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 immunotherapy being studied for breast cancer, specifically triple negative breast cancer (TNBC). It is being developed by BioNTech SE as a monoclonal antibody-based treatment in the oncology therapeutic area. The only completed clinical trial to date enrolled 42 female patients aged 18 years and older with TNBC.
IVAC_W_bre1_uID is being developed by BioNTech SE, which trades under the ticker BNTX. BioNTech is the sponsor of the clinical program evaluating this agent in triple negative breast cancer.
IVAC_W_bre1_uID is in Phase 1 clinical development. It has completed one Phase 1 trial and is not currently listed as active in any ongoing trials. As a Phase 1 investigational agent, it has not been approved by the FDA for any indication.
IVAC_W_bre1_uID has been evaluated in one completed Phase 1 clinical trial, NCT02316457, titled RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uID. The trial enrolled 42 female patients with triple negative breast cancer across sites in Germany and Sweden. It was a controlled study without randomization or double-blinding.
Yes, IVAC_W_bre1_uID is a biomarker-selected therapy. Its clinical development in triple negative breast cancer has used biomarker selection to identify appropriate patients for treatment. This approach is common in oncology trials to target patients most likely to respond based on specific molecular characteristics.