Main Product Candidates
Pipeline
wholly controlled
Alliance
(or foreign equivalent)
(or foreign equivalent)
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.