Hørsholm, Denmark, 30 June 2025 - ExpreS2ion Biotech Holding AB (Nasdaq First North Growth Market: EXPRS2, "ExpreS2ion" or the "Company"), a clinical-stage biotechnology company with a focused portfolio of immunotherapy candidates for infectious diseases and cancer, today announced that the Austrian regulatory authorities have approved the Company's protocol amendment to evaluate its breast cancer immunotherapy candidate, ES2B-C001, in combination with HER2-targeted antibody-drug conjugates (ADCs) and to expand the number of trial sites.
Filed on 13 May 2025, the amendment enables concurrent administration of ES2B-C001 alongside HER2-targeted ADCs (such as trastuzumab deruxtecan) in select patients and allows for an increase in the number of clinical trial sites in Austria. The Company had anticipated approval by mid-Q3 2025; this was received ahead of schedule on 30 June. The expanded protocol is expected to support improved patient recruitment.
CEO Bent Frandsen Comments:
"The approval of this amendment enables us to evaluate ES2B-C001 in combination with standard-of-care HER2-targeted ADCs, representing an important step in exploring synergistic treatment strategies for HER2-expressing breast cancers. We are especially pleased to receive this early approval, helping us accelerate patient enrolment and data readout."
Interim safety and tolerability data from the first cohort in the ongoing Phase I trial of ES2B-C001 remains on track for release before year-end 2025.
About ES2B-C001 (HER2-VLP)
ES2B-C001 is an innovative immunotherapy developed to treat HER2-expressing cancers by stimulating a patient's own immune system, offering a novel alternative to existing antibody-based approaches. This novel approach combines ExpreS2ion's ExpreS2 production platform with AdaptVac's VLP technology, both of which have been proven in clinical Phase III. The HER2-VLP vaccine's design aims to stimulate a robust and durable polyclonal immune response against HER2-expressing tumours, offering a complementary strategy to current treatments. Preclinical studies, as highlighted by Ruzzi et al. (2022), have demonstrated the safety and efficacy across multiple animal models, significantly inhibiting tumour growth and improving survival rates. By leveraging the patient's immune system, ES2B-C001 addresses the complexities of HER2-expressing breast cancers, potentially offering enhanced therapeutic options and filling critical gaps in the current treatment landscape.
This press release constitutes inside information that ExpreS2ion Biotech Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation 596/2014. The information was sent for publication, through the agency of the contact persons set out above, at the time stated by the Company's news distributor, Cision, at the publication of this press release.
For further information about ExpreS2ion, please contact:
Bent U. Frandsen, CEO
Keith Alexander, CFO
E-mail: investor@expres2ionbio.com
Certified Adviser
Svensk Kapitalmarknadsgranskning AB
About ExpreS2ion
ExpreS2ion is a biotechnology company that develops innovative vaccines for a healthier world. We want to transform healthcare by developing novel vaccines, that are life-saving and improve quality of life across the world. ExpreS2ion has developed the unique human clinical Phase III-validated technology platform, ExpreS2, for fast and efficient development and production of the active material in vaccines. The platform, under the brand GlycoX-S2, includes functionally modified glycosylation variants for enhanced immunogenicity and pharmacokinetics. Since 2010, ExpreS2ion has produced more than 500 proteins and virus-like particles (VLPs) in collaboration with leading research institutions and companies. ExpreS2ion develops novel VLP based vaccines in association with AdaptVac ApS, of which ExpreS2ion owns 34%. For additional information, please visit www.expres2ionbio.com.
