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TREGZI: A precision-engineered stem and T cell therapy for allogeneic stem cell transplant

To best understand what TREGZI is, it will help to understand how it differs from traditional allogeneic stem cell transplant approaches. Both TREGZI and traditional allogeneic stem cell transplant replace cancer cells with healthy ones. With a traditional allogeneic stem cell transplant, all donor cells are infused, which can increase the risk for complications such as infections and graft-versus-host disease (GVHD).

Through allogeneic stem cell transplant, healthy blood-forming cells from a matched donor are put into your body to replace the diseased cells—and this can offer a chance for a cure from certain blood cancers.

With traditional transplant, all cells from the donor are infused into your bloodstream, delivering the beneficial blood-forming and immune cells as well as a variety of other cells that are a natural part of the donor’s blood. These other cells may increase the risk of serious side effects or transplant-related complications, like infections and GVHD.

GVHD can happen when the transplanted donor cells (the graft) attack your cells (the host). If you develop GVHD, the disease may cause symptoms that range from mild to severe and, in some cases, can be life-threatening. Your care team is aware of the chance of GVHD development and will take steps to reduce this risk and manage any symptoms you may experience.

Symptoms may include:

  • Diarrhea
  • Joint pain
  • Mouth sores
  • Nausea or vomiting
  • Organ failure
  • Skin rash or itching
  • Stomach pain
  • Tiredness
  • Yellowing of your eyes (jaundice)

Some of these side effects can happen early or may be delayed, can last for months to years, and may affect daily life. To help manage them, you may need to take medications called immunosuppressants. These medications may be taken for months or possibly for the rest of your life after transplant to help lower the risk of infection.

TREGZI is a precision-engineered stem cell and T cell therapy with a defined set of 3 types of cells working together to rebuild your blood and immune system and its ability to target the cancer

TREGZI contains a specific combination of stem cells and T cells:

  1. The donor stem cells contained in TREGZI grow and divide into the healthy blood and immune cells your body needs
  2. The donor T cells in TREGZI help your body fight the cancer while reducing the potential for GVHD

Each of the different types of cells in TREGZI is delivered into your body at a set time. This allows your immune system to rebuild and reduces the risk of complications such as GVHD.

HSPCs

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Starter cells

These cells, called hematopoietic stem and progenitor cells (HSPCs), are the cells that grow into the different types of blood cells your body needs, including red blood cells, white blood cells, and platelets.

Tregs

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Suppressor cells

Regulatory T cells (Tregs) lower (suppress) the powerful immune response started by the body’s conventional T cells once the infected or cancerous cells have been eliminated.

Tregs can also suppress harmful immune attacks caused by the donor cells against your body, which can help protect your tissues and lower the risk of complications, including GVHD.

Tcons

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Fighter cells

Conventional T cells (Tcons) travel through your bloodstream seeking out infected or cancerous cells. When they find them, Tcons recruit other immune cells and direct a robust response to eliminate them.

2 types of T cells

There’s a good reason why TREGZI balances 2 different types of T cells: Tcons send a “go” signal to the immune cells to defend you while Tregs send a signal to “slow down” that protects you from an overreactive immune system.

A healthy immune system relies on a balance between signals to fight disease without harming the body itself.

Key characteristics TREGZI Traditional stem cell transplant
Potentially curative for certain blood cancers
Can be given early in the treatment journey or after having tried other therapies 
Replaces damaged blood cells and the immune system with new healthy cells
Uses cells from a donor
Transplants stem cells and other cells found in the donor’s blood at one time
Transplants donor stem cells in a set order
Made of purified sets of donor HSPCs, Tregs, and Tcons

IMPORTANT SAFETY INFORMATION AND INDICATION

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INDICATION

  • TREGZI is a treatment used in stem cell transplant for adult patients who have blood cancer to rebuild the blood and immune systems and improve survival without chronic graft-versus-host disease (cGVHD).
  • TREGZI is made by selecting certain types of blood cells from a matched donor.

IMPORTANT SAFETY INFORMATION

Before you receive TREGZI, tell your healthcare provider about all your medical conditions, including if you have:

  • Lung or breathing problems
  • Heart problems
  • Liver problems
  • Kidney problems
  • A recent or active infection

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

TREGZI can cause serious side effects, including:

  • Graft Failure. Failure to rebuild the blood and/or immune system, which may be fatal, can occur after receiving TREGZI. Your healthcare provider will monitor you closely after TREGZI administration.

  • Graft-Versus-Host Disease (GVHD). Immune reactions from the donor’s cells may occur soon (days) or long (months) after receiving TREGZI. Tell your healthcare provider right away about any signs and symptoms including rash, joint pain, diarrhea, or yellowing of the eyes.
  • Infusion Reactions. Infusion reactions can occur after TREGZI infusion. Tell your healthcare provider right away about any signs and symptoms including fever, chills, flushing, fatigue, shortness of breath, and dizziness/lightheadedness.
  • Secondary Cancer and Cancer from Donor Cells. New cancers can develop after treatment with TREGZI. If you are diagnosed with a new cancer after treatment, contact Orca Bio at 1-877-290-6722.
  • Transfer of Serious Infections. Transfer of serious infectious diseases can occur because TREGZI is made from the human blood cells of a donor. Transfer may occur even though donors are screened and tested for infectious diseases.

The most common side effects of TREGZI include inflammation of the digestive tract, diarrhea, rash, viral infections, infections from an unknown pathogen, abdominal pain, vomiting, nausea, bacterial infections, bleeding, acute graft-versus-host disease (aGVHD), swelling and fungal infections.

These are not all the possible side effects of TREGZI. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION

  • TREGZI is a treatment used in stem cell transplant for adult patients who have blood cancer to rebuild the blood and immune systems and improve survival without chronic graft-versus-host disease (cGVHD).
  • TREGZI is made by selecting certain types of blood cells from a matched donor.

Please see accompanying full Prescribing Information including Patient Information.