{"id":818977,"date":"2025-02-27T07:08:45","date_gmt":"2025-02-27T12:08:45","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/adicet-bio-receives-fda-fast-track-designation-for-adi-001-for-the-treatment-of-systemic-sclerosis-ssc\/"},"modified":"2025-02-27T07:08:45","modified_gmt":"2025-02-27T12:08:45","slug":"adicet-bio-receives-fda-fast-track-designation-for-adi-001-for-the-treatment-of-systemic-sclerosis-ssc","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/adicet-bio-receives-fda-fast-track-designation-for-adi-001-for-the-treatment-of-systemic-sclerosis-ssc\/","title":{"rendered":"Adicet Bio Receives FDA Fast Track Designation for ADI-001 for the Treatment of Systemic Sclerosis (SSc)"},"content":{"rendered":"

<\/p>\n

Adicet Bio Receives FDA Fast Track Designation for ADI-001 for the Treatment of Systemic Sclerosis (SSc)<\/b><\/p>\n

REDWOOD CITY, Calif. & BOSTON–(BUSINESS WIRE<\/a>)–
\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 announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of adult patients with systemic sclerosis (SSc).<\/p>\n

\nFast Track Designation is a process designed to facilitate development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need.<\/p>\n

About ADI-001<\/b><\/p>\n

\nADI-001 is aninvestigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy targeting CD20 for the treatment of autoimmune diseases. ADI-001 has been granted Fast Track Designation by the FDA for the treatment of relapsed\/refractory class III or class IV lupus nephritis (LN), systemic lupus erythematosus (SLE) with extrarenal involvement and systemic sclerosis (SSc). The Company is advancing ADI-001 across six autoimmune indications. Patient enrollment is ongoing in the Phase 1 study evaluating ADI-001 for the treatment of LN. Patient enrollment in SLE, SSc, idiopathic inflammatory myopathy (IIM, or myositis), and stiff person syndrome (SPS) is expected to be initiated in the second quarter of 2025. Initiation of enrollment in anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) is expected in the second half of 2025. In the Phase 1 GLEAN trial, ADI-001 was shown to target B-cells via an anti-CD20 CAR and demonstrated robust exposure and complete CD19+ B-cell depletion both in blood and secondary lymphoid tissue.<\/p>\n

About Adicet Bio, Inc.<\/b><\/p>\n

\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 https:\/\/www.adicetbio.com<\/a>.<\/p>\n

Forward-Looking Statements<\/b><\/p>\n

\nThis press release contains “forward-looking statements” 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 the initiation of patient enrollment for the Phase 1 trial of ADI-001 in SLE, SSc, IIM, SPS and ANCA AAV and potential benefits resulting from the Fast Track Designation.<\/p>\n

\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 geopolitical conflicts and economic conditions on Adicet\u2019s business and financial results, including with respect to disruptions to Adicet\u2019s 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 FDA 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 entitled \u201cRisk Factors\u201d in Adicet\u2019s most recent annual report on Form 10-K and periodic and current reports on Form 10-Q and Form 8-K filed 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>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20250227143374\/en\/<\/a><\/span><\/p>\n

Adicet Bio, Inc.
\n<\/b>
Investor and Media Contacts<\/b><\/p>\n

I<\/b>nvestors:
\n<\/b>
Anne Bowdidge
\n
abowdidge@adicetbio.com<\/a><\/p>\n

\nJanhavi Mohite
\n
Precision AQ
\n
212-362-1200
\n
janhavi.mohite@precisionaq.com<\/a><\/p>\n

Media:
\n<\/b>
Kerry Beth Daly
\n
kbdaly@adicetbio.com<\/a><\/p>\n

KEYWORDS:<\/b> California Massachusetts United States North America<\/p>\n

INDUSTRY KEYWORDS:<\/b> Research FDA Public Relations\/Investor Relations Communications Clinical Trials Biotechnology Health General Health Science<\/p>\n

MEDIA:<\/b><\/p>\n\n","protected":false},"excerpt":{"rendered":"

Adicet Bio Receives FDA Fast Track Designation for ADI-001 for the Treatment of Systemic Sclerosis (SSc) REDWOOD CITY, Calif. & BOSTON–(BUSINESS WIRE)– Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of adult patients with systemic sclerosis (SSc). Fast Track Designation is a process designed to facilitate development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. About ADI-001 ADI-001 is aninvestigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy targeting CD20 for the treatment … <\/p>\n

Continue reading “Adicet Bio Receives FDA Fast Track Designation for ADI-001 for the Treatment of Systemic Sclerosis (SSc)”<\/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-818977","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nAdicet Bio Receives FDA Fast Track Designation for ADI-001 for the Treatment of Systemic Sclerosis (SSc) - Market Newsdesk<\/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:\/\/www.marketnewsdesk.com\/index.php\/adicet-bio-receives-fda-fast-track-designation-for-adi-001-for-the-treatment-of-systemic-sclerosis-ssc\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Adicet Bio Receives FDA Fast Track Designation for ADI-001 for the Treatment of Systemic Sclerosis (SSc) - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Adicet Bio Receives FDA Fast Track Designation for ADI-001 for the Treatment of Systemic Sclerosis (SSc) REDWOOD CITY, Calif. & BOSTON–(BUSINESS WIRE)– Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of adult patients with systemic sclerosis (SSc). Fast Track Designation is a process designed to facilitate development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. 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