Allogene Granted Three U.S. FDA Fast Track Designations (FTD) for ALLO-329, a Next-Generation Dual-Targeted CD19/CD70 Allogeneic CAR T, for the Treatment of Lupus, Myositis and Scleroderma
Allogene Therapeutics (ALLO) has received three FDA Fast Track Designations for ALLO-329, a next-generation dual-targeted CD19/CD70 allogeneic CAR T therapy. The designations cover treatments for systemic lupus erythematous (SLE), idiopathic inflammatory myopathy (IIM), and diffuse systemic sclerosis (SSc).
The company plans to initiate the Phase 1 RESOLUTION basket trial in mid-2025, with initial proof-of-concept expected by year-end 2025. The trial will evaluate ALLO-329's safety and preliminary efficacy using the proprietary Dagger® technology, which aims to reduce or eliminate lymphodepletion requirements. The study includes two lymphodepletion arms: one using cyclophosphamide alone and another without lymphodepletion.
Allogene Therapeutics (ALLO) ha ricevuto tre designazioni Fast Track dalla FDA per ALLO-329, una terapia CAR T allogenica di nuova generazione a doppio bersaglio CD19/CD70. Le designazioni riguardano i trattamenti per lupus eritematoso sistemico (LES), miopatia infiammatoria idiopatica (IIM) e sclerosi sistemica diffusa (SSc).
L'azienda prevede di avviare il trial RESOLUTION di Fase 1 a metà del 2025, con una prova di concetto iniziale attesa entro la fine del 2025. Lo studio valuterà la sicurezza e l'efficacia preliminare di ALLO-329 utilizzando la tecnologia proprietaria Dagger®, che mira a ridurre o eliminare i requisiti di linfodeplezione. Il trial include due bracci di linfodeplezione: uno che utilizza solo ciclofosfamide e l'altro senza linfodeplezione.
Allogene Therapeutics (ALLO) ha recibido tres designaciones de Fast Track de la FDA para ALLO-329, una terapia CAR T alogénica de nueva generación dirigida a dos objetivos CD19/CD70. Las designaciones abarcan tratamientos para lupus eritematoso sistémico (LES), miopatía inflamatoria idiopática (IIM) y esclerosis sistémica difusa (SSc).
La compañía planea iniciar el ensayo clínico RESOLUTION de Fase 1 a mediados de 2025, con una prueba de concepto inicial prevista para finales de 2025. El ensayo evaluará la seguridad y la eficacia preliminar de ALLO-329 utilizando la tecnología patentada Dagger®, que busca reducir o eliminar los requisitos de linfodepleción. El estudio incluye dos brazos de linfodepleción: uno que utiliza solo ciclofosfamida y otro sin linfodepleción.
Allogene Therapeutics (ALLO)는 ALLO-329에 대해 FDA의 패스트 트랙 지정을 세 번 받았습니다. ALLO-329는 차세대 이중 표적 CD19/CD70 알로겐 CAR T 치료제입니다. 이 지명은 전신 홍반 루푸스 (SLE), 특발성 염증성 근육병 (IIM), 확산성 전신 경화증 (SSc) 치료를 포함합니다.
회사는 2025년 중반에 1상 RESOLUTION 바구니 시험을 시작할 계획이며, 초기 개념 증명은 2025년 연말까지 예상됩니다. 이 시험은 ALLO-329의 안전성과 초기 효능을 평가하며, 림프 탈락 요구 사항을 줄이거나 없애는 것을 목표로 하는 독점 기술인 Dagger®를 사용합니다. 연구에는 두 개의 림프 탈락 팔이 포함됩니다: 하나는 사이클로포스파미드만 사용하고, 다른 하나는 림프 탈락 없이 진행됩니다.
Allogene Therapeutics (ALLO) a reçu trois désignations Fast Track de la FDA pour ALLO-329, une thérapie CAR T allogénique de nouvelle génération ciblant deux cibles, CD19/CD70. Les désignations concernent les traitements pour lupus érythémateux systémique (LES), myopathie inflammatoire idiopathique (IIM) et sclérose systémique diffuse (SSc).
L'entreprise prévoit de commencer l'essai RESOLUTION de Phase 1 à la mi-2025, avec une première preuve de concept attendue d'ici la fin de 2025. L'essai évaluera la sécurité et l'efficacité préliminaire d'ALLO-329 en utilisant la technologie propriétaire Dagger®, qui vise à réduire ou éliminer les exigences de lymphodéplétion. L'étude comprend deux bras de lymphodéplétion : l'un utilisant uniquement la cyclophosphamide et l'autre sans lymphodéplétion.
Allogene Therapeutics (ALLO) hat drei FDA Fast-Track-Bezeichnungen für ALLO-329 erhalten, eine neuartige dual-targeted CD19/CD70 allogene CAR T-Therapie. Die Bezeichnungen betreffen Behandlungen für systemischen Lupus erythematodes (SLE), idiopathische entzündliche Myopathie (IIM) und diffuse systemische Sklerose (SSc).
Das Unternehmen plant, die Phase-1-RESOLUTION-Studie Mitte 2025 zu starten, mit einem ersten Nachweis des Konzepts, der bis Ende 2025 erwartet wird. Die Studie wird die Sicherheit und die vorläufige Wirksamkeit von ALLO-329 unter Verwendung der proprietären Dagger®-Technologie bewerten, die darauf abzielt, die Anforderungen an die Lymphodepletion zu reduzieren oder zu eliminieren. Die Studie umfasst zwei Lymphodepletion-Arme: einen, der nur Cyclophosphamid verwendet, und einen anderen ohne Lymphodepletion.
- Received three FDA Fast Track Designations, potentially accelerating development and review
- Novel dual-targeted CD19/CD70 approach may enhance therapeutic benefit
- Proprietary Dagger® technology could eliminate need for lymphodepletion
- Rapid timeline to proof-of-concept results (end of 2025)
- Phase 1 trial not starting until mid-2025
- No clinical efficacy data available yet
- Multiple competing treatment approaches in autoimmune diseases
Insights
Allogene's triple Fast Track Designation (FTD) for ALLO-329 represents a significant regulatory milestone that substantially accelerates their development pathway in autoimmune diseases. The FDA's decision provides tangible validation for Allogene's innovative approach of using allogeneic dual-targeted CD19/CD70 CAR T therapy beyond oncology applications.
What makes this particularly valuable is that FTD enables more frequent FDA interactions, rolling review of future submissions, and potential eligibility for Priority Review. This regulatory advantage could compress development timelines by months or even years across three substantial autoimmune markets with significant unmet needs.
The company's proprietary Dagger® technology addresses a critical barrier in autoimmune applications – the need for lymphodepletion, which is particularly problematic in already immunocompromised patients. By potentially eliminating this requirement, ALLO-329 could dramatically improve the risk-benefit profile and expand patient eligibility.
The basket trial design is strategically sound, allowing simultaneous investigation across multiple autoimmune conditions with shared pathophysiology. This approach, combined with the "off-the-shelf" nature of allogeneic therapy, positions Allogene to potentially overcome the manufacturing, logistical, and cost challenges that have CAR T adoption beyond specialized cancer centers.
The mid-2025 trial initiation with proof-of-concept data expected by year-end demonstrates an aggressive but achievable development timeline that could position Allogene as a frontrunner in expanding cell therapy into autoimmune diseases.
The three Fast Track Designations for ALLO-329 mark a pivotal advancement in applying CAR T technology to autoimmune diseases. The dual-targeting mechanism against both CD19 (targeting B cells) and CD70 (targeting plasma cells and pathogenic T cells) represents a sophisticated immunological approach that could provide more comprehensive immune modulation than current therapies.
The targeted conditions – lupus, myositis, and scleroderma – are devastating autoimmune diseases with treatment options and significant morbidity. Current treatments often involve broad immunosuppression with serious side effects and variable efficacy. A targeted cell therapy approach could fundamentally change treatment paradigms.
Most revolutionary is the potential elimination of lymphodepletion preconditioning. Traditional CAR T therapy requires aggressive lymphodepletion that poses substantial risks, especially in autoimmune patients who may already have compromised immune systems from years of immunosuppressive treatments. ALLO-329's Dagger® technology, if successful in preventing rejection without lymphodepletion, would dramatically improve safety profiles and potentially enable outpatient administration.
The inclusion of two distinct lymphodepletion approaches in the RESOLUTION trial design (reduced conditioning with cyclophosphamide alone versus complete elimination) shows scientific rigor and provides multiple paths to success. This is particularly meaningful for rheumatologists who are familiar with cyclophosphamide but may be hesitant about more intensive lymphodepleting regimens used in oncology.
While early-stage, this therapy represents a potential paradigm shift in how we approach autoimmune diseases that have remained challenging to treat effectively despite decades of research.
- Designations Follow Recent Investigational New Drug (IND) Application Clearance for the RESOLUTION Basket Study of ALLO-329 in Rheumatology
- Dual CD19/CD70 CAR T Specifically Designed to Enhance Therapeutic Benefit, Expanding Treatment Potential Across a Range of Autoimmune Indications
- Leverages Proprietary Dagger® Technology to Reduce or Eliminate Lymphodepletion, Potentially Expanding Access to a Broader Patient Population
- Phase 1 RESOLUTION Trial Initiation Planned for Mid-2025 with Initial Proof-of-Concept by Year-End 2025
SOUTH SAN FRANCISCO, Calif., April 07, 2025 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced that ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic CAR T, has received three Fast Track Designations (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with:
- active refractory moderate-to-severe systemic lupus erythematous (SLE);
- active severe/refractory idiopathic inflammatory myopathy (IIM), specifically dermatomyositis, immune mediated necrotizing myopathy and anti-synthetase syndrome; and
- active refractory diffuse systemic sclerosis (SSc).
"Receiving these designations for ALLO-329 underscores the versatility and transformative promise of this next-generation allogeneic CAR T investigational product in redefining the autoimmune treatment landscape," said Zachary Roberts, M.D., Ph.D., EVP of Research and Development and Chief Medical Officer of Allogene. "Leveraging our extensive expertise, we've developed this off-the-shelf CAR T specifically for autoimmune diseases, prioritizing both scalability and the reduction or elimination of lymphodepletion – a key barrier in this patient population."
The Company expects to initiate the Phase 1 RESOLUTION basket trial in mid-2025. The trial is designed to evaluate the safety and preliminary efficacy of ALLO-329 in patients with SLE, IIM, and SSc. This innovative trial design, which leverages the clinically validated Dagger® technology to drive CAR T cell expansion and prevent rejection, includes two distinct lymphodepletion arms: one using a dose of cyclophosphamide alone, which is used by rheumatologists, and another that eliminates lymphodepletion entirely. Proof-of-concept from the RESOLUTION trial is expected by year-end 2025, aiming to provide critical insights into the potential of ALLO-329 to transform the treatment landscape for autoimmune diseases.
FDA's Fast Track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening diseases and that demonstrate the potential to address unmet medical needs.
About ALLO-329
ALLO-329 is a CD19/CD70 dual AlloCAR T™ investigational product being developed for the treatment of autoimmune diseases. ALLO-329 utilizes CRISPR-based site-specific integration for dual CAR expression. This approach targets both CD19+ B cells and CD70+ T cells, which play a role in autoimmune disease pathogenesis. Additionally, ALLO-329 incorporates Allogene's clinically validated Dagger® technology, designed to reduce or eliminate the need for lymphodepletion, a pre-treatment regimen that may be a significant barrier to CAR T cell therapy adoption in autoimmune indications.
About Allogene Therapeutics
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow Allogene Therapeutics on X and LinkedIn.
Cautionary Note on Forward-Looking Statements for Allogene
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as “potential,” “designed to,” “planned,” “will,” “may,” “promise,” “aim,” “redefining,” “goal,” “expects,” “transform,” “target,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability for a dual-targeted CD19/CD70 allogeneic Car T to enhance therapeutic benefit and expand treatment across a range of autoimmune indications; the potential for ALLO-329 and our Dagger technology to drive CAR T cell expansion and prevent rejection and reduce or eliminate lymphodepletion, and expand access to a broader patient population; our ability to initiate our Phase 1 RESOLUTION rheumatology basket trial in mid-2025, and achieve proof-of-concept to demonstrate the Dagger™ effect on lymphodepletion by year-end 2025; the potential benefits of ALLO-329 and our Dagger technology; the potential for ALLO-329 to transform the treatment landscape for autoimmune diseases; the potential for ALLO-329 to treat patients with SLE, IIM, or SSc; and our ability to manufacture to meet the scale required to treat autoimmune disease. Various factors may cause material differences between Allogene’s expectations and actual results, including, risks and uncertainties related to: Fast Track designation may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval and the designation can be revoked if the criteria for eligibility ceases to be met; our product candidates are based on novel technologies, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval; the limited nature of our pre-clinical data and the extent to which such data may or may not be validated in any future clinical trial; our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval or limit their commercial potential; the extent to which the Food and Drug Administration disagrees with our clinical or regulatory plans or the import of our clinical results, which could cause future delays to our clinical trials, including initiation of clinical trials, or require additional clinical trials; we may encounter difficulties enrolling patients in our clinical trials; we may not be able to demonstrate the safety and efficacy of our product candidates in our clinical trials, which could prevent or delay regulatory approval and commercialization; and the challenges with manufacturing or optimizing manufacturing of our product candidates. These and other risks are discussed in greater detail in Allogene’s filings with the SEC, including without limitation under the “Risk Factors” heading in its Form 10-K filed for the year ended December 31, 2024. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
AlloCAR T™ and Dagger® are trademarks of Allogene Therapeutics, Inc.
ALLO-329 (CD19/CD70) in autoimmune disease uses CRISPR gene-editing technology.
Allogene Media/Investor Contact:
Christine Cassiano
EVP, Chief Corporate Affairs & Brand Strategy Officer
Christine.Cassiano@allogene.com
FAQ
When will Allogene (ALLO) start the Phase 1 RESOLUTION trial for ALLO-329?
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What is unique about ALLO-329's treatment approach?
When does Allogene (ALLO) expect proof-of-concept results for ALLO-329?
