Biostar Completes Patient Recruitment for US Phase 1 Utidelone Study

Biostar Pharma, Inc., a subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd., has completed the subject recruitment for its US Phase 1 clinical study of Utidelone Capsule (UTD2), a key pipeline product aimed at treating advanced solid tumors. This study, identified as NCT05681000, is a significant milestone for the synthetic biology-driven biopharma company that focuses on innovative oncology drugs.

The Phase 1 clinical study, which is open-label and dose-escalation in design, was conducted across multiple US institutions including the Sarah Cannon Research Institute, University of Southern California, and Washington University in St. Louis. The primary goal of this study was to establish the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of UTD2. Secondary objectives included assessing the efficacy and pharmacokinetic profile of UTD2 monotherapy in patients with advanced solid tumors.

The study explored five different dosage cohorts. Diarrhea was identified as the DLT in the highest dose cohort, leading to the determination of 75mg/m2/day for five days as the MTD. A total of 18 patients, with over 10 different types of advanced solid tumors, were enrolled. The median age was 63, and two-thirds of these patients had undergone three or more lines of prior treatment.

Efficacy evaluations were completed on 12 of these patients, revealing promising results: one complete response (CR) and one partial response (PR), both in ovarian cancer, and eight cases of stable disease (SD) in various cancers such as prostate, testicular, non-small cell lung, pancreatic, appendix adenocarcinoma, and soft tissue sarcoma. The clinical benefit rate stood at 83%, showcasing the broad-spectrum anti-tumor potential of Utidelone. Over half of the patients received at least three cycles of treatment, with the longest response duration reaching 36 weeks.

Regarding safety, the majority of treatment-related adverse events (TRAEs) were manageable and classified as grade 1-2. The most frequently observed TRAEs, occurring in 20% or more of the patients, included diarrhea (55.6%), fatigue (33.3%), and neutropenia (22.2%). These preliminary results were also presented at the 2024 ASCO meeting.

Dr. Li Tang, Chairman of Biostar Pharma, expressed satisfaction with the study outcomes, highlighting the successful achievement of primary objectives and encouraging efficacy and safety profiles. He emphasized the dedication of US clinical institutions and investigators in this project and voiced confidence in UTD2’s potential to revolutionize microtubule inhibitor administration. Looking ahead, Biostar plans to expedite the development of UTD2, aiming to introduce it to the market rapidly to benefit cancer patients globally.

Biostar is also conducting clinical studies of UTD2 in China. A pivotal study for advanced breast cancer is underway, led by Professor Xu Binghe from the Cancer Hospital of the Chinese Academy of Medical Sciences. Preliminary findings from this study were also showcased at ASCO 2024. Additionally, a Phase 2 study for advanced solid tumors, including ovarian cancer and cholangiocarcinoma, is being initiated in China. The US FDA has granted Orphan Drug Designation (ODD) to UTD2 for the treatment of advanced gastric cancer, and Biostar is preparing for an IND filing for a Phase 2/3 multi-regional clinical study (MRCT) led by Professor Ruihua Xu from Sun Yat-sen University Cancer Center in both China and the US.

Utidelone, a new-generation microtubule inhibitor, has shown promising results since its introduction in China in 2021 for metastatic breast cancer. The drug demonstrates improved anti-tumor activity, a broader anti-tumor spectrum, and a better safety profile compared to conventional taxanes. It also shows effectiveness against multidrug-resistant tumors and can cross the blood-brain barrier, making it suitable for brain tumor treatments. Biostar’s synthetic biology technology platform has developed Utidelone Capsule, which offers enhanced convenience, patient compliance, lower treatment costs, and ease of combination with other oral anti-cancer drugs, making it ideal for adjuvant and maintenance therapy.