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

Pipeline_11.30.22

The Industry's First Allogeneic CAR T Phase 2 Trial: ALLO-501A ALPHA2 Phase 2 Study TARGETING CD19 IN RELAPSED/REFRACTORY NON-HODGKIN LYMPHOMA

Allo 501A
Timeline_for_Allogene 501A

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

B Cell Maturation Antigen
ALLO-715 UNIVERSAL Study Overview

Primary Objective:

  • Safety and tolerability

Key Secondary Objectives:

  • Recommended ALLO-715 Phase 2 dose and lymphodepletion regimen
  • Anti-tumor activity (ORR, duration of response, PFS, and MRD)
  • ALLO-715 cellular kinetics (blood levels of anti-BCMA CAR T cells)
  • ALLO-647 pharmacokinetics (serum ALLO-647 concentrations)

ALLO-605: IGNITE STUDY UTILIZING FIRST TurboCAR™ TO TARGET BCMA

  • TurboCAR™ is designed to recapitulate cytokine signaling selectively in CAR T
    • - Does not stimulate host immune cells which could cause systemic toxicity or reject CAR
    • - Delivers survival benefit selectively to CAR T cells
  • Opportunities for development include improving the efficacy of CAR T cells
ALLO-605 Ignite Study Overview
Primary Endpoints (Phase 1):

  • Safety and tolerability of ALLO-605
Secondary Endpoints (Phase 1):

  • Anti-tumor activity and cellular kinetics of ALLO-605
  • ALLO-647 pharmacokinetics
  • Evaluate immunogenicity against ALLO-605 and ALLO-647
  • Evaluate responses in subjects with previous treatment with an anti-BCMA targeted therapy
Safety Assessment

ALLO-316: INVESTIGATING AN AlloCAR T™ IN RENAL CELL CARCINOMA

ALLO-316 is an anti CD70 AlloCAR T™ candidate for renal cell carcinoma (RCC) as well as several hematological malignancies

CD70 target selectively expressed in several cancers1:

  • RCC (80-100% of tumors)
    • High prevalence with limited ‘off tumor’ expression

Phase 1 TRAVERSE trial in RCC initiated in 1H 2021

  • ALLO-316 is associated with minimal or no fratricide
  • Study endpoints
    • Primary endpoints: Safety and tolerability
    • Secondary endpoints: Anti-tumor efficacy, PK/PD
Safety Assessment
  1. Expert Opin Ther Targets. 2008 Mar; 12(3): 341–351. doi: 10.1517/14728222.12.3.341

CLINICAL TRIALS

Allogene is committed to the development of AlloCAR T™ products 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 INDICATION
ALLO-501A 2 The ALPHA2 Trial: Relapsed or refractory non-Hodgkin lymphoma (NHL)
MORE
TO
COME
ALLO-501A/ALLO-647 2 The EXPAND Trial: Relapsed or refractory non-Hodgkin lymphoma (NHL)
MORE
TO
COME
ALLO-715 1 The UNIVERSAL Trial: Relapsed or refractory multiple myeloma (MM)
ALLO-316 1 TRAVERSE Study: Renal Cell Carcinoma
ALLO-605 1 The IGNITE Study: Relapsed or refractory multiple myeloma (MM)

ALLOGENE’S EXPANDED ACCESS POLICY

“Expanded Access” refers to the use of an investigational product outside of a clinical trial for potential treatment of a serious or life-threatening condition. Allogene Therapeutics is developing allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for patients with blood and solid tumors. Consistent with our commitment to bring innovative, safe, and effective products to patients, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our products broadly available as quickly and safely as possible. Participation in one of our clinical trials is the best and preferred route to access these investigational products. Allogene does not currently have any active Expanded Access protocols nor do we currently provide access to our investigational products on an Expanded Access basis. We encourage patients interested in our investigational products to learn more about our ongoing studies by visiting clinicaltrials.gov.

 

Treating physicians may request information about Allogene’s Expanded Access policy by contacting our clinical trials team:

Allogene will respond to inquiries within 5 business days from receipt.

In the event Allogene decides to consider making one or more of its investigational candidates available for patients who have a serious or life-threatening condition through an Expanded Access program, general criteria to be considered may include: availability of alternative products, the potential risks and benefits to the patient, adequate supply, and potential interference with Allogene’s ongoing clinical trials. All requests would be evaluated on a case-by-case basis in a fair and equitable manner.

This policy shall not serve as a guarantee of access to any specific investigational candidates by any individual patient. Allogene reviews its policies from time to time to ensure conformity with applicable laws and regulations. We reserve the right to revise this policy at any time.

SCIENTIFIC PUBLICATIONS

CD19

ALPHA Study
December 2021
ALPHA Study: ALLO-501 Produced Deep and Durable Responses in Patients with Relapsed/Refractory Non-Hodgkin’s Lymphoma, Comparable to Autologous CAR
ALPHA2 Study
December 2021
ALPHA2 Study: ALLO-501A Allogeneic CAR T in LBCL, Updated Results Continue to Show Encouraging Safety and Efficacy with Consolidation Dosing
First In Human Data of Allo 501A
June 2021
First-In-Human Data of ALLO-501A, An Allogeneic Chimeric Antigen Receptor (CAR) T Cell Therapy, and ALLO-647 in Relapsed/Refractory Large B Cell Lymphoma (R/R LBCL): ALPHA2 Study
First In Human Data of Allo 501
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
ALPHA2 Study
December 2018
American Society of Hematology (ASH) Dec. 2018 — UCART19 PALL and CALM Studies

BCMA

Allogene_Cancer Research_BCMA Publication_March 2022_Page_01
March 2022
Allogeneic Anti-BCMA CAR T Cells Are Superior to Multiple Myeloma-derived CAR T Cells in Preclinical Studies and May Be Combined with Gamma Secretase Inhibitors
UNIVERSAL Updated Phase 1 Data Validates the Feasibility of Allogeneic
December 2021
UNIVERSAL Updated Phase 1 Data Validates the Feasibility of Allogeneic Anti-BCMA ALLO-715 Therapy for Relapsed/Refractory Multiple Myeloma
Preclinical Evaluation of ALLO 605
December 2020
Preclinical Evaluation of ALLO-605, an Allogeneic BCMA TurboCAR T™ Cell Therapy for the Treatment of Multiple Myeloma
First In Human Data of Allo 715
December 2020
First-in-Human Study of the Allogeneic Anti-BCMA ALLO-715 CAR T cell Therapy and the Anti-CD52 Mab ALLO-647 in Relapsed/Refractory Multiple Myeloma (UNIVERSAL Study)
American Society of Hermatology
December 2019
American Society of Hematology (ASH) Dec. 2019 – Allogeneic Anti-BCMA CAR T Cells Show Tumor Specific Killing Against Primary Multiple Myeloma Cells

CD70

Preclinical Development and Evaluation of Allogeneic CAR T Cells Targeting CD70 for the Treatment of Renal Cell Carcinoma_Poster
April 2022
Preclinical Development and Evaluation of Allogeneic CAR T Cells Targeting CD70 for the Treatment of Renal Cell Carcinoma
Preclinical Development and Evaluation of Allogeneic CAR T Cells Targeting CD70 for the Treatment of Renal Cell Carcinoma_Publication
April 2022
Preclinical Development and Evaluation of Allogeneic CAR T Cells Targeting CD70 for the Treatment of Renal Cell Carcinoma
Investigation of ALLO-316
December 2020
Investigation of ALLO-316: A Fratricide-Resistant Allogeneic CAR T Targeting CD70 As a Potential Therapy for the Treatment of AML
American Association for Cancer Research
April 2019
American Association for Cancer Research (AACR) April 2019 – AlloCAR T™ Targeting CD70 For RCC

FLT3

Allogeneic FLT3 CAR T Cells
October 2020
Allogeneic FLT3 CAR T Cells with an Off-Switch Exhibit Potent Activity against AML and Can Be Depleted to Expedite Bone Marrow Recovery
Preclinical Evaluation of ALLO-819
December 2019
American Society of Hematology (ASH) Dec. 2019 – Preclinical Evaluation of ALLO-819, Targeting FLT3, in Acute Myeloid Leukemia
ALLO-819
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

DLL3

June 2020 Screening and Characterization of AlloCAR T Targeting
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

ALLO-647

Safety and PK/PD of ALLO-647
June 2021
Safety and PK/PD of ALLO-647, an Anti-CD52 Antibody, With Fludarabine (Flu)/Cyclophosphamide (Cy) for Lymphodepletion in Allogeneic CAR T Cell Therapy

PLATFORM

2022_SITC_poster
November 2022
Generation of Hypoimmunogenic Allogeneic CAR T Cells by Inactivation of Transcriptional Regulators
of HLA Class I and II Genes
Allogeneic CAR T Cells Derived From Younger Donor T Cells Have More Desirable T Cell Phenotype And Better in vitro Functionality
May 2022
Allogeneic CAR T Cells Derived From Younger Donor T Cells Have More Desirable T Cell Phenotype And Better in vitro Functionality
PD1 TurboCAR T Cells
April 2021
PD1 TurboCAR™ T Cells: PD1-Resistant CAR T Cells With Programmable Cytokine Signaling Outputs
June 2020 SMIC CAR T Cells
June 2020
American Association for Cancer Research (AACR) June 2020 – SMIC CAR T Cells: CAR T with Temporally-Controlled, Programmable Cytokine Signaling Outputs
May 2020 TurboCAR T Cells
May 2020
American Society of Gene and Cell Therapy (ASGCT) May 2020 - TurboCAR™ T Cells: CAR T Cells with Constitutive, Programmable Cytokine Signaling Outputs
Off the Shelf Allogeneic CAR T Cells
April 2020
Toward “Off-the-Shelf” Allogeneic CAR T Cells
Safeguards for Chimeric Antigen Receptor T-Cell
June 2018
A Versatile Safeguard for Chimeric Antigen Receptor T-Cell Immunotherapies Valton J, Guyot V, Boldajipour B, et al.
Scientific Reports
May 2018 American Society of Gene and Cell Therapy
May 2018
American Society of Gene and Cell Therapy (ASGCT) May 2018 – Development of an In Vitro Cynomolgus Macaque Allogeneic CAR T Cell Platform