Biontech Se Sponsored Adr ((BNTX)), Biontech SE (($CC:BNTX.CUR)) announced an update on their ongoing clinical study.
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Study Overview: BioNTech SE, in collaboration with DualityBio Inc., is conducting a Phase III clinical study titled A Phase III, Randomized, Multi-site, Open-label Trial of BNT323/DB-1303 Versus Investigator’s Choice of Chemotherapy in Previously Treated Patients With HER2- Expressing Recurrent Endometrial Cancer. The study aims to evaluate the efficacy of BNT323/DB-1303 compared to standard chemotherapy in improving progression-free survival in patients with recurrent endometrial cancer who have previously undergone immune checkpoint inhibitor treatment.
Intervention/Treatment: The study tests BNT323/DB-1303, an investigational drug administered via intravenous infusion, against standard chemotherapy options, doxorubicin or paclitaxel, chosen by the investigator.
Study Design: This is an open-label, randomized study with a parallel intervention model. Participants are randomly assigned in a 2:1 ratio to receive either BNT323/DB-1303 or chemotherapy. The primary purpose is treatment, with no masking involved.
Study Timeline: The study began on June 10, 2025, and is currently recruiting participants. The last update was submitted on July 8, 2025. These dates are crucial for tracking the study’s progress and potential market impact.
Market Implications: The ongoing study could significantly impact BioNTech’s stock performance, especially if BNT323/DB-1303 demonstrates superior efficacy. Positive results may boost investor confidence and position BioNTech favorably against competitors in the oncology space.
The study is ongoing, with further details available on the ClinicalTrials portal.