BioNTech's BNT327 Shows Promise in Small-Cell Lung Cancer, Faces Patent Challenges

Impressive Phase II Results for BNT327 in SCLC

BioNTech has reported encouraging results from a Phase II study of its investigational bispecific antibody BNT327 in patients with extensive-stage small-cell lung cancer (SCLC). The data, presented at the 2025 European Lung Cancer Congress, revealed that more than 85% of patients responded to the treatment when given as a first-line therapy in combination with chemotherapy and platinum.

The study enrolled 50 patients, with 48 completing at least one tumor evaluation. Among these, 85.4% achieved a confirmed objective response rate, while the disease control rate reached an impressive 97.9%. The median progression-free survival was 6.9 months, and the 12-month overall survival rate stood at 72.7%, although BioNTech cautioned that survival data were not yet mature.

BNT327, which targets both PD-L1 and VEGF pathways, represents a new class of cancer therapies aiming to surpass the efficacy of established treatments like Keytruda. By simultaneously boosting the immune system's ability to detect and destroy cancer cells and inhibiting the formation of new blood vessels that feed tumors, BNT327 offers a dual approach to fighting cancer.

Safety Profile and Treatment Challenges

While the efficacy data are promising, the study also highlighted some safety concerns. All patients experienced at least one treatment-related adverse event, with 86% reporting severe side effects. However, events of special interest, including hypertension, proteinuria, and various forms of hemorrhage, were reported to be less problematic.

Two patient deaths occurred during the study, though neither was attributed to the study drug. Three patients discontinued treatment due to toxicities, and 13 required dose reductions. These safety findings underscore the need for careful monitoring and management of side effects in future studies and potential clinical applications.

Patent Dispute with CureVac

In a separate development, BioNTech faces legal challenges regarding its mRNA technologies. The company recently lost a case before the European Patent Office, where it sought to invalidate certain claims by CureVac related to mRNA technologies. The matter will now proceed to the Regional Court Düsseldorf, which will determine whether BioNTech infringed on these patents. A hearing is scheduled for July 1, 2025.

This patent dispute highlights the competitive and complex landscape of mRNA technology, which has gained significant attention following the success of mRNA-based COVID-19 vaccines. The outcome of this legal battle could have far-reaching implications for BioNTech's future developments in the mRNA space.