Niclosamide

Penetrium™ Achieves Historic Breakthrough Overcoming Cold Tumor Failure and the Challenge of Metastatic Cancer in Immunotherapy and Antibody Therapy Presented at AACR 2025, Chicago CHICAGO, May 7, 2025 /PRNewswire/ -- Hyundai Bioscience presented the results of its Penetrium™ combination preclinical studies at the 2025 American Association for Cancer Research (AACR) Annual Meeting, held in Chicago. The studies established that the repeated failures of immunotherapy and antibody treatments in cold tumors are not primarily caused by genetic resistance, as traditionally believed, but by pseudo-resistance**—a physical failure of infiltration resulting from extracellular matrix (ECM) stiffening. For the first time, Penetrium™ has been shown to structurally overcome this barrier. Correcting 80 Years of Misconception: The Real Problem Is Not Genetic Mutations—It's Pseudo-Resistance For decades, the dominant theory behind cancer treatment failure centered around genetic mutations. However, Hyundai Bioscience's latest findings show that the actual obstacle lies in stiffened ECM that prevents immune cells and antibodies from reaching the tumor core. Penetrium™ remodels the ECM, restoring infiltration pathways and enabling effective drug and immune cell access—providing a fundamental solution to the cold tumor problem. Penetrium™ + Immunotherapy: Exceptional Results in Triple-Negative Breast Cancer (TNBC) Models ① In a TNBC mouse model, Penetrium™ combined with anti-PD-1 therapy led to: A 48.3% reduction in tumor burden compared to anti-PD-1 monotherapy, Complete elimination of metastasis observed in the combination group, which remained present in the monotherapy group. Significantly, necrosis was induced within 3 days of Penetrium™ administration, and necrotic areas continued to grow with repeated dosing**—a trend not observed in the control group. ② Penetrium™ + Antibody Therapy: Complete Suppression of Lung Metastasis in a Metastatic Lung Cancer Model In a metastatic lung cancer model: Bevacizumab monotherapy showed only 33% metastasis suppression, The Penetrium™ combination group recorded 0% lung metastasis at 100 mg/kg dosage. Additionally, a marked decrease in MMP-9 and VEGF expression confirmed ECM normalization and the restoration of drug penetration routes at the molecular level. ③ Penetrium™ + Chemotherapy: Overcoming the Limitations of Paclitaxel Paclitaxel monotherapy was found to paradoxically promote lung metastasis. However, when combined with Penetrium™, metastatic lesion areas were reduced by over 70–80% compared to controls. Furthermore, suppression of MMP-9 and restoration of E-cadherin demonstrated that Penetrium™ not only enhances chemotherapy efficacy but also structurally blocks metastasis—without additional toxicity. Validated in Naturally Occurring Canine Mammary Cancer Model: Stronger Responses Observed in Metastatic Tumors In a naturally occurring canine mammary cancer model: The Penetrium™ + POLYTAXEL® combination reduced primary tumor volume by up to 38.7%, compared to 21.1% with monotherapy, Metastatic lymph node lesions showed up to 78.99% tumor volume reduction. Notably, metastatic lesions responded more strongly than primary tumors, challenging the long-standing notion that metastatic cancer is untreatable. Proven Safety and Clinical Readiness Penetrium™ was administered at less than 9% of the NOAEL dose established in a 13-week GLP-compliant toxicity study. Its safety has also been verified in humans during a Phase 2 COVID-19 trial using the same API, niclosamide. These results confirm Penetrium™ is fully prepared for human clinical application. Official Statement from Dr. Soo-Jung Kim, Head of Research "Penetrium™ is the world's first platform to structurally solve the infiltration failure that has caused repeated failure of immunotherapy and antibody therapy in cold tumors. Our combination study with immunotherapy exceeded expectations, and Hyundai Bioscience will soon initiate clinical trials of Penetrium™ combinations for both TNBC and metastatic lung cancer." — Dr. Soo-Jung Kim, Head of Research, Hyundai Bioscience Clinical Expansion Underway Hyundai Bioscience is currently: Conducting a Phase 1 trial for prostate cancer in South Korea, Preparing an investigator-initiated trial for acute myeloid leukemia (AML) in France. Penetrium™: Launching a Tumor-Agnostic Cancer Treatment Platform Penetrium ECM Remodeling Therapy™ is evolving into a tumor-agnostic universal cancer treatment platform with applicability not only to TNBC and metastatic lung cancer, but also to pancreatic, gallbladder, ovarian cancers, and hematological malignancies such as AML. This breakthrough research is the first to structurally resolve infiltration failure in cold tumors, while also proving that metastatic cancers can be effectively treated**—a historic achievement in oncology. About Hyundai Bioscience Hyundai Bioscience is a global biotech company dedicated to developing innovative therapeutics for cancer, viral diseases, and rare conditions. Through Penetrium ECM Remodeling Therapy™, the company is opening a new era of universally applicable cancer treatment across all tumor types. In the viral therapeutics space: Hyundai Bioscience successfully completed a Phase 2 clinical trial for COVID-19 in Korea, Is conducting a global Phase 2 dengue fever trial in Vietnam in collaboration with DNDi (Drugs for Neglected Diseases initiative), And is developing influenza and avian influenza treatments in partnership with the NIH and global institutions. Driven by its core belief that "There is no disease that cannot be treated," Hyundai Bioscience continues to lead global innovation in cancer, antiviral, and rare disease therapeutics. SOURCE Hyundai Bioscience WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SAN DIEGO, Sept. 17, 2024 /PRNewswire/ -- Hyundai Bioscience USA announced that it has signed an MOU with the University of California San Diego (UCSD) to conduct an investigator-initiated trial to evaluate the efficacy of Xafty®, a niclosamide-based antiviral developed by its Korean headquarters, in treating "Long-COVID". The trial will be led by UCSD Professor Ajay Bharti, an infectious disease specialist and clinical trialist. Dr. Bharti's particular expertise in the neurocognitive effects of viral illnesses make him perfectly suited to run the investigator initiated trial. "This is an outstanding opportunity for UC San Diego and Hyundai Bioscience to partner together to tackle Long-COVID," Professor. Davey Smith, Director of the UCSD Altman Clinical and Translational Research Institute (ACTRI) of UCSD and an authority on viral illnesses, especially COVID, said about the collaboration. "There is no therapy currently available for the condition, which affects millions of people around the world." Xafty, an oral antiviral agent, is a new drug that improved the bioavailability of niclosamide, which is known to have antiviral efficacy against more than 30 viruses. It is currently in a phase 3 clinical trial in Korea targeting high-risk groups for COVID-19 and is expected to apply for phase 3 to the U.S. FDA soon. In a previous phase 2 clinical trial, Xafty successfully met the FDA's primary endpoints, demonstrating a faster symptom improvement rate than other existing treatments, especially in high-risk groups. "Being able to reduce symptoms during acute COVID-19 is an impressive accomplishment," Dr. Smith, who has helped run numerous antiviral trials in COVID-19, HIV, and Mpox, said. "Many large recent trials testing antivirals have not had such success. This may point to Xafty's effectiveness in Long-COVID as well." Long-COVID is a complex disease that is suggested to be caused by residual virus, excessive inflammation, and consequent nerve damage. Patients suffer from various symptoms such as chronic fatigue, inflammation, and cognitive decline, but existing treatments rely on a single mechanism and fail to resolve these complex symptoms. This is one of the reasons why a clear treatment for Long-COVID has not yet been developed. Xafty is expected to resolve the complex symptoms of Long-COVID through inflammation inhibition and neuro-protection mechanisms, rather than simply suppressing the virus. It is because niclosamide, Xafty's main pharmaceutical ingredient, is anticipated to provide practical therapeutic effects to patients through multiple mechanisms such as virus removal, suppression of immune hypersensitivity, and recovery of nerve damage. In a recent Parkinson's disease preclinical study conducted by Hyundai Bioscience, Xafty demonstrated to promote dopamine production and nerve cell recovery. When Xafty was administered to a Parkinson's animal model with suppressed dopamine production, a higher dopamine level was confirmed than in the group administered with the existing Parkinson's disease treatment, dopamine precursor (Madopar®), suggesting that it can make a significant contribution to improving symptoms such as brain fog and cognitive impairment due to nerve damage in people with Long-COVID. Dr. Ajay Bharti, the PI of this study, said, "We already knew about the broad-spectrum antiviral efficacy of niclosamide, but after seeing data showing that Xafty, having improved the long-standing problem of bioavailability, showed excellent symptom improvement in a COVID-19 clinical trial, especially in the high-risk group, we came up with the idea of using the drug to treat Long COVID." He added, "In particular, the fact that Xafty recovered neurons in a preclinical study of Parkinson's disease and promoted dopamine production, resulting in higher dopamine levels than the control group that took Madopar®, was an important trigger for this clinical study." Dr. Smith added, "The goal of this study is to confirm that niclosamide can solve the complex symptoms of Long COVID through multiple mechanisms such as virus suppression, inflammation suppression, and neuroprotection. We hope that the clinical trial will be successful and provide a practical treatment option for Long COVID patients, which will be historic." About Hyundai Bioscience Hyundai Bioscience is a biotechnology company that develops drugs based on its novel drug delivery system technologies to deliver active ingredients safely and efficiently to targeted areas of the human body. Founded in 2000, Hyundai Bioscience focuses on repurposing or expanding indications of existing drugs using its proprietary organic-inorganic hybrid technologies. Hyundai Bioscience is a public company listed on KOSDAQ (symbol: 048410) in South Korea. For more information, please contact Ms. Joobin Jung, Global PR Manager ([email protected]). SOURCE Hyundai Bioscience WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED