-Information exhibit traits important for therapy of autoimmune illnesses, together with strong tissue homing and full CD19+ B cell depletion in secondary lymphoid tissue
-Outcomes spotlight the potential advantages distinctive to gamma delta 1 CAR T cell remedy and ADI-001’s potential as a best-in-class off-the-shelf cell remedy for autoimmune illnesses
-The corporate is pursuing ADI-001 in a basket research throughout six indications together with lupus nephritis (LN), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff particular person syndrome (SPS) and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV)
REDWOOD CITY, Calif. & BOSTON–(BUSINESS WIRE)–Adicet Bio, Inc. (Nasdaq: ACET), a scientific stage biotechnology firm discovering and creating allogeneic, gamma delta T cell therapies for autoimmune illnesses and most cancers, at this time introduced that scientific biomarker information from the ADI-001 Part 1 GLEAN trial which demonstrates strong tissue homing, vital CAR T cell activation, and full CD19+ B cell depletion in secondary lymphoid tissue can be featured in an oral session at ACR Convergence 2024 in Washington, D.C., November 14-19.
We imagine the important thing to advancing look after autoimmune sufferers is to develop a therapeutic candidate that demonstrates strong tissue homing, full CD19+ B cell depletion in tissue, and superior drug publicity in secondary lymphoid tissue with a constructive security profile. We’re proud to share information and analyses, together with scientific biomarker information, at ACR that help the potential of ADI-001 in autoimmune illnesses, mentioned Francesco Galimi, M.D., Ph.D., Chief Medical (TASE:) Officer. After activating scientific trial websites for LN and receiving investigational new drug utility (IND) clearances to pursue further autoimmune indications, we’re dedicated to advancing ADI-001 in a basket research throughout six autoimmune indications. This technique highlights our deal with addressing the numerous unmet medical wants of sufferers who urgently require progressive and efficient new therapy choices.
A abstract of the outcomes is reported under:
- ADI-001 demonstrated vital ranges of CAR T cell activation and tissue publicity in lymph node biopsies within the GLEAN trial, representing a variety of 27-64% of whole mobile materials detected by ddPCR in evaluable biopsies on the 1E9 dose, and exceeding ranges beforehand reported for sufferers who obtained autologous alpha-beta CAR T therapies. CAR T cells detected in tissues additionally demonstrated a sturdy activation profile, primarily based on in situ ranges of granzyme B.
- Not too long ago printed research have demonstrated depletion of CD19+ plasmablasts, reminiscence B cells and naïve B cells in peripheral blood utilizing anti-CD20 focused antibodies, nonetheless, these CD20-targeted antibody modalities failed to completely deplete B cells inside secondary lymphoid tissue.
- Concurrent with ADI-001 tissue trafficking and activation, full depletion of CD19+ B cells inside analyzed lymph node tissue was additionally noticed. These outcomes help ADI-001’s potential for attaining full B-cell depletion in peripheral blood and inside tissues.
Particulars of the oral presentation
ADI-001: An Allogeneic CD20-targeted γδ CAR T Cell Remedy with Potential for Improved Tissue Homing in Autoimmune Indications
Session Title: Abstracts: Miscellaneous Rheumatic & Inflammatory Ailments II
Summary Quantity: 1866169
Presenting Writer: Monica Moreno, Ph.D.
Date and Time: November 19, 2024; 12:00 p.m. “ 12:15 p.m. ET
About ADI-001 in Autoimmune Ailments
ADI-001 is an investigational allogeneic gamma delta CAR T cell remedy focusing on B-cells through an anti-CD20 CAR. ADI-001 was granted Quick Monitor Designation by the FDA for the potential therapy of relapsed/refractory class III or class IV lupus nephritis (LN). Adicet is exploring the potential of ADI-001 in a basket research throughout six indications together with lupus nephritis (LN), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff particular person syndrome (SPS) and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV).
For extra details about turning into a research website, please e mail clinicaltrials@adicetbio.com or go to https://www.adicetbio.com/hcp/autoimmune/.
In regards to the Part 1 Scientific Trial
The Part 1 research has 4 separate arms, enrolling LN and SLE sufferers into one arm, SSc sufferers right into a second arm, IIM and SPS sufferers in a 3rd arm and AAV sufferers right into a fourth arm. Enrolled sufferers will obtain a single dose of ADI-001. The dose-limiting toxicity window is 28 days with response and security assessments carried out on Day 28 and in the course of the follow-up interval on months 3, 6, 9, 12, 18 and 24. The first targets of the research are to guage the protection and tolerability of ADI-001. Secondary targets embody measuring mobile kinetics, pharmacodynamics, modifications in autoantibody titers, and applicable illness exercise scores in every indication.
About Adicet Bio, Inc.
Adicet Bio, Inc. is a scientific stage biotechnology firm discovering and creating allogeneic gamma delta T cell therapies for autoimmune illnesses and most cancers. Adicet is advancing a pipeline of off-the-shelf gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate sturdy exercise in sufferers. For extra info, please go to our web site at https://www.adicetbio.com.
Ahead-Trying Statements
This press launch accommodates forward-looking statements of Adicet throughout the which means of the Personal Securities Litigation Reform Act of 1995 regarding the enterprise and operations of Adicet. The phrases anticipate, imagine, proceed, might, estimate, count on, intend, could, plan, potential, predict, undertaking, ought to, goal, would and comparable expressions are supposed to determine forward-looking statements, though not all forward-looking statements comprise these figuring out phrases. These forward-looking statements embody, however should not restricted to, categorical or implied statements relating to: the potential security, tolerability and efficacy of ADI- 001 in a number of autoimmune indications; the potential for ADI-001 to be best-in-class allogenic cell remedy for autoimmune illnesses; and the scientific improvement of ADI-001 in LN, SLE, SSc, IIM, SPS and AAV.
Any forward-looking statements on this press launch are primarily based on administration’s present expectations and beliefs of future occasions, and are topic to a lot of dangers and uncertainties that might trigger precise outcomes to vary materially and adversely from these set forth in or implied by such forward-looking statements, together with with out limitation, the impact of worldwide financial situations and public well being emergencies on Adicet’s enterprise and monetary outcomes, together with with respect to disruptions to our preclinical and scientific research, enterprise operations, worker hiring and retention, and skill to lift further capital; Adicet’s potential to execute on its technique together with acquiring the requisite regulatory approvals on the anticipated timeline, if in any respect; that constructive outcomes, together with interim outcomes, from a preclinical or scientific research could not essentially be predictive of the outcomes of future or ongoing research; scientific research could fail to exhibit ample security and efficacy of Adicet’s product candidates, which might stop, delay, or restrict the scope of regulatory approval and commercialization; and regulatory approval processes of the U.S. Meals and Drug Administration and comparable overseas regulatory authorities are prolonged, time-consuming, and inherently unpredictable; and Adicet’s potential to satisfy manufacturing and product launch expectations. For a dialogue of those and different dangers and uncertainties, and different vital elements, any of which might trigger Adicet’s precise outcomes to vary from these contained within the forward-looking statements, see the part entitled Danger Elements in Adicet’s most up-to-date annual report on Kind 10-Q and subsequent filings with the U.S. Securities and Trade Fee (SEC), in addition to discussions of potential dangers, uncertainties, and different vital elements in Adicet’s different filings with the SEC. All info on this press launch is as of the date of the discharge, and Adicet undertakes no responsibility to replace this info except required by legislation.
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