Paving the Way for European Clinical Entry and Global Technology Transfer
A Milestone Partnership Highlighting Korea's Expanding Influence in Global Biotech Innovation
MarkHerz Inc., a biotechnology company specializing in AAV-based gene therapies targeting cardiovascular and metabolic diseases, announced that it has signed a Memorandum of Understanding (MOU) on May 16, 2025 with Klinikum rechts der Isar, the university hospital affiliated with the Technical University of Munich (TUM), Germany.
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MarkHerz has signed an MOU with TUM Hospital for the joint development of AAV-based cardiovascular gene therapies. Second from left is Dr. Seungmin Lee, CEO of MarkHerz. Far right is Prof. Christian Kupatt. (Photo: MarkHerz Inc.)
The agreement aims to establish a broad-based collaboration on the joint research and development of next-generation gene therapies for ischemic heart and peripheral vascular diseases. This will center around MarkHerz's proprietary MAAV Platform, which enables the development of precision-targeted AAV gene therapies, particularly its MRTF-A candidate. The collaboration will include preclinical and clinical trials, technology consulting, and the sharing of research infrastructure.
The signing ceremony was attended by leading cardiovascular gene therapy expert Prof. Christian Kupatt (MD, TUM), patent attorney Dr. Rudolph Schön of Germany's Neymeyr Partner, Seungmin Lee (Dr. Mark Lee), CEO of MarkHerz, and Jeongseo Baek (Grace Baek), Head of the company's German office.
Building a Strategic Gateway into the European Clinical Landscape
MarkHerz's entry into Germany reflects a strategic initiative to complement Korea's increasingly regulated domestic environment by leveraging Europe's flexible clinical trial pathways, such as EMA's Early Access programs and Investigator-Initiated Trials. TUM Hospital's extensive cardiovascular preclinical models and translational research capacity are expected to generate high-quality data recognized by global regulatory agencies, including the EMA, FDA, PMDA, and MFDS.
Dr. Seungmin Lee emphasized, "The clinical validation of cardiovascular gene therapies is a critical factor in licensing negotiations with global pharma partners. This partnership goes beyond R&D; it marks the beginning of international clinical and commercial deployment of our platform technology."
MRTF-A gene therapy: expanding the horizons of regenerative medicine
MarkHerz's MRTF-A treatment aims to overcome the limitations of existing protein-based treatments, such as VEGF and FGF, by promoting functional blood vessel regeneration through endothelial recovery. This treatment is designed to deliver long-term efficacy in a single dose while addressing the core promise of gene therapy: sustained, one-time treatment.
The company's vector innovations using AAV9, AAVrh74 and AAV-LK03, optimized for specific organ targeting, establish a platform for expansion beyond rare diseases into cardiovascular and neurological diseases, aligning with global trends and further validating the scalability of the technology.
Deepening Ties with Europe's Leading Research Ecosystem
This agreement positions MarkHerz to strengthen ties with not only TUM, but also Ludwig Maximilian University (LMU) Munich and the BioM Cluster, forming a robust network across Europe's premier scientific institutions. These partners represent the heart of Europe's innovation engine, together having produced more than 50 Nobel laureates and offer broad potential for collaboration across biotechnology, neuroscience, and translational medicine.
Dr. Rudolph Schön noted, "Successful gene therapy commercialization in Europe requires a seamless integration of regulation, technology, and strategic partnerships. This MOU represents a vital first step."
Prof. Kupatt added, "This agreement is a turning point, translating years of research into clinical and commercial reality."
A Global Bridge Strategy Beyond Borders
MarkHerz is pursuing a "global bridge" strategy that aims not only to transfer technology or engage in joint research, but to actively overcome structural barriers in Korea's biotech ecosystem, such as regulatory bottlenecks, limited venture investment, and a high reliance on large conglomerates.
"Korea's biotech sector is rapidly growing but still faces fundamental challenges," said Dr. Seungmin Lee. "Through this Korea-Germany partnership, MarkHerz aims to lead by example and establish a new model for successful global clinical and commercial integration."
MarkHerz currently collaborates with over 250 partner institutions and, through formal alliances with 15 of them, operates eight distinct pipelines. Notably, active joint research projects valued at approximately KRW 15 billion are underway in AAV-based cardiovascular therapies (licensed in 10 European countries), diabetes treatments, cerebrovascular disorder therapies and CAR-Treg-based cancer immunotherapies.
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Contacts:
Grace Baek, Director
100pro@markherzen.com
http://markherzen.com
