Product Candidates

Pipeline

wholly-controlled

Alliance

Drag
7. Phase II
6. Phase I
5. IND filing (or foreign equivalent)
4. manufacturing
3. Preclinical studies
2. product development
1. Discovery
7. Phase II
6. Phase I
5. IND filing (or foreign equivalent)
4. manufacturing
3. Preclinical studies
2. product development
1. Discovery
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UCART19
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UCART123 - On hold
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UCART22
i
UCARTCS1
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UCART38

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 in 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.