Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT324 · 2 trials · 2 indications
By arm. rPFS is defined as time from randomization to radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, or death from any cause, whichever occurs first.
By arm. OS is defined as time from randomization to death from any cause.
ORR defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) is observed as best overall response (per response evaluation criteria in solid tumors \[RECIST\] version 1.1 based on the investigator's assessment).
ORR, defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per RECIST version 1.1 based on the investigator's assessment).
| Arm | Type | Description |
|---|---|---|
| BNT324 | EXPERIMENTAL | - |
| Docetaxel plus prednisone/ prednisolone | ACTIVE_COMPARATOR | - |
| Part 1 - BNT324 + BNT327 combination therapy | EXPERIMENTAL | Escalating combination dose levels of BNT324 and BNT327 to define RP2D and RP2D-1 for NSCLC and SCLC. |
| Part 2 - Cohort 1: RP2D of BNT324 + BNT327 and RP2D-1 of BNT324 + BNT327 | EXPERIMENTAL | In subpopulation 1 of NSCLC actionable oncogenic alteration (AGA) negative, first-line (1L) |
| Part 2 - Cohort 2: RP2D of BNT324 + BNT327 and RP2D-1 of BNT324 + BNT327 | EXPERIMENTAL | In SCLC, second-line plus (2L+) |
| Part 2 - Cohort 3: RP2D of BNT324 + BNT327 | EXPERIMENTAL | In subpopulation 1 of NSCLC AGA negative, 2L+ |
| Part 2 - Cohort 4: RP2D of BNT324 + BNT327 | EXPERIMENTAL | In subpopulation 2 of NSCLC AGA negative, 1L |
| Part 2 - Cohort 5: RP2D of BNT324 + BNT327 | EXPERIMENTAL | In subpopulation 2 of NSCLC AGA negative, 2L+ |
| Part 2 - Cohort 6: RP2D of BNT324 + BNT327 | EXPERIMENTAL | In NSCLC AGA positive |
| Part 2 - Cohort 7: RP2D of BNT324 + BNT327 | EXPERIMENTAL | In SCLC, 1L |
| Name | Type | Description |
|---|---|---|
| BNT324 | DRUG | Intravenous infusion |
| Docetaxel | DRUG | Intravenous infusion |
| Prednisone/prednisolone | DRUG | Oral |
| BNT327 | BIOLOGICAL | Intravenous infusion |
Key Inclusion Criteria: * Are male adults (defined as ≥18 years of age or of an acceptable age according to local regulations at the time of giving informed consent). * Must have documented progressive prostate cancer based on at least one of the following criteria: * Serum/plasma PSA progressio...
BNT324 is an investigational monoclonal antibody being studied for advanced lung cancer and metastatic castration-resistant prostate cancer. It is in Phase 1 clinical development for advanced lung cancer and Phase 3 for metastatic castration-resistant prostate cancer. The drug has received Fast Track designation from the FDA.
BNT324 is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker BNTX. The company is conducting clinical trials of BNT324 in multiple countries, including the United States, China, and several European nations.
BNT324 is in Phase 1 clinical development for advanced lung cancer and Phase 3 clinical development for metastatic castration-resistant prostate cancer. It is an investigational drug and has not been approved by regulatory authorities. The FDA has granted it Fast Track designation.
BNT324 is being studied in two clinical trials. NCT06892548 is a Phase 1 trial testing BNT324 in combination with BNT327 in advanced lung cancer. NCT07365995 is a Phase 3 trial comparing BNT324 to docetaxel in metastatic castration-resistant prostate cancer. Both trials are currently recruiting participants.
No, BNT324 and BNT327 are distinct investigational drugs. BNT324 is being studied as a monotherapy in a Phase 3 trial for prostate cancer and in combination with BNT327 in a Phase 1 trial for lung cancer. BNT327 is a separate agent used as part of the combination therapy.