ExpreS2ion provides an update on its novel breast cancer vaccine candidate ES2B-C001

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Hørsholm, Denmark, February 8, 2022 – ExpreS2ion Biotech Holding AB’s affiliate ExpreS2ion Biotechnologies ApS (“ExpreS2ion" or the “Company”) announces constructive feedback from its scientific advice meeting pertaining to the therapeutic breast cancer vaccine candidate, ES2B-C001, with the Danish Medicines Agency (“DKMA”). Based on this feedback, ExpreS2ion plans to conduct an additional preclinical safety study in the first half of 2023, which will increase the robustness of the project’s preclinical data. Consequently, the Company is now aiming to file the clinical trial application for the Phase I trial in the second half of 2023, with the aim of dosing first in human in the first half of 2024.

ExpreS2ion’s scientific advice meeting with the DKMA provided feedback on important topics in the development plan regarding manufacturing, non-clinical safety, and the first-in-human (FIH) clinical trial design. Overall, the feedback was reassuring and constructive for the on-going development. The main comment from the DKMA with effect on the timing in the ES2B-C001 development plan was related to a requirement to conduct an additional preclinical safety study. ExpreS2ion is outsourcing its preclinical safety testing studies to a contract research organisation and has received feedback that a new study will take place in the first half of 2023. Additionally, the DKMA also provided some helpful suggestions for the clinical Phase I trial design, which will be addressed in an updated clinical Phase I trial plan. As a result, ExpreS2ion aims to file the clinical trial application for the Phase I clinical trial in the second half of 2023, with the aim of dosing first in human in the first half of 2024.

The updated preclinical plan for the therapeutic breast cancer vaccine will not have any substantial effect on ExpreS2ion’s financial position.

CEO Bent Frandsen comments:        

“The feedback received from the DKMA on our intensive development plan for ES2B-C001 reassures that we are firmly on the right track, and that our preclinical studies will deliver all the data we need to design the clinical program in the best way possible. The additional preclinical study will assist in de-risking the project considerably, thus creating an even more attractive risk/reward ratio as we progress towards the first in human clinical trial in 2024.”

About the therapeutic HER2+ breast cancer vaccine candidate, ES2B-C001

Breast cancer is a widespread oncology indication affecting more than 1.3 million people worldwide annually, resulting in more than 450,000 deaths (Tao, 2015: www.ncbi.nlm.nih.gov/pubmed/25543329). The most common treatment today is based on monoclonal antibodies, where the dominating therapy Herceptin (trastuzumab) generates annual global sales of USD 7 billion.

In February 2021, ExpreS2ion exclusively licensed in ES2B-C001 from its joint venture AdaptVac. ES2B-C001 is tailored to be highly competitive both in terms of cost and efficacy, thus aiming at a significant market share. The license gives ExpreS2ion full control over and responsibility for driving this valuable asset forward, hereby realising the very significant value of this project.

At the end of 2021, ExpreS2ion’s candidate demonstrated strong tumor-growth inhibiting effect in a mice model, thus reaching an important pre-clinical milestone ahead of schedule. Additionally, anti-HER2 antibodies from these studies were found to effectively inhibit tumor growth in human cancer cells. The candidate also demonstrated proof-of-concept in HER2-transgenic preventive as well as therapeutic tumor mice models, thus reaching a further important pre-clinical milestone.

Certified Adviser

Svensk Kapitalmarknadsgranskning AB

Telefon: +46 11 32 30 732

E-post: ca@skmg.se

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 Biotech Holding AB, please contact:

Bent U. Frandsen, CEO
Telephone: +45 4256 6869

Keith Alexander, CFO
Telephone: +45 5131 8147

About ExpreS2ion

ExpreS2ion Biotechnologies ApS is a fully owned Danish subsidiary of ExpreS2ion Biotech Holding AB with company register number 559033-3729. ExpreS2ion has developed a unique technology platform, ExpreS2, for fast and efficient non-clinical development and production of complex proteins for new vaccines and diagnostics. ExpreS2 is regulatorily validated for clinical supply. The platform includes functionally modified glycosylation variants for enhanced immunogenicity and pharmacokinetics. Since 2010, the Company has produced more than 500 proteins and virus-like particles (VLPs) in collaboration with leading research institutions and companies. ExpreS2ion develops novel capsid VLP based vaccines through its 34%-owned joint venture AdaptVac ApS. For additional information, please visit www.expres2ionbio.com.