BioNTech Results Presentation Deck slide image

BioNTech Results Presentation Deck

SITC 2021 - BNT111 Phase 1: Strong Immunogenicity and Promising Clinical Activity in Cutaneous Melanoma Patients with Evidence of Disease and No Evidence of Disease FixVac off-the-shelf mRNA vaccine targeting 4 tumor-associated shared antigens Open-label, multicenter non-randomized trial in patients with pretreated, Stage III or IV cutaneous melanoma (n=115) ● ● 22 BNT111 Monotherapy 6 weekly and 2 biweekly injections (7 dose escalation cohorts and 3 expansion cohorts) Favorable Safety profile Most common treatment-related AEs: Mostly mild-to-moderate flu-like symptoms Similar safety profile between evidence of disease & no evidence of disease populations Low rate of related Serious AE Low rate of TEAE of Grade 23 nature¹ An RNA vaccine drives immunity in checkpoint- inhibitor-treated melanoma Ugur Sahin, Petra Oehm, [...]Özlem Türeci •O Data cutoff: May 24, 2021. AEs, adverse events; TEAE, treatment-emergent adverse events; CI, confidence interval ¹Sahin U, et al. Nature 2020; 585:107-112 (https://www.nature.com/articles/s41586-020-2537-9) No evidence of disease (n=33) Evidence of disease (n=38) Long-term follow up To be presented at SITC Continued treatment phase Previously reported in Nature ¹ CD4+ and CD8+ T cell responses Frequent high magnitude T cell responses; comparable between evidence of disease & no evidence populations In no evidence of disease patients 95% CI: 7.0-not reached Ex vivo ELISpot response against ≥1 tumor-associated antigen in: 14/22 (63.6%) evidence of disease patients 19/28 (67.7%) no evidence of disease patients Substantial fraction of de novo induced responses Median disease-free survival 34.8 months BIONTECH
View entire presentation