In short
BNT324 is an investigational protein-based medicine given by intravenous infusion. It is being studied in three clinical trials in advanced lung cancer and other solid tumours, including a Phase 3 trial in metastatic castration-resistant prostate cancer. The largest trial has 693 participants, and the smallest has 409.
Key points
- BNT324 is an investigational protein-based substance with no marketing authorisation.
- It is being studied in advanced lung cancer in a Phase 1 trial with 581 participants.
- A Phase 2 trial is testing BNT324 in solid tumours including NSCLC, cervical cancer and melanoma with 409 participants.
- A Phase 3 trial is comparing BNT324 with docetaxel in metastatic castration-resistant prostate cancer with 693 participants.
- All three trials give BNT324 by intravenous infusion.
- The trials measure safety, dose-limiting toxicities, objective response rate and survival.
What is BNT324?
BNT324 is an investigational protein-based substance developed by BioNTech SE. It has no marketing authorisation in the product records, meaning it is not yet approved as a medicine. The substance is classified in the therapeutic area of neoplasms, which covers cancers. BNT324 appears as the test substance in one trial and is also listed as an intervention in two other trials.
How does BNT324 work?
The registry records do not state the molecular target or mechanism of action of BNT324. The substance is described as a protein-based product given by intravenous infusion, and it is being tested in combination with other investigational cancer medicines. The trials focus on whether the combination is safe and whether tumours shrink or stop growing.
Which conditions is BNT324 being studied for?
- Advanced lung cancer — a Phase 1 trial is testing BNT324 in combination with BNT327 in people with advanced lung cancer.
- Non-small cell lung cancer (NSCLC) — one of the lead indications in the Phase 2 trial.
- Small cell lung cancer (SCLC) — the second lead indication in the Phase 2 trial, specifically relapsed or progressive SCLC.
- Cervical cancer, melanoma, hepatocellular carcinoma, ovarian cancer and squamous cell carcinoma of head and neck — additional tumour types in the Phase 2 trial.
- Metastatic castration-resistant prostate cancer (mCRPC) — a Phase 3 trial is comparing BNT324 with docetaxel in this condition.
How is BNT324 given?
BNT324 is given by intravenous infusion. The pharmaceutical form is a powder for concentrate for solution for injection or infusion, which is prepared before use. In the Phase 3 trial, BNT324 is given at a dose of 6 mg per kilogram of body weight intravenously. The Phase 1 and Phase 2 trial records do not report the dose of BNT324 used.
What do the clinical trials show?
Three clinical trials of BNT324 are registered. They cover Phase 1, Phase 2 and Phase 3, and together they plan to enrol 1,683 participants.
What phases and status do the trials have?
The Phase 1 trial in advanced lung cancer is authorised and has 581 participants. The Phase 2 trial in solid tumours is authorised and has 409 participants. The Phase 3 trial in mCRPC is authorised and has 693 participants. All three trials are interventional studies, meaning participants receive the treatment as part of the research.
What are the trials measuring?
The Phase 1 trial measures dose-limiting toxicities, treatment-emergent adverse events, and the objective response rate (ORR), which is the proportion of participants whose tumour shrinks or disappears completely. The Phase 2 trial also measures dose-limiting toxicities and ORR, as well as safety. The Phase 3 trial measures radiographic progression-free survival (rPFS), which is the time until the cancer grows on imaging or the participant dies, and overall survival (OS), which is the time until death from any cause.
Who can take part in these trials?
The Phase 1 trial is for people with advanced lung cancer. The Phase 2 trial is for people with NSCLC, SCLC, cervical cancer, melanoma, hepatocellular carcinoma, ovarian cancer or squamous cell carcinoma of head and neck. The Phase 3 trial is for people with metastatic castration-resistant prostate cancer.
What side effects are known?
The trial records do not report side effects from completed studies. The trials are designed to collect information on dose-limiting toxicities and treatment-emergent adverse events, which are side effects that appear during treatment. No supplementary sources with side effect data were provided.