One of BioNTech’s first mRNA cancer vaccine candidates has cleared a key mid-stage trial, setting it up for a potential showdown with a closely-watched and more advanced program from Merck and Moderna.
Its personalized immunotherapy, BNT111, boosted overall response rates by a statistically significant margin when given alongside Regeneron’s PD-1 Libtayo in a Phase 2 melanoma trial. The study enrolled patients with unresectable stage 3 or 4 melanoma whose disease had progressed following treatment containing PD-(L)1 inhibitors and compared the results with historical control.
BioNTech first teamed up with Regeneron to test this approach in 2020 and dosed the first patient in 2021. Having catapulted to pandemic fame with its Covid vaccines, the German company has renewed its cancer focus over the past year, building an “extensive” pipeline of both internal R&D and a string of deals.
Özlem Türeci, BioNTech co-founder and chief medical officer, said in a statement that the data offer a proof of concept in three dimensions: For its mRNA vaccine technology using an engineered, non-coding backbone and a special delivery technology; its computational approaches for selecting tumor antigens; and its strategy to combine synergistic modalities, in this case, BNT111 with an established immune checkpoint treatment.
BNT111 is made on BioNTech’s FixVac platform and carries four mRNA-encoded, tumor-associated antigens designed to trigger an immune response against cancer cells.
BioNTech and Regeneron said they will continue to follow the trial for secondary endpoints, which were not mature at the time of the primary analysis. They also plan to present more detailed data at a medical conference. The trial enrolled 184 patients, according to a ClinicalTrials.gov listing.
But they will have to contend with Merck and Moderna, which have launched a Phase 3 trial for their own PD-1/cancer vaccine combo after seeing positive results on recurrence-free survival.