Atara Biotherapeutics (ATRA) Stifel's 2024 Virtual Cell Therapy Forum summary

Strategic platform and product pipeline

• Focus on allogeneic T-cell therapies for oncology and autoimmune diseases, leveraging EBV T-cells from healthy donors.

• Only company with an approved allogeneic T-cell therapy (tab-cel/Ebvallo) in Europe; BLA filed with FDA in May, aiming for US approval and launch in early 2025.

• Lead CAR-T program ATA3219 in first-in-human study for NHL, with initial data expected by year-end; also advancing in lupus nephritis and SLE, with data in 2025.

• Second dual-target CAR-T (ATA3431, CD19/CD20) IND planned for second half of 2025, targeting lymphoma and potentially autoimmune diseases.

• Commercialization in Europe and US partnered with Pierre Fabre; launch preparations and site awareness well underway.

Differentiated technology and clinical approach

• Utilizes partial HLA matching to enhance cell persistence and reduce immune rejection, with over 600 patients treated using this approach.

• HLA matching enables treatment without lymphodepletion, simplifying administration and reducing patient risk.

• Logistics allow for rapid treatment: HLA typing, inventory matching, and shipment can be completed within 3 days for 90–95% of patients.

• ATA3219 preserves native EBV TCR, avoiding gene editing and reducing risk of GvHD, while maintaining high cell fitness and potency.

• Incorporates 1XX co-stimulatory domain and memory phenotype to further enhance persistence and efficacy.

Clinical development and study design

• NHL phase I study uses dose escalation (40M, 80M, 160M cells), enrolling both CD19-naive and previously treated patients; initial data to focus on PK/PD, expansion, persistence, and B-cell depletion.

• Lupus nephritis and SLE cohorts mirror academic protocols, with SLE cohort testing treatment without lymphodepletion.

• Efficacy benchmarks set by high-performing academic data; aim to match or exceed these with improved safety and accessibility.

• Dual-target CAR-T (CD19/CD20) designed to address antigen escape in lymphoma, with preclinical data showing superior potency to existing products.