\"><i>First patient dosed and enrollment ongoing in Phase 1 clinical trial of ADI-270 in metastatic\/advanced clear cell renal cell carcinoma (ccRCC); preliminary data expected in 1H25<\/i><\/p>\n<p>REDWOOD CITY, Calif. &amp; BOSTON&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nAdicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today provided corporate updates and highlighted upcoming milestones for 2025.<\/p>\n<p>\n\u201c2024 was a momentous year for Adicet as we amplified our efforts in autoimmune diseases and solid tumors. We dosed our first patients in our clinical trials evaluating our gamma delta 1 chimeric antigen receptor (CAR) T cell candidates, ADI-001 in LN and ADI-270 in ccRCC. Notably, ADI-270 is the first gamma delta CAR T cell therapy to enter clinical development for solid tumors, underscoring our commitment to pioneering innovative treatments. In the first half of 2025, we look forward to reporting preliminary data for both programs,\u201d said Chen Schor, President and Chief Executive Officer at Adicet Bio. \u201cWithin our autoimmune portfolio, the successful expansion of our Phase 1 trial of ADI-001 into six autoimmune indications, building upon clinical biomarker data demonstrating ADI-001\u2019s robust tissue trafficking and complete CD19+ B cell depletion in secondary lymphoid tissue, further reinforces ADI-001\u2019s potential as an off-the-shelf treatment option.<\/p>\n<p>\nMr. Schor continued: \u201cIn our oncology pipeline, the initiation of our Phase 1 trial of ADI-270 in ccRCC patients marked a crucial achievement as the first gamma delta 1 CAR T cell product candidate for the treatment of solid tumors. As we look ahead to 2025, we believe we are well positioned to build on this momentum to advance our product candidates to patients living with autoimmune diseases and cancer.\u201d<\/p>\n<p><b>Clinical Program Progress and Upcoming Milestones:<\/b><\/p>\n<p><b><i>Autoimmune Diseases Clinical Programs<\/i><\/b><\/p>\n<ul class=\"bwlistdisc\">\n<li>\nIn June 2024, the Company announced that the Food and Drug Administration (FDA) had granted Fast Track Designation to ADI-001 for the potential treatment of relapsed\/refractory class III or class IV LN.<\/p>\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\nIn September 2024, Adicet presented clinical biomarker data from the Phase 1 GLEAN trial of ADI-001 at the 9th Annual CAR-TCR Summit demonstrating robust tissue trafficking resulting in high levels of ADI-001, significant CAR T cell activation, and complete CD19+ B cell depletion in secondary lymphoid tissue.<\/p>\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\nIn October 2024, the Company received FDA clearance for an amendment to its Investigational New Drug (IND) application to evaluate ADI-001 in IIM and SPS as part of the Phase 1 trial of ADI-001 in autoimmune diseases. This followed the clearance of an IND amendment in August 2024 to expand clinical development of ADI-001 in the Phase 1 trial beyond LN to include SLE, SSc and AAV.<\/p>\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\nIn November 2024, Adicet announced the dosing of the first LN patient in the Phase 1 trial of ADI-001 in autoimmune diseases. The Company expects to initiate enrollment for patients with SLE, SSc, IIM, and SPS in the first quarter of 2025, and for patients with AAV in the second half of 2025.<\/p>\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\nPreliminary clinical data from the Phase 1 trial of ADI-001\u2019s LN patient cohort are anticipated in the first half of 2025. Preliminary data from the Phase 1 trial\u2019s other patient cohorts are expected in the second half of 2025.<\/p>\n<\/li>\n<\/ul>\n<p><b><i>Hematologic Malignancies and Solid Tumor Clinical Programs<\/i><\/b><\/p>\n<ul class=\"bwlistdisc\">\n<li>\nIn April 2024, Adicet presented preclinical data for ADI-270 at the American Society of Gene and Cell Therapy (ASGCT) showing robust anti-tumor activity in an in vivo model of ccRCC, including tumor infiltration, resistance to the immunosuppressive tumor microenvironment, and potent activity via CAR and innate-mediated targeting.<\/p>\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\nIn July 2024, the Company announced that FDA Fast Track Designation had been granted to ADI-270 for the potential treatment of patients with metastatic\/advanced ccRCC who have been treated with an immune checkpoint inhibitor and a vascular endothelial growth factor inhibitor.<\/p>\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\nIn December 2024, Adicet announced the dosing of the first patient in the Phase 1 clinical trial evaluating ADI-270 in patients with metastatic\/advanced ccRCC.<\/p>\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\nPreliminary clinical data from the ADI-270 Phase 1 trial in ccRCC are expected in the first half of 2025.<\/p>\n<\/li>\n<\/ul>\n<p><b>About Adicet Bio, Inc.<\/b><\/p>\n<p>\nAdicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of \u201coff-the-shelf\u201d gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.adicetbio.com&amp;esheet=54175567&amp;newsitemid=20250108585728&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.adicetbio.com&amp;index=1&amp;md5=9d942dbcdb299f0c9fe719a48148cd0e\">https:\/\/www.adicetbio.com<\/a>.<\/p>\n<p><b>Forward-Looking Statements<\/b><\/p>\n<p>\nThis press release contains \u201cforward-looking statements\u201d of Adicet within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the business and operations of Adicet. The words \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccontinue,\u201d \u201ccould,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cpredict,\u201d \u201cproject,\u201d \u201cshould,\u201d \u201ctarget,\u201d \u201cwould\u201d and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: clinical development of Adicet\u2019s product candidates, including future plans or expectations for ADI-001 and ADI-270 and the potential safety, tolerability and efficacy for the treatment of autoimmune diseases and cancer; ADI-001\u2019s potential to be an off-the-shelf treatment option for autoimmune indications; ADI-270\u2019s potential to be the first gamma delta CAR T cell therapy to address solid tumors; timing and success of the Phase 1 clinical trial of ADI-001 in LN, SLE, SSc, AAV, IIM and SPS, including timing and expectations for enrollment and future data releases; timing and success of the Phase 1 clinical trial of ADI-270 in ccRCC, including expectations for future data releases; and expectations regarding Adicet\u2019s uses of capital, expenses and financial results, including the expected cash runway.<\/p>\n<p>\nAny forward-looking statements in this press release are based on management\u2019s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including without limitation, the effect of global economic conditions and public health emergencies on Adicet\u2019s business and financial results, including with respect to disruptions to our preclinical and clinical studies, business operations, employee hiring and retention, and ability to raise additional capital; Adicet\u2019s ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; that positive results, including interim results, from a preclinical or clinical study may not necessarily be predictive of the results of future or ongoing studies; clinical studies may fail to demonstrate adequate safety and efficacy of Adicet\u2019s product candidates, which would prevent, delay, or limit the scope of regulatory approval and commercialization; and regulatory approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; and Adicet\u2019s ability to meet production and product release expectations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Adicet\u2019s actual results to differ from those contained in the forward-looking statements, see the section titled \u201cRisk Factors\u201d in Adicet\u2019s most recent annual report on Form 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC), as well as discussions of potential risks, uncertainties, and other important factors in Adicet\u2019s other filings with the SEC. All information in this press release is as of the date of the release, and Adicet undertakes no duty to update this information unless required by law.<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20250108585728r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20250108585728\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20250108585728\/en\/<\/a><\/span><\/p>\n<p><b>Adicet Bio, Inc.<br \/>\n<\/b><br \/><b>Investor and Media Contacts<\/b><\/p>\n<p><b>Investors:<br \/>\n<\/b><br \/>Anne Bowdidge<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:abowdidge@adicetbio.com\">abowdidge@adicetbio.com<\/a><\/p>\n<p>\nJanhavi Mohite<br \/>\n<br \/>Precision AQ<br \/>\n<br \/>212-362-1200<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:janhavi.mohite@precisionaq.com\">janhavi.mohite@precisionaq.com<\/a><\/p>\n<p><b>Media:<br \/>\n<\/b><br \/>Kerry Beth Daly<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:kbdaly@adicetbio.com\">kbdaly@adicetbio.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> California Massachusetts United States North America<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Oncology Health Other Health General Health Clinical Trials Pharmaceutical Biotechnology<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250108585728\/en\/1339314\/3\/adicet_logo_500x300_%28002%29_%28004%29.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Adicet Bio Provides Corporate Update and Highlights Expected 2025 Milestones Adicet made significant progress in 2024 and is well-positioned for success in 2025: Advancing Phase 1 clinical trial evaluating ADI-001 across six autoimmune diseases; preliminary data in lupus nephritis (LN) patients anticipated in 1H25, data from other patient cohorts expected in 2H25 Patient enrollment in systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS) expected to be initiated in 1Q25; initiation of patient enrollment in anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV) expected in 2H25 First patient dosed and enrollment ongoing in Phase 1 clinical trial of ADI-270 in metastatic\/advanced clear cell renal cell carcinoma (ccRCC); preliminary data expected in 1H25 REDWOOD CITY, &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/adicet-bio-provides-corporate-update-and-highlights-expected-2025-milestones\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Adicet Bio Provides Corporate Update and Highlights Expected 2025 Milestones&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-799087","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - 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