• Stem and progenitor cell therapy: derived from cord blood and intended for use as a non-engrafting adjuvant cell therapy with chemotherapy to enhance remission rates and improve overall survival in AML patients

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• Universal donor therapy: any dose for any patient; no matching required

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• Off-the-shelf fixed doses: fully released and ready for infusion on the patient's timeline

Dilanubicel Key Characteristics

Dilanubicel is positioned for de novo and treatment related Acute Myeloid Leukemia patients and not limited to specific sub-populations

• ​Clinically convenient: easily added to standard of care regimens as determined by the treating physician

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• Easily administered: simple infusion at the bedside over minutes

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• Generally well-tolerated: >300 patients infused over multiple trials and indications

About Acute Myeloid Leukemia (AML)

Achieving remission with initial  treatment is critical to survival and quality of life

DEVERRA IS ADDRESSING THE UNMET NEED WITH DILANUBICEL

Dilanubicel is a novel, non-engrafting adjuvant cell therpay to enhance remission rates and improve survival and quality of life.

82% are ≥ 6o years

at diagnosis

> 50,000 (global) / 20,240 (US)

new AML patients

per year by 2025

Significant toxicity with intensive chemotherapy limits use in older patients

5-year overall survival is < 30%

AML is a complex and difficult to treat blood cancer with poor long-term survival

• Can be used as an allogeneic therapy without HLA matching to the patient

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• Have a proven safety record as a cell therapy, generating no graft vs host disease or cytokine release syndrome

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Advantages of NK Cells as Immunotherapy

• ​Can be generated ahead of time and crypopreserved to be ready for immediate off-the-shelf use for any patient

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• Repeat dosing regimens possible

NK CELLS ARE:

• A type of white blood cell (lymphocyte) of the immune system

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• The body's first line of defense against cells transformed by cancer or virally infected cells

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• Known for their ability to directly kill their target (cancer cells/virally infected cells) without the need for prior education or prior activation

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MYELOID CELLS ARE:

• A family of white blood cell subtypes that includes monocytes, macrophages, and dendritic cells

• Recruited to sites of tissue damage or infection where they phagocytized (eat) abnormal cells, bacteria, and other pathogens

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• Able to activate and educate other immune cells by releasing cytokines and presenting parts of the pathogens they have eaten (antigens)​

CELL SOURCE

MANUFACTURING

EXPANSION POTENTIAL

PERSISTENCY
& POTENCY

Cord blood

HPSCs​​

• Natural: no genetic modifications of the starting material required compared to iPSC

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• No specific cellular typing required of donor units

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• Plentiful,  sustainable starting material versus mature NK cells

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• Pooled donor product results in improved lot-to-lot consistency

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• No feeder cells required for activation

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• Animal component free

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• Cryopreservation SOP established

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Simple, scalable, cost-effective process for off-the-shelf use

• Fewer inhibitory markers compared to adult NK cells

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• Superior in vitro killing compared to activated adult NK cells

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• Intratumoral in vivo persistence for ~4 weeks post fusion

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• Anti-tumor activity in AML mouse model​

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Potent NK

cell product

• Hundreds of doses generated per manufacturing run at full scale

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• Leverages enhanced expansion and priming of cord blood HSPCs on Notch platform prior to NK differentiation

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High cell yield eliminates NK cell dose limitations

• NK cells are highly potent lymphocytes that target cancer through multiple broadly expressed activating ligands and they can be used allogeneically without the risk of graft versus host disease (GvHD) that is associated with T cell therapies

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• Engineering is a way of enhancing NK cells to specifically identify and more potently kill their targets 

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Why Engineer Immune Effector Cells?

• ​Macrophages form an indispensable part of the immune response, performing a host of tasks crucial for the regulation of the immune system. Not only are they professional antigen-presenting cells, but they also actively participate in the immune response through phagocytosis and clearance of cellular debris

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• Macrophages engineered to secrete stimulatory cytokines may recruit additional immune cells and enhance killing of resistant solid tumor cells​