BNT326

Table of contents

• What is BNT326?
• How does BNT326 work?
• Which conditions is BNT326 being studied for?
• How is BNT326 given?
• What do the clinical trials show?
• Who can take part in these trials?
• What are the trials measuring?
• What side effects are known?

What is BNT326?

BNT326 is an investigational protein-based substance developed by BioNTech SE.^[1] It is not an authorised medicine: the product records show no marketing authorisation, meaning it is still being studied in clinical trials.^[1] BNT326 is classified in the therapeutic area of neoplasms, which refers to cancers and tumours.^[1] The substance appears only under the name BNT326 in the registry records.^[1]

How does BNT326 work?

The registry records describe BNT326 as a protein-based substance, but the available data do not explain its molecular target or exact mechanism of action.^[1] What is known from the trial design is that BNT326 is being tested both on its own and in combination with BNT327, another investigational drug, and with standard chemotherapy medicines.^[1][2] This combination approach is common in cancer research, where drugs with different mechanisms may work together, but the specific way BNT326 acts is not described in the provided sources.

Which conditions is BNT326 being studied for?

• Advanced solid tumours — a broad category of cancers that form solid masses in organs or tissues and have spread or cannot be removed by surgery. This is studied in the first trial.^[1]
• Non-small cell lung cancer (NSCLC) — the most common type of lung cancer, which tends to grow and spread more slowly than small cell lung cancer. This is studied in the second trial.^[2]

How is BNT326 given?

BNT326 is given as an intravenous infusion, meaning it is delivered directly into a vein over a period of time.^[1] The pharmaceutical form is a powder for concentrate for solution for infusion, which means the powder is first dissolved to make a concentrate, then diluted into a solution before being infused.^[1] The same form and route are used in both trials.^[1][2]

What do the clinical trials show?

BNT326 is being investigated in two authorised Phase 1 trials.^[1][2] Phase 1 trials are the earliest stage of testing in people, focusing mainly on safety, tolerability and finding the right dose. The first trial (2024-517261-16-00) has 1,438 participants and tests BNT326 both alone and in combination with BNT327 in people with advanced solid tumours.^[1] The second trial (2024-519344-32-00) has 880 participants and tests BNT326 in combination with BNT327, with or without chemotherapy drugs such as pembrolizumab, carboplatin, paclitaxel and pemetrexed, in people with advanced NSCLC.^[2] Both trials are currently authorised, meaning they have received regulatory approval to proceed but may not yet be recruiting.^[1][2]

Who can take part in these trials?

The trials enrol adults with advanced cancers. The first trial includes people with advanced solid tumours, a broad group covering many cancer types.^[1] The second trial is specifically for people with advanced non-small cell lung cancer.^[2] The registry records do not provide detailed eligibility criteria such as age limits, previous treatments or specific tumour markers, so the full inclusion and exclusion criteria would need to be checked in the trial records.

What are the trials measuring?

Both trials measure safety primarily, as expected in Phase 1. The first trial records the occurrence of treatment-emergent adverse events, which are side effects that appear after treatment starts, including serious adverse events, and how often treatment has to be interrupted, reduced or stopped because of them.^[1] It also measures the objective response rate (ORR), which is the proportion of participants whose tumours shrink completely or partially, assessed using RECIST 1.1 criteria.^[1] The second trial measures dose-limiting toxicities, which are side effects severe enough to prevent increasing the dose, as well as adverse events and the objective response rate.^[2] It also aims to determine the recommended Phase 2 dose of BNT326 in combination with BNT327.^[2]

What side effects are known?

The provided sources do not include information on the specific side effects of BNT326. The trials are designed to collect this information, and the primary outcomes include recording treatment-emergent adverse events and serious adverse events.^[1][2] Until the trial results are published, the side effect profile of BNT326 remains unknown.