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Analyst Comment

ExpreS2ion Biotechnologies: Combination testing and site expansion approved ahead of schedule

By Michael FriisHead of Equities
ExpreS2ion Biotech Holding

ExpreS2ion today announced that Austrian authorities have approved the company's protocol amendment to test its breast cancer immunotherapy candidate, ES2B-C001, in combination with HER2-targeted antibody-drug conjugates (ADCs) such as trastuzumab deruxtecan, as well as to expand the number of trial sites.

The protocol amendment was filed in mid-May and was originally expected to be approved in Q3 2025. However, the approval came ahead of schedule, supporting the current timeline and possibly indicating an unmet medical need in this indication.

In this announcement, the company also confirmed that interim safety and tolerability data from the first cohort in the ongoing Phase I trial remain on track for release before the end of 2025.

This announcement follows the news from July 23, when the company revealed that the first patient had been dosed in the study.

You can read more about the background of the amendment in Here.

ExpreS2ion Biotechnologies is a Danish pharmaceutical company, which focuses on the development of vaccines through the use of its ExpreS2 production platform with AdaptVac's VLP technology

Disclaimer: HC Andersen Capital receives payment from ExpreS2ion Biotechnologies for a Digital IR agreement.— Michael Friis, 15:40, 30-06-2025 (updated 08:07, 01-07-2025).

ExpreS2ion is a Danish-based biotech company listed in Sweden. The company develops a portfolio of vaccines for diseases such as COVID-19, influenza, and breast cancer through the use of its non-viral cell-based expression system, ExpreS2, which is recognized for handling protein challenges. ExpreS2ion has developed Expres2, which is a technology platform for efficient and fast non-clinical development and production of complex proteins for new vaccines and diagnostics. The company’s current primary product is the corona vaccine candidate, ABNCoV2 in phase 2, co-developed with its partner, AdaptVac of which ExpreS2ion owns 34%. The vaccine candidate has been licensed to Bavarian Nordic has global commercialization rights and responsibility for further clinical development of the vaccine and is expected to initiate phase 3 testing for the product candidate in the first half of 2022.

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