Bio-Thera Solutions has initiated dosing in a Phase I clinical trial of BAT8013, an antibody drug conjugate (ADC) designed to target cluster of differentiation 25 (CD25), in patients with advanced solid tumours.
The dose-escalation, open-label, multicentre study aims to assess the tolerability and safety of BAT8013 and identify the recommended dose for Phase II trials.
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CD25 is also known as interleukin-2 receptor alpha chain (IL-2Rα).
Encoded by the IL2RA gene, this transmembrane glycoprotein is mainly found on activated T and B cells, regulatory T cells (Tregs), as well as certain haematologic cancers.
It is overexpressed on Tregs in the solid tumour microenvironment.
Bio-Thera Solutions has developed BAT8013 using its anti-CD25 antibody and linker-payload system, which includes a systemically stable and cleavable linker bound to a small molecule topoisomerase I inhibitor.
The compant noted that Tregs elimination with BAT8013 could enhance the efficacy of other immune-oncology agents such as PD-1 and PD-L1 monoclonal antibodies.
Preclinical research demonstrated apparent stability, safety, and strong anti-tumour activity for BAT8013, particularly when combined with the company’s PD-1 inhibitor, BAT1308.
The topoisomerase I inhibitor payload has been described as having the capacity to penetrate cell membranes, potentially leading to the elimination of surrounding Treg cells through a bystander effect.
Study objectives for the current Phase I trial include determining the maximum tolerated dose, evaluating pharmacokinetics, and gathering preliminary data on efficacy in advanced solid tumour patients.
Bio-Thera Solutions is also working on other ADCs targeting Folate Receptor alpha, Her2, and Trop2, alongside early-stage clinical assets targeting immuno-oncology pathways such as bispecific antibodies for PD-L1/4-1BB and PD1/IL15.
The company is advancing more than 20 candidates in clinical development, focusing on immuno-oncology and targeted therapies, including ADCs.
ADC content on Pharmaceutical Technology (or Clinical Trials Arena) is supported by Syngene. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.
