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

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

CD19

ALPHA: ALL0-501 (NHL)2
ALPHA2: ALL0-501A (NHL)2

BCMA

UNIVERSAL: ALL0-715 (MM)
UNIVERSAL: ALL0-715 + nirogacestat (MM)3
IGNITE: ALL0-605 (TurboCARTM/MM)
ALL0-316 (CD70/AML)
ALL0-819 (FLT3/AML)
Solid Tumors TRAVERSE: ALLO-316 (CD70/RCC)
DLL3 (SCLC)
10 Undisclosed Targets
Lymphodepletion Agent ALLO-647 (Anti-CD52 mAb)4
CATEGORY PROGRAM
Hematological
Malignancies

CD19

ALPHA: ALL0-501 (NHL)1 »
ALPHA2: ALL0-501A (NHL)1 »

BCMA

UNIVERSAL: ALL0-715 (MM) »
UNIVERSAL: ALL0-715 + nirogacestat (MM)2 »
IGNITE: ALL0-605 (TurboCARTM/MM) »
ALL0-316 (CD70/AML) »
ALL0-819 (FLT3/AML)
Solid Tumors TRAVERSE: ALLO-316 (CD70/RCC) »
DLL3 (SCLC)
10 Undisclosed Targets
Lymphodepletion
Agent
ALLO-647 (Anti-CD52 mAb)3 »

¹Servier holds ex-US commercial rights
²Allogene sponsored trial in combination with SpringWorks Therapeutics
³ALLO-647 intended to enable expansion and persistence

¹Phase 3 may not be required if Phase 2 is registrational
²Servier holds ex-US commercial rights
³Allogene sponsored trial in combination with SpringWorks Therapeutics
⁴ALLO-647 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 ALLO-647/Flu/Cy followed by ALLO-501
    Key Secondary Objectives:
    • Overall response rate
    • ALLO-501 cell kinetics
    • ALLO-647 PK
ALLO-501/501A alpha study Timeline

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

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

ALPHA2: Phase 1/2, Open-label, Multicenter Dose-Escalation and Dose-Expansion Study

ALPHA2 Study Overview
    Primary Endpoints:
    • Safety and dose-limiting toxicity of ALLO-647/Flu/Cy followed by ALLO-501A
    • Overall response rate by central imaging review
    Key Secondary Endpoints:
    • Overall response rate by investigator assessment
    • ALLO-501A cell kinetics
    • ALLO-647 PK
ALLO-715 Timeline

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

ALLO-715 + Nirogacestat Cohort
    Primary Endpoints:
    • Safety and tolerability of ALLO-715 in combination with nirogacestat
    Secondary Endpoints:
    • Anti-tumor activity and cellular kinetics of ALLO-715 in combination with nirogacestat
    • ALLO-647 and nirogacestat pharmacokinetics
    • Evaluate the expression of BCMA in bone marrow plasma cells with and without nirogacestat
ALLO-715 Timeline

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
ALLO-605 Timeline

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
  • AML (96% of tumors)
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
ALLO-316 Timeline
  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™ 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 ALLOGENE
The ALPHA2 Trial:
Relapsed or refractory NHL
The ALPHA2 Trial:
Relapsed or refractory NHL
ALLO-715 ALLO-715 + nirogascestat 1 ALLOGENE
The UNIVERSAL Trial:
Relapsed or refractory multiple myeloma (MM)
The UNIVERSAL Trial:
Relapsed or refractory multiple myeloma (MM)
ALLO-316 1 ALLOGENE
TRAVERSE Study:
Renal Cell Carcinoma
TRAVERSE Study:

Renal Cell Carcinoma
ALLO-605 1 ALLOGENE
The IGNITE Study:
Relapsed or refractory multiple myeloma (MM)
The IGNITE Study:

Relapsed or refractory multiple myeloma (MM)

ALLOGENE’S EXPANDED ACCESS POLICY

“Expanded Access” refers to the use of an investigational therapy 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™) therapies for patients with blood and solid tumors. Consistent with our commitment to bring innovative, safe, and effective therapies to patients, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our therapies 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 therapies. Allogene does not currently have any active Expanded Access protocols nor do we currently provide access to our investigational therapies on an Expanded Access basis. We encourage patients interested in our investigational therapies 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:

By phone
415-604-5696

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 therapy 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 therapies, 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 therapy 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.

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