Allogene Therapeutics Secures U.S. FDA IND Clearance for ALLO-329, Advancing its Next-Generation Allogeneic CAR T into Autoimmune Diseases
Allogene Therapeutics (ALLO) has received FDA clearance for its Investigational New Drug (IND) application for ALLO-329, a dual-targeted CD19/CD70 allogeneic CAR T product designed for autoimmune diseases. The company plans to initiate the Phase 1 RESOLUTION basket trial in mid-2025, targeting systemic lupus erythematosus, lupus nephritis, idiopathic inflammatory myopathies, and systemic sclerosis.
The trial will utilize Allogene's proprietary Dagger® technology to enhance CAR T cell expansion and prevent rejection, featuring two lymphodepletion arms: one using cyclophosphamide alone and another without lymphodepletion. ALLO-329's dual-targeting design against CD19+ B-cells and CD70+ activated T-cells aims to address immune dysregulation in autoimmune diseases. The company's manufacturing capacity can potentially produce up to 60,000 doses annually.
Allogene Therapeutics (ALLO) ha ricevuto l'approvazione della FDA per la sua richiesta di Nuovo Farmaco Investigativo (IND) per ALLO-329, un prodotto CAR T allogenico a doppio targeting CD19/CD70 progettato per le malattie autoimmuni. L'azienda prevede di avviare il trial di Fase 1 RESOLUTION a metà del 2025, mirato al lupus eritematoso sistemico, alla nefriti lupica, alle miopatie infiammatorie idiopatiche e alla sclerosi sistemica.
Il trial utilizzerà la tecnologia proprietaria di Allogene, Dagger® technology, per migliorare l'espansione delle cellule CAR T e prevenire il rigetto, presentando due bracci di limfodeplezione: uno con solo ciclofosfamide e l'altro senza limfodeplezione. Il design a doppio targeting di ALLO-329 contro le cellule B CD19+ e le cellule T attivate CD70+ mira a affrontare la disregolazione immunitaria nelle malattie autoimmuni. La capacità produttiva dell'azienda può potenzialmente produrre fino a 60.000 dosi all'anno.
Allogene Therapeutics (ALLO) ha recibido la aprobación de la FDA para su solicitud de Nuevo Medicamento Investigacional (IND) para ALLO-329, un producto CAR T alogénico dirigido a los objetivos duales CD19/CD70 diseñado para enfermedades autoinmunes. La empresa planea iniciar el ensayo de Fase 1 RESOLUTION a mediados de 2025, con el objetivo de lupus eritematoso sistémico, nefritis lúpica, miopatías inflamatorias idiopáticas y esclerosis sistémica.
El ensayo utilizará la tecnología propietaria de Allogene, Dagger® technology, para mejorar la expansión de células CAR T y prevenir el rechazo, con dos brazos de linfodepleción: uno utilizando solo ciclofosfamida y otro sin linfodepleción. El diseño de doble objetivo de ALLO-329 contra células B CD19+ y células T activadas CD70+ tiene como objetivo abordar la disfunción inmunitaria en enfermedades autoinmunes. La capacidad de producción de la empresa puede potencialmente generar hasta 60,000 dosis anuales.
Allogene Therapeutics (ALLO)는 자가면역 질환을 위해 설계된 CD19/CD70 이중 표적 CAR T 제품인 ALLO-329의 신약 임상시험 (IND) 신청에 대해 FDA의 승인을 받았습니다. 이 회사는 2025년 중반에 RESOLUTION 1상 시험을 시작할 계획이며, 전신성 홍반 루푸스, 루푸스 신염, 특발성 염증성 근육병 및 전신성 경화증을 목표로 하고 있습니다.
이번 시험에서는 CAR T 세포의 확장과 거부 반응 방지를 강화하기 위해 Allogene의 독점 기술인 Dagger® technology를 사용할 예정이며, 림프용해 팔을 두 개 갖추고 있습니다: 하나는 사이클로포스파미드만 사용하고, 다른 하나는 림프용해 없이 진행됩니다. ALLO-329의 CD19+ B세포와 CD70+ 활성화된 T세포를 겨냥한 이중 표적 설계는 자가면역 질환에서 면역 조절의 비정상적 상태를 해결하는 것을 목표로 합니다. 이 회사의 생산 능력은 매년 최대 60,000개의 용량을 잠재적으로 생산할 수 있습니다.
Allogene Therapeutics (ALLO) a reçu l'autorisation de la FDA pour sa demande de médicament expérimental (IND) pour ALLO-329, un produit CAR T allogène à double ciblage CD19/CD70 conçu pour les maladies auto-immunes. L'entreprise prévoit de lancer l'essai de phase 1 RESOLUTION au milieu de 2025, visant le lupus érythémateux systémique, la néphrite lupique, les myopathies inflammatoires idiopathiques et la sclérose systémique.
L'essai utilisera la technologie propriétaire d'Allogene, Dagger® technology, pour améliorer l'expansion des cellules CAR T et prévenir le rejet, avec deux bras de lymphodéplétion : l'un utilisant uniquement de la cyclophosphamide et l'autre sans lymphodéplétion. La conception à double ciblage d'ALLO-329 contre les cellules B CD19+ et les cellules T activées CD70+ vise à traiter la dysrégulation immunitaire dans les maladies auto-immunes. La capacité de production de l'entreprise pourrait potentiellement produire jusqu'à 60 000 doses par an.
Allogene Therapeutics (ALLO) hat die Genehmigung der FDA für seinen Antrag auf ein Investigational New Drug (IND) für ALLO-329, ein dual-targeted CD19/CD70 allogenes CAR T-Produkt, das für Autoimmunerkrankungen entwickelt wurde, erhalten. Das Unternehmen plant, Mitte 2025 die Phase 1 RESOLUTION-Studie zu starten, die sich auf systemischen Lupus erythematodes, Lupusnephritis, idiopathische entzündliche Myopathien und systemische Sklerose konzentriert.
Die Studie wird die proprietäre Dagger® technology von Allogene nutzen, um die Expansion von CAR T-Zellen zu fördern und eine Abstoßung zu verhindern, mit zwei Lymphodepletion-Arm: einer mit Cyclophosphamid allein und einer ohne Lymphodepletion. Das duale Targeting-Design von ALLO-329 gegen CD19+-B-Zellen und CD70+-aktivierte T-Zellen zielt darauf ab, die Immunregulation bei Autoimmunerkrankungen zu adressieren. Die Produktionskapazität des Unternehmens könnte potenziell bis zu 60.000 Dosen jährlich herstellen.
- FDA clearance received for ALLO-329 IND application
- Innovative dual-targeting design addressing both B-cell and T-cell dysfunction
- Manufacturing capacity of up to 60,000 doses per year
- Proprietary Dagger® technology may reduce or eliminate need for lymphodepletion
- Phase 1 trial not starting until mid-2025
- Early-stage development with no efficacy data yet
Insights
The FDA IND clearance for ALLO-329 marks a pivotal strategic expansion beyond Allogene's traditional oncology focus into the vast autoimmune disease market, estimated at over
The RESOLUTION trial's basket design is strategically brilliant for three reasons: 1) It enables rapid proof-of-concept across multiple indications simultaneously, potentially accelerating the development timeline 2) It tests two lymphodepletion approaches, including a no-lymphodepletion arm that could revolutionize the treatment paradigm 3) It targets severe conditions with treatment options, positioning ALLO-329 for potential breakthrough designation.
The manufacturing capacity of 60,000 doses annually is a game-changing element often overlooked. This scale demonstrates Allogene's readiness to address the much larger autoimmune patient population compared to oncology, while the off-the-shelf nature of their allogeneic approach could provide significant cost advantages over autologous alternatives.
The mid-2025 trial initiation timeline, with proof-of-concept data expected by year-end 2025, suggests an aggressive but achievable development schedule. Success could position Allogene as a pioneer in allogeneic CAR T for autoimmune diseases, potentially capturing first-mover advantage in this untapped market.
The selection of systemic lupus erythematosus, lupus nephritis, idiopathic inflammatory myopathies and systemic sclerosis as initial targets is strategically sound. These conditions represent severe, often treatment-resistant diseases with significant unmet medical needs and clear biological rationale for CAR T intervention.
The innovative trial design with two lymphodepletion arms is particularly noteworthy. The potential elimination of lymphodepletion through Dagger® technology could fundamentally transform CAR T therapy administration, making it more accessible and reducing treatment-related complications. This approach could significantly improve the risk-benefit profile, particularly important in chronic autoimmune conditions where safety considerations differ from oncology applications.
The basket trial design enables efficient evaluation across multiple indications while gathering valuable safety data. Success in any of these indications could rapidly lead to expansion into related autoimmune conditions, creating a domino effect for broader adoption of allogeneic CAR T therapy in autoimmune diseases.
- Dual-Targeted CD19/CD70 Allogeneic CAR T: Best-in-Class Design to Enhance Therapeutic Benefit and Expand Treatment Potential Across a Range of Autoimmune Disease Indications
- Innovative Dagger® Technology: Empowers ALLO-329 to Overcome Rejection, Potentially Reducing or Eliminating Reliance on Traditional Lymphodepletion
- Phase 1 RESOLUTION Rheumatology Basket Trial: Initiation Planned for Mid-2025, Targeting Proof-of-Concept to Demonstrate Allogeneic Potential and the Dagger® Effect on Lymphodepletion by Year-End 2025
SOUTH SAN FRANCISCO, Calif., Jan. 28, 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 the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a rheumatology basket study of ALLO-329, an investigational allogeneic CAR T product.
The Phase 1 RESOLUTION basket trial will evaluate the safety and preliminary efficacy of ALLO-329 in patients with systemic lupus erythematosus, including lupus nephritis, idiopathic inflammatory myopathies, and systemic sclerosis. 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. The RESOLUTION trial is scheduled to begin in mid-2025, aiming to provide critical insights into the potential of ALLO-329 to transform the treatment landscape for autoimmune diseases.
“A year ago, we unveiled the concept of ALLO-329, an allogeneic CAR T product specifically designed to address the unique challenges faced by patients with autoimmune diseases. Today, with the FDA’s clearance of our IND, that vision has become a reality, achieved at an extraordinary pace thanks to Allogene’s unparalleled expertise in research, manufacturing, and clinical development,” said David Chang, M.D., Ph.D., President, CEO, and Co-Founder of Allogene. “Demonstrating the power of an allogeneic CAR T to reset the immune system, combined with the ability of our Dagger® technology to reduce or eliminate lymphodepletion, could represent a transformative step forward. Successful proof-of-concept in this basket study has the potential to not only validate our best-in-class approach but also paves the way for expanding into a broad range of autoimmune indications beyond rheumatology.”
ALLO-329 represents a next-generation approach to autoimmune therapy, featuring a dual-targeting design against CD19+ B-cells and CD70+ activated T-cells. This innovative strategy is designed to deliver superior therapeutic benefit by addressing both B-cell and T-cell dysfunction, which drive immune dysregulation in autoimmune diseases. The incorporation of Allogene’s proprietary Dagger® technology further empowers ALLO-329 to resist immune rejection, potentially reducing or eliminating the need for lymphodepletion before cell infusion. If successful, this CAR T advancement could significantly simplify treatment protocols, meet the potential scale required to treat autoimmune disease with the capacity to manufacture upwards of 60,000 doses per year, and expand access to transformative CAR T therapy across a wide range of autoimmune disease indications.
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 @AllogeneTx 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,” “could,” “designed to,” “planned,” “will,” “advance,” “aim,” “scheduled,” “goal,” “empower,” 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 overcome, or prevent, rejection and reduce or eliminate lymphodepletion; our ability to initiate our Phase 1 RESOLUTION rheumatology basket trial by 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 ability to target CD19+ B-cells and CD70+ activated T-cells to deliver superior therapeutic benefit; the ability for ALLO-329 to address both B-cell and T-cell dysfunction, drive immune dysregulation in autoimmune diseases, and simplify treatment protocols; the potential for ALLO-329 to transform the treatment landscape for autoimmune diseases; the potential for ALLO-329 to treat patients with systemic lupus erythematosus; the ability for an allogeneic CAR T to reset the immune system; the potential to expand into a broad range of autoimmune indications beyond rheumatology; 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: IND clearance 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 from our clinical trials 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-Q filed for the quarter ended September 30, 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) begin the Phase 1 RESOLUTION trial for ALLO-329?
What autoimmune conditions will ALLO-329 target in the RESOLUTION trial?
What is unique about ALLO-329's targeting mechanism?
What is the manufacturing capacity for ALLO-329?
How does ALLO's Dagger® technology benefit ALLO-329 treatment?
