Product candidates

 

Development of a product candidate takes place in several stages

 

Discovery

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

Product development

Engineering of “Chimeric Antigen Receptor” (CAR) T-cell is the technology developed by Cellectis to construct new potential products. This approach allows Cellectis to develop allogeneic products through a geneediting 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 compatibility with the standard of care.

In Vitro Studies

Studies performed on specific cell lines to have some preliminary results on the activity of a potential product candidate.

In Vivo Studies

Preclinical 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 to validate clinical trials before its investigation.

CTA/IND filing

The Clinical Trial Application (CTA) or the Investigational New Drug (IND) filing in the USA (FDA) is the regulatory step consisting on the submission of the required study documentation package to the health authority to obtain the authorization to perform clinical investigation.
 
 
Phases of clinical trials
Clinical trials take place in several phases:
  • 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