ExpreS2ion Biotechnologies: First Patient Dosed in Phase 1 Clinical Trial of ES2B-C001

EXPRS2Analyst Comment2025-06-23 15:31

ExpreS2ion today announced that the first patient has been dosed with ES2B-C001, and the treatment was well tolerated. This successful dosing marks the transition of the trial from the enrollment phase to the treatment phase. The primary endpoint of the study is to evaluate safety, tolerability, and the maximum tolerated dose. The secondary endpoints include assessing the immunological response and signs of clinical efficacy, such as tumor size reduction.

In today’s announcement, the company also confirmed the timeline (Q3 2025) for a potential response to the amendment. This amendment is intended to support patient enrollment further by enabling the evaluation of the breast cancer vaccine candidate, ES2B-C001, in combination with antibody-drug conjugates (ADCs) and expanding the number of study sites.

At the Q1 2025 results presentation, the CEO stated that the company is still on track to potentially receive preliminary outcomes before the end of this year, with further results expected in 2026. With an anticipated 40-48 weeks to interim data, this timeline remains feasible.

Read the full announcement here:

https://www.inderes.dk/releases/expres2ion-biotechnologies-expres2ion-announces-dosing-of-first-patient-in-phase-i-clinical-trial-of-es2b-c001-its-novel-therapeutic-breast-cancer-immunotherapy

Disclaimer: HC Andersen Capital receives payment from ExpreS2ion Biotechnologies for a Digital IR/Corporate Visibility subscription agreement. Michael Friis, 15:30, 23-06-2025

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.