EXPRS2
ExpreS2ion Reports Positive DSMB Outcome and Expanded Preliminary Phase I Data for ES2B-C001
Hørsholm, Denmark, 12 August 2026 – ExpreS2ion Biotech Holding AB’s affiliate ExpreS2ion Biotechnologies ApS ("ExpreS2ion"), a clinical-stage biotechnology company with a pipeline of novel immunotherapies targeting oncology and infectious diseases, today announces the outcome of the third scheduled Data Safety Monitoring Board ("DSMB") meeting in the Phase I trial of ES2B-C001 (HER2-VLP), its first-in-class active immunotherapy targeting HER2-expressing cancers, together with updated preliminary immunogenicity and safety observations. The DSMB identified no dose-limiting toxicities across the three dose cohorts and recommended expanding the highest-dose cohort (450 μg) by three additional patients, strengthening the dataset at the top dose ahead of the primary readout. Preliminary data show anti-HER2 antibody responses in 12 of 13 evaluable patients, including all five patients who have completed the dosing schedule, with a median 16-fold peak increase in antibody levels among completers. The Phase I primary readout target of end-2026 is unchanged. Phase II initiation is now targeted for the second half of 2027 to allow the Phase II plan to be reviewed with regulatory authorities in both Europe and the United States ahead of trial start.
