Atara Biotherapeutics

Pipeline

A Robust Pipeline

Multiple T-Cell Immunotherapy Product Candidates in Clinical Development

Atara Biotherapeutics’s robust, late-stage pipeline features a host of potentially transformative T-cell immunotherapies for cancer and autoimmune diseases. Tabelecleucel (tab-cel®) is in Phase 3 development for patients with Epstein-Barr virus associated post-transplant lymphoproliferative disease (EBV+ PTLD) as well as in earlier stage development for other EBV-associated diseases.

Pipeline

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).
Indication
RR EBV+ PTLD following SOT or HCT
Phase
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).
Indication
Multi-cohort: EBV+ cancers
Phase
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).
Indication
Nasopharyngeal carcinoma (NPC)
Phase
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).

ATA188

Indication Preclinical Phase 1 Phase 2 Phase 3
Progressive MS
EMBOLD Study
  • ATA188, developed using Atara’s T-cell immunotherapy technology from QIMR Berghofer, has the potential to target EBV-infected cells that may be associated with MS pathophysiology.
  • Atara is currently enrolling EMBOLD, a Phase 2 clinical study of ATA188 for the treatment of patients with progressive forms of MS, across clinical sites in North America and Australia. To learn more about Atara’s clinical studies, please click here.
Indication Phase
Progressive MS Phase 2
  • ATA188, developed using Atara’s T-cell immunotherapy technology from QIMR Berghofer, has the potential to target EBV-infected cells that may be associated with MS pathophysiology.
  • Atara is currently enrolling EMBOLD, a Phase 2 clinical study of ATA188 for the treatment of patients with progressive forms of MS, across clinical sites in North America and Australia. To learn more about Atara’s clinical studies, please click here.
Indication
Progressive MS
Phase
Phase 2
  • ATA188, developed using Atara’s T-cell immunotherapy technology from QIMR Berghofer, has the potential to target EBV-infected cells that may be associated with MS pathophysiology.
  • Atara is currently enrolling EMBOLD, a Phase 2 clinical study of ATA188 for the treatment of patients with progressive forms of MS, across clinical sites in North America and Australia. To learn more about Atara’s clinical studies, please click here.

ATA2271/ATA3271

Program/Indication Preclinical Phase 1 Phase 2 Phase 3
ATA2271: Mesothelioma & other solid tumors
  • Target: Mesothelin
  • Technologies: CAR T PD-1 DNR; Novel CAR T 1XX co-stimulation
  • Autologous (ATA2271)
  • Mesothelin is expressed at high levels on the surface of cells in aggressive solid tumors including mesothelioma, triple-negative breast cancer, esophageal cancer, pancreatic cancer and non-small cell lung cancer
  • MSK investigator-sponsored Phase 1 study (NCT04577326) of a mesothelin-targeted CAR T immunotherapy is ongoing
  • ATA2271 Atara’s CAR T collaboration with MSK will focus on development of a next-generation, mesothelin-targeted CAR T using novel 1XX CAR signaling and PD-1 dominant negative receptor (DNR) checkpoint inhibition technologies.
ATA3271: Mesothelioma & other solid tumors
  • Target: Mesothelin
  • Technologies: CAR T PD-1 DNR; Novel CAR T 1XX co-stimulation
  • Off-the-shelf, allogeneic (ATA3271)
  • Mesothelin is expressed at high levels on the surface of cells in aggressive solid tumors including mesothelioma, triple-negative breast cancer, esophageal cancer, pancreatic cancer and non-small cell lung cancer
Program/Indication Phase
ATA2271: Mesothelioma & other solid tumors Phase 1
  • Target: Mesothelin
  • Technologies: CAR T PD-1 DNR; Novel CAR T 1XX co-stimulation
  • Autologous (ATA2271)
  • Mesothelin is expressed at high levels on the surface of cells in aggressive solid tumors including mesothelioma, triple-negative breast cancer, esophageal cancer, pancreatic cancer and non-small cell lung cancer
  • MSK investigator-sponsored Phase 1 study (NCT04577326) of a mesothelin-targeted CAR T immunotherapy is ongoing
  • ATA2271 Atara’s CAR T collaboration with MSK will focus on development of a next-generation, mesothelin-targeted CAR T using novel 1XX CAR signaling and PD-1 dominant negative receptor (DNR) checkpoint inhibition technologies.
ATA3271: Mesothelioma & other solid tumors Preclinical
  • Target: Mesothelin
  • Technologies: CAR T PD-1 DNR; Novel CAR T 1XX co-stimulation
  • Off-the-shelf, allogeneic (ATA3271)
  • Mesothelin is expressed at high levels on the surface of cells in aggressive solid tumors including mesothelioma, triple-negative breast cancer, esophageal cancer, pancreatic cancer and non-small cell lung cancer
Program/Indication
ATA2271: Mesothelioma & other solid tumors
Phase
Phase 1
  • Target: Mesothelin
  • Technologies: CAR T PD-1 DNR; Novel CAR T 1XX co-stimulation
  • Autologous (ATA2271)
  • Mesothelin is expressed at high levels on the surface of cells in aggressive solid tumors including mesothelioma, triple-negative breast cancer, esophageal cancer, pancreatic cancer and non-small cell lung cancer
  • MSK investigator-sponsored Phase 1 study (NCT04577326) of a mesothelin-targeted CAR T immunotherapy is ongoing
  • ATA2271 Atara’s CAR T collaboration with MSK will focus on development of a next-generation, mesothelin-targeted CAR T using novel 1XX CAR signaling and PD-1 dominant negative receptor (DNR) checkpoint inhibition technologies.
Program/Indication
ATA3271: Mesothelioma & other solid tumors
Phase
Preclinical
  • Target: Mesothelin
  • Technologies: CAR T PD-1 DNR; Novel CAR T 1XX co-stimulation
  • Off-the-shelf, allogeneic (ATA3271)
  • Mesothelin is expressed at high levels on the surface of cells in aggressive solid tumors including mesothelioma, triple-negative breast cancer, esophageal cancer, pancreatic cancer and non-small cell lung cancer

ATA3219

Program/Indication Preclinical Phase 1 Phase 2 Phase 3
ATA3219: B-cell malignancies
  • Target: CD19
  • Technologies: Novel CAR T 1XX co-stimulation
  • Off-the-shelf, allogeneic
Program/Indication Phase
ATA3219: B-cell malignancies Preclinical
  • Target: CD19
  • Technologies: Novel CAR T 1XX co-stimulation
  • Off-the-shelf, allogeneic
Program/Indication
ATA3219: B-cell malignancies
Phase
Preclinical
  • Target: CD19
  • Technologies: Novel CAR T 1XX co-stimulation
  • Off-the-shelf, allogeneic

Other Next Gen CAR T Programs

Program/Indication Preclinical Phase 1 Phase 2 Phase 3
ATA2431: B-cell malignancies
  • Targets: Multi-targeted CD19-CD20-CD22
  • Technologies: Novel co-stimulation
  • Development expected to start in autologous setting
  • Partnered with Moffitt Cancer Center
Solid Tumor and Infectious disease CAR T programs
  • Targets: Undisclosed
  • Technologies: Novel CAR T 1XX co-stimulation
  • Partnered with Memorial Sloan Kettering Cancer Center
Program/Indication Phase
ATA2431: B-cell malignancies Preclinical
  • Targets: Multi-targeted CD19-CD20-CD22
  • Technologies: Novel co-stimulation
  • Development expected to start in autologous setting
  • Partnered with Moffitt Cancer Center
Solid Tumor and Infectious disease CAR T programs Preclinical
  • Targets: Undisclosed
  • Technologies: Novel CAR T 1XX co-stimulation
  • Partnered with Memorial Sloan Kettering Cancer Center
Program/Indication
ATA2431: B-cell malignancies
Phase
Preclinical
  • Targets: Multi-targeted CD19-CD20-CD22
  • Technologies: Novel co-stimulation
  • Development expected to start in autologous setting
  • Partnered with Moffitt Cancer Center
Program/Indication
Solid Tumor and Infectious disease CAR T programs
Phase
Preclinical
  • Targets: Undisclosed
  • Technologies: Novel CAR T 1XX co-stimulation
  • Partnered with Memorial Sloan Kettering Cancer Center
Tabelecleucel (tab-cel®)

T-cell immunotherapy for EBV-associated ultra-rare diseases

FDA breakthrough designation & EMA PRIME for EBV+ PTLD

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ATA188
EBV T-cell immunotherapy for progressive multiple sclerosis (MS)
View Program
ATA2271/ATA3271
Mesothelin CAR T for solid tumors
View Programs
ATA3219

EBV CD19 CAR T

Next-generation off-the-shelf, allogeneic CD19-1XX CAR+ EBV T-cell immunotherapy containing a modified CD3ζ signaling domain, 1XX

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Allogeneic Technology

Developing T cells to Treat Specific Conditions

Building upon years of ground-breaking clinical research of collaborators enables us to harness the potential of allogeneic technology and develop unique, off-the-shelf T-cell immunotherapies for the treatment of patients suffering from cancer and certain autoimmune diseases.

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