ExpreS[2]ion'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. ExpreS[2]ion 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, ExpreS[2]ion 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 ExpreS[2]ion'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, ExpreS[2]ion 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 ExpreS[2]ion 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, ExpreS[2]ion'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.

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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.