Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NeoVax · 1 trial · 1 indication
The proportion of all enrolled patients for whom sequencing and analysis leads to identification of at least 7 actionable peptides to initiate vaccine production
Of the patients who generate at least 7 actionable peptides, the proportion for whom the time from sample collection to vaccine availability is less than 12 weeks
The number of patients with treatment-limiting toxicities based on NCI CTCAE v5.0
| Arm | Type | Description |
|---|---|---|
| NeoVax | EXPERIMENTAL | * NeoVax will be administered in a priming and booster phase. * The priming shots will comprise days 1, 4, 8, 15, and 22. * Booster shots will be given on days 78 and 134. |
| Neovax + Low-dose cyclophosphamide | EXPERIMENTAL | * NeoVax will be administered in a priming and booster phase. * The priming shots will comprise days 1, 4, 8, 15, and 22. * Booster shots will be given on days 78 and 134. * Low dose cyclophosphamide is administered twice daily on weeks -2, 1, 3, 5 |
| Neovax + Low-dose cyclophosphamide + Pembrolizumab | EXPERIMENTAL | * NeoVax will be administered in a priming and booster phase. * The priming shots will comprise days 1, 4, 8, 15, and 22. * Booster shots will be given on days 78 and 134. * Low dose cyclophosphamide is administered twice daily on weeks -2, 1, 3, 5 * Pembrolizumab will be administered starting on Week 12 Day 78 and for up to 17 cycles (approximately 1 year). |
| Name | Type | Description |
|---|---|---|
| NeoVax | DRUG | It stimulates the immune system to attack cancer cells. |
| Cyclophosphamide | DRUG | It is a chemotherapy drug used to treat many cancers. At low doses, it is an investigational drug to help the immune cells to be better at attacking cancer cells while avoiding chemotherapy toxicity. |
| Pembrolizumab | DRUG | Is a monoclonal antibody that helps the immune cells to be better at attacking cancer cells. |
Inclusion Criteria: * Diagnosis of CLL as per IWCLL 2018 criteria * Patient's CLL must have an unmutated immunoglobulin heavy chain variable (IGHV) region gene, defined as \< 2% mutated compared to germline. * Patient must have had no history of CLL-directed therapy due to meeting IWCLL 2018 criter...
NeoVax is an investigational personalized neoantigen cancer vaccine being studied for the treatment of lymphocytic leukemia, specifically in treatment-naive, asymptomatic patients with IGHV unmutated chronic lymphocytic leukemia. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
NeoVax is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker symbol BNTX. The company is conducting a Phase 1 clinical trial to evaluate the safety and efficacy of this personalized cancer vaccine in patients with lymphocytic leukemia.
NeoVax is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is actively recruiting participants to assess the vaccine's safety and preliminary efficacy in lymphocytic leukemia.
NeoVax is being evaluated in a single Phase 1 clinical trial registered as NCT03219450. This trial is titled 'A Personalized Neoantigen Cancer Vaccine in Treatment Naïve, Asymptomatic Patients With IGHV Unmutated CLL.' The study is recruiting 15 participants in the United States and is currently active.
Yes, NeoVax is classified as a small molecule modality. It is a personalized neoantigen cancer vaccine designed to target specific mutations in a patient's tumor. The drug is being studied in an oncology setting for the treatment of lymphocytic leukemia.