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

EXPRS2Analytikerkommentar30.06.2025, 15.39

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 er en biotekvirksomhed med base i Danmark, men børsnoteret i Sverige. Virksomheden udvikler en portefølje af vacciner mod sygdomme som COVID-19, influenza og brystkræft gennem brugen af dets cellebaserede ekspressionssystem, ExpreS2, som er anerkendt for at håndtere protein udfordringer. ExpreS2ion har udviklet Expres2, som er en teknologiplatform til effektiv og hurtig ikke-klinisk udvikling og produktion af komplekse proteiner til nye vacciner og diagnostik. På nuværende tidspunkt er selskabets primære produkt corona-vaccinekandidaten, ABNCoV2 som er i fase 2, udviklet sammen med sin partner, AdaptVac, hvoraf ExpreS2ion ejer 34%. Vaccinekandidatens licensret tilhører Bavarian Nordic som har globale kommercialiseringsrettigheder og ansvar for yderligere klinisk udvikling af vaccinen.

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