BioNTech adds two conjugates to its immunotherapy effort

BioNTech has been hinting that part of its increasingly combination-focused strategy would involve mRNA immunotherapies, and now it’s official: the company has added two ADC cohorts to a phase 1 trial of its FixVac candidate BNT116. The lung cancer study Luca-Merit-1 will evaluate BNT116 alongside ADCs targeting B7-H3 and HER3, according to a recent update on clinicaltrials.gov. These seem likely to be BNT324 (via DualityBio), and BNT326 (via MediLink) respectively. Various other arms are already ongoing; at AACR BioNTech reported data from cohort 4, testing BNT116 plus Regeneron’s checkpoint inhibitor Libtayo in frail patients unfit for first-line chemo. A 45% overall response rate among 20 patients was deemed promising. Still, other cohorts have looked less impressive: there were no responses in cohort 1, testing BNT116 with or without Libtayo in late-line, PD-L1-relapsed patients. Unlike BioNTech’s personalised neoantigen contender autogene cevumeran, BNT116 employs a fixed combination of six mRNA-encoded, tumour-associated antigens (MAGE-A3, MAGE-A4, MAGE-C1, Claudin6, KK-LC-1 and PRAME). The group’s other FixVac projects include BNT111 (melanoma) and BNT113 (head and neck cancer). BioNTech is already busy combining its PD-L1 x VEGF bispecific antibody BNT327 with ADCs, and recently reported the first combo data, alongside the TROP2-targeting BNT325.

Cohorts of Luca-Merit-1 trial of BNT116 in NSCLC

Source: OncologyPipeline & clinicaltrials.gov.