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Tabelecleucel (tab‑cel® )

Tabelecleucel (tab‐cel®) – Investigational PTLD T-cell immunotherapy

Tabelecleucel (tab‐cel®) is an off-the-shelf, allogeneic T-cell immunotherapy in development for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD). EBV+ PTLD is a type of lymphoma (cancer) that may occur after a solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT). There are currently no approved treatments indicated to treat PTLD. A significant unmet need exists for patients who fail currently available therapies, as treatment options are limited.

Tab‐cel® is currently being investigated in the Phase 3 registration-enabling ALLELE study to assess efficacy and safety for the treatment of EBV+ PTLD in SOT and HCT after failure of initial treatment. These data support the recent EMA-validated Marketing Authorization Application for tab‐cel® as the first off-the-shelf allogeneic T-cell immunotherapy to be reviewed by a regulatory agency. The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted tab‐cel® Accelerated Assessment and an EU approval decision is anticipated for second half of 2022.

Tab‐cel® has been granted Breakthrough Therapy Designation for EBV+ PTLD following allogeneic HCT by the U.S. Food and Drug Administration (FDA) and PRIME designation by the European Medicines Agency (EMA) for the same indication. Tab‐cel® has orphan drug designation in the U.S. and EU.

Atara is committed to pursuing the development of tab‐cel® in additional EBV-positive patient populations, with a primary focus on immunodeficiency-associated lymphoproliferative diseases (IA-LPDs).

Enrollment is continuing at sites in the Phase 2 multi-cohort study, which is evaluating six patient populations, including four within IA-LPDs and two in other EBV-driven diseases, in the U.S. and EU. Phase 2 study data is expected in 2023.

Tab‐cel® is also available to eligible patients with Epstein-Barr virus-associated diseases and malignancies for whom there are no other appropriate therapeutic options through an expanded access program.

If you are interested in learning more about our ongoing clinical studies, please contact us at ClinicalStudies@atarabio.com.

Post-Transplant Lymphoproliferative Disease (PTLD)

Post-Transplant Lymphoproliferative Disease (PTLD) is a type of cancer or lymphoma that may occur after hematopoietic cell transplant (HCT) or solid organ transplant (SOT).

A patient who receives a transplant must take medications to suppress their immune system (immunosuppression) so that their body will not reject the new hematopoietic cell transplant (HCT) or solid organ transplant (SOT). When the immune system is suppressed, it is easier to become sick. Sometimes when a transplant patient is infected with Epstein-Barr virus (EBV), the virus may cause a serious cancer of the blood known as PTLD.

EBV is a common human virus that infects over 90% of people in the world. For most healthy individuals, it causes common cold like symptoms and then stays in the body but is usually controlled by the immune system, so there are no further symptoms after the initial infection. If a person has a suppressed immune system, the EBV can become reactivated and cause an uncontrolled growth of cells in the patient’s lymph nodes and other organs. When abnormal cells multiply out of control, it may result in cancer.

PTLD is a cancer of the blood after transplant and is considered a rare disease that only occurs in a small percentage of transplant patients. Rates of PTLD cancer are higher for people who have bone marrow and organ transplants that require higher levels of immunosuppression.

In immunocompromised patients, such as those undergoing allogeneic HCT or SOT, Epstein-Barr virus associated post-transplant lymphoproliferative disease (EBV+ PTLD), may represent a life-threatening condition.

  • The poor median survival (0.7 months for HCT, 4.1 months for SOT) reported in patients with EBV+ PTLD for whom rituximab ± CT failed demonstrates an urgent unmet need in this patient population1,2


(1,2)  1. Sanz J et al. ASH 2021. Abstract #1454. 2. Dharnidharka V et al. ASH 2021. Abstract #2528

Tabelecleucel (tab-cel®)

Indication Preclinical Phase 1 Phase 2 Phase 3
RR EBV+ PTLD following SOT or HCT
ALLELE
 Study
  • Tabelecleucel (tab-cel®), Atara’s most clinically advanced T-cell immunotherapy in development, is an investigational treatment for Epstein-Barr virus (EBV) positive post-transplant lymphoproliferative disease (EBV+ PTLD), as well as other EBV associated hematologic and solid tumors.
  • Tab-cel® is currently being investigated in the Phase 3 registration-enabling ALLELE study to assess efficacy and safety for the treatment of EBV+ PTLD in SOT after failure of rituximab or rituximab and chemotherapy, and in HCT after failure of rituximab (NCT03394365, ALLELE study).
Multi-cohort: EBV+ cancers
ALLELE
 Study
  • Phase 2 multi-cohort study including EBV+ PTLD with CNS involvement, EBV+ PID/AID LPD, EBV+ LMS and other potential EBV-associated diseases (NCT04554914, 205 study).
Nasopharyngeal carcinoma (NPC)
ALLELE
  • Tab-cel® in combination with anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), is in Phase 1b/2 clinical development for patients with platinum-resistant or recurrent EBV-associated NPC (NCT03769467).
Indication Phase
RR EBV+ PTLD following SOT or HCT Phase 3
  • Tabelecleucel (tab-cel®), Atara’s most clinically advanced T-cell immunotherapy in development, is an investigational treatment for Epstein-Barr virus (EBV) positive post-transplant lymphoproliferative disease (EBV+ PTLD), as well as other EBV associated hematologic and solid tumors.
  • Tab-cel® is currently being investigated in the Phase 3 registration-enabling ALLELE study to assess efficacy and safety for the treatment of EBV+ PTLD in SOT after failure of rituximab or rituximab and chemotherapy, and in HCT after failure of rituximab (NCT03394365, ALLELE study).
Multi-cohort: EBV+ cancers Phase 1
  • Phase 2 multi-cohort study including EBV+ PTLD with CNS involvement, EBV+ PID/AID LPD, EBV+ LMS and other potential EBV-associated diseases (NCT04554914, 205 study).
Nasopharyngeal carcinoma (NPC) Phase 2
  • Tab-cel® in combination with anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), is in Phase 1b/2 clinical development for patients with platinum-resistant or recurrent EBV-associated NPC (NCT03769467).

EBV at a Glance

Persistent lifelong, asymptomatic infection

~90%


Of adults carry EBV by age 35

Implicated in a wide range of cancers and autoimmune diseases

 

Clinical Studies

Clinical Studies Aimed at Addressing Unmet Medical Needs

There is a high unmet medical need for additional effective immunotherapies. We believe our novel treatments currently in clinical development have the potential to change the way we approach certain life-threatening diseases.
Clinical Studies Aimed at Addressing Unmet Medical Needs