o Encouraging preliminary efficacy was observed, with a confirmed ORR of 38.5%
(5 out of 13 PD-L1-positive patients) compared to 19.1% in the reported
historical control with standard of care (pembrolizumab monotherapy) in a
comparable first-line setting. In patients with high PD-L1 expression (CPS >=
20), the ORR was 50.0% (3 out of 6 patients) compared to historical 23.3%.
o The overall disease control rate (DCR) was 69.2% (vs. 47.1% in the historical
control). In patients with high PD-L1 expression (CPS >= 20), the DCR was 100.0%
(vs. 53.4% in the historical control).
o Robust immunogenicity was demonstrated, with 100% of evaluable patients in the
6 mg and 9 mg cohorts showing HPV-16 specific T cell responses.
o The combination showed a favorable safety profile, with all abi-suva dose
levels safety cleared and only transient, manageable Grade 1-2 adverse events,
and with no treatment discontinuations or fever.
o Safety data and dose regimen are superior to recent competitor data together
with a strong efficacy profile