Hyundai ADM Bio Voluntarily Withdraws IND for Clinical Study of Docetaxel Combination Cancer Therapy to Focus on Immunotherapy Strategy

Declares a strategic pivot to lead the post-patent immunotherapy combination era

SEOUL, South Korea, May 13, 2025 /PRNewswire/ -- Hyundai ADM Bio (KOSDAQ symbol 187660) today 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.

This decision reflects not merely the termination of a single trial, but a forward-looking repositioning aligned with the structural transformation of the global oncology landscape and a refined scientific understanding of tumor microenvironment dynamics.

Merck's immune checkpoint inhibitor Keytruda^® has been investigated in over 1,600 combination trials worldwide. With key patents scheduled to expire starting in 2028, major biopharmaceutical companies such as Celltrion and Samsung Bioepis are accelerating efforts to secure biosimilar pipelines and manufacturing infrastructure.

At the American Association for Cancer Research (AACR) Annual Meeting 2025, key themes that emerged across presentations and investor discussions included the expanded access to immunotherapy, diversification of combination approaches, and competitive advancement of next-generation oncology pipelines.

Despite the ongoing democratization of immunotherapy, one of the most persistent clinical challenges remains the extracellular matrix (ECM) barrier in tumors—particularly in so-called "cold tumors." When surrounded by stiff, fibrotic ECM, tumors can effectively block the infiltration of T cells and antibody-based therapies, rendering immune checkpoint inhibitors ineffective.

Hyundai ADM has termed this phenomenon as "pseudo-resistance" and has positioned ECM reprogramming as the core of its oncology strategy to overcome this structural and immunological blockade.

Penetrium™, a novel ECM-modifying therapeutic developed by Hyundai ADM, works by softening fibrotic tumor matrices, thereby enabling deeper penetration of immune cells and therapeutic antibodies. Preclinical data announced 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 the potential to serve as a backbone in post-patent immuno-oncology strategies.

"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."

Soo-Jung Kim, Head of New Drug Development at Hyundai ADM, added: "Our AACR announcement highlighted that 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.

The move is viewed as a pioneering step toward establishing scientific and strategic leadership in the post-patent era of immune-oncology combinations—positioning Hyundai ADM at the forefront of the next wave in cancer therapy.

SOURCE Hyundai ADM Bio