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 studied for the treatment of advanced malignant solid tumors and metastatic colorectal cancer. It is currently in Phase 1 clinical development for these oncology indications.
BNT314 targets PD-1, a protein involved in immune checkpoint regulation. By binding to PD-1, the antibody is designed to modulate immune responses against cancer cells.
BNT314 is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker symbol BNTX.
BNT314 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities.
BNT314 is being evaluated in two Phase 1 trials. NCT06150183 assesses its safety and preliminary efficacy in patients with advanced malignant solid tumors. NCT07079631 tests 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 being studied in combination with BNT314.