Applied StemCell Inc. Partners with CIRM to Provide Clinical-Grade iPSCs and Access to Its Proprietary Gene Editing Technologies to Accelerate the Development of Regenerative Therapies

MILPITAS, Calif.--(BUSINESS WIRE)--Applied StemCell, Inc. (ASC) and the California Institute for Regenerative Medicine (CIRM) have partnered as Industry Resource Partners. ASC is offering its IP-based gene insertion technology and TARGATT iPSC master cell line, along with resources to support cell therapy process development and GMP manufacturing, to CIRM Translational and Clinical awardees. Additionally, the award recipients will gain access to Applied StemCell’s newly expanded GMP clean room suites dedicated to iPSC, MSC, and cell manufacturing, animal facilities, and state-of-the-art equipment.

The partnership focuses on increasing accessibility to ASC’s TARGATT master iPSCs and its wild type (WT) induced pluripotent stem cell (iPSC) master cell bank (MCB) and working cell bank (WCB), as well as the necessary proprietary culture conditions to ensure genomic stability of iPSCs. Furthermore, awardees will have access to ASC's CDMO services and its upcoming new technologies SSelect (Single-step site-specific, efficient, large-cargo targeting) and ceBE-X (with no off-target gene editing). These comprehensive services will be provided at ASC's newly established GMP suites in the heart of the Bay Area, California. The collaboration makes ASC’s key resources accessible to CIRM-funded programs.

"We are thrilled about this new partnership with CIRM. ASC's clinical-grade iPSCs and comprehensive gene editing tools accelerate cell-based therapy projects and enable CIRM researchers to bring new regenerative medicine to the clinic faster and more cost-effectively," stated Dr. Ruby Chen-Tsai, CEO of Applied StemCell.

"CIRM's Industry Resource Partner Program aims to leverage the resources, experience, and expertise of industry partners to expedite CIRM-funded regenerative medicine research projects," explained Dr. Shyam Patel, Senior Director of Business Development & Alliance Management at CIRM. "By providing access to its clinical iPSC clones, Applied StemCell joins our collaborative network of partners who share our unwavering commitment to advancing transformative regenerative medicine therapies for patients."

About Applied StemCell: Applied StemCell (ASC) is a prominent CRO/CDMO based in the California Bay Area that specializes in cell and gene therapy. With over 15 years of experience in the stem cell and gene editing fields, Applied StemCell offers comprehensive, end-to-end support for cell and gene therapy programs. Its expertise extends to iPSC/MSC platforms, proprietary gene editing technologies, and differentiation platforms for disease modeling and GMP manufacturing. ASC has successfully developed two cGMP iPSC lines that comply with FDA and EMA regulations for cell therapy product development. Applied StemCell has a Drug Manufacturing License from the California Department of Public Health, Food and Drug Branch (FDB).

About TARGATT:

TARGATT™ technology revolutionizes gene editing with fast and precise integration of large DNA fragments (up to 20 kb) into a specific safe harbor locus. This method ensures stable integration at an active site with high efficiency. By utilizing an "attP" landing pad and an "attB" donor plasmid, single-copy gene insertion is achieved. The TARGATT™ platform offers versatility for various applications, including the development of cell lines with large fragment knock-ins, bioproduction, and library construction. It overcomes challenges associated with random integration, such as position effect, gene silencing, and instability from multiple transgene copies.

About CIRM:

At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission.

To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today’s most promising stem cell technologies.

With $5.5 billion in funding and more than 161 active stem cell programs in our portfolio, CIRM is the world’s largest institution dedicated to helping people by bringing the future of cellular medicine closer to reality.