Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IVAC_W_bre1_uID · 1 trial · 1 indication
Assessment of AEs
Assessment of AEs, End of treatment visit is depending on treatment schedule
| Arm | Type | Description |
|---|---|---|
| ARM1 IVAC_W_bre1_uID | EXPERIMENTAL | Patients enrolled in ARM1 will receive a treatment with four RNAs. This includes two to three variant RNAs selected from the WAREHOUSE plus p53 RNA. The selection process of RNAs from the warehouse is based on RT-PCR-based profiling of RNA extracted from patient tumor sample specimens, pre-defined cut-offs and algorithms to select the three relevant RNAs for a given patient. |
| ARM2 IVAC_W_bre1_uID/IVAC_M_uID | EXPERIMENTAL | Patients enrolled in ARM2 will optionally receive the WAREHOUSE treatment as described above followed by the personalized IVAC® MUTANOME immunotherapy. The mutation selection process constitutes a multi-step process including identification of somatic mutations by NGS, mutation confirmation and prioritization, selection, and on demand manufacturing. |
| ARM3 IVAC_W_bre1_uID + RBLTet.1 | EXPERIMENTAL | Patients enrolled in ARM3 will receive a treatment with four RNAs. This includes two to three variant RNAs selected from the WAREHOUSE plus p53 RNA. The selection process of RNAs from the warehouse is based on RT-PCR-based profiling of RNA extracted from patient tumor sample specimens, pre-defined cut-offs and algorithms to select the three relevant RNAs for a given patient. RBLTet.1 RNA will be added to each RNA applied. |
| Name | Type | Description |
|---|---|---|
| IVAC_W_bre1_uID | BIOLOGICAL | vaccination |
| IVAC_W_bre1_uID/IVAC_M_uID | BIOLOGICAL | vaccination |
Inclusion Criteria: * Histologically confirmed invasive adenocarcinoma triple negative breast cancer (TNBC), pT1cN0M0 - anyTanyNM0 confirmed by physical examination or imaging * Triple negative breast cancer was defined as: * HER2 negative * IHC 0-1+ * IHC 2+ and FISH negative (ratio \< 2.0 ...
IVAC_W_bre1_uID is an investigational cancer immunotherapy being studied for the treatment of triple negative breast cancer (TNBC). It is a monoclonal antibody modality, though its specific molecular target has not been disclosed. The drug is currently in clinical development and is not approved by regulatory authorities.
IVAC_W_bre1_uID is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker symbol BNTX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy in patients with triple negative breast cancer.
IVAC_W_bre1_uID is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development.
IVAC_W_bre1_uID has been studied in one clinical trial registered as NCT02316457, titled "RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uID." This Phase 1 trial was completed and enrolled 42 female participants aged 18 years and older with triple negative breast cancer. The study was conducted in Germany and Sweden.
IVAC_W_bre1_uID and IVAC_M_uID are distinct investigational agents studied together in the same clinical trial, NCT02316457. The trial evaluated the combination of these two RNA-based immunotherapies in patients with triple negative breast cancer. They are separate drug candidates developed by BioNTech SE.