Main Product Candidates

Allogeneic CAR-T Cell Pipeline

 

Fully Owned Product

Candidate / Target

Indication

Study

Preclinical

Phase 1 Dose Escalation

Phase 1 Dose Expansion

Pivotal Phase (2)

Cellectis
UCART22 Acute Lymphoblastic Leukemia BALLI-01
     
UCART123 Acute Myeloid Leukemia AMELI-01
     
UCART20x22 Non Hodgkin Lymphoma NatHaLi-01
     
  Licensed to:              
Servier, moved by you Allogene Therapeutics, U.S. rights

CEMACABTAGENE ANSEGEDLEUCEL1

Large B-cell Lymphoma

ALPHA3

     

CEMACABTAGENE ANSEGEDLEUCEL1

Chronic Lymphocytic Leukemia

ALPHA2

     
Allogene Therapeutics

ALLO-715 3

Multiple Myeloma

UNIVERSAL

     

ALLO-605 3

Multiple Myeloma

IGNITE

     

ALLO-316 4

Renal Cell Carcinoma

TRAVERSE

     

1 Cemacabtagene ansegedleucel has been developed under a collaboration agreement between Servier and Allogene based on an exclusive license granted by Cellectis to Servier. Servier grants to Allogene exclusive rights to Cemacabtagene ansegedleucel in the U.S. The ALPHA3 and ALPHA2 studies target Large B-Cell Lymphoma (LBCL) and Chronic Lymphocytic Leukemia (CLL), respectively.

2 Phase 3 may not be required if Phase 2 is registrational.

3 ALLO-715 and ALLO-605 utilize TALEN® gene-editing technology pioneered and owned by Cellectis. Allogene has an exclusive license to the Cellectis technology for allogeneic products directed at the BCMA target. Allogene holds global development and commercial rights for this investigational candidate.

4 ALLO-316 utilizes TALEN® gene-editing technology pioneered and owned by Cellectis. Allogene has an exclusive license to the Cellectis technology for ​allogeneic products directed at the CD70 target. Allogene holds global development and commercial rights for this investigational.

Development of a product candidate takes place in several stages

Discovery

Identification of a new potential target that could lead to a future product candidate.

Product development

Engineering of “Chimeric Antigen Receptor” (CAR) T-cells is one of the technologies developed by Cellectis to construct new product candidates. This approach allows us to design allogeneic product candidates through a gene editing mechanism of T-cells derived from healthy donors. Gene editing is performed using TALEN®, which allow very precise and targeted gene modification and provide new attributes to the product such as additional levels of safety or compatibility with the standard of care.

Preclinical Studies

- In vitro studies performed on specific cell lines to have some preliminary results on the activity of a potential product candidate.
- In vivo studies performed on animal models in order to have preliminary results on the dose-dependent toxicity and on the activity of a potential product candidate before further clinical investigation.

IND filing (or foreign equivalent)

The Investigational New Drug (IND) filing in the USA consists of submitting the required study documentation package to the health authority (FDA) to obtain the authorization to perform clinical investigation.

Clinical Studies

Testing of the product candidate in humans.

Phases of clinical trials

Phase I

First time an experimental drug or treatment is tested in humans to examine how well the drug is tolerated.

Phase II

Trials designed to examine if the drug or treatment has a clinical activity.

Phase III

Trials designed to assess the treatment effect on a clinically meaningful endpoint.

Phase IV

Post-marketing studies to gain additional information.

Phase I

First time an experimental drug or treatment is tested in humans to examine how well the drug is tolerated.

Phase II

Trials designed to examine if the drug or treatment has a clinical activity.

Phase III

Trials designed to assess the treatment effect on a clinically meaningful endpoint.

Phase IV

Post-marketing studies to gain additional information.