On June 13, 2023 Biostar Pharma, Inc., the US subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of innovative oncology drugs, reported that the first patient has been enrolled today for a Phase 1 clinical study (BG02-2201; NCT05681000) of its proprietary oral formulation product of utidelone, UTD2 (utidelone capsule) in advanced solid tumor patients in the US (Press release, Biostar, JUN 13, 2023, View Source [SID1234632677]). This study will be conducted at multiple clinical research centers including Sarah Cannon Research Institute (Florida Cancer Specialists & Research Institute), University of Southern California, Washington University School of Medicine in St. Louis, et al.
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Unmet Medical Need
With the improvement of treatment regimen, the overall survival of cancer patients has increased significantly in the past years. Therefore, good patient compliance is an important factor for clinical efficacy in the long-term care of cancer patients. Chemotherapy, represented by microtubule inhibitors, remains the most common systemic treatment for cancer, However, most microtubule inhibitors are through I.V. administration, which may potentially cause allergic reactions and inconvenience. So far there have been barely oral dosage forms of microtubule inhibitors successfully developed due to low solubility and being a substrate of drug-resistant P-glycoprotein. Liporaxel is an oral taxane that has only been approved for marketing in South Korea, and its oral bioavailability was still quite low. Other oral dosage forms such as Tesetaxel and Oraxol have failed in clinical trials due to safety and other problems, suggesting a huge unmet medical need.
Advantage for Oral Administration
UTD2 is the world’s first oral epothilone microtubule inhibitor. Utidelone has the advantage for oral formulation since it’s not the substrate of P-glycoprotein. Pre-clinical studies of UTD2 demonstrated good PK and safety profiles and relatively high bioavailability. Compared with injections, utidelone capsules do not require the addition of organic solvents and surfactants. Thus, they may reduce the adverse events caused by intravenous administration, shorten the hospital stay of patients, improve administration convenience, enhance patient compliance and broaden the potential for combination therapy with other anti-cancer drugs.
Dr. Li Tang, Chairman of Biostar Pharma said: "The first patient enrollment of UTD2 in the US clinical trial is an important step for our international development strategy. We are honored to have a number of well-known research institutions and investigators in the US to carry out the study. We are confident that this breakthrough product will provide more benefits for numerous cancer patients and bring about a substantial change to microtubule inhibitors administration. The company is fully committed to advancing this study in order to meet substantial clinical needs around the world."
About UTD2 and Utidelone
UTD2 is the oral formulation of utidelone (utidelone capsule), which is developed through the proprietary microbial drug formulation platform of Beijing Biostar Pharmaceuticals Co., Ltd. Utidelone is a genetically engineered microtubule inhibitor and its injectable dosage has been launched in China in 2021 for the treatment of metastatic breast cancer (MBC). It is the only approved new molecular of microtubule inhibitor in the past 10 years around the world. Among all single agent or combination regimen of non-taxane chemotherapies, utidelone injectable is the only one to achieve both PFS and OS benefits for heavily pretreated MBC patients. It demonstrated several advantageous features, such as overcoming taxane-resistant, low hematological toxicity suitable for longer term exposure, ability to cross the blood-brain barrier that is able to prevent and treat tumor brain metastasis. The phase 3 study results of utidelone injectable were twice selected for oral presentations at ASCO (Free ASCO Whitepaper) annual meetings and invited to publish in Lancet Oncology and Annals of Oncology. It is also recommended by "2023 CSCO Guidelines for Diagnosis and Treatment of Breast Cancer" as Class I (category IA). Clinical studies for multiple indication expansion are in progress, including phase 3 trials for non-small-cell lung cancer and breast cancer neoadjuvant, respectively, as well as phase 2 trial for the first line treatment of advanced esophageal cancer and gastric cancer.
About BG02-2201 Study
BG02-2201 represents the "Phase I Clinical Study on the Tolerability of Utidelone Capsule in Patients with Advanced Solid Tumors" (NCT05681000), which is an open-label phase I dose escalation study and will be conducted at several clinical research centers in the United States. 16-28 patients with advanced solid tumors are expected to be enrolled. The primary objective is to evaluate the safety and tolerability of UTD2 to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT). The secondary objectives are to evaluate the pharmacokinetic profile of UTD2 and to preliminarily assess the anti-tumor efficacy of UTD2 in advanced solid tumor patients.