Penetrium (niclosamide-based nanohybrid) / Hyundai Bioscience, Penetrium Bioscience - LARVOL DELTA

South Korea’s Penetrium Bioscience announced on Sept. 4 that the U.S. Food and Drug Administration has cleared a Phase 2a clinical trial of Penetrium, an experimental cancer treatment designed to help existing drugs penetrate tumors more effectively. (Korea News Plus)

IND • New P2a trial • Solid Tumor

Penetrium Is a Novel Niclosamide-Based Therapeutic That Modulates Cancer-Associated Fibroblasts in the NSCLC Tumor Microenvironment (IASLC-WCLC 2026) - "Pathway enrichment analysis in Penetrium-treated organoids and CAF co-culture models. Conclusions : Penetrium alters the NSCLC microenvironment with CAF-selective cytotoxicity, Treg depletion, and in vivo ICI synergy collectively establishing a translationally compelling preclinical rationale for clinical investigation in NSCLC and other solid tumors."

Biomarker • IO biomarker • Tumor microenvironment • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CAFs • LY6E

Penitrium Confirms Efficacy of Combination Therapy Targeting "Pseudo-Resistance" in Cancer Treatment (The Asia Business Daily) - "The organoid study unveiled at the symposium highlighted the combinatorial effect of Penitrium with Daraxonrasib—a RAS-targeted anticancer drug recently approved by the U.S. Food and Drug Administration (FDA). According to the research, in an environment where lung cancer organoids were co-cultured with CAFs, the calculated residual resistance based on cell viability was 89.6%; however, this was reduced to 7.5% after additional administration of Penitrium." "

Preclinical • Prostate Cancer

South Korea’s Penetrium Bioscience announced on June 17 that it has launched a Phase 1 clinical trial combining its investigational cancer drug Penetrium with Merck’s blockbuster immunotherapy Keytruda (Korea News Plus) - "The company said that the trial will enroll patients with non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC) who have failed previous treatments...The study will be conducted primarily at Ajou University Hospital in South Korea following regulatory approval for a tablet formulation of Penetrium...Under the combination strategy, Keytruda targets cancer cells while Penetrium seeks to dismantle the protective tumor environment, potentially allowing immune cells to penetrate tumors more effectively and restore responsiveness to immunotherapy."

New P1 trial • Non Small Cell Lung Cancer • Triple Negative Breast Cancer

Hyundai ADM Bio wins approval for phase 1 trial of Penitrium - "South Korea’s Ministry of Food and Drug Safety approved the trial, which will evaluate the safety and maximum tolerated dose of the Penitrium–Keytruda combination in patients with triple-negative breast cancer and non-small cell lung cancer, according to the firm."

New P1 trial • Non Small Cell Lung Cancer • Triple Negative Breast Cancer

Disrupting the Oncobiosphere: CAF-Targeting Therapy with Penetrium™ Reverses Pseudo-Resistance in Tumors (AACR-NCI-EORTC 2025) - "This CAF-directed modulation restored gemcitabine sensitivity under previously resistant conditions and achieved complete ablation of CAF-integrated organoids. Together, these results demonstrate the potential of Penetrium™ as a tumor microenvironment–modulating agent that selectively eliminates CAFs to dismantle and reprogram the oncobiosphere. By targeting the structural basis of tumor resistance, Penetrium™ offers a novel strategy to overcome pseudo-resistance and augment the efficacy of immune checkpoint inhibitors and other anticancer modalities across diverse tumor types."

Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • CAFs

Hyundai Bio announced its research findings at the Boston Cancer Society. [Google translation] (Nate) - "The research results showed that Psoriasis showed a 33.6% decrease in PASI (skin lesion severity index), and when used in combination with the standard treatment (Methotrexate), it was 1.66 times more effective than the MTX monotherapy group, Crohn's disease showed a 47.0% decrease in DAI (disease activity index), and when used in combination with the standard treatment (Prednisolone), it was 2.13 times better than the Prednisolone monotherapy group, and Rheumatoid arthritis showed complete remission in 4 out of 6 mice after 9 days of administration when used in combination with the standard treatment (Methotrexate). In multiple sclerosis, it was confirmed that the motor function recovery rate improved by 62.0% compared to the untreated group when used in combination with the standard treatment (Ozanimod)."

Preclinical • Crohn's disease • Multiple Sclerosis • Psoriasis • Rheumatoid Arthritis

Hyundai Bio to Conduct World’s First Pancreatic Cancer Clinical Trial Using Pseudoreceptor-Resistant Target Penitrium and Chemotherapy [Google translation] (Hankyung) - "The exclusive patent rights for the pancreatic cancer indication of Penetrium were granted free of charge by its parent company, C&Pharm, to help Hyundai Bioscience quickly initiate clinical trials and achieve early commercialization, and are expected to become a key asset for Hyundai Bioscience."

New trial • Patent • Pancreatic Cancer

Hyundai Bio's pancreatic cancer trial using a combination of Penetrium and phenytrium demonstrates simultaneous reductions in toxicity and side effects, sustained treatment, and suppression of metastasis. [Google translation] (BioTimes) - "In an animal experiment on pancreatic cancer, the tumor growth inhibition rate (TGI) on the 20th day of the gemcitabine 50 mg/kg single administration group was 92.61%, and the tumor growth inhibition rate on the 20th day of the gemcitabine + phenytrium combination administration group at half the dose (25 mg/kg) was 92.07%, showing almost the same inhibition rate."

Preclinical • Pancreatic Cancer

Hyundai ADM Bio claims breakthrough for anti-cancer drug Penitrium in trials (Chosun Biz) - "Hyundai ADM Bio announced on the 21st that the anti-cancer drug candidate 'Penitrium,' developed in collaboration with its parent company HYUNDAI BIOSCIENCE, demonstrated the ability to overcome 'pseudo-resistance' in preclinical trials...On the same day, Hyundai ADM Bio announced the results of patient-derived organoid tests for Penitrium at the Jeongdong 1928 Art Center in Seoul. Patient-derived organoids are three-dimensional cultures of a patient's cancer cells and surrounding tissues grown in the laboratory...Hyundai ADM and HYUNDAI BIOSCIENCE announced that they will present a paper containing this information at the international cancer conference co-hosted by the American Association for Cancer Research (AACR) and the European Association for Cancer Research (EACR) to be held in Boston, USA, in October."

Preclinical • Solid Tumor

Hyundai ADM Bio claims breakthrough for anti-cancer drug Penetrium in trials (Chosun Biz) - "Hyundai ADM Bio announced on the 21st that the anti-cancer drug candidate 'Penetrium,' developed in collaboration with its parent company HYUNDAI BIOSCIENCE, demonstrated the ability to overcome 'pseudo-resistance' in preclinical trials....On the same day, Hyundai ADM Bio announced the results of patient-derived organoid tests for Penetrium at the Jeongdong 1928 Art Center in Seoul....The results tested on patient-derived organoids proved the therapeutic principle and effects of Penetrium for pancreatic cancer and also confirmed the possibility of combination therapy for difficult-to-treat solid tumors such as lung and breast cancers, the company stated."

Preclinical • Breast Cancer • Lung Cancer • Pancreatic Cancer • Solid Tumor

Hyundai ADM files IND application for Phase 1 clinical trial of combination therapy with Penitrium and Keytruda [Google translation] (BioTimes) - "Hyundai ADM Bio...announced on the 18th that it submitted an Investigational New Drug (IND) phase 1 clinical trial plan for the combination therapy of its new drug candidate Penetrium and the immunotherapy anticancer drug Keytruda (ingredient name: Pembrolizumab) to the Ministry of Food and Drug Safety. This clinical trial aims to confirm the safety of combined administration of Penitrium and immunotherapy in patients with terminal solid cancer who did not respond to treatment with existing immunotherapy, in the process of restoring the infiltration of immune cells and existing anticancer drugs into the tumor, and to evaluate whether the antitumor effect reappears in patients who did not respond to treatment with immunotherapy."

New P1 trial • Oncology • Solid Tumor

Hyundai ADM Bio Voluntarily Withdraws IND for Clinical Study of Docetaxel Combination Cancer Therapy to Focus on Immunotherapy Strategy (PRNewswire) - "Hyundai ADM Bio...announced the voluntary withdrawal of its Investigational New Drug (IND) application for Phase 1 clinical trial evaluating Penetrium in combination with docetaxel, as part of a strategic redirection to focus on immunotherapy-based combinations. The company plans to resubmit an IND application within this month for a new trial combining its ECM-targeting agent, Penetrium, with immune checkpoint inhibitors."

IND • Lung Cancer • Oncology • Triple Negative Breast Cancer

Hyundai Bio applies for phase 1/2a trial of pseudo-resistant drug ’Phenitrium’ for prostate cancer to the Ministry of Food and Drug Safety [Google translation] (BioTimes) - "Hyundai Bioscience announced on the 25th that it is applying for a clinical trial (phase 1/2a) of ‘Penetrium’, a pseudo-resistant treatment targeting prostate cancer patients. Initially, parent company C&P had applied for the clinical trial plan (IND) to the Ministry of Food and Drug Safety, but C&P and Hyundai Bio have agreed that Hyundai Bio will proceed with the IND, and C&P plans to voluntarily withdraw the existing IND."

New P1/2 trial • Prostate Cancer

Penetrium Breaks Oncology Barriers: The Solution to Cold Tumors and Metastatic Cancer Unveiled at AACR 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...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...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...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."

Preclinical • Lung Cancer • Triple Negative Breast Cancer

ADM Korea Announces Niclosamide-based Metabolic Anticancer Drug’s First Clinical Trial Target as ’Prostate Cancer Patients Resistant to Hormone Therapy’ (PRNewswire) - "ADM Korea, a subsidiary of Hyundai Bioscience, announced on the 8th that the first clinical trial target population for its niclosamide-based oral metabolic anticancer drug will be 'prostate cancer patients resistant to hormone therapy.'...CNPharm, which plans to enter into an exclusive license agreement with ADM Korea, has overcome these two issues with its patented technology, successfully repurposing niclosamide as an oral metabolic anticancer drug...Initially, in August, ADM Korea will submit an IND to the Ministry of Food and Drug Safety of the Republic of Korea for a clinical study combining hormone therapy and the niclosamide-based metabolic anticancer drug in prostate cancer patients resistant to hormone therapy."

Clinical • New trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Hyundai Bioscience announces its successful result from a preclinical study of a Niclosamide-based oral anticancer drug to treat triple-negative breast cancer (PRNewswire) - "Hyundai Bioscience...announced the positive results from its preclinical study on triple-negative breast cancer, investigating combination therapy of 'Niclosamide-based oral anti-cancer drug' jointly developed with CNPharm and Docetaxel, one of widely-used chemical anticancer agents. As a result, the combination therapy was found to be more effective than Docetaxel alone...From the in vitro test, Niclosamide successfully inhibited the proliferation and survival of cancer cells by disrupting their metabolism, preventing the anticancer drug-resistance by blocking the cell signaling pathways of tumor cells and recurrence and metastasis of cancer by inhibiting cancer stem cells."

Preclinical • Triple Negative Breast Cancer

Hyundai Bioscience Announces Clinical Development Plan for Niclosamide-based Metabolic Anticancer Drug Targeting P53 Mutation Cancer (PRNewswire) - "...in a triple-negative breast cancer in vivo studies, Hyundai Bioscience demonstrated that the combination therapy group with oral niclosamide-based anticancer agent and docetaxel, the widely-used chemotherapeutic drug, showed 67% higher anticancer effects compared to the docetaxel-alone treatment group. Long-term (13 weeks) animal toxicity tests confirmed that the blood concentration when administering the No-observed-adverse-effect level (NOAEL) of Niclosamide was 7,888 ng/mL. Considering that the IC50 for most types of cancer cell is 65~654 ng/mL, niclosamide is expected to inhibit the proliferation of most cancer cell types even when administered at less than one-tenth of the NOAEL...'Through our subsidiary ADM Korea, we plan to conduct clinical trials targeting cancer patients with intractable cancer caused by p53 mutations...'"

Preclinical • Triple Negative Breast Cancer