Adicet Bio Announces FDA Clearance of IND Amendment to Evaluate ADI-001 in Idiopathic Inflammatory Myopathy and Stiff Person Syndrome | ACET Stock News

Oct 17, 2024

Adicet Bio (Nasdaq: ACET) announced FDA clearance of an IND amendment to evaluate ADI-001 in idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS) as part of its ongoing Phase 1 trial in autoimmune diseases. This expands ADI-001's clinical development program to six autoimmune diseases. Patient enrollment for the IIM and SPS cohort is expected to begin in Q1 2025.

The company plans to report initial clinical data from the Phase 1 study in multiple autoimmune diseases in H1 2025. The ADI-001 Phase 1 program will have four separate arms, enrolling patients with various autoimmune conditions. Enrolled patients will receive a single dose of ADI-001, with primary objectives to evaluate safety and tolerability.

Adicet Bio (Nasdaq: ACET) ha annunciato l'approvazione da parte della FDA di un'emendamento IND per valutare l'ADI-001 in miopatia infiammatoria idiopatica (IIM) e sindrome della persona rigida (SPS) come parte del suo ongoing studio di Fase 1 su malattie autoimmuni. Questo amplia il programma di sviluppo clinico dell'ADI-001 a sei malattie autoimmuni. L'arruolamento dei pazienti per il gruppo IIM e SPS è previsto per Q1 2025.

La società pianifica di riportare dati clinici iniziali dallo studio di Fase 1 in diverse malattie autoimmuni nel H1 2025. Il programma di Fase 1 dell'ADI-001 avrà quattro braccia separate, arruolando pazienti con varie condizioni autoimmuni. I pazienti arruolati riceveranno una singola dose di ADI-001, con obiettivi primari per valutare sicurezza e tollerabilità.

Adicet Bio (Nasdaq: ACET) anunció la aprobación de la FDA de una enmienda IND para evaluar el ADI-001 en miopatía inflamatoria idiopática (IIM) y sindrome de la persona rígida (SPS) como parte de su ensayo clínico en curso de Fase 1 en enfermedades autoinmunes. Esto amplía el programa de desarrollo clínico del ADI-001 a seis enfermedades autoinmunes. Se espera que el reclutamiento de pacientes para el grupo de IIM y SPS comience en Q1 2025.

La empresa planea reportar datos clínicos iniciales del estudio de Fase 1 en múltiples enfermedades autoinmunes en H1 2025. El programa de Fase 1 del ADI-001 tendrá cuatro brazos separados, reclutando pacientes con diversas condiciones autoinmunes. Los pacientes reclutados recibirán una dosis única de ADI-001, con los objetivos principales de evaluar la seguridad y tolerabilidad.

Adicet Bio(Nasdaq: ACET)는 자가면역 질환에 대한 진행 중인 1상 시험의 일환으로 특발성 염증성 근육병(IIM) 및 강직성 인물 증후군(SPS)에서 ADI-001을 평가하는 IND 수정에 대한 FDA 승인을 발표했습니다. 이를 통해 ADI-001의 임상 개발 프로그램이 여섯 가지 자가면역 질환으로 확대됩니다. IIM 및 SPS 집단의 환자 등록은 2025년 1분기에 시작될 것으로 예상됩니다.

회사는 H1 2025에 여러 자가면역 질환에 대한 1상 연구의 초기 임상 데이터를 보고할 계획입니다. ADI-001의 1상 프로그램은 네 개의 분리된 팔로 구성되어 다양한 자가면역 상태를 가진 환자를 등록할 예정입니다. 등록된 환자들은 ADI-001의 단일 투여량을 받게 되며, 주요 목표는 안전성과 내약성을 평가하는 것입니다.

Adicet Bio (Nasdaq: ACET) a annoncé l'approbation par la FDA d'un amendement IND pour évaluer l'ADI-001 dans la myopathie inflammatoire idiopathique (IIM) et le syndrome de la personne rigide (SPS) dans le cadre de son essai clinique de Phase 1 sur les maladies auto-immunes. Cela élargit le programme de développement clinique de l'ADI-001 à six maladies auto-immunes. L'inscription des patients pour le groupe IIM et SPS devrait commencer au Q1 2025.

L'entreprise prévoit de communiquer des données cliniques initiales de l'étude de Phase 1 sur plusieurs maladies auto-immunes au H1 2025. Le programme de Phase 1 de l'ADI-001 comprendra quatre bras séparés, recrutant des patients atteints de diverses conditions auto-immunes. Les patients recrutés recevront une dose unique d'ADI-001, avec pour principaux objectifs d'évaluer la sécurité et la tolérabilité.

Adicet Bio (Nasdaq: ACET) gab die Genehmigung einer IND-Änderung durch die FDA bekannt, um das ADI-001 bei idiopathischer entzündlicher Myopathie (IIM) und starrer Personensyndrom (SPS) im Rahmen seiner laufenden Phase-1-Studie zu Autoimmunerkrankungen zu bewerten. Dies erweitert das klinische Entwicklungsprogramm von ADI-001 auf sechs Autoimmunerkrankungen. Die Patientenrekrutierung für die IIM- und SPS-Gruppe wird voraussichtlich im Q1 2025 beginnen.

Das Unternehmen plant, erste klinische Daten aus der Phase-1-Studie zu mehreren Autoimmunerkrankungen im H1 2025 zu berichten. Das ADI-001-Phase-1-Programm wird vier separate Arme haben, in denen Patienten mit verschiedenen Autoimmunerkrankungen rekrutiert werden. Die rekrutierten Patienten erhalten eine einzelne Dosis von ADI-001, wobei die Hauptziele die Bewertung von Sicherheit und Verträglichkeit sind.

The FDA clearance for Adicet Bio's IND amendment to evaluate ADI-001 in idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS) is a significant development. This expansion to six autoimmune diseases demonstrates the potential versatility of ADI-001, a gamma delta T cell therapy. The planned initiation of patient enrollment in Q1 2025 and expected initial clinical data in H1 2025 provide clear timelines for investors to monitor.

Key points to consider:

This expansion into rare autoimmune diseases could position Adicet Bio favorably in a niche market with high unmet medical needs. However, investors should note that clinical trials are still in early stages and success is not guaranteed.

ADI-001 clinical development program now addresses six autoimmune diseases

Patient enrollment for idiopathic inflammatory myopathy and stiff person syndrome cohort expected to be initiated in the first quarter of 2025

Company plans to report initial clinical data from Phase 1 study in multiple autoimmune diseases in the first half of 2025

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 that the U.S. Food and Drug Administration (FDA) has agreed to an amendment to the Company’s Investigational New Drug (IND) application to evaluate ADI-001 in idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS) as part of the ongoing Phase 1 trial in autoimmune diseases. The Company plans to initiate enrollment for IIM and SPS patients in the first quarter of 2025. This announcement follows the FDA’s recent agreements on amendments to the Company’s ADI-001 IND application to evaluate three additional indications beyond lupus nephritis (LN), including systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV).

“The FDA’s acceptance of our IND amendment to evaluate ADI-001 in patients with IIM and SPS builds on our recent momentum in autoimmune diseases, expanding our efforts to six autoimmune indications as we aim to bring our differentiated gamma delta T cell therapy candidates to more patients in need of new treatment options,” said Chen Schor, President and Chief Executive Officer at Adicet Bio. “Following our recent announcement highlighting clinical biomarker data which demonstrated robust B-cell depletion and preferential trafficking to tissues and organs, we believe in ADI-001’s best-in-class potential for the treatment of autoimmune diseases, and we look forward to initiating patient enrollment in IIM and SPS in the first quarter of 2025 in our ongoing Phase 1 clinical program.”

The ADI-001 Phase 1 program in autoimmune diseases will have four separate arms, enrolling LN and SLE patients into one arm, SSc patients into a second arm, AAV patients into a third arm, and IIM and SPS patients into a fourth arm. The fourth cohort combines several rare autoimmune muscle diseases into a single dose-finding population, including SPS and the following IIM subtypes: dermatomyositis, anti-synthetase syndrome, immune-mediated necrotizing myopathy, polymyositis, and overlap myositis. 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 Idiopathic Inflammatory Myopathy

Idiopathic inflammatory myopathy (IIM, or myositis) refers to a group of rare autoimmune disorders characterized by chronic muscle inflammation and progressive muscle weakness. IIM primarily affects skeletal muscles but can also involve other organs such as the lungs, heart, and skin. Five of the main subtypes include dermatomyositis, anti-synthetase syndrome, immune-mediated necrotizing myopathy, polymyositis, and overlap myositis, all of which can lead to significant functional impairment and have the potential to be life threatening. There is no available cure for IIM and many patients on current treatments have refractory disease and may experience significant side effects.

About Stiff Person Syndrome

Stiff person syndrome (SPS) is a rare neurological autoimmune disorder characterized by severe muscle stiffness and spasms, primarily affecting the torso and limbs. Muscle stiffness caused by SPS often impairs mobility, making it difficult for patients to walk, bend, or perform daily activities. Muscle spasms can be triggered by sudden stimuli such as loud noises, physical contact, or emotional distress, and can result in a "statue-like" posture when severe. Due to its rarity and overlapping symptoms with other conditions, SPS is frequently misdiagnosed, often as an anxiety disorder or movement disorder. There is currently no available cure for SPS.

About ADI-001

ADI-001 is an investigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy targeting CD20 for the treatment of autoimmune diseases. ADI-001 was granted Fast Track Designation by the FDA for the treatment of relapsed/refractory class III or class IV lupus nephritis (LN), and the ongoing Phase 1 study is also evaluating ADI-001 for the treatment of systemic lupus erythematosus (SLE), systemic sclerosis (SSc), anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myopathy (IIM, or myositis), and stiff person syndrome (SPS). 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 peripheral blood and secondary lymphoid tissue.

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 the potential safety, tolerability and efficacy of ADI-001 for the treatment of autoimmune diseases; the potential for ADI-001 to be a best-in-class treatment for autoimmune diseases; the clinical development of ADI-001 in LN, SLE, SSc and AAV; and the expected progress, timing and success of the Phase 1 clinical study of ADI-001 in IIM and SPS, including timing and expectations for enrollment and future data releases.

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 entitled “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.

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Adicet Bio, Inc.Investor and Media Contacts

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Source: Adicet Bio, Inc.