Successful IND Approval for Universal Solid Tumor Cell Therapy Using KACTUS Cas9
In a groundbreaking development for the biotech industry, KACTUS's GMP-grade Cas9 has critically helped Yizun Bio secure IND clearance for a universal solid tumor cell therapy. Yizun Bio’s CNK-UT002 cell injection, an innovative allogeneic T cell therapy designed for advanced solid tumors such as liver cancer and melanoma, was granted IND clearance by the Center for Drug Evaluation (CDE) of the National Medical Products Administration, marking a significant step forward in cancer treatment. This achievement underscores Yizun Bio’s relentless pursuit of innovation and excellence in cell therapy.
The Revolutionary CNK-UT002 Allogenic T Cell Therapy
CNK-UT002 cell injection leverages Yizun Bio's proprietary CNK-UT technology, which ingeniously combines CNK-T and U-T platform technologies. The CNK-UT is a powerful cell therapy with a multiple of indications including liver cancer, melanoma, colorectal cancer, kidney cancer, and T-cell leukemia.
KACTUS played a crucial role in this project by providing GMP-grade Cas9 protein, the key material for gene editing and comprehensive documentation support for the IND filing.
A Message from Dr. Liu Lingfeng
Dr. Liu Lingfeng, the founder, CEO, and CSO of Yizun Bio, shared his excitement about this milestone:
“The IND clearance of Yizun Bio’s independently developed CNK-UT002 cell injection by CDE made it the first approved clinical trial on the universal solid tumor cell therapy... This fills the blank page in the field of universal cell therapy for solid tumors and is a critical milestone in the development of Yizun Bio. It also marks the beginning of a new journey. We will continue to upgrade and optimize our CNK-UT technology platform, as well as promote our clinical research, to achieve clinical breakthroughs in cell therapy for solid tumors as soon as possible. Strategically, we aim to become a leading pharmaceutical company in cell therapy. We will accelerate the large-scale,standardized cell therapy drug manufacturing o promote the large-scale clinical application of cell therapy, bringing hope to patients with incurable diseases."
Challenges of Gene Editing
For ex vivo gene editing therapies, gene editing tools are considered key components of production. Following the approval of Casgevy, the first CRISPR ex vivo gene editing drug, the biotech industry has set higher quality standards for these tools.
To meet the ever growing demands of cell and gene therapy drug development, KACTUS has established a nearly 10,000 square meter GMP manufacturing facility and a certified quality system, aiming to become the leader in gene editing enzyme manufacturing. KACTUS has developed a diverse portfolio of gene editing enzymes, including GMP-grade Cas9 (FDA DMF registered) and the GMP-grade base editor Accubase®. In the future, KACTUS will continue providing high-quality enzymes and strong technical and quality support for global cell and gene therapy development.
AccuBase™ Cytosine Base Editor (GMP-KD-0001):
AccuBase™ is a next-generation base editing tool known for its high editing activity and extremely low off-target rates. This enzyme is essential for precise genome editing, offering significant advantages over traditional CRISPR/Cas systems by enabling single base modifications without creating DNA double-strand breaks. KACTUS offers both Research-Grade and GMP-grade AccuBase™ for use in a range of therapeutic applications, ensuring high standards for clinical use.
CRISPR Cas9 Protein (GMP-CAS-EE109):
This GMP-grade Cas9 protein, derived from S. pyogenes, is engineered for exceptional genome editing performance. Its applications range from stem cells to T-cells, making it a robust tool for various genetic modifications. Our GMP-Grade Cas9 is being utilized in clinical trials to treat sickle cell disease (SCD), in collaborations with Reforgene for allogeneic CAR-T cell therapy development, and BRL Medicine for HBG gene-modified autologous CD34+ hematopoietic stem cell injection products.
A Bright Future for Solid Tumor Treatment
Solid tumor treatment has long been facing numerous challenges. Fortunately, the IND clearance of CNK-UT002’s IND marks a major breakthrough in solid tumor cell therapy research and development. Yizun Bio is keen to accelerate the clinical trial progress of its other promising pipelines, bringing new hope to patients battling solid tumors.
About Yizun Bio
Founded in 2018, Yizun Bio is a trailblazing cell therapy company with world-leading cell therapy platform technologies. Focused on the treatment of solid tumors and leveraging allogeneic universal cell technologies, the company’s mission is "coding cells, reshaping life." With core technologies like CNK-T, VAC-T, and UT, Yizun Bio has demonstrated significant efficacy in treating advanced liver cancer and neuroblastoma. The company’s state-of-the-art production base and R&D center meet international GMP standards, positioning it as a key player in the biotech field.
About KACTUS
KACTUS was founded in 2018 and is a company focused on the upstream sector of the biopharmaceutical industry, driven by independent innovation and specializing in the production of enzymes for CGT manufacturing. Relying on its unique protein research and development platform, SAMS™, KACTUS has entered the antibody drug market from the challenging field of transmembrane proteins and, with its high-quality products, expanded into the fields of cell and gene therapy as well as RNA therapy, committed to addressing unmet market demands.
In the field of gene therapy, KACTUS provides localized GMP-grade Cas9 enzymes that meet the clinical needs of gene editing. KACTUS also supplies GMP-grade MaxNuclease for AAV and vaccine research, MHC complexes for cell therapy, and enzymes for GMP manufacturing of mRNA. KACTUS has filed multiple GMP-grade enzyme products with the FDA Drug Master Files (DMF). KACTUS’ GMP products are strictly tested and validated according to pharmacopeia methodologies and are equipped with an MES digital production management system, ensuring high batch-to-batch consistency and strict compliance with regulatory submission requirements.
KACTUS has a professional technical team of nearly 200 people, a 10,000 square-meter GMP-grade enzyme manufacturing facility, and a 5,000 square-meter R&D facility and operates on a global scale.
