BioTech IP Review

Patent Number: US 12,365,873 B2
Filing Date: January 28, 2022
Issue Date: July 22, 2025
Assignee: Allogene Therapeutics, Inc.
Filed With: USPTO (Jointly indicated in other sources as the patent grant for transducing CAR‑T cells)

---

What This Patent Covers

This patent protects improved methods for introducing therapeutic genes into immune cells, especially T cells used in adoptive cell therapy (e.g., CAR‑T cells). It is particularly relevant to Allogene’s allogeneic CAR‑T programs, where donor‑derived T cells are engineered off‑the‑shelf rather than individually for each patient. The key elements include:

• Transduction Methods: Optimized protocols for transducing immune cells (such as T cells) with vectors encoding exogenous genetic constructs (e.g., chimeric antigen receptors or other therapeutic gene products). These methods can improve transduction efficiency, enhancing the proportion of engineered cells that successfully express the therapeutic gene(s).
• Expression of CARs or Other Gene Products: The patent covers methods that ideally maximize the number and quality of immune cells expressing the intended therapeutic constructs, such as CARs directed against cancer antigens or dual‑target designs like CD19/CD70 in next‑generation products.
• Associated Cell Populations & Compositions: It also encompasses engineered cell populations and compositions of cells transduced using these methods, which are used in manufacturing AlloCAR T™ cell products such as cema‑cel and other pipeline candidates targeting cancer and autoimmune diseases.

Overall, this patent fortifies the manufacturing foundation for Allogene’s allogeneic cell therapies — protecting key steps in how donor T cells are genetically modified and expanded for patient dosing.

---

Why This Patent Is Important

1) Central to Allogene’s Commercial Strategy
Allogene’s value proposition lies in “off‑the‑shelf” allogeneic CAR‑T therapies that can be manufactured at scale and delivered more rapidly than autologous products. Reinforced IP on immune cell transduction is foundational to that capability and helps secure regulatory and competitive positioning.

2) Enables Multiple Product Candidates
This transduction tech isn’t limited to a single product — it underlies multiple Allogene investigational therapies (e.g., cema‑cel for large B‑cell lymphoma, ALLO‑316 for RCC, ALLO‑329 for autoimmune diseases) that address large unmet needs in oncology and immune disorders.

3) Strengthens Manufacturing Know‑How & Exclusivity
Methods for transducing immune cells at high efficiency and quality directly impact manufacturing robustness, product consistency, and clinical efficacy — all commercially critical to cell therapies competing with other CAR‑T developers.

4) Long Patent Life
Since it issues in 2025 and is based on a 2022 filing, this patent is likely to provide protective coverage into the early 2040s, aligning with anticipated commercialization timelines for Allogene’s late‑stage candidates.