BNT327, a PD L1/VEGF antibody, belongs to a class of next-generation immunotherapies hoping to beat out Keytruda.
More than 85% of patients with small-cell lung cancer dosed with BioNTech’s investigational bispecific antibody BNT327 responded to the treatment, according to a mid-stage readout on Friday.
The data, presented at the 2025 European Lung Cancer Congress, come from a Phase II study that enrolled 50 patients with extensive-stage small-cell lung cancer. BNT327 was given as a first-line treatment, in combination with chemotherapy and platinum, once every three weeks for four cycles. Thereafter, patients were put on BNT327 maintenance doses until disease progression or unacceptable toxicity.
At the time of the data analysis, 48 study participants had completed at least one tumor evaluation, of whom 85.4% had a confirmed objective response rate. Disease control rate was 97.9% while the median progression-free survival was 6.9 months. Overall survival (OS) at 12 months was 72.7%, though BioNTech cautioned that these data were not yet mature.
As for safety, the mid-stage study recorded at least one treatment-related adverse event in all patients, with 86% experiencing severe side effects. Nevertheless, all side effects that BioNTech labeled as “of special interest” in its presentation were less problematic: hypertension, proteinuria and different forms of hemorrhage.
Two patients in the study died, though neither mortality was deemed related to the study drug. Three patients discontinued treatment due to toxicities, while 13 needed dose reductions.
BNT327 is BioNTech’s contender in the emerging class of cancer therapies that target both the PD-1 and VEGF pathways. This approach first captured the industry’s attention in September 2024 when Akeso and Summit Therapeutics announced that their own PD-1/VEGF therapy ivonescimab bested Keytruda in a Phase III study of non-small cell lung cancer.
By targeting PD-L1, the bispecific antibody boosts the immune system’s ability to detect and destroy cancer cells, while its action on VEGF-A prevents the formation of new blood vessels, thereby starving tumors of crucial nutrients.
Two months later, in November 2024, BioNTech acquired its partner Biotheus for $800 million upfront, gaining full ownership of BNT327.
BioNTech followed the deal up with a Phase Ib/II readout in December 2024, touting a 73.8% overall response rate at a median of 18.1 months of follow-up. Median duration of response was 11.7 months, while disease control rate was 95.2%.
But the news wasn’t all positive Thursday on the BioNTech front. The company lost its case before the European Patent Office, seeking to invalidate certain claims by CureVac over certain mRNA technologies. According to CureVac’s statement on the patent verdict, the matter will now move to the Regional Court Düsseldorf, which will decide whether BioNTech had infringed on these patents. The hearing is set for July 1, 2025.
