Hyundai ADM Bio announced today the voluntary withdrawal of its Investigational New Drug (IND) application for a Phase 1 clinical trial evaluating Penetrium™ in combination with docetaxel. This decision represents a strategic redirection as the company shifts its focus toward immunotherapy-based combinations for cancer treatment.
The South Korean biopharmaceutical company plans to resubmit an IND application within the month for a new trial combining Penetrium™, its novel extracellular matrix (ECM)-targeting agent, with immune checkpoint inhibitors.
Strategic Pivot Toward Immunotherapy
This strategic shift aligns with the structural transformation occurring in the global oncology landscape, particularly as key patents for major immunotherapies approach expiration. Merck's immune checkpoint inhibitor Keytruda® has been investigated in over 1,600 combination trials worldwide, with patents scheduled to expire beginning in 2028.
"While the docetaxel combination demonstrated modest activity, Penetrium™'s mechanism is most compelling when paired with immunotherapy," stated a Hyundai ADM spokesperson. "Both scientific rationale and market momentum are converging toward immune checkpoint inhibitor combinations. This shift is not optional—it is essential."
The company's decision follows the 2025 American Association for Cancer Research (AACR) Annual Meeting, where key themes included expanded access to immunotherapy, diversification of combination approaches, and competitive advancement of next-generation oncology pipelines.
Addressing the "Cold Tumor" Challenge
Despite advances in immunotherapy, one persistent clinical challenge remains the extracellular matrix barrier in tumors, particularly in "cold tumors." These tumors are surrounded by stiff, fibrotic ECM that effectively blocks the infiltration of T cells and antibody-based therapies, rendering immune checkpoint inhibitors ineffective.
Hyundai ADM has termed this phenomenon "pseudo-resistance" and has positioned ECM reprogramming as the core of its oncology strategy to overcome this structural and immunological blockade.
Penetrium™: Enhancing Immunotherapy Efficacy
Penetrium™ works by softening fibrotic tumor matrices, enabling deeper penetration of immune cells and therapeutic antibodies. Preclinical data presented at AACR 2025 demonstrated that in triple-negative breast cancer (TNBC) in vivo models, the combination of Penetrium™ and anti-PD-1 therapy reduced tumor volume by 48.3% compared to monotherapy.
Moreover, while lung metastases were observed in monotherapy groups, no such metastases were detected in the combination treatment group.
Industry observers have described Penetrium™ as the most clinically advanced ECM-based immunotherapy combination candidate to date, with potential to serve as a backbone in post-patent immuno-oncology strategies.
Market Opportunity and Future Plans
Soo-Jung Kim, Head of New Drug Development at Hyundai ADM, commented: "Our AACR announcement highlighted Penetrium™'s potential as a gateway therapy in the era of democratized immunotherapy. With major patent expirations approaching, we are advancing our development strategy to secure global leadership in combination immunotherapy."
According to industry analysts, the global immuno-oncology market is expected to expand from $43.7 billion in 2023 to $284.7 billion by 2033. With this strategic transition, Hyundai ADM plans to initiate new combination trials, starting with triple-negative breast cancer and metastatic lung cancer, followed by expansion into broader solid tumor indications.
Positioning for the Post-Patent Era
Major biopharmaceutical companies such as Celltrion and Samsung Bioepis are accelerating efforts to secure biosimilar pipelines and manufacturing infrastructure as key immunotherapy patents approach expiration.
Hyundai ADM's strategic pivot is viewed as a pioneering step toward establishing scientific and strategic leadership in the post-patent era of immune-oncology combinations—positioning the company at the forefront of the next wave in cancer therapy.
The company's focus on ECM modification as a means to enhance immunotherapy efficacy represents a novel approach to addressing current limitations in cancer treatment, particularly for patients with tumors that have historically been resistant to immunotherapy alone.
