On April 23, OBI Pharma announced via material disclosure that the Data and Safety Monitoring Board (DSMB), composed of independent medical and statistical experts, has recommended the termination of its Phase III clinical trial for the therapeutic cancer vaccine Adagloxad Simolenin (OBI-822) / OBI-821, which targets triple-negative breast cancer (TNBC). This marks another setback for the drug following its failed and highly controversial Phase II trial in 2016. Analysts expect the news to negatively impact the company's stock performance.
CEO Heidi Wang stated that, after careful evaluation, the company has decided to halt the trial and reallocate its resources toward the development of next-generation antibody-drug conjugates (ADCs).
The Phase III trial for Adagloxad Simolenin (OBI-822) / OBI-821 enrolled early-stage TNBC patients who had undergone surgery and were at high risk with Globo H-positive tumor markers. The trial was designed to include two interim analyses, allowing the DSMB to estimate the likelihood of final success based on accumulated data. The first interim analysis was completed in early 2024, and the DSMB had then recommended continuing the trial. However, the trial has since reached the threshold for the second interim analysis, with 113 of the planned 187 primary endpoint events having occurred. Following a meeting to discuss the latest data, the DSMB recommended terminating the study.
After thorough internal analysis, modeling, and expert consultation, OBI Pharma ultimately decided to stop the trial. In accordance with the clinical trial protocol, the company will continue to provide appropriate care to trial participants and manage the trial drug in compliance with relevant regulations and Good Clinical Practice (GCP) guidelines.
Wang acknowledged that the decision to terminate the trial—after many years of commitment to developing Globo H-related products—was deeply difficult and regretful. “But drug development always carries risks, with both successes and failures. This is the nature of the process. Every step is a foundation for future success,” she said.
She added that such outcomes are not uncommon in the world of drug development. Each drug has its own life cycle. “We don’t see today’s failure to meet endpoints as the end for Globo H. There may come a time, when we understand it better, that it regains attention.” Wang emphasized that OBI Pharma views this setback as a learning opportunity and remains humble in facing the challenges.
Wang also highlighted that OBI Pharma has undergone a transformation over the past two years and will now focus its efforts on the development of next-generation ADCs. The company has built an experienced team and established an innovative key technology platform in the ADC space, with a promising product pipeline that has already earned recognition from international experts. OBI Pharma is actively seeking early licensing and global partnership opportunities.
Resource: 浩鼎OBI-822新藥三期期中分析失利
