This section highlights FDA-related milestones and regulatory updates for drugs developed by Cellectis (CLLS).
Over the past two years, Cellectis has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TALEN® and UCART22. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
TALEN® - FDA Regulatory Timeline and Events
TALEN® is a drug developed by Cellectis for the following indication: For triple negative breast cancer (TNBC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TALEN®
- Announced Date:
- September 3, 2024
- Indication:
- For triple negative breast cancer (TNBC)
Announcement
Cellectis today published a scientific article in Science Advances suggesting that TALEN®-edited MUC1 CAR T-cells could be a potential treatment option for advance-stage triple negative breast cancer (TNBC) patients with limited therapeutic options.
AI Summary
Cellectis recently published a study in Science Advances showing that TALEN®‐edited MUC1 CAR T-cells may offer a new treatment option for patients with advanced-stage triple-negative breast cancer (TNBC), a form of cancer with few current treatment choices. The research describes a multi-layered engineering strategy where CAR T-cells are modified using TALEN® and synthetic biology to improve their ability to fight tumors. These multi-armored CAR T-cells are designed with several edits—including PD1 knockout, tumor-specific IL12 release, and TGFBR2 knockout—to overcome the tumor’s immunosuppressive microenvironment.
The study’s preclinical tests in mouse models demonstrated that both intravenous and intratumoral delivery of these cells effectively reduced large, metastatic tumors. This approach may not only target primary tumors but also help control distant lesions, suggesting a promising new option for treating TNBC patients with limited alternatives.
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UCART22 - FDA Regulatory Timeline and Events
UCART22 is a drug developed by Cellectis for the following indication: For patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- UCART22
- Announced Date:
- July 25, 2024
- Indication:
- For patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia
Announcement
Cellectis announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) Status
AI Summary
Cellectis announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) Status to its UCART22 product candidate. The RPDD status is awarded to therapies addressing serious, life‐threatening diseases that mainly affect individuals from birth to 18 years old, which shows the FDA’s recognition of the need for new treatments in this area.
UCART22 is designed for the treatment of acute lymphoblastic leukemia (ALL), a fast-progressing disease responsible for about 10% of all leukemia cases in the United States and often fatal if left untreated. This designation is an important step in developing an allogeneic CAR T-cell therapy. It may help expedite the drug’s development and review process while potentially reducing costs. The achievement supports Cellectis' commitment to advancing promising new therapies for children with this challenging disease.
Read Announcement- Drug:
- UCART22
- Announced Date:
- July 25, 2024
- Indication:
- For patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia
Announcement
Cellectis announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug (ODD)
AI Summary
Cellectis announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug and Rare Pediatric Disease Designation status to its UCART22 product candidate for treating acute lymphoblastic leukemia (ALL). ALL accounts for about 10% of all leukemia cases in the United States and is known for its rapid progression and high fatality rate if left untreated.
Mark Frattini, M.D., Ph.D., Chief Medical Officer at Cellectis, highlighted that this FDA designation underlines the potential of UCART22 to offer a new therapeutic option for patients who cannot undergo hematopoietic stem cell transplantation or have relapsed after previous treatments. The designations are expected to accelerate and reduce the development costs associated with UCART22, helping move this promising allogeneic CAR T-cell therapy closer to becoming a readily available treatment for ALL patients.
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