Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT314 · 2 trials · 2 indications
Assessed according to Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) including Grade ≥3, serious, fatal TEAEs by relationship.
Assessed according to CTCAE v5.0 including Grade ≥3, serious, fatal TEAEs by relationship.
Defined as the percentage of participants in whom a complete response (CR) or confirmed partial response (PR) (assessed by the blinded independent central review \[BICR\] per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\]) is observed as best overall response.
Defined as the time from randomization to first documented tumor progression (progressive disease assessed by BICR per RECIST v1.1), or death from any cause, whichever occurs first.
In patients receiving at least one dose of BNT314 per cohort
In patients receiving at least one dose of BNT314 per cohort
In patients receiving at least one dose of BNT314 per cohort
| Arm | Type | Description |
|---|---|---|
| Phase 1 (Part A): BNT314 (escalating dose levels) + pumitamig | EXPERIMENTAL | Up to 5 dose levels of BNT314. One or two dose levels of pumitamig. |
| Phase 1 (Part B): BNT314 + pumitamig + SoC chemotherapy 1 | EXPERIMENTAL | BNT314 (optimized dose level 1 or 2 as determined based on data from Part A) + pumitamig + SoC combination chemotherapy 1. One selected dose level of pumitamig. |
| Phase 1 (Part B): BNT314 + pumitamig + SoC chemotherapy 2 | EXPERIMENTAL | BNT314 (optimized dose level 1 or 2 as determined based on data from Part A) + pumitamig + SoC combination chemotherapy 2. One selected dose level of pumitamig. |
| Phase 2 (Part C): BNT314 + pumitamig + SoC chemotherapy 1 | EXPERIMENTAL | Recommended phase 2 dose of BNT314 + pumitamig + SoC combination chemotherapy 1. One selected dose level of pumitamig. |
| Phase 2 (Part C): Bevacizumab + SoC chemotherapy 1 | ACTIVE_COMPARATOR | Combination of two different SoC therapies |
| Phase 2 (Part C): Pumitamig + SoC chemotherapy 1 | EXPERIMENTAL | Pumitamig + SoC combination chemotherapy 1. One selected dose level of pumitamig. |
| BNT314 Monotherapy | EXPERIMENTAL | Escalating dose levels and backfill cohorts |
| Name | Type | Description |
|---|---|---|
| BNT314 | BIOLOGICAL | Intravenous (IV) infusion |
| Pumitamig | DRUG | IV infusion |
| SoC chemotherapy treatment 1 | DRUG | IV infusion / IV bolus |
| SoC chemotherapy treatment 2 | DRUG | IV infusion / IV bolus / oral |
| Bevacizumab | DRUG | IV infusion |
Key Inclusion Criteria: * Have unresectable histologically confirmed adenocarcinoma of the colon or rectum. * Have confirmed non-microsatellite instability-high (non-MSI-H)/pMMR mCRC per Food and Drug Administration (FDA)/European Commission (EC) approved test or based on local testing. * Have meas...
BNT314 is an investigational monoclonal antibody being developed for the treatment of advanced malignant solid tumors and metastatic colorectal cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
BNT314 targets PD-1, a protein involved in immune checkpoint regulation. By binding to PD-1, the antibody is designed to modulate the immune system's response against cancer cells, though its full mechanism of action is still under investigation in clinical trials.
BNT314 is being developed by BioNTech SE, a biotechnology company listed on the NASDAQ under the ticker symbol BNTX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy.
BNT314 is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The ongoing trials are designed to assess its safety, tolerability, and preliminary efficacy in patients with advanced solid tumors.
BNT314 is being evaluated in two Phase 1 trials. NCT06150183 is studying the drug as a monotherapy in patients with advanced malignant solid tumors. NCT07079631 is testing BNT314 in combination with pumitamig (BNT327) and chemotherapy in patients with metastatic colorectal cancer.
No, BNT314 is not the same as pumitamig. BNT314 is a PD-1-targeting monoclonal antibody, while pumitamig (also known as BNT327) is a separate investigational treatment. The two drugs are being studied together in a combination trial for metastatic colorectal cancer.