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REDEFINING THE FUTURE OF CAR T

Allogene is working to overcome the limitations of autologous CAR T therapies by creating investigational allogeneic CAR T cell products, or AlloCAR T products. Unlike autologous cell therapy, AlloCAR T products use T cells from healthy donors.

These cells are isolated in a manufacturing facility, engineered to express CARs to recognize and destroy disease, and modified via gene editing to limit autoimmune response when given to a patient. These products are then stored for off-the-shelf use on demand. We believe that, at scale, a single manufacturing run has the potential to yield treatment for 100+ patients.

Doing What No Autologous Treatment Has Done Before

ACCESS

  • Potential to treat all eligible patients
  • No need for complex logistics

COST

  • Scalable and efficient manufacturing
  • Potential to treat 100+ patients from a single manufacturing run
  • Lower ancillary costs

SPEED/RELIABILITY

  • Off-the-shelf for on-demand treatment
  • Less product variability, made from healthy T cells

INNOVATION

  • Multiplex
    gene-engineering and gene-editing capabilities
  • Opportunity for product optimization

LEARN MORE ABOUT THE ALLOGENEIC ADVANTAGE »

The next revolution in cell therapy is the development of AlloCAR T products engineered from the T cells of healthy donors. These off-the-shelf CAR T products, enhanced by gene editing, could be the next most important breakthrough in the field.

THE DIFFERENCE STARTS WITH HEALTHY DONORS

A healthy donor's T cells become CAR T cells that can treat approximately 100 patients

THE DIFFERENCE STARTS WITH HEALTHY DONORS

Healthy donor
CAR T cells
Approximately 100 patients

AlloCAR T PRODUCTS HAVE THE POTENTIAL TO TREAT PATIENTS IN DAYS

AlloCAR T treatment journey timeline: autologous CAR T therapies take 3 weeks to 6+ months, AlloCAR T products 2 to 5 days.

Transforming a complex procedure. Autologous CAR T therapies, 3 weeks to 6+ months:

  1. Patient identification
  2. Attain manufacturing slot
  3. Leukapheresis scheduling
  4. Leukapheresis
  5. Manufacturing
  6. Lymphodepletion
  7. CAR T therapy administration

Into an “off-the-shelf” biopharmaceutical product. AlloCAR T products, 2 to 5 days:

  1. Patient identification
  2. Lymphodepletion
  3. AlloCAR T product administration

Source: Allogene data on file.

ALLOGENE IS CREATING THE AlloCAR T PRODUCT PLATFORM FOR TOMORROW

The platform opportunities: AlloCAR T across autoimmune diseases, heme malignancies and solid tumors, and the AlloCAR T difference.

Three overlapping circles with AlloCAR T at their centre:

  • ALLO-329: a next generation dual CD19/CD70 CAR T to transform the treatment of autoimmune diseases.
  • Cema-cel: maximizing the curative potential of CD19 CAR T by targeting MRD+ LBCL in 1L consolidation, in heme malignancies.
  • ALLO-316: leveraging proprietary Dagger® technology to treat solid tumors.

The AlloCAR T difference:

  • Highly scalable, off-the-shelf product
  • One-time treatment
  • Simplified logistics, ideal for community clinicians
  • Ability to leapfrog competition
  • Vast array of potential indications

May Reduce or Eliminate Need for Lymphodepleting Chemotherapy

ALLO-329 Dagger technology diagram: the CD70 CAR on ALLO-329 binds CD70 on host alloreactive T cells (anti-rejection activity) and its CD19 CAR binds CD19 on host B cells (B cell depletion).

ELIMINATION OF TCR IN DONOR T CELLS MAY CONTROL GvHD

TCR elimination diagram, part 1: the T cell receptor (TCR) of a donor CAR T cell recognizes a normal host cell and attacks it.
TCR elimination diagram, part 2: with the TCR gene edited out, the CAR T cell has no TCR and no longer recognizes the normal host cell.

MODULAR, FLEXIBLE DESIGN

Our modular, 136,000 square-foot facility was designed for growth. It currently has three production suites, with the ability to accommodate five as we look ahead to bringing new therapies onto the market.

IN-HOUSE QUALITY CONTROL AND TESTING

We believe in the critical importance of understanding the quality of our investigational AlloCAR T products, which is why we operate the entire scope of product testing and maintain an open data strategy in-house.

COMMITMENT TO SUSTAINABILITY

Cell Forge 1 is a carbon-free facility that is fully powered by electricity, much of which will be delivered by the 2,400 solar panels on the rooftop. CF1 received LEED Gold certification.

COLLABORATIVE DESIGN

We included large windows throughout the facility to promote a culture of transparency and connection. Open workspaces, as well as the facility’s proximity to Allogene’s Headquarters, allow for regular cross-functional collaboration.

STATE-OF-THE-ART, IN-HOUSE MANUFACTURING FOR ON-DEMAND AlloCAR T PRODUCT AVAILABILITY

Cell Forge 1 manufacturing facility in Newark, California

Maintaining state-of-the-art, world-class manufacturing capabilities is at the core of our strategy to deliver readily available cell products faster, more reliably, and at greater scale. Our manufacturing facility, Cell Forge 1, located in Newark, California, in the eastern region of the San Francisco Bay Area, is designed for clinical and commercial manufacturing, analytical testing and distribution of cell products. This facility provides in-house quality assurance and quality control, per current good manufacturing practices (cGMPs), to ensure a reliable supply of AlloCAR T products for our clinical programs and commercial products, pending regulatory approval.

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