Danish biotechnology company ExpreS2ion Biotech Holding AB (STO:EXPRS2) on Thursday announced initial immunogenicity data based on the first patient enrolled in its Phase I clinical trial of ES2B-C001, a therapeutic vaccine targeting HER2-expressing breast cancer.
The patient received two vaccine doses over six weeks, with blood samples taken before dosing and three weeks after each dose. Analysis showed a significant rise in HER2-specific antibodies following the second dose, indicating a vaccine-induced immune response.
Researchers highlighted that the antibody increase is independent of prior monoclonal antibody or antibody-drug conjugate therapies. This represents the first confirmation that ES2B-C001 can activate the human immune system and break tolerance toward HER2, consistent with its intended mechanism of action.
Investigators emphasised the preliminary nature of the findings, noting the results are limited to one patient. Additional data from the first cohort are expected after review by the Data Safety Monitoring Board later this year.
ExpreS2ion's leadership described the results as an important milestone, underscoring both the potential of ES2B-C001 and the value of the company's vaccine platform. The Phase I trial, which commenced in June 2025, continues to recruit patients.
LakeShore Biopharma receives Nasdaq delisting determination letter
Valneva reports strong Phase 2 booster results for Lyme disease vaccine candidate VLA15
GC Biopharma files IND for Phase 3 trial of BARYCELA in Thailand
Novavax COVID-19 vaccine approved in US
WHO and UNICEF deploy PharmaJet's Tropis ID system in Afghanistan polio campaign
FDA grants priority review for GSK's gepotidacin gonorrhoea indication
GSK to receive USD370m and future royalties in CureVac/BioNTech settlement
FDA lifts pause on Valneva's chikungunya vaccine IXCHIQ for elderly, updates prescribing information
Anixa Biosciences begins US FDA approved IND transfer to support Phase 2 breast cancer vaccine trial
Pfizer and BioNTech receive EU regulatory backing for LP.8.1-adapted COVID-19 vaccine
Sanofi to acquire Vicebio for USD1.15bn to strengthen respiratory vaccine pipeline
Bavarian Nordic chikungunya vaccine enters Health Canada review process