On May 7, 2025 Hyundai Bioscience reported the results of its Penetrium combination preclinical studies at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held in Chicago (Press release, Hyundai Bioscience, MAY 7, 2025, View Source [SID1234652665]).

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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.