BioSyngen Pte Ltd.

BARCELONA, Spain, Sept. 20, 2024 /PRNewswire/ -- The highly anticipated 2024 European Society for Medical Oncology (ESMO) Annual Congress has taken place from September 13 to 17 in Barcelona, Spain. As one of the most influential annual gatherings in oncology, this congress brings together leading cancer experts and researchers from around the globe, showcasing the latest advancements in the field and providing high-quality educational and networking opportunities for oncology professionals. Continue Reading Figure 1 BSGTIL antitumor efficacy Biosyngen, an innovative biotechnology company specializing in immune cell therapies, has showcased its groundbreaking technology on gene-modified, functionally enhanced tumor-infiltrating lymphocytes (TILs) derived from liver cancer biopsy samples. BioSyngen has secured ten clinical trial approvals in China and the U.S. for its innovative fourth-generation oncology therapies. Currently, our leading pipeline product, BRG01, is in the pivotal Phase II clinical trial stage for solid tumors. Additionally, the first patients have been enrolled in the Phase I trials for our other groundbreaking therapies, BST02 and BRL03, with completion of Phase I trials anticipated later this year. Abstract Title Pre-clinical Development of Genetically Modified Tumor-infiltrating Lymphocytes using Biopsy Samples from Liver Cancer Patients Abstract No. 1034P Tumor-infiltrating lymphocytes (TILs) are heterogeneous lymphocyte populations within the tumor microenvironment that contains T cells capable of recognizing tumor- or virus-associated antigens. In February of this year, the FDA approved the first TIL-based therapy used with IL-2 for advanced metastatic/recurrent melanoma. However, due to the variability in T cell infiltration between hot and cold tumors, differential abundance of antigen-specific T cells with robust immune response functionality, and the dependence of TIL anti-tumor efficacy on concomitant use of high-dose IL-2 combination therapy, the therapeutic applications of non-edited TILs are quite limited outside of melanoma. To address these challenges, Biosyngen has developed a proprietary platform for expanding TILs from biopsy samples, achieving production of 1011 cells within four weeks. Additionally, the company has established a stable gene modification platform that reprograms TIL metabolism, enhances TIL activity and sustained antitumor efficacy by expressing membrane anchor proteins. Anti-tumor efficacy has significantly enhanced (without IL-2 co-injection) and no obvious toxicity observed. Biosyngen houses best-in-class proprietary TIL platform aiming to expand the clinical applications of TIL technology with following features: Efficient Automated TILs Manufacturing System: Pioneering the use of tumor biopsy samples for TIL preparation with the ability to cryopreserve both tumor tissue and final products, overcoming logistical constraints. Effective In Vitro Gene-engineering System: Employs viral vector technology for stable gene modification, maintaining high gene expression efficiency in TILs. Enhanced In Vivo Expansion and Persistence: Increased proportion of central memory T cells (TCM) in the final product, leading to prolonged persistence. Powerful Antitumor Efficacy: Demonstrates strong tumor-killing effects without the need for concomitant use of IL-2. SOURCE Biosyngen WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BARCELONA, Spain, Sept. 18, 2024 /PRNewswire/ -- The highly anticipated 2024 European Society for Medical Oncology (ESMO) Annual Congress has taken place in Barcelona, Spain. As one of the most influential annual gatherings in oncology, this congress brings together leading cancer experts and researchers from around the globe, showcasing the latest advancements in the field and providing high-quality educational and networking opportunities for oncology professionals. Continue Reading From left to right: Ma Yuxiang, Associate chief physician in Phase I Unit in Clinical Trial Center and PhD in Oncology, Sun Yat-sen University Cancer Center; Professor Zhao Hongyun, Director in Phase I Unit in Clinical Trial Center and Deputy director in Clinical Research, Sun Yat-sen University Cancer Center; Statham Liu, Senior R&D Scientist, Biosyngen 75% of patients experiencing a sustained reduction in tumor burden and diminished metabolic activity, and several lesions achieving complete response (CR) with 100% tumor reduction. Patients treated with BRG01 have shown a progression-free survival exceeding six months post-infusion, demonstrating significantly extended antitumor effects compared to the current standard treatment, checkpoint inhibitors like PD-1 antibodies. BRG01 exhibited remarkable antiviral efficacy, with a significant reduction in EBV viral load in peripheral blood to normal levels post-infusion.

SINGAPORE, Aug. 12, 2024 /PRNewswire/ -- Biosyngen is proud to announce that the U.S. Food and Drug Administration (FDA) has approved its BRG01, an EBV-specific CAR-T cell therapy, to proceed with a pivotal Phase lI clinical trial. This marks the first cell therapy to enter Phase lI trials in both the U.S. and China for the treatment of relapsed/metastatic EBV-positive nasopharyngeal carcinoma, demonstrating a breakthrough in solid tumor treatment. The Center for Drug Evaluation (CDE) of the National Medicinal Product Administration (NMPA) in China had previously granted approval for the pivotal Phase II clinical trial of BRG01. Patient enrollment for the Phase I clinical trial in China and the U.S. began in late January this year, with all participants having completed the BRG01 infusion. The Phase I study has successfully concluded dose-limited toxicity (DLT) observation and efficacy evaluation in nine patients with advanced nasopharyngeal carcinoma who had at least one prior immune checkpoint inhibitor treatment, including PD-1 antibodies. Preliminary data indicates that BRG01 demonstrates exceptional safety and preliminary efficacy. All patients are late-stage cancer patients failing standard treatment including checkpoint inhibitors. BRG01 is well tolerated and expanded in patient with no dose-limiting toxicity. More efficient disease control and tumor shrinkage effects were observed with dose escalation. 75% patients in the high dose group showed necrosis and metabolic reduction of tumor lesions as determined by PET-CT. Biosyngen aims to expedite BRG01's clinical development and commercial availability, offering new hope for nasopharyngeal cancer patients worldwide. This FDA's approval underscores BRG01's potential in tumor and anti-viral therapies and recognizes Biosyngen's innovation and R&D capability in cellular immunotherapy. Biosyngen has established itself as a leading biotech with a portfolio of cell therapies, including CAR-T, TCRT, and TIL, addressing various solid tumors and hematologic malignancies. The company's multiple products have been granted approval to proceed with Phase I/II clinical trials in the U.S. and China, targeting a range of solid tumors such as lung and liver cancer. Looking ahead, with Biosyngen's efficient execution and rapid development progress, the company anticipates further clinical breakthroughs in solid tumor cell therapies, providing new treatment options and hope for patients. SOURCE Biosyngen