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- 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 8, 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.