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) |
|
---|---|---|---|---|---|---|---|---|
|
UCART22 | Acute Lymphoblastic Leukemia | BALLI-01 | |||||
UCART123 | Acute Myeloid Leukemia | AMELI-01 | ||||||
UCART20x22 | Non Hodgkin Lymphoma | NatHaLi-01 | ||||||
Licensed to: | ||||||||
|
CEMACABTAGENE ANSEGEDLEUCEL1 |
Large B-cell Lymphoma | ALPHA3 |
|||||
CEMACABTAGENE ANSEGEDLEUCEL1 |
Chronic Lymphocytic Leukemia | ALPHA2 |
||||||
|
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.