Allogene Therapeutics, Inc.

What the company does

• Clinical-stage biopharmaceutical company developing off-the-shelf, genetically engineered allogeneic CAR T cell therapies for cancer and autoimmune diseases.
• Allogeneic T cells are derived from healthy donors and engineered to minimize graft-versus-host disease (GvHD) and to enable broader patient access.
• Four pillars of the approach:
  1. Minimize GvHD by gene editing
  2. Create a window of persistence for CAR T cells
  3. Build a leading manufacturing platform
  4. Use next-generation technologies to improve CAR T function
• Uses TALEN gene editing from Cellectis for oncology programs and CRISPR-based editing from Arbor Biotechnologies for an autoimmune program. Also employs Dagger® technology to improve persistence and reduce lymphodepletion needs in some programs.
• In-house manufacturing at Cell Forge 1 (CF1) in Newark, California, with additional manufacturing through CDMOs as needed.

Core product candidates and development programs

• Cemacabtagene ansegedleucel (cema-cel; formerly ALLO-501A)
  • Lead oncology/autoimmune product targeting CD19.
  • Being developed as a consolidation therapy for large B-cell lymphoma (LBCL); the ALPHA3 trial is evaluating cema-cel as a first-line consolidation in MRD-positive LBCL patients after first-line treatment.
  • ALPHA3 design changed after discontinuation of an ALLO-647–containing FCA lymphodepletion arm; the trial now proceeds with an FC arm versus observation, with an interim futility analysis planned for April 2026. Enrollment is expected to complete by the end of 2027.
• ALLO-316
  • Allogeneic CAR T targeting CD70 for renal cell carcinoma (ccRCC) and other cancers; incorporates Dagger technology to limit alloreactive rejection.
  • TRAVERSE Phase 1 trial in adults with advanced/metastatic RCC; Phase 1b expansion cohort showed activity in CD70-high tumors. RMAT designation received (Oct 2024).
  • The company is discussing partnering opportunities to advance the program.
• ALLO-329
  • Allogeneic CAR T targeting CD19 and CD70 for autoimmune diseases; designed to deplete CD19+ B cells and CD70+ activated T cells.
  • RESOLUTION Phase 1 trial in systemic lupus erythematosus (SLE), lupus nephritis, idiopathic inflammatory myopathies (IIM), and systemic sclerosis (SSc); includes two lymphodepletion pathways (cyclophosphamide-only vs. no lymphodepletion).
  • FDA Fast Track Designations received (April 2025) for SLE, IIM, and SSc; initial proof-of-concept data expected June 2026.

Pipeline breadth and strategic focus

• Prioritizing cema-cel (LBCL), ALLO-316 (CD70), and ALLO-329 (CD19/CD70) while pursuing partnerships for additional programs as appropriate.
• Additional targets and opportunities may be advanced through licensing, partnerships, or acquisitions.

Manufacturing, facilities, and supply

• CF1 is a dedicated, in-house GMP manufacturing facility in Newark, CA used for clinical product candidates.
• The company uses CDMOs for certain raw materials (for example, viral vectors) and may employ external manufacturers for specific steps.
• Manufacturing strategy focuses on a scalable, integrated process to produce multiple doses per run; the company has stated potential to manufacture approximately 100 doses or more per run at scale for donor-derived allogeneic CAR T cells.

Strategic collaborations and relationships

• Servier Agreement: exclusive license and collaboration to develop and commercialize cema-cel and related programs; the relationship has undergone restructurings and arbitration outcomes related to CD19 programs.
• Cellectis: exclusive worldwide rights to TALEN gene-editing for multiple targets (BCMA, CD70, DLL3, Claudin 18.2) for allogeneic programs; exclusive U.S./EU/UK rights to cema-cel-related patents.
• Arbor Biotechnologies: exclusive worldwide license for CRISPR-based gene editing for autoimmune targets (including CD19 and CD70) for ALLO-329.
• Foresight Diagnostics (CLARITY MRD test): non-exclusive collaboration to identify MRD-positive LBCL patients for ALPHA3; Foresight was acquired by Natera in December 2025 and continues to operate as a standalone unit for ALPHA3 activities.
• Pfizer: past asset collaboration and license activities related to earlier CAR T assets that shaped the company’s rights to certain technologies.
• Notch Therapeutics (Roche): collaboration related to additional technology and targets.

Intellectual property

• Broad patent portfolio and licenses related to CAR T constructs, targets (CD19, CD70, BCMA, DLL3, Claudin 18.2, FLT3, etc.), and gene-editing methods (TALEN and CRISPR-based technologies).
• Multiple arrangements involve co-ownership or exclusive licenses with Servier, Cellectis, Pfizer, Arbor, and others, covering CAR constructs, targets, manufacturing, and methods of treatment.

Financial highlights (as of reported dates)

• Net loss: $190.9 million (2025).
• Accumulated deficit: $2.0 billion as of December 31, 2025.
• Cash and cash equivalents and investments: $258.3 million as of December 31, 2025.
• Patients treated in clinical studies: over 200 across six clinical studies historically referenced.
• Employees: 152 total employees as of March 2, 2026 (150 full-time). Workforce reductions occurred in 2024 (22% in January) and 2025 (28% in May); the May 2025 reduction in manufacturing-related headcount totaled 61 employees.
• Site activity: ALPHA3 trial has over 60 sites activated and actively screening MRD-positive LBCL patients.

Global footprint and regulatory posture

• Trials and programs span the United States, Canada, and planned EU engagement; ALPHA3 is designed to potentially support an EU regulatory strategy depending on outcomes and regulatory discussions.
• The CLARITY MRD test is being pursued as a companion diagnostic in support of cema-cel; regulatory considerations for companion diagnostics and MRD testing are ongoing, and the CLARITY acquisition by Natera may affect operational dynamics.

Operating status

• The company is advancing a portfolio of off-the-shelf allogeneic CAR T cell therapies, with cema-cel as the lead program in LBCL, ALLO-316 for RCC, and ALLO-329 for autoimmune diseases.
• Development and potential commercialization are supported by CF1 manufacturing, third-party manufacturers, and multiple strategic collaborations and licensing arrangements.
• The company maintains a cash position to fund ongoing activities and will pursue additional financing as needed to advance clinical programs and potential commercialization.