Base Therapeutics announced that its in house-developed NK510 cell injection—the world’s first base-edited universal NK cell product—has received IND approvals in both China and the United States. Following the IND approval from the NMPA in October 2024 in China, the product has now also received an IND approval from the FDA for clinical trial of advanced solid tumors. This series of significant advancements not only marks a milestone achievement for Base Therapeutics in the field of cell therapy, but also signals a new wave of transformation in global cancer treatment methods.

The NK510 cell injection represents a major breakthrough in the field of cell therapy. Using Base Therapeutics’ proprietary AccuBase® zero off-target base editing system, it achieves precise and safe editing of key genes in NK cells, with an editing efficiency of over 90%.

The company has further enhanced NK510's logic-gate characteristics by base editing technology, enabling it to more accurately assess both activation and inhibition signals in the tumor microenvironment, thereby optimizing its anti-tumor response. In both in vitro and in vivo experiments, NK510 cells have shown strong anti-tumor activity and tumor-targeting capability.

NK510 not only overcomes immune evasion by cancer cells but also specifically targets and kills cancer cells. It has demonstrated powerful anti-solid tumor effects in both preclinical and clinical studies.

Additionally, Base Therapeutics has optimized the ex vivo expansion process for NK cells. Through meticulous refining of dozens of processes and hundreds of parameters, the NK510 cells have been successfully expanded up to millions of times in Base Therapeutics’ GMP-compliant facilities, overcoming global challenges such as low expansion rates and low transfection efficiency in allogeneic NK cell products.

About the AccuBase® Base Editing Technology

AccuBase® is an innovative, protein-based gene editing system developed by Base Therapeutics. Unlike traditional CRISPR technologies, AccuBase® directly modifies target DNA bases without inducing double-strand breaks, offering a safer, more precise alternative for gene editing. It is the only base editing system available in protein form globally, making it highly suitable for large-scale production. With proven applications across various cell types and species, AccuBase® has garnered international recognition, including non-exclusive licensing to a leading CAR-T cell therapy company.

Advantages of AccuBase®:

Zero Off-Target Editing: AccuBase® ensures precision by preventing unintended mutations at non-target sites, significantly enhancing both the safety and consistency of gene edits.

High Editing Efficiency: AccuBase® delivers over 90% editing efficiency at randomly ed genomic sites, demonstrating exceptional precision in gene modification.

Broad Applicability: AccuBase® has been successfully validated in a wide range of cell lines and primary cells—including T cells, NK cells, ESC stem cells—and across multiple species, including mammals and fish. It is compatible with hundreds of gene targets.

World’s Only Protein-Based Base Editing: As the only base editing system available in protein form, AccuBase® is uniquely suited for large-scale production, with superior stability and compatibility with the RNP (ribonucleoprotein) format, considered optimal for gene editing.

Global Patent Protection: Base Therapeutics holds multiple patents for AccuBase® in China, the US, and Europe, ensuring freedom to operate (FTO) in major markets.

About Base Therapeutics

Base Therapeutics, founded in 2021, is a leading high-tech company specializing in gene editing and cell-based therapies, with a focus on cancer and genetic diseases. The company is a pioneer in base-editing technologies, developing products like NK510, NK520, and base-edited CAR-T therapies.

With 2,500 square meters of GMP-compliant manufacturing space and 1,500 square meters of lab facilities, Base Therapeutics meets rigorous production standards which satisfy the regulatory requirements both in China and the U.S. The company has raised significant funding in Seed and Series A rounds, backed by top-tier biopharma investors. It holds over 30 global patents and has earned multiple awards, including top honors at national innovation competitions.

Committed to advancing gene editing technology, Base Therapeutics aims to lead the global market in delivering innovative therapies to patients worldwide.

For more information, please the company’s website: www.basetherapeutics.com.

For partnering, please mail to: BD@basetherapeutics.com.