R Bio Co., Ltd.

SAN FRANCISCO, Sept. 3, 2024 /PRNewswire/ -- 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, is pleased to announce that subject recruitment of a US Phase 1 clinical study of Utidelone Capsule (UTD2), a company's key pipeline product, for advanced solid tumors (NCT05681000) has been completed. This study is an open-label, dose-escalation Phase 1 clinical study, and conducted in several institutions across the US including Sarah Cannon Research Institute (Florida Cancer Specialists & Research Institute), University of Southern California, and the Washington University in St. Louis. The primary objective of this study is to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT); the secondary objective is to evaluate the efficacy and pharmacokinetic profile of UTD2 monotherapy in patients with advanced solid tumors. Five dose cohorts were explored in this study. After confirming the DLT (diarrhea) in the highest dose cohort, 75mg/m2/day x 5 days was determined as MTD. A total of 18 patients with more than 10 different types of advanced solid tumors were enrolled. The median age was 63 years old, and 2/3 of the patients had received ≥ 3 lines of prior treatments. As of now, efficacy evaluations were completed in 12 patients, and 1 complete response (CR, ovarian cancer), 1 partial response (PR, ovarian cancer), and 8 stable disease (SD, prostate cancer, testicular cancer, non-small cell lung cancer, pancreatic cancer, appendix adenocarcinoma, soft tissue sarcoma, etc.) were obtained with a clinical benefit rate of 83%. The results further demonstrated the broad-spectrum anti-tumor property of Utidelone. As for treatment duration, more than half of these patients received ≥3 cycles of treatments, and the maximum duration of response reached 36 weeks. In terms of safety, most treatment-related adverse events (TRAEs) were grade 1-2, and the most frequently seen TRAEs (incidence ≥ 20%, including all grades) were diarrhea (55.6%), fatigue (33.3%), and neutropenia (22.2%), all of which were manageable. The preliminary results of this study were also presented at the 2024 ASCO meeting. Dr. Li Tang, Chairman of Biostar Pharma commented: "This is the first study of UTD2 that has completed enrollment globally. We successfully achieved the primary objectives and observed encouraging efficacy and safety profiles. We are very grateful for the joint engagement and dedication of our US clinical institutions and investigators. We are confident that this blockbuster product will substantially change the administration regimen of microtubule inhibitors. We will advance the following pipelines for UTD2 at full speed and hopefully bring it to the market to benefit global cancer patients as soon as possible". Biostar is actively carrying out clinical studies of UTD2 in China and abroad. A pivotal study in China for advanced breast cancer led by Professor Xu Binghe, Cancer Hospital of Chinese Academy of Medical Sciences, is in recruitment. The preliminary findings of this study were also presented at the ASCO meeting in 2024; the China Phase 2 study for advanced solid tumors including ovarian cancer and cholangiocarcinoma, etc. is in initiation. In addition, US FDA has granted an Orphan Drug Designation (ODD) to UTD2 for the treatment of advanced gastric cancer, and Biostar is preparing for IND filing of a Phase 2/3 multi-reginal clinical study (MRCT) led by Professor Ruihua Xu of Sun Yat-sen University Cancer Center in both China and US simultaneously. Utidelone is a new-generation genetically engineered microtubule inhibitor. Utidelone Injection (UTD1) has been launched in China in 2021 for the treatment of metastatic breast cancer (MBC) progressed after at least one anthracycline- or taxane-containing chemotherapy regimen. The phase 3 study data showed that UTD1 is the only one to achieve both PFS and OS benefits for heavily pretreated MBC patients, and the results were twice orally presented at ASCO annual meetings. Utidelone has similar mechanism of action with that of taxanes while demonstrating multiple advantages, including better anti-tumor activity, broader anti-tumor spectrum, better safety profile with very low hematologic toxicity, effective against multidrug-resistant tumors with less prone to develop drug resistance, capability of crossing the blood-brain barrier so as to prevent and treat brain tumor, and high oral bioavailability. Multiple indication expansion clinical studies for UTD1 are also in progress in China and US, including but not limited to MRCT Phase 3 study for non-small-cell lung cancer (NSCLC), Phase 2 pivotal study for breast cancer brain metastasis in US and NSCLC brain metastasis in China, and Phase 3 study for breast cancer neoadjuvant in China. Compared to taxanes, which are difficult for oral formulation development, Utidelone is not susceptible to P-glycoprotein thus cannot be pumped out of the cancer cell by P-glycoprotein and has the advantage for higher oral bioavailability. By utilizing its synthetic biology technology platform, Biostar developed Utidelone Capsule, and its efficacy and safety have been confirmed in both US and China's studies. Utidelone Capsule will significantly improve the convenience of administration, compliance of patients, decrease in treatment cost and ease of combination therapy with other oral anti-cancer drugs, meaning more suitable for adjuvant and maintenance therapy. About Beijing Biostar Pharmaceuticals Co., Ltd. Beijing Biostar Pharmaceuticals Co., Ltd. is an integrated biopharma company focusing on the development of first- and best-in-class innovative anti-cancer drugs with independent intellectual property through state-of-the-art technology platforms of combinatorial biosynthesis, microbial fermentation production and microbial drug formulation development. With an insight-driven strategy, experienced R&D teams, cGMP-compliant manufacturing facility and domestic commercialization capability, the company have built a balanced product pipeline, covering both lead product life-cycle expansion and early-stage projects development. Further information can be found on the company's website or by contacting our business development team at [email protected] on partnering with us. SOURCE Beijing Biostar Pharmaceuticals Co., Ltd.

JACKSONVILLE, Fla.--( BUSINESS WIRE )-- MMI (Medical Microinstruments, Inc.), a robotics company dedicated to increasing treatment options and improving clinical outcomes for patients with complex conditions, today announced the completion of a preclinical study that demonstrated the feasibility of the Symani ® Surgical System in neurosurgical procedures. Adnan Siddiqui, M.D., Ph.D., Chief Executive Officer and Chief Medical Officer of the Jacobs Institute and Vice Chair and Professor of Neurosurgery in the Jacobs School of Medicine and Biomedical Sciences, successfully repaired a blood vessel in the brain in an animal model using the Symani Surgical System, the first such robotic-assisted microsurgery demonstration in the brain. “Dr. Siddiqui’s breakthrough demonstration showed the benefits of robotic precision and control when operating on brain tissue,” said Mark Toland, CEO of MMI. “The robotic platform allowed him to perform extremely delicate maneuvers deep in the skull cavity that would not have been possible with the human hand alone. The success of this procedure opens the possibility of expanding Symani’s reach into neurosurgery, a field of medicine that involves the most fragile anatomy and has yet to benefit from robotic-assisted microsurgical capabilities.” The study aimed to both collect feedback on Symani from a highly experienced neurosurgeon and assess the feasibility of the platform as a tool to treat neurological conditions. It was performed at the Jacobs Institute, a nonprofit medical device innovation center located in Buffalo, N.Y., which aims to accelerate the development of next-generation technologies in vascular medicine. “Symani offered added control that allowed me to access and repair a vein just under 1 millimeter in diameter, with clips spaced 4 millimeters apart,” said Dr. Siddiqui. “It required techniques that would be extraordinarily difficult for most micro-neurosurgeons to replicate without robotic assistance, using sutures so small they are barely visible to the naked eye. Based on this excellent initial experience, I have no doubt Symani could be highly effective during a wide range of complex neurosurgical procedures with the development of additional microsurgical tools. In fact, I believe it is ready for superficial temporal to middle cerebral artery bypass surgery today.” The Symani Surgical System is designed to provide enhanced precision and control for the anastomosis and suturing of microscopic vessels with the thinnest available sutures. With the world’s smallest surgical robotic wrist, called NanoWrist®, Symani enables surgeons to replicate the natural movements of the human hand at the micro scale. It also features motion-scaling technology that reduces the hand’s scale of movement by as much as 20x, giving surgeons more freedom to operate on microscopic anatomy. Surgeons have leveraged the Symani Surgical System in over 1,000 cases globally and more than two dozen publications highlight positive clinical outcomes. It is designed to help restore quality of life for patients, accelerate the number of surgeons able to push the boundaries of complex procedures for delicate anatomy, and enable hospitals to expand their open surgical programs. The U.S. Food and Drug Administration (FDA) granted De Novo Classification to the Symani Surgical System in April 2024, making it the only commercially available platform in the U.S. for reconstructive microsurgery. It is available for commercial use in Europe and parts of Asia Pacific. To learn more about MMI and the Symani Surgical System, visit MMI’s website here: https://mmimicro.com . About MMI MMI (Medical Microinstruments, Inc.) is on a mission to advance robotic technology that pushes the limits of soft tissue open surgery and opens new opportunities for surgeons to restore quality of life for more patients with complex conditions. The company was founded in 2015 near Pisa, Italy, and its proprietary Symani® Surgical System combines the world’s smallest wristed microinstruments with tremor-reducing and motion-scaling technologies to address significant unmet patient needs across the globe. This first-of-its-kind surgical robotic platform for open, soft tissue micro-level surgery can help address microvascular repair and lymphatic repair. In Europe and APAC, it also addresses peripheral nerve repair. The Symani System is authorized for use in the U.S. by the FDA and is a CE Marked medical device in Europe. MMI is backed by global investors including Fidelity Management & Research Company, Andera Partners, BioStar, Deerfield Management, Fountain Healthcare Partners, Panakès Partners, RA Capital, Sambatech, and Wellington Partners. About the Jacobs Institute The Jacobs Institute is a non-profit organization whose mission is to accelerate the development of next-generation technologies for vascular and neurologic diseases through collisions of physicians, engineers, entrepreneurs, and industry. The JI’s vision is to improve the treatment of vascular and neurologic disease in Western New York and the world, while fostering local economic development. The JI fosters medical collaboration and innovation through partnerships with the University of Buffalo (UB), Kaleida Health, and industry to be a fitting tribute to the work and memory of Lawrence D. Jacobs, MD. Additionally, the JI’s i2R, or Idea to Reality Center, is taking ideas for vascular and neurologic medical devices and moving them through the proof-of-concept process. Finally, the JI also increases physician and industry knowledge of vascular and neurologic diseases through clinical education programs.

SAN FRANCISCO, July 5, 2024 /PRNewswire/ -- Biostar Pharma, Inc., the U.S. subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. (Biostar), which is a synthetic biology-driven biopharma company focusing on the development and commercialization of innovative oncology drugs, announced today that their core pipeline product Utidelone Injection (UTD1) had been granted to conduct a phase 2 study (BG01-2402) for HER2- breast cancer brain metastasis (BCBM) by the US FDA. Depending on the molecular classification of breast cancer, approximately 20~50% of metastatic breast cancer patients develop brain metastases.[1] The current standard of care for BCBM is primarily local treatment with surgery and radiation therapy, supplemented by drug therapy. Due to blood-brain barrier (BBB) and blood-tumor barrier (BTB), many drugs that are effective for extracranial metastasis of breast cancer have very limited intracranial permeability, leading to poor prognosis for BCBM patients, especially with HER2- BCBM.[2-3] The mPFS for HR+/HER2- BCBM is about 4-6 months,[4-8] while the mFPS for TNBC brain metastasis is only 2.8 months.[9] In recent years, multiple small-molecule TKIs and ADC drugs have brought survival benefits to HER2+ BCBM patients. However, there is still a lack of drug treatment regimens with proven efficacy for HER2- BCBM, and no drug has been approved for HER2- BCBM worldwide, suggesting a significant unmet medical need. Utidelone can penetrate BBB due to its unique physicochemical characteristics and insusceptibility to P-glycoprotein-mediated efflux, which has been confirmed by preclinical drug tissue distribution studies and several clinical trials. A phase 2 study of utidelone in combination with bevacizumab for the treatment of HER2- BCBM presented at the ASCO 2024 demonstrated efficacy outcomes of 42.6% of CNS-ORR, 7.7 months of mPFS, and 74.4% of 12-month OS rate with total 47 eligible patients being enrolled. The efficacy was even better in HR-/HER2- subgroup, showing 55% of CNS-ORR and 8.4 months of mPFS. The safety was manageable with majority of the AEs being Grade 1~2, suggesting a promising efficacy and manageable safety pro utidelone for HER2- BCBM, and the potential of utidelone to become a new treatment option in the space. Utidelone has been granted an "orphan drug designation" by the US FDA for the treatment of BCBM in Mar 2024. Biostar then filed an IND application for this phase 2 study for HER2- BCBM. The US FDA clearance of the application marks an important milestone of Biostar's globalization development strategy. About BG01-2402 Study BG01-2402 study refers to "A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients with Brain Metastases". The purpose of the study is to evaluate the intracranial and systemic efficacy of Utidelone Injection in combination with capecitabine in HER2- BCBM patients. This study follows a Simon's 2-stage design, and is planned to be conducted at 10-15 sites in the US with enrollment target of 120 patients. The primary endpoint is CNS-ORR; the secondary endpoints include PFS, DOR and OS, etc. About Beijing Biostar Pharmaceuticals Co., Ltd. Beijing Biostar Pharmaceuticals Co., Ltd. is an integrated biopharma company focusing on the development of first- and best-in-class innovative anti-cancer drugs with independent intellectual property through state-of-the-art technology platforms of combinatorial biosynthesis, microbial fermentation production and microbial drug formulation development. With an insight-driven strategy, experienced R&D teams, cGMP-compliant manufacturing facility and domestic commercialization capability, the company have built a balanced product pipeline, covering both lead product life-cycle expansion and early-stage projects development. Further information can be found on the company's website or by contacting our business development team at bd@biostar-pharma.com on partnering with us. View original content: SOURCE Biostar Pharma, Inc.