OBI-822 Completes Second Interim Analysis of Phase III Trial OBI Announces Trial Termination, Refocuses Resources on ADC Development

TAIPEI, Taiwan, April 23, 2025 — OBI Pharma (4174.TWO) today announced that the Phase III clinical trial of its active cancer immunotherapy, Adagloxad Simolenin (OBI-822)/OBI-821, for the treatment of triple-negative breast cancer (TNBC), has completed its second interim analysis. The recommendation from the independent Data and Safety Monitoring Board (DSMB), composed of external medical and statistical experts, the company was to terminate the study. Following a thorough internal evaluation, OBI has decided to follow the DSMB recommendation and to terminate the trial. Further, OBI will redirect its resources to focus on the development of next-generation Antibody-Drug Conjugates (ADCs). The Phase III clinical trial of Adagloxad Simolenin (OBI-822)/OBI-821 targeted patients with early-stage triple-negative breast cancer (TNBC) who were considered high risk and tested positive for Globo H following surgery. The clinical study was designed to include two interim analyses, during which the DSMB would assess the likelihood of the trial’s ultimate success based on the available data. The first interim analysis was completed in early 2024, at which time the DSMB recommended continuation of the study. The second interim analysis was triggered upon reaching 113 of the 187 primary endpoint events. Following their review of the second interim data, the DSMB convened and recommended that the trial be terminated. Following a comprehensive internal assessment and consultations with experts, OBI has decided to terminate the trial. In accordance with the clinical study protocol, OBI will continue to provide appropriate medical care to enrolled patients and will manage the investigational products in compliance with applicable regulations and Good Clinical Practice (GCP) guidelines. Dr. Heidi Wang, CEO of OBI Pharma, stated that the company has been dedicated to the development of Globo H-related products for many years, and making this decision was by no means easy. However, drug development inherently involves risks and uncertainties. Successes and setbacks are a part of the process, and every step taken helps to lay the groundwork for future breakthroughs. In the field of new drug development, such cases are not uncommon. Each drug has its own development journey. “We do not view today’s unsatisfactory outcome as a failure of Globo H,” Dr. Wang added. “There may come a time, with a deeper scientific understanding of the Globo H function, it may play a meaningful role once again.” OBI Pharma will view today’s setback as a learning opportunity. Dr. Wang emphasized that OBI Pharma has undergone a transformation over the past two years and will now focus its resources on the development of next-generation Antibody-Drug Conjugates (ADCs). The company has a seasoned team and has established two innovative, key technology platforms and innovative enabling technologies in the ADC field. With a promising pipeline and growing recognition from the global industry experts, OBI is actively exploring licensing and global partnership opportunities. Dr. Wang also expressed her sincere gratitude to all the patients, healthcare professionals, and investigators who contributed to the clinical trial. Their support made it possible to study a first-in-class drug. She also thanked the OBI team for their continued dedication. Dr. Wang emphasized that OBI is committed to new drug development for patients.

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