Hyundai ADM Bio Shifts Focus Toward Immunotherapy in Oncology, Withdraws IND Application
In a significant strategic shift, Hyundai ADM Bio (KOSDAQ symbol 187660) has recently announced the voluntary withdrawal of its Investigational New Drug (IND) application. This move pertains to the Phase 1 clinical trial evaluating its drug Penetrium™ in combination with docetaxel—a chemotherapy agent. Instead, the company is now focusing on its immunotherapy strategy, indicating a marked shift in its priorities within the oncology landscape.
The decision to withdraw the IND is not merely about halting one clinical trial; it outlines a broader realignment in response to the evolving nature of cancer treatments and an improved understanding of tumor microenvironments. The global oncology field is undergoing significant transformations, particularly with a shift toward immunotherapy solutions, which have begun to revolutionize treatment methodologies.
As part of its newly outlined strategy, Hyundai ADM intends to submit a new IND application within the month. This application will propose a clinical trial that combines Penetrium™ with immune checkpoint inhibitors. This pivot underscores the company’s belief that immunotherapy-oriented approaches will be crucial in enhancing cancer treatment outcomes.
Immunotherapy has been gaining momentum in the oncology market, exemplified by Merck's Keytruda®, which is currently engaged in over 1,600 combination trials globally. With significant patents expiring starting in 2028, many biopharmaceutical companies, including Celltrion and Samsung Bioepis, are quickly accelerating their efforts to establish a foothold in the biosimilar market. Hyundai ADM is positioning itself among these industry leaders with its innovative approach.
Discussion panels at the recent American Association for Cancer Research (AACR) Annual Meeting 2025 indicated critical trends surrounding the accessibility of immunotherapy, the diversification of combination treatment approaches, and advancements in next-generation oncology pipelines. These topics echoed throughout the discussions, highlighting the industry's trajectory towards innovative and effective immunological treatments.
Despite the progress, one persistent challenge remains: the extracellular matrix (ECM) surrounding tumors. This barrier, particularly prominent in "cold tumors," can inhibit the infiltration of T cells and antibody therapies, significantly hindering the efficacy of immune checkpoint inhibitors. In this context, Hyundai ADM has characterized this challenge as "pseudo-resistance," advocating for a reprogramming of the ECM as a cornerstone of its oncology strategy.
Penetrium™, an avant-garde ECM-modifying therapeutic developed by Hyundai ADM, aims to counter this by softening rigid tumor matrices. This action facilitates deeper penetration of immune cells and therapeutic antibodies into tumors, which is crucial for treatment efficacy. During AACR 2025, preclinical data showcased Penetrium™'s effectiveness in triple-negative breast cancer (TNBC) models, where its combination with anti-PD-1 treatment reduced tumor volume by approximately 48.3% compared to monotherapy. The data also exemplified a notable absence of lung metastases in the combination treatment cohort, further underscoring the promising potential of this approach.
Industry experts have recognized Penetrium™ as one of the most clinically advanced ECM-targeting immunotherapy candidates, with the potential to emerge as a foundational treatment in the next wave of post-patent immuno-oncology strategies. "While the docetaxel combination showed only modest effects, Penetrium™’s clinical impact is amplified alongside immunotherapies," emphasized a spokesperson from Hyundai ADM. "The convergence of scientific understanding and market trends is steering us toward combinations with immune checkpoint inhibitors—this shift is imperative to stay ahead in the field."
Soo-Jung Kim, Head of New Drug Development at Hyundai ADM, also remarked on the significance of Penetrium™ as a potentially groundbreaking therapy in the evolving landscape of immunotherapy. "Our announcement at AACR confirmed the potential of Penetrium™ as a cornerstone therapy in the era of expanded immunotherapy access. Given the forthcoming patent expirations, we are refinedly steering our development to dominate in combination immunotherapy strategies on a global scale," she stated.
According to market forecasts, the global immuno-oncology market is poised for remarkable growth, anticipated to rise from $43.7 billion in 2023 to $284.7 billion by 2033. With this strategic transition, Hyundai ADM is set to kick off new clinical trials combining its therapies, beginning with triple-negative breast cancer and extending into metastatic lung cancer, and plans to broaden into other solid tumor indications.
This maneuver is viewed as a pioneering effort to solidify scientific and strategic leadership in the impending post-patent era of immuno-oncology combinations, placing Hyundai ADM at the forefront of advancing cancer treatment paradigms in a rapidly evolving industry landscape.
The decision to withdraw the IND is not merely about halting one clinical trial; it outlines a broader realignment in response to the evolving nature of cancer treatments and an improved understanding of tumor microenvironments. The global oncology field is undergoing significant transformations, particularly with a shift toward immunotherapy solutions, which have begun to revolutionize treatment methodologies.
As part of its newly outlined strategy, Hyundai ADM intends to submit a new IND application within the month. This application will propose a clinical trial that combines Penetrium™ with immune checkpoint inhibitors. This pivot underscores the company’s belief that immunotherapy-oriented approaches will be crucial in enhancing cancer treatment outcomes.
Immunotherapy has been gaining momentum in the oncology market, exemplified by Merck's Keytruda®, which is currently engaged in over 1,600 combination trials globally. With significant patents expiring starting in 2028, many biopharmaceutical companies, including Celltrion and Samsung Bioepis, are quickly accelerating their efforts to establish a foothold in the biosimilar market. Hyundai ADM is positioning itself among these industry leaders with its innovative approach.
Discussion panels at the recent American Association for Cancer Research (AACR) Annual Meeting 2025 indicated critical trends surrounding the accessibility of immunotherapy, the diversification of combination treatment approaches, and advancements in next-generation oncology pipelines. These topics echoed throughout the discussions, highlighting the industry's trajectory towards innovative and effective immunological treatments.
Despite the progress, one persistent challenge remains: the extracellular matrix (ECM) surrounding tumors. This barrier, particularly prominent in "cold tumors," can inhibit the infiltration of T cells and antibody therapies, significantly hindering the efficacy of immune checkpoint inhibitors. In this context, Hyundai ADM has characterized this challenge as "pseudo-resistance," advocating for a reprogramming of the ECM as a cornerstone of its oncology strategy.
Penetrium™, an avant-garde ECM-modifying therapeutic developed by Hyundai ADM, aims to counter this by softening rigid tumor matrices. This action facilitates deeper penetration of immune cells and therapeutic antibodies into tumors, which is crucial for treatment efficacy. During AACR 2025, preclinical data showcased Penetrium™'s effectiveness in triple-negative breast cancer (TNBC) models, where its combination with anti-PD-1 treatment reduced tumor volume by approximately 48.3% compared to monotherapy. The data also exemplified a notable absence of lung metastases in the combination treatment cohort, further underscoring the promising potential of this approach.
Industry experts have recognized Penetrium™ as one of the most clinically advanced ECM-targeting immunotherapy candidates, with the potential to emerge as a foundational treatment in the next wave of post-patent immuno-oncology strategies. "While the docetaxel combination showed only modest effects, Penetrium™’s clinical impact is amplified alongside immunotherapies," emphasized a spokesperson from Hyundai ADM. "The convergence of scientific understanding and market trends is steering us toward combinations with immune checkpoint inhibitors—this shift is imperative to stay ahead in the field."
Soo-Jung Kim, Head of New Drug Development at Hyundai ADM, also remarked on the significance of Penetrium™ as a potentially groundbreaking therapy in the evolving landscape of immunotherapy. "Our announcement at AACR confirmed the potential of Penetrium™ as a cornerstone therapy in the era of expanded immunotherapy access. Given the forthcoming patent expirations, we are refinedly steering our development to dominate in combination immunotherapy strategies on a global scale," she stated.
According to market forecasts, the global immuno-oncology market is poised for remarkable growth, anticipated to rise from $43.7 billion in 2023 to $284.7 billion by 2033. With this strategic transition, Hyundai ADM is set to kick off new clinical trials combining its therapies, beginning with triple-negative breast cancer and extending into metastatic lung cancer, and plans to broaden into other solid tumor indications.
This maneuver is viewed as a pioneering effort to solidify scientific and strategic leadership in the impending post-patent era of immuno-oncology combinations, placing Hyundai ADM at the forefront of advancing cancer treatment paradigms in a rapidly evolving industry landscape.
Topics Health）
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