ExpreS2ion announces completion of GLP safety study for ES2B-C001 (HER2-VLP) breast cancer vaccine candidate

Hørsholm, Denmark, 16 April 2024 – ExpreS2ion Biotech Holding AB’s affiliate ExpreS2ion Biotechnologies ApS (“ExpreS2ion") is pleased to announce the completion of the final report for the Good Laboratory Practice (GLP) safety study in non-human primates of the ES2B-C001 (HER2-VLP) breast cancer vaccine candidate.

This significant milestone marks an important step towards enabling a clinical trial application. The Company is currently focusing on Good Manufacturing Practice (GMP) production and designing the Phase I clinical trial, with the aim to initiate the Phase I trial within the next year.

CEO of ExpreS2ion, Bent U. Frandsen, comments, "The completion of the GLP safety study for our ES2B-C001 (HER2-VLP) breast cancer vaccine candidate is a testament to our team's dedication and hard work. This is a significant step forward in our mission to bring a potentially life-saving treatment to patients. We are now focusing our efforts on GMP production and designing the clinical trial, with the goal of initiating clinical trials within the next year. We look forward to driving this project further and making a meaningful impact in the fight against breast cancer."

About ES2B-C001 (HER2-VLP)
ES2B-C001 represents a novel development in the field of breast cancer therapeutics, specifically targeting human epidermal growth factor receptor 2 (HER2) positive breast cancers. This innovative vaccine is based on proven clinical Phase III-validated technology platforms, leveraging ExpreS2ion's production platform, ExpreS2, and AdaptVac's virus-like particle (VLP) technology. Extensive preclinical data underscore the safety and efficacy of ES2B-C001 across multiple animal models for breast cancer, as documented in the work of Ruzzi et al. (2022). HER2-positive breast cancer, marked by the overexpression of the human HER2 protein, represents a significant subset of breast cancer cases, impacting a notable proportion of patients. The treatment landscape for HER2-positive breast cancer has witnessed significant advancements, notably with targeted therapies like trastuzumab playing a pivotal role. However, ES2B-C001 sets itself apart by offering a novel approach. By harnessing the patient's immune system, it stimulates the production of polyclonal antibodies tailored to combat HER2-positive breast cancers. This approach not only adds a complementary dimension to existing therapeutic strategies but also holds promise in addressing the complexities of this challenging oncological domain.

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