Cell depletion in autoimmune disorders
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Allogene Therapeutics (NasdaqGS:ALLO) Conference Transcript
2025-11-12 22:30
Summary of Allogene Therapeutics Conference Call Company Overview - **Company**: Allogene Therapeutics (NasdaqGS:ALLO) - **Event**: Conference at TD Cowen's I&I Summit on November 12, 2025 Key Points on ALLO-329 and Autoimmune Research - **Product Introduction**: ALLO-329 is an allogeneic, off-the-shelf CAR T therapy currently in phase 1 clinical trials targeting autoimmune conditions [4][5] - **Differentiation**: ALLO-329 is designed to bypass lymphodepletion requirements, which is a common issue in CAR T therapies. This is expected to enhance safety and broaden its application in autoimmune disorders [5][6] - **Mechanism of Action**: ALLO-329 targets both CD19 and CD70, allowing it to address not only B cells but also T cells and antigen-presenting cells, which are crucial in the development of autoimmunity [6][7] - **Patient Population**: The phase 1 study focuses on patients with rheumatologic disorders, including lupus and lupus nephritis, inflammatory myositis, and scleroderma [10][11] - **Study Design**: The trial includes two cohorts: one with reduced lymphodepletion and another without any lymphodepletion, aiming to establish safety and early efficacy [12][20] Enrollment and Study Progress - **Enrollment Strategy**: The study is primarily enrolling patients at academic centers, with a focus on generating excitement around the unique mechanism of action and off-the-shelf availability of ALLO-329 [19][20] - **Initial Data Expectations**: Initial proof of concept data is anticipated in the first half of the following year, with a focus on biomarkers related to CAR T cell behavior and disease-related biomarkers [21][22] Dagger Technology and Lymphodepletion - **Confidence in Technology**: The ability to reduce or eliminate lymphodepletion is supported by preclinical data and clinical experience with CD70 targeting in other studies [13][14] - **Clinical Outcomes**: The goal is to reset the immune system without permanently depleting B or T cells, allowing for a more manageable immune response [16][17] ALPHA3 Trial and MRD Conversion - **Trial Overview**: The ALPHA3 trial aims to convert MRD-positive patients to MRD-negative status using cema-cel, with a focus on high-risk patients post-R-CHOP treatment [32][34] - **Expected Outcomes**: A MRD conversion rate of around 30% is considered a benchmark for continued pivotal development, with the control arm expected to show minimal spontaneous conversions [40][42] Conclusion - **Overall Sentiment**: There is significant optimism regarding the enrollment and initial data from both ALLO-329 and the ALPHA3 trial, with a strong focus on innovative treatment approaches in the autoimmune and oncology spaces [30][41]