OUR AlloCAR T™ PIPELINE TARGETS A VAST ARRAY OF TUMOR TYPES

CATEGORY PROGRAM PRE-CLINICAL PHASE 1 PHASE 2/3¹
Hematological Malignancies

CD19

UCART19 (ALL)2
ALL0-501 (NHL)2,3
ALL0-501A (NHL)2,3

BCMA

ALL0-715 (MM)
ALL0-715 + nirogacestat (MM)4
ALL0-605 (TurboCARTM/MM)
ALL0-316 (CD70)
ALL0-819 (FLT3/AML)
Solid Tumors ALLO-316 (CD70/RCC)
DLL3 (SCLC)
Multiple Undisclosed Targets
Lymphodepletion Agent ALLO-647 (Anti-CD52 mAB)5

¹Phase 3 may not be required if Phase 2 is registrational.
²Servier will hold ex-US commercial rights. Servier is the sponsor of the UCART19 trials.
³Allogene is the sponsor of the ALLO-501 and ALLO-501A trials.
⁴Allogene sponsored trial in combination with SpringWorks Therapeutics.
⁵ALLO-647 is intended to enable expansion and persistence of allogeneic CAR T product candidates.

ALL0-501/501A ALPHA STUDIES TARGETING CD19 IN RELAPSED/REFRACTORY (R/R) NON-HODGKIN LYMPHOMA

Diagram showing the ALLO-501/501A alpha study
  1. TALEN-mediated TRAC KO eliminates TCRα expression to minimize risk of GvHD​
  2. TALEN-mediated CD52 KO allows selective lymphodepletion with ALLO-647

TALEN® is a Cellectis gene editing technology.

ALLO-501 ALPHA Study Overview
    Primary Objectives:
    • Safety and dose-limiting toxicity of ALO-647/Flu/Cy followed by ALLO-501
    Key Secondary Objectives:
    • Overall response rate
    • ALLO-501 cell kinetics
    • ALLO-647 PK
    Key Eligibility Criteria:
    • R/R LBCL or FL
    • At least 2 prior lines of therapy, including an anti-CD20 monoclonal antibody
    • ECOG 0 or 1
    • Prior autologous CAR T allowed if tumor remains CD19+
    • Patients with donor-specific antibodies and rituximab > 15ng/ml were excluded
ALLO-501/501A alpha study Timeline
    Treatment:
    • Dose escalation: 40, 120, and 360 x 106 CAR+ cells
    Lymphodepletion Regimens:
    • LD1: Flu/Cy and ALLO-647 13 mg/d x 3 days
    • LD2/LD3: Flu/Cy and ALLO-647 30 mg/d x 3 days (concomitant/staggered)

Fludarabine (Flu): 30 mg/m2/d x 3 days

Cyclophosphamide (Cy): 300 mg/m2/d x 3 days

Servier holds ex-US rights to ALLO-501 and ALLO-501A.

ALLO-501 TRANSITION TO NEXT-GENERATION ALLO-501A IN RELAPSED/REFRACTORY NON-HODGKIN LYMPHOMA (NHL)

Diagram showing the ALLO-501/501A alpha study
    ALLO-501A
    • Next generation anti-CD19 AlloCAR T™
    • Entered Phase 1/2 study in June 2020 as the ALPHA2 trial, leveraging the ALPHA trial to finalize the ALLO-501A cell dose and the ALLO-647-based lymphodepletion regimen
    • Eliminates the rituximab recognition domains in ALLO-501, which we believe will allow for use in a broader patient population, including those NHL patients with recent rituximab exposure
    • Abbreviated Phase 1 trial initiated in Q2 2020

Servier holds ex-US rights to ALLO-501 and ALLO-501A.

ALLO-715: UNIVERSAL STUDY TARGETING B CELL MATURATION ANTIGEN (BCMA) IN RELAPSED/REFRACTORY (R/R) MULTIPLE MYELOMA (MM)

Diagram showing ALLO-715 universal study
ALLO-715 UNIVERSAL Study Overview
    Primary Objective:
    • Safety and tolerability
    Key Secondary Objectives:
    • Recommended Phase 2 dose for ALLO-715 and lymphodepletion regimen
    • Antitumor activity
    Key Eligibility Criteria:
    • R/R MM
    • At least 3 prior lines of MM therapy, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody
ALLO-715 universal study timeline
    Treatment:
    • Dose escalation: 40, 120, and 320 x 106 CAR+ cells
    Lymphodepletion:
    • ALLO-647: 39 to 90 mg
    • Fludarabine: 30 mg/m2/d x 3 days
    • Cyclophosphamide: 300 mg/m2/d x 3 days

ALLO-715: EXPLORING GAMMA SECRETASE INHIBITION (GSI) IN MULTIPLE MYELOMA (MM)

In a collaboration with SpringWorks Therapeutics, Allogene is sponsoring an exploratory clinical trial of ALLO-715.

  • Combination study: ALLO-715 with nirogacestat (GSI)
  • Potential increase in antitumor efficacy:
    • - Nirogacestat increases B cell maturation antigen (BCMA) expression in MM cell lines1
    • - Others have shown that GSI may increase the antitumor efficacy of autologous BCMA-directed CAR T therapy2
  1. Data on File. Allogene Therapeutics.
  2. Blood. 2019;134(19):1585-1597. doi:10.1182/blood.2019000050

ALLO-316 (ANTI-CD70): THE NEXT AlloCAR T™ CLINICAL CANDIDATE

  • ALLO-316 is an anti-CD70 AlloCAR T™ candidate for renal cell carcinoma (RCC) as well as several hematological malignancies
  • CD70 expression1
    • - RCC (80%-100%)
    • - Acute myeloid leukemia (96%)
    • - Diffuse large B cell lymphoma (71%), multiple myeloma (63%), chronic lymphocytic leukemia (50%)
    • - Glioblastoma mutiforme (35%)
    • - CD70 is also expressed on activated T cells
  • CD70 in RCC
    • - High prevalence with limited off-tumor expression
    • - Good expression in metastatic disease
  • ALLO-316 is associated with minimal or no fratricide
  1. Expert Opin Ther Targets. 2008;12(3):341-351. doi:10.1517/14728222.12.3.341

CLINICAL TRIALS

Allogene is committed to the development of AlloCAR T™ therapies for cancer. Successful clinical trials are required to gain regulatory approval for new medications to advance patient care and may be required to support any approved products.

A list of existing Allogene clinical trials is below. For more information on Allogene clinical trials that may be recruiting, search Allogene at www.clinicaltrials.gov

PROGRAM PHASE SPONSOR INDICATION
ALLO-501 1 ALLOGENE
The ALPHA Trial:
Relapsed or refractory non-Hodgkin lymphoma (NHL)
The ALPHA Trial:
Relapsed or refractory non-Hodgkin lymphoma (NHL)
ALLO-501A 1/2 ALLOGENE
The ALPHA2 Trial:
Relapsed or refractory NHL
The ALPHA2 Trial:
Relapsed or refractory NHL
ALLO-715 1 ALLOGENE
The UNIVERSAL Trial:
Relapsed or refractory multiple myeloma (MM)
The UNIVERSAL Trial:
Relapsed or refractory multiple myeloma (MM)
UCART19 1 SERVIER
The PALL Trial:
Relapsed or refractory acute lymphoblastic leukemia (ALL) in pediatric patients
The PALL Trial:
Relapsed or refractory acute lymphoblastic leukemia (ALL) in pediatric patients
UCART19 1 SERVIER
The CALM Trial:
Relapsed or refractory ALL in adults
The CALM Trial:
Relapsed or refractory ALL in adults

ALLOGENE’S EXPANDED ACCESS POLICY

Allogene does not currently have any active Expanded Access protocols but we do have clinical trials open. These can be found on www.clinicaltrials.gov

Treating physicians may request information about Expanded Access for an Allogene therapy by contacting our clinical trials team:

By phone
415-604-5696

Allogene will evaluate these requests individually and may provide the physician with the requested Expanded Access for an Allogene therapy for patients with no other available therapies and for patients who are not eligible to participate in a current Allogene clinical trial. Allogene will acknowledge receipt of the request via telephone call or email within 5 business days of receipt of the request.

Pursuant to the 21st Century Cures Act: The posting of policies by manufacturers and distributors shall not serve as a guarantee of access to any specific investigational therapy by any individual patient.

SCIENTIFIC PUBLICATIONS

Check out the latest publications and poster presentations related to our science.

Screening and Characterization of AlloCAR T™ Targeting DLL3 for the Treatment of Small Cell Lung Cancer
June 2020
American Association for Cancer Research (AACR) June 2020 – Screening and Characterization of AlloCAR T™ Targeting DLL3 for the Treatment of Small Cell Lung Cancer
SMIC CAR T Cells: CAR T with Temporally-Controlled, Programmable Cytokine Signaling Outputs
June 2020
American Association for Cancer Research (AACR) June 2020 – SMIC CAR T Cells: CAR T with Temporally-Controlled, Programmable Cytokine Signaling Outputs
First-in-Human Data of ALLO-501 and ALLO-647 in Relapsed/Refractory Large B-cell or Follicular Lymphoma (R/R LBCL/FL): ALPHA Study
May 2020
American Society of Clinical Oncology (ASCO) May 2020 – First-in-Human Data of ALLO-501 and ALLO-647 in Relapsed/Refractory Large B-cell or Follicular Lymphoma (R/R LBCL/FL): ALPHA Study
TurboCARTM T Cells: CAR T Cells with Constitutive, Programmable Cytokine Signaling Outputs
May 2020
American Society of Gene and Cell Therapy (ASGCT) May 2020 - TurboCAR™ T Cells: CAR T Cells with Constitutive, Programmable Cytokine Signaling Outputs
April 2020
Toward “Off-the-Shelf” Allogeneic CAR T Cells
Allogeneic Anti-BCMA CAR T Cells Show Tumor Specific Killing Against Primary Multiple Myeloma Cells
December 2019
American Society of Hematology (ASH) Dec. 2019 – Allogeneic Anti-BCMA CAR T Cells Show Tumor Specific Killing Against Primary Multiple Myeloma Cells
Preclinical Evaluation of ALLO-819, Targeting FLT3, in Acute Myeloid Leukemia
December 2019
American Society of Hematology (ASH) Dec. 2019 – Preclinical Evaluation of ALLO-819, Targeting FLT3, in Acute Myeloid Leukemia
AlloCAR T™ Targeting CD70 For RCC
April 2019
American Association for Cancer Research (AACR) April 2019 – AlloCAR T™ Targeting CD70 For RCC
An Allogeneic FLT3 CAR T Therapy Possessing An Off-Switch for the Treatment of Acute Myeloid Leukemia
December 2018
American Society of Hematology (ASH) Dec. 2018 – ALLO-819, An Allogeneic FLT3 CAR T Therapy Possessing An Off-Switch for the Treatment of Acute Myeloid Leukemia
UCART19 PALL and CALM Studies
December 2018
American Society of Hematology (ASH) Dec. 2018 — UCART19 PALL and CALM Studies
A Versatile Safeguard for Chimeric Antigen Receptor T-Cell Immunotherapies
June 2018
A Versatile Safeguard for Chimeric Antigen Receptor T-Cell Immunotherapies Valton J, Guyot V, Boldajipour B, et al.
Scientific Reports
Development of an In Vitro Cynomolgus Macaque Allogeneic CAR T Cell Platform
May 2018
American Society of Gene and Cell Therapy (ASGCT) May 2018 – Development of an In Vitro Cynomolgus Macaque Allogeneic CAR T Cell Platform
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