Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NEO-PV-01 · 2 trials · 9 indications
Rate of adverse events and severe adverse events leading to treatment discontinuation and those adverse events and severe adverse events detected during symptom-directed physical examinations (changes in safety laboratory evaluations, physical examination findings. vital signs, and ECOG PS)
| Arm | Type | Description |
|---|---|---|
| NEO-PV-01/Adjuvant + pembrolizumab + chemotherapy | EXPERIMENTAL | Pembrolizumab at a dose of 200 mg administered by intravenous infusion (IV) plus chemotherapy with carboplatin (AUC 5) + pemetrexed (500 mg/m2) every 3 weeks for 4 cycles. At Week 12, all patients, regardless of their disease status, will receive NEO-PV-01 + adjuvant administered subcutaneously (one vial of pooled peptides per injection site) in up to four distinct sites (each extremity or flanks) while continuing therapy with pembrolizumab. |
| Drug: NEO-PV-01 + Nivolumab + Adjuvant | EXPERIMENTAL | Nivolumab at a dose of 240 mg administered by intravenous (IV) infusion over 30 minutes every two weeks. At Week 12, all patients, regardless of their disease status, will receive NEO-PV-01 + adjuvant administered subcutaneously (one vial of pooled peptides per injection site) in up to four distinct sites (each extremity or flanks) while continuing therapy with nivolumab. |
| Name | Type | Description |
|---|---|---|
| NEO-PV-01 | BIOLOGICAL | Personal Cancer Vaccine |
| Pembrolizumab | BIOLOGICAL | monoclonal antibody against PDL1 |
| Adjuvant | OTHER | immune adjuvant |
| Carboplatin | DRUG | chemotherapy |
| Pemetrexed | DRUG | chemotherapy |
| Nivolumab | BIOLOGICAL | monoclonal antibody against PD1 |
Inclusion Criteria: * Willing and able to give written informed consent. * Have histologically confirmed unresectable or metastatic nonsquamous NSCLC and having received no prior systemic therapy for metastatic disease. * Have at least 1 site of disease measurable by RECIST v1.1 that has not been t...
NEO-PV-01 is an investigational personalized cancer vaccine being studied for the treatment of non-small-cell lung cancer and urinary bladder cancer. It is in Phase 1 clinical development and has not been approved by the FDA. The vaccine is designed to target neoantigens specific to a patient's tumor.
NEO-PV-01 is a personalized cancer vaccine that targets neoantigens, which are unique mutations present on a patient's tumor cells. By directing the immune system to these specific targets, the vaccine aims to generate an anti-tumor immune response. It is being studied in combination with checkpoint inhibitors.
NEO-PV-01 is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker symbol BNTX. BioNTech is conducting clinical trials to evaluate the safety and efficacy of this personalized cancer vaccine in patients with certain solid tumors.
NEO-PV-01 is in Phase 1 clinical development. It is an investigational agent and has not received FDA approval. Two Phase 1 trials have been completed, and the drug is no longer in active clinical testing according to the available data.
NEO-PV-01 has been studied in two completed Phase 1 clinical trials. NCT02897765 evaluated the vaccine with nivolumab in patients with melanoma, lung cancer, or bladder cancer. NCT03380871 evaluated the vaccine with pembrolizumab and chemotherapy in patients with non-small-cell lung cancer.
NEO-PV-01 is a personalized cancer vaccine, meaning it is individually manufactured for each patient based on the specific mutations found in their tumor. It is designed to stimulate the immune system to recognize and attack cancer cells carrying those unique neoantigens.