Adicet Bio Presents Clinical Biomarker Data for Off-the-Shelf CAR T Cell Therapy in an Oral Session at the American College of Rheumatology (ACR) Convergence 2024
Adicet Bio (NASDAQ: ACET) presented clinical biomarker data for ADI-001, their off-the-shelf gamma delta CAR T cell therapy, at ACR Convergence 2024. The data showed robust tissue homing and complete CD19+ B cell depletion in secondary lymphoid tissue, with CAR T cell activation levels of 27-64% at the 1E9 dose. The company is advancing ADI-001 in a basket study across six autoimmune indications, including lupus nephritis, systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myopathy, stiff person syndrome, and ANCA-associated vasculitis.
Adicet Bio (NASDAQ: ACET) ha presentato dati clinici sui biomarcatori per ADI-001, la loro terapia CAR T a cellule gamma delta pronta all'uso, durante l'ACR Convergence 2024. I dati hanno mostrato un'elevata oming nei tessuti e una completa deplezione delle cellule B CD19+ nel tessuto linfatico secondario, con livelli di attivazione delle cellule CAR T compresi fra il 27 e il 64% alla dose di 1E9. L'azienda sta avanzando con ADI-001 in uno , tra cui nefrite lupica, lupus eritematoso sistemico, sclerosi sistemica, miopatia infiammatoria idiopatica, sindrome della persona rigida e vasculite associata ad ANCA.
Adicet Bio (NASDAQ: ACET) presentó datos clínicos de biomarcadores para ADI-001, su terapia de células T CAR gamma delta lista para usar, en el ACR Convergence 2024. Los datos mostraron una fuerte homing en los tejidos y una completa depleción de células B CD19+ en el tejido linfoide secundario, con niveles de activación de células CAR T del 27 al 64% en la dosis de 1E9. La compañía está avanzando ADI-001 en un estudio en
Adicet Bio (NASDAQ: ACET)는 ACR Convergence 2024에서 자체 조달 가능 gamma delta CAR T 세포 치료제인 ADI-001의 임상 바이오마커 데이터를 발표했습니다. 데이터는 조직 이주가 견고하고 완전한 CD19+ B 세포 고갈이 2차 림프 조직에서 이루어졌으며, 1E9 용량에서 CAR T 세포 활성화 수준이 27-64%에 이른다는 것을 보여주었습니다. 이 회사는 ADI-001을 여섯 가지 자가면역 질환에 대한 바구니 연구에 진전시키고 있으며, 여기에는 루푸스 신염, 전신 루푸스 에리테마토수스, 전신 경화증, 특발성 염증성 근육병증, 뻣뻣한 사람 증후군 및 ANCA 관련 혈관염이 포함됩니다.
Adicet Bio (NASDAQ: ACET) a présenté des données cliniques sur les biomarqueurs pour ADI-001, leur thérapie CAR T à cellules gamma delta prête à l'emploi, lors de l'ACR Convergence 2024. Les données ont montré une forte homing tissulaire et une déplétion complète des cellules B CD19+ dans le tissu lymphoïde secondaire, avec des niveaux d'activation des cellules CAR T de 27 à 64 % à la dose de 1E9. L'entreprise fait progresser ADI-001 dans une étude en basket comprenant six indications auto-immunes, dont la néphrite lupique, le lupus érythémateux systémique, la sclérose systémique, la myopathie inflammatoire idiopathique, le syndrome de l'homme rigide et la vascularite associée aux ANCA.
Adicet Bio (NASDAQ: ACET) präsentierte klinische Biomarkerdaten für ADI-001, ihre sofort einsatzbereite gamma delta CAR-T-Zelltherapie, auf der ACR Convergence 2024. Die Daten zeigten eine robuste Gewebe-Homing und eine vollständige CD19+ B-Zell-Depletion im sekundären lymphatischen Gewebe, mit Aktivierungsniveau von CAR-T-Zellen von 27-64% bei der Dosis von 1E9. Das Unternehmen entwickelt ADI-001 in einer Basket-Studie mit sechs autoimmunen Indikationen, darunter Lupusnephritis, systemischer Lupus erythematodes, systemische Sklerose, idiopathische entzündliche Myopathie, die Steife-Person-Syndrom und ANCA-assoziierte Vaskulitis.
- ADI-001 demonstrated significant CAR T cell activation levels of 27-64% in lymph node biopsies, exceeding previously reported levels for autologous therapies
- Complete depletion of CD19+ B cells achieved in analyzed lymph node tissue
- Received IND clearances to pursue multiple autoimmune indications
- None.
Insights
The clinical biomarker data for ADI-001 reveals significant therapeutic potential in autoimmune diseases. The key findings show CAR T cell activation levels of 27-64% in lymph node biopsies at the 1E9 dose - notably higher than previous autologous alpha-beta CAR T therapies. The complete depletion of CD19+ B cells in lymphoid tissue is particularly promising, as current anti-CD20 antibody treatments fail to achieve this.
This data is especially meaningful for treating autoimmune conditions because it demonstrates both robust tissue penetration and complete B cell depletion in target areas. The basket trial approach across six different autoimmune indications suggests broad therapeutic potential. However, investors should note that while biomarker data is encouraging, efficacy and safety data from the broader trials will be important for market success.
-Data demonstrate characteristics essential for treatment of autoimmune diseases, including robust tissue homing and complete CD19+ B cell depletion in secondary lymphoid tissue
-Results highlight the potential benefits unique to gamma delta 1 CAR T cell therapy and ADI-001's potential as a best-in-class off-the-shelf cell therapy for autoimmune diseases
-The company is pursuing ADI-001 in a basket study across six indications including lupus nephritis (LN), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS) and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV)
“We believe the key to advancing care for autoimmune patients is to develop a therapeutic candidate that demonstrates robust tissue homing, complete CD19+ B cell depletion in tissue, and superior drug exposure in secondary lymphoid tissue with a positive safety profile. We are proud to share data and analyses, including clinical biomarker data, at ACR that support the potential of ADI-001 in autoimmune diseases,” said Francesco Galimi, M.D., Ph.D., Chief Medical Officer. “After activating clinical trial sites for LN and receiving investigational new drug application (IND) clearances to pursue additional autoimmune indications, we are committed to advancing ADI-001 in a basket study across six autoimmune indications. This strategy highlights our focus on addressing the significant unmet medical needs of patients who urgently require innovative and effective new treatment options.”
A summary of the results is reported below:
-
ADI-001 demonstrated significant levels of CAR T cell activation and tissue exposure in lymph node biopsies in the GLEAN trial, representing a range of 27
-64% of total cellular material detected by ddPCR in evaluable biopsies at the 1E9 dose, and exceeding levels previously reported for patients who received autologous alpha-beta CAR T therapies. CAR T cells detected in tissues also demonstrated a robust activation profile, based on in situ levels of granzyme B.- Recently published studies have demonstrated depletion of CD19+ plasmablasts, memory B cells and naïve B cells in peripheral blood using anti-CD20 targeted antibodies, however, these CD20-targeted antibody modalities failed to fully deplete B cells within secondary lymphoid tissue.
- Concurrent with ADI-001 tissue trafficking and activation, complete depletion of CD19+ B cells within analyzed lymph node tissue was also observed. These results support ADI-001’s potential for achieving complete B-cell depletion in peripheral blood and within tissues.
Details of the oral presentation
Title: ADI-001: An Allogeneic CD20-targeted γδ CAR T Cell Therapy with Potential for Improved Tissue Homing in Autoimmune Indications
Session Name: Abstracts: Miscellaneous Rheumatic & Inflammatory Diseases II
Abstract Number: 1866169
Presenting Author: Monica Moreno, Ph.D.
Date and Time: November 19, 2024; 12:00 p.m. – 12:15 p.m. ET
About ADI-001 in Autoimmune Diseases
ADI-001 is an investigational allogeneic gamma delta CAR T cell therapy targeting B-cells via an anti-CD20 CAR. ADI-001 was granted Fast Track Designation by the FDA for the potential treatment of relapsed/refractory class III or class IV lupus nephritis (LN). Adicet is exploring the potential of ADI-001 in a basket study across six indications including lupus nephritis (LN), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS) and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV).
For more information about becoming a study site, please email clinicaltrials@adicetbio.com or visit https://www.adicetbio.com/hcp/autoimmune/.
About the Phase 1 Clinical Trial
The Phase 1 study has four separate arms, enrolling LN and SLE patients into one arm, SSc patients into a second arm, IIM and SPS patients in a third arm and AAV patients into a fourth arm. Enrolled patients will receive a single dose of ADI-001. The dose-limiting toxicity window is 28 days with response and safety assessments conducted on Day 28 and during the follow-up period on months 3, 6, 9, 12, 18 and 24. The primary objectives of the study are to evaluate the safety and tolerability of ADI-001. Secondary objectives include measuring cellular kinetics, pharmacodynamics, changes in autoantibody titers, and appropriate disease activity scores in each indication.
About Adicet Bio, Inc.
Adicet 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 “off-the-shelf” 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.
Forward-Looking Statements
This 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 “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” 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 potential safety, tolerability and efficacy of ADI- 001 in multiple autoimmune indications; the potential for ADI-001 to be best-in-class allogenic cell therapy for autoimmune diseases; and the clinical development of ADI-001 in LN, SLE, SSc, IIM, SPS and AAV.
Any forward-looking statements in this press release are based on management’s 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’s 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’s 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’s product candidates, which would prevent, delay, or limit the scope of regulatory approval and commercialization; and regulatory approval processes of the
View source version on businesswire.com: https://www.businesswire.com/news/home/20241116291819/en/
Adicet Bio, Inc.
Investor and Media Contacts
Investors:
Anne Bowdidge
abowdidge@adicetbio.com
Janhavi Mohite
Precision AQ
212-362-1200
janhavi.mohite@precisionaq.com
Media:
Kerry Beth Daly
kbdaly@adicetbio.com
Source: Adicet Bio, Inc.
FAQ
What were the key findings of Adicet Bio's ADI-001 clinical biomarker data presented at ACR 2024?
Which autoimmune indications is Adicet Bio (ACET) targeting with ADI-001?
How does ADI-001's B cell depletion compare to anti-CD20 targeted antibodies?
