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Adicet Bio Provides Corporate Update and Highlights Expected 2025 Milestones

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Adicet Bio (NASDAQ: ACET) provided updates on its clinical programs and 2025 milestones. The company is advancing a Phase 1 trial of ADI-001 across six autoimmune diseases, with preliminary data in lupus nephritis expected in 1H25 and other cohorts in 2H25. Patient enrollment for various conditions including systemic lupus erythematosus and systemic sclerosis is set to begin in Q1 2025.

The company has also dosed its first patient in the Phase 1 trial of ADI-270 for renal cell carcinoma, marking the first gamma delta CAR T cell therapy in clinical development for solid tumors. Preliminary data is expected in 1H25. Both ADI-001 and ADI-270 have received FDA Fast Track Designation for their respective indications.

Clinical biomarker data from the Phase 1 GLEAN trial demonstrated ADI-001's robust tissue trafficking and complete CD19+ B cell depletion in secondary lymphoid tissue, supporting its potential as an off-the-shelf treatment option.

Adicet Bio (NASDAQ: ACET) ha fornito aggiornamenti sui suoi programmi clinici e sugli obiettivi per il 2025. L'azienda sta portando avanti uno studio di Fase 1 di ADI-001 su sei malattie autoimmuni, con dati preliminari sulla nefrite lupica attesi nella prima metà del 2025 e altri gruppi nella seconda metà del 2025. L'arruolamento dei pazienti per varie condizioni, tra cui il lupus eritematoso sistemico e la sclerosi sistemica, inizierà nel primo trimestre del 2025.

L'azienda ha anche trattato il suo primo paziente nello studio di Fase 1 di ADI-270 per il carcinoma renale, segnando la prima terapia CAR T cell gamma delta in sviluppo clinico per tumori solidi. I dati preliminari sono attesi nella prima metà del 2025. Sia ADI-001 che ADI-270 hanno ricevuto la Designazione Fast Track dalla FDA per le rispettive indicazioni.

I dati clinici dei biomarcatori dallo studio di Fase 1 GLEAN hanno dimostrato il robusto traffico tissutale di ADI-001 e la completa deplezione delle cellule B CD19+ nel tessuto linfatico secondario, supportando il suo potenziale come opzione di trattamento pronta all'uso.

Adicet Bio (NASDAQ: ACET) proporcionó actualizaciones sobre sus programas clínicos y los hitos para 2025. La empresa está avanzando en un ensayo de Fase 1 de ADI-001 en seis enfermedades autoinmunes, con datos preliminares en nefritis lúpica esperados en la primera mitad de 2025 y otros grupos en la segunda mitad de 2025. La inscripción de pacientes para varias condiciones, incluyendo lupus eritematoso sistémico y esclerosis sistémica, comenzará en el primer trimestre de 2025.

La compañía también ha tratado a su primer paciente en el ensayo de Fase 1 de ADI-270 para carcinoma de células renales, marcando la primera terapia CAR T celular gamma delta en desarrollo clínico para tumores sólidos. Se esperan datos preliminares en la primera mitad de 2025. Tanto ADI-001 como ADI-270 han recibido la Designación Fast Track de la FDA para sus respectivas indicaciones.

Los datos clínicos de biomarcadores del ensayo GLEAN de Fase 1 demostraron el robusto tráfico tisular de ADI-001 y la completa depleción de células B CD19+ en el tejido linfoide secundario, respaldando su potencial como opción de tratamiento listo para usar.

Adicet Bio (NASDAQ: ACET)는 임상 프로그램 및 2025년 이정표에 대한 업데이트를 제공했습니다. 이 회사는 ADI-001의 1상 시험을 여섯 가지 자가면역 질환에서 진행 중이며, 루푸스 신염에 대한 초기 데이터는 2025년 상반기에 예상되며 다른 집단은 2025년 하반기에 있을 예정입니다. 전신 루푸스 홍반증 및 전신 경화증을 포함한 다양한 질환에 대한 환자 등록은 2025년 1분기에 시작될 예정입니다.

이 회사는 또한 신세포 암 치료를 위한 ADI-270의 1상 시험에서 첫 환자를 투여했으며, 이는 고형 종양에 대한 임상 개발에서 첫 번째 감마 델타 CAR T 세포 치료법을 의미합니다. 초기 데이터는 2025년 상반기에 예상됩니다. ADI-001과 ADI-270 모두 해당 적응증에 대해 FDA의 패스트 트랙 지정을 받았습니다.

1상 GLEAN 시험에서의 임상 바이오마커 데이터는 ADI-001의 Robust한 조직 이동 및 2차 림프 조직에서 CD19+ B 세포의 완전한 고갈을 보여 주며, 이는 이는 비상시 사용할 수 있는 치료 옵션으로서의 잠재력을 뒷받침합니다.

Adicet Bio (NASDAQ: ACET) a fourni des mises à jour sur ses programmes cliniques et ses objectifs pour 2025. L'entreprise avance dans un essai de Phase 1 de ADI-001 sur six maladies auto-immunes, avec des données préliminaires sur la néphrite lupique attendues dans la première moitié de 2025 et d'autres cohortes dans la seconde moitié de 2025. L'inscription des patients pour diverses conditions, y compris le lupus érythémateux systémique et la sclérose systémique, débutera au premier trimestre de 2025.

L'entreprise a également dosé son premier patient dans l'essai de Phase 1 de ADI-270 pour le carcinome à cellules rénales, marquant la première thérapie de cellules T CAR gamma delta en développement clinique pour les tumeurs solides. Des données préliminaires sont attendues dans la première moitié de 2025. Tant ADI-001 qu'ADI-270 ont reçu la désignation Fast Track de la FDA pour leurs indications respectives.

Les données cliniques des biomarqueurs de l'essai GLEAN de Phase 1 ont démontré le trafic tissulaire robuste d'ADI-001 et la déplétion complète des cellules B CD19+ dans le tissu lymphoïde secondaire, soutenant son potentiel en tant qu'option de traitement prête à l'emploi.

Adicet Bio (NASDAQ: ACET) hat Updates zu seinen klinischen Programmen und Zielen für 2025 bereitgestellt. Das Unternehmen führt eine Phase-1-Studie zu ADI-001 bei sechs Autoimmunerkrankungen durch, wobei erste Daten zur Lupusnephritis für die erste Hälfte von 2025 erwartet werden und andere Kohorten in der zweiten Hälfte 2025. Die Patientenrekrutierung für verschiedene Erkrankungen, einschließlich systemischem Lupus erythematodes und systemischer Sklerose, soll im ersten Quartal 2025 beginnen.

Das Unternehmen hat auch seinen ersten Patienten in der Phase-1-Studie zu ADI-270 bei Nierenzellkarzinom behandelt, was die erste gamma-delta CAR T-Zelltherapie in der klinischen Entwicklung für solide Tumoren markiert. Erste Daten werden für die erste Hälfte von 2025 erwartet. Sowohl ADI-001 als auch ADI-270 haben von der FDA die Fast Track Designation für ihre jeweiligen Indikationen erhalten.

Klinische Biomarker-Daten aus der Phase-1-Studie GLEAN zeigten die robuste Gewebedurchdringung von ADI-001 und die vollständige CD19+ B-Zell-Depletion im sekundären lymphatischen Gewebe und unterstützen sein Potenzial als sofort verfügbare Behandlungsoption.

Positive
  • FDA Fast Track Designation granted for both ADI-001 and ADI-270
  • Successful expansion of ADI-001 Phase 1 trial to six autoimmune indications
  • First-in-class gamma delta CAR T cell therapy (ADI-270) entering clinical development for solid tumors
  • Clinical biomarker data showed complete CD19+ B cell depletion and robust tissue trafficking
Negative
  • None.

Insights

The pipeline update reveals significant clinical developments for Adicet Bio's gamma delta T cell therapies. The expansion of ADI-001's Phase 1 trial across six autoimmune indications demonstrates aggressive portfolio advancement. The FDA Fast Track designations for both ADI-001 in lupus nephritis and ADI-270 in renal cell carcinoma indicate regulatory recognition of unmet medical needs.

Key near-term catalysts include preliminary data readouts in 1H 2025 for both ADI-001 in lupus nephritis and ADI-270 in ccRCC. The biomarker data showing complete CD19+ B cell depletion and robust tissue trafficking suggests promising mechanism validation. The expansion into multiple autoimmune indications (SLE, SSc, IIM, SPS, AAV) creates multiple shots on goal and risk diversification.

Adicet's gamma delta T cell platform represents a novel approach in both autoimmune diseases and solid tumors. ADI-270's position as the first gamma delta CAR T therapy in solid tumors is particularly noteworthy, as solid tumors have historically been challenging for cell therapies. The preclinical data showing tumor infiltration and resistance to immunosuppressive environments addresses key historical limitations.

The company's dual focus on autoimmune diseases and oncology provides strategic diversification. The allogeneic (off-the-shelf) nature of their therapies offers potential manufacturing and accessibility advantages over autologous approaches. The upcoming data readouts in 2025 could validate this platform technology and potentially unlock significant value.

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, 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 provided corporate updates and highlighted upcoming milestones for 2025.

“2024 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,” said Chen Schor, President and Chief Executive Officer at Adicet Bio. “Within 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’s robust tissue trafficking and complete CD19+ B cell depletion in secondary lymphoid tissue, further reinforces ADI-001’s potential as an off-the-shelf treatment option.

Mr. Schor continued: “In 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.”

Clinical Program Progress and Upcoming Milestones:

Autoimmune Diseases Clinical Programs

  • In 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.
  • In 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.
  • In 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.
  • In 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.
  • Preliminary clinical data from the Phase 1 trial of ADI-001’s LN patient cohort are anticipated in the first half of 2025. Preliminary data from the Phase 1 trial’s other patient cohorts are expected in the second half of 2025.

Hematologic Malignancies and Solid Tumor Clinical Programs

  • In 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.
  • In 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.
  • In 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.
  • Preliminary clinical data from the ADI-270 Phase 1 trial in ccRCC are expected in the first half of 2025.

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: clinical development of Adicet’s 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’s potential to be an off-the-shelf treatment option for autoimmune indications; ADI-270’s 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’s uses of capital, expenses and financial results, including the expected cash runway.

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 U.S. Food and Drug Administration and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; and Adicet’s 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’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in Adicet’s 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’s 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.

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

When will Adicet Bio (ACET) release preliminary data for ADI-001 in lupus nephritis?

Adicet Bio expects to release preliminary clinical data from the Phase 1 trial of ADI-001 in lupus nephritis patients in the first half of 2025.

What autoimmune conditions will ACET's ADI-001 trial include in Q1 2025?

In Q1 2025, Adicet will initiate patient enrollment for systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), and stiff person syndrome (SPS).

When did Adicet Bio (ACET) receive FDA Fast Track Designation for ADI-270?

Adicet Bio received FDA Fast Track Designation for ADI-270 in July 2024 for the treatment of patients with metastatic/advanced clear cell renal cell carcinoma.

What makes ACET's ADI-270 therapy significant in solid tumor treatment?

ADI-270 is significant as it represents the first gamma delta CAR T cell therapy to enter clinical development for solid tumors, specifically for clear cell renal cell carcinoma.

Adicet Bio, Inc.

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