ExpreS2ion announces approval to initiate a Phase I clinical trial of ES2B-C001, its novel therapeutic vaccine, being developed for HER2-expressing breast cancer
Hørsholm, Denmark, 2 December 2024 – ExpreS2ion Biotech Holding AB’s affiliate ExpreS2ion Biotechnologies ApS (“ExpreS2ion"), a clinical-stage biotechnology company with a focused portfolio of vaccine candidates targeting infectious diseases and cancer, is proud to announce the approval of its Phase I clinical trial application (CTA) by the Austrian Agency for Health and Food Safety for its novel therapeutic vaccine candidate, ES2B-C001, against HER2-expressing breast cancer.
Bent U. Frandsen, Chief Executive Officer said: “This is the first time we advance a development project into the clinical setting, and I am of course excited for reaching this very important milestone and for the opportunities that lie ahead. ES2B-C001 is a promising vaccine candidate with the potential to address multiple severe cancer indications, from breast cancer to gastro-oesophageal cancer. However, first we must start and complete this Phase I trial, where dosing of the first patient can start soon.”
The Phase I clinical trial follows a series of successful preclinical safety and efficacy studies in animal models that demonstrated ES2B-C001's potential to overcome resistance to the current immunotherapies used as standard of care.
Dr. Farshad Guirakhoo, Chief Science Officer said: “In preclinical mouse models, ES2B-C001 demonstrated remarkable efficacy by significantly inhibiting human breast cancer tumour growth and achieving 100% survival when used both prophylactically and therapeutically. Additionally, sera from vaccinated mice effectively blocked colony formation by human breast cancer cells, including those resistant to Herceptin. We are confident that ES2B-C001 has the potential to extend survival and enhance the quality of life for patients with HER2-expressing cancers.”
ES2B-C001 is a first-in-class therapeutic vaccine targeting HER2-expressing cancer cells. It utilizes virus like particles (VLP) to display the full extracellular domain of the human HER2 protein on its surface, stimulating a robust and durable polyclonal immune response.
The open label, dose-escalation Phase 1 trial will assess the safety, tolerability, and maximum tolerated dose (MTD) of ES2B-C001, either alone or combined with the adjuvant Montanide. Up to 30 patients with metastatic breast cancer will participate in the study.
The VLP platform underpinning ES2B-C001 has previously been validated in a Phase III pivotal trial conducted by Bavarian Nordic for the ABNCoV2 COVID-19 vaccine. This trial demonstrated the safety and tolerability of the VLP-based technology in over 4,000 participants, with no related serious adverse events reported.
About ES2B-C001 (HER2-VLP)
ES2B-C001 is an innovative therapeutic vaccine developed specifically for HER2-expressing breast cancers. This novel approach combines ExpreS2ion's ExpreS2 production platform with AdaptVac's clinically validated VLP technology. The vaccine’s design aims to stimulate a robust and durable polyclonal immune response against HER2-expressing tumors, offering a complementary strategy to current treatments. Preclinical studies, as highlighted by Ruzzi et al. (2022), have demonstrated the vaccine’s safety and efficacy across multiple animal models, significantly inhibiting tumor growth and improving survival rates. ES2B-C001 builds upon proven Phase III technology, ensuring its development is grounded in established and reliable platforms. 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.
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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.
For further information about ExpreS2ion, please contact:
Bent U. Frandsen, CEO
Keith Alexander, CFO
Email: investor@expres2ionbio.com
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Svensk Kapitalmarknadsgranskning AB
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 below, at the time stated by the Company’s news distributor, Cision, at the publication of this press release.
For further information about ExpreS2ion Biotech Holding AB, please contact:
Bent U. Frandsen, CEO
Keith Alexander, CFO
E-mail: investor@expres2ionbio.com
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.