
New platform positions Korea as a strategic alternative for investigator initiated trials (IIT) and early translational studies in cell and gene therapy
COLLEGE STATION, Texas and SEOUL, South Korea, June 18, 2026 /PRNewswire/ --Matica Biotechnology, Inc. (Matica Bio), a leading viral vector contract development and manufacturing organization (CDMO) specializing in advanced therapies, today announced the launch of the Accelerated Matica Korea IIT Integrated Platform Solution, a collaborative framework designed to accelerate investigator initiated trials (IITs) and early translational development programs for global cell and gene therapy innovators.
Developed in collaboration with Korea's top clinical and hospital network, the integrated platform combines globally recognized Korean clinical execution with Matica Bio's U.S. based manufacturing, process development, analytical development, and translational CMC expertise.
The launch comes at a pivotal time for the global advanced therapy industry as sponsors increasingly seek efficient, high-quality, and globally accepted clinical development pathways in Asia. Korea's established Good Clinical Practice (GCP) infrastructure, experienced principal investigators, advanced translational medicine ecosystem, and strong regulatory alignment with FDA, EMA, and PMDA expectations position the country as an emerging hub for investigator-driven studies and early proof-of-concept programs. Korea IITs also benefit from experienced CRO support for well organized clinical data, accurate donor eligibility verification, fast patient enrollment, and relatively efficient clinical review timelines from the MFDS.
The Matica Korea IIT Integrated Platform Solution is designed to support:
- Investigator initiated trials (IITs) for cell and gene therapies
- Translational oncology programs and proof-of-concept studies
- Integrated GMP manufacturing and clinical development strategies
- IND-enabling CMC and scalable development pathways
- Flexible collaboration models for hospitals, academic institutions, and emerging biotech companies
Unlike fragmented development approaches that often require multiple disconnected vendors and lengthy coordination timelines, the integrated platform provides a streamlined framework connecting Korean clinical execution with Matica Bio's advanced manufacturing and technical capabilities.
"Global demand for high quality, globally accepted clinical data continues to accelerate, particularly in advanced therapies," said Paul Kim, Chief Executive Officer of Matica Bio. "Korea has emerged as one of the most strategically positioned environments for investigator initiated and translational clinical studies due to its clinical excellence, operational efficiency, and strong regulatory credibility."
"Our integrated platform is designed to reduce complexity for innovators by aligning clinical execution, CMC strategy, and manufacturing support within a single collaborative framework," Kim added. "This enables companies to move faster from translational research into globally scalable clinical development."
The platform leverages several core advantages of the Korean advanced therapy ecosystem, including:
- Globally trusted clinical execution and digital hospital infrastructure
- Strong investigator expertise across cell and gene therapy studies
- Efficient coordination between hospitals and manufacturing partners
- Clinical datasets suitable for global regulatory pathways
- Strong intellectual property protection through U.S. based manufacturing support
Through the integrated platform, Matica Bio will provide an integrated U.S. to Korea development pathway designed specifically for IIT and early clinical stage advanced therapy programs. The framework enables Korean investigators and global biotech innovators to leverage Korea's highly efficient clinical and translational environment while accessing Matica Bio's U.S. based GMP manufacturing, process development, analytical development, assay characterization, and regulatory support capabilities.
The platform is structured to streamline coordination between U.S. manufacturing operations and Korean clinical execution, helping sponsors reduce operational complexity, improve program agility, and accelerate development timelines. By combining U.S. based manufacturing and IP protection with Korea's globally recognized clinical infrastructure, the integrated model is designed to support globally credible datasets and scalable development strategies that can transition efficiently into regional and global clinical programs.
Matica Bio will support programs across the full development continuum, including technology transfer, IND enabling CMC strategies, process optimization, comparability support, clinical material manufacturing, and scalable development planning aligned with future global regulatory pathways.
The initiative also reflects Matica Bio's broader commitment to enabling flexible and scalable development models for emerging advanced therapy companies through collaborative partnerships and open access development strategies.
About Matica Biotechnology, Inc.
Matica Biotechnology is a viral vector Contract Development and Manufacturing Organization (CDMO) that leverages advanced technologies at its purpose-built cGMP facility. With industry-leading expertise in process development, assay development, and cGMP manufacturing, Matica Bio serves as a trusted partner, seamlessly supporting its clients with streamlined operations throughout every stage of projects. Collaborating across five Matica sites worldwide, Matica Bio delivers excellence in the CDMO domain through innovations such as MatiMax™ proprietary cell lines, in-line process monitoring, and single-use technologies.
In addition to its manufacturing and development capabilities, Matica Bio supports integrated investigator initiated trial (IIT) and translational development programs through collaborative global platform models that connect U.S. based manufacturing with leading international clinical ecosystems. These integrated frameworks are designed to accelerate early clinical development, enable globally credible clinical datasets, and support scalable pathways from translational research to global clinical expansion. Visit www.maticabio.com for more information.
SOURCE Matica Biotechnology, Inc.
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