Silicon Valley-based Taiwanese biotechnology company Yushibo releases preliminary data from phase 1 clinical trial

In a recent discussion, I had the opportunity to interview Dr. Shin-Jia Hsiao, the co-founder of Yushibo Biotech, a pioneering company specializing in next-generation cancer cell immunotherapy. Established in 2017 by Dr. Yu-Min Yang and Dr. Hsiao, Yushibo operates from both Taipei and the San Francisco Bay Area, positioning itself as one of the few Taiwanese firms focused on developing allogeneic cell therapy technologies.

On May 7, Yushibo made headlines by participating in a conference hosted by William Blair & Company, where they presented findings from the initial dosing group of their Phase I clinical trial for the cell therapy drug ACE1831. This group included five patients diagnosed with non-Hodgkin’s lymphoma, three of whom had previously undergone CAR-T therapy. Notably, three patients completed the safety observation period defined in the clinical trial protocol, allowing for a review of safety data related to dose escalation.

Dr. Hsiao highlighted that all participants in this initial group did not experience any severe adverse events associated with ACE1831. Furthermore, there were no instances of cytokine release syndrome (CRS) or graft-versus-host disease (GvHD) linked to the treatment.

When discussing efficacy, Dr. Hsiao pointed out that among the three patients who met the safety criteria, one achieved a complete response (CR), while two exhibited stable disease (SD) post-treatment with ACE1831. Notably, the patient who attained complete remission has maintained this status for over three months without any signs of disease progression.

This clinical trial is a multinational, multicenter study designed to evaluate the safety and efficacy of ACE1831 in adult patients with relapsed or refractory CD20-positive B-cell lymphoma, an area targeted by this innovative therapy.

A key aspect of Yushibo’s strategy is the Antibody-Cell Conjugation (ACC) technology, which originates from the pioneering research of Nobel laureate Dr. Carolyn Bertozzi in bioorthogonal chemistry. This method enables scientists to attach antibodies to cells without the need for gene editing, thereby amplifying the immune cells’ capability to identify and eliminate cancer cells. By integrating ACC technology with γδ2 T cells, Yushibo aims to address challenges faced by existing immune checkpoint inhibitors, such as T-cell exhaustion and failures in tumor antigen recognition, ultimately striving to enhance immune efficacy and improve treatment outcomes.