{"id":893054,"date":"2025-10-07T06:58:58","date_gmt":"2025-10-07T10:58:58","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/adicet-bio-announces-positive-preliminary-data-from-adi-001-phase-1-study-in-patients-with-lupus-nephritis-ln-and-systemic-lupus-erythematosus-sle\/"},"modified":"2025-10-07T06:58:58","modified_gmt":"2025-10-07T10:58:58","slug":"adicet-bio-announces-positive-preliminary-data-from-adi-001-phase-1-study-in-patients-with-lupus-nephritis-ln-and-systemic-lupus-erythematosus-sle","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/adicet-bio-announces-positive-preliminary-data-from-adi-001-phase-1-study-in-patients-with-lupus-nephritis-ln-and-systemic-lupus-erythematosus-sle\/","title":{"rendered":"Adicet Bio Announces Positive Preliminary Data from ADI-001 Phase 1 Study in Patients with Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE)"},"content":{"rendered":"

<\/p>\n

Adicet Bio Announces Positive Preliminary Data from ADI-001 Phase 1 Study in Patients with Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE)<\/b><\/p>\n

\n-Clinical data to date supports a potentially transformational approach to treating autoimmune diseases with an off-the-shelf, one-time therapy-<\/p>\n

\n-As of the August 31, 2025 data cut-off date, all seven evaluable LN and SLE patients experienced rapid and sustained reductions in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score and Physician\u2019s Global Assessment (PGA) highlighting ADI-001\u2019s potential fordurable effect on a broad range of lupus symptoms-<\/p>\n

\n-As of the August 31, 2025 data cut-off date, all five LN patients experienced improved renal function, including three complete renal responses and Definition Of Remission In Systemic lupus erythematosus (DORIS) remissions, and two partial renal responses, with all responses ongoing-<\/p>\n

\n-Generally well tolerated with a favorable safety profile to date, supporting the potential for outpatient administration; no Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and no Grade 2 or higher Cytokine Release Syndrome (CRS) was observed-<\/p>\n

\n-All patients discontinued immunosuppressants and either discontinued or tapered corticosteroids to physiological levels-<\/p>\n

\n-Clear evidence of immune reset with subsequent emergence of na\u00efve and previously undetected B cell repertoire following single treatment-<\/p>\n

\n-Recent momentum has resulted in more than 25 clinical sites open for enrollment to date-<\/p>\n

\n-Adicet plans to request a meeting with the U.S. Food and Drug Administration (FDA) in 1Q\/2026 to inform Phase 2 pivotal trial design with a study anticipated to commence in 2Q\/2026-<\/p>\n

\n-Company to host investor webcast on Tuesday, October 7 at 8:00am ET-<\/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 initial safety and efficacy data from the first seven patients dosed with ADI-001 in the ongoing Phase 1 study evaluating ADI-001 as a potential treatment for patients with autoimmune diseases. The data cut as of August 31, 2025, includes seven patients (five LN and two SLE patients), with follow-up ranging from two to nine months. Based on these results, Adicet will request a meeting with the FDA to inform trial design for a potentially pivotal Phase 2 trial for LN, or for LN and SLE.<\/p>\n

This press release features multimedia. View the full release here: https:\/\/www.businesswire.com\/news\/home\/20251006091236\/en\/<\/a><\/p>\n

\"Figure<\/p>\n

Figure 1 \u2013 Summary of SLEDAI-2K Score Across All Patients as of the August 31, 2025 cut-off date<\/p>\n<\/div>\n

\n\u201cWe are extremely encouraged to share preliminary results highlighting disease remissions or a halting of disease progression in the first seven patients treated in our Phase 1 trial. After a single dose of ADI-001, all patients discontinued immunosuppressant medications and all either discontinued or tapered corticosteroids to below physiological levels,\u201d said Julie Maltzman, M.D., Chief Medical Officer of Adicet Bio. \u201cADI-001 has also demonstrated a favorable safety and tolerability profile with no ICANS, and only two patients experiencing Grade 1 CRS, which is promising and has the potential to support outpatient administration of ADI-001. In addition, ADI-001’s potential availability as an off-the-shelf therapy may allow for far broader accessibility to many more patients and treating physicians. We believe ADI-001 represents a potential paradigm shift in the treatment of autoimmune diseases that traditionally has required chronic therapy to treat unpredictable and dangerous flares, potentially resulting in end-organ damage.\u201d<\/p>\n

\nDr. Maltzman continued, \u201cWe have now activated over 25 clinical sites globally, which is a testament to our team\u2019s focus and execution as well as demonstrated investigator interest in ADI-001. The pace of enrollment and site activation we are now observing reinforces our confidence in our timelines for future milestones as we advance our Phase 1 study in LN and SLE as well as cohorts in other autoimmune diseases, including systemic sclerosis, idiopathic inflammatory myopathy, stiff person syndrome and anti-neutrophil cytoplasmic autoantibody associated vasculitis, as well as a new Phase 1 study that is now open for enrollment for the treatment of rheumatoid arthritis.\u201d<\/p>\n

\n\u201cThese preliminary results reinforce our belief that ADI-001 has the potential to transform the treatment landscape for autoimmune diseases,\u201d said Chen Schor, President and Chief Executive Officer of Adicet Bio. “We observed clear evidence of immune reset with subsequent emergence of na\u00efve B cell repertoire following a single treatment of ADI-001. ADI-001’s potential to reset the immune system with a one-time, off-the-shelf therapy and a generally favorable safety profile could be practice-changing for patients and providers alike. With these data in hand, we plan to engage with the FDA in the first quarter of 2026 to discuss the design of a potentially pivotal study that we anticipate initiating in the second quarter of 2026.\u201d<\/p>\n

\nData highlights as of the August 31, 2025 cut-off date were as follows:<\/p>\n