HuidaGene Therapeutics ("HuidaGene"), a global clinical-stage biotechnology company focused on advancing CRISPR-based genomic medicines, and Synthego Corporation ("Synthego"), a leading provider of innovative CRISPR solutions for developing cell and gene therapies, proudly announce a partnered licensing agreement for the high-fidelity Cas12 CRISPR nuclease (hfCas12Max). This partnership underscores the significant clinical utility of hfCas12Max, naturally complementing Synthego's focus on advanced GMP manufacturing capabilities. Under this licensing agreement and pursuant to undisclosed financial terms between HuidaGene and Synthego, HuidaGene grants Synthego manufacturing and commercialization rights for the hfCas12Max nuclease and optimized gRNA for research; HuidaGene also grants Synthego the right to sublicense the nuclease for therapeutic use.

This partnership will streamline the development of CRISPR-based therapeutic applications, providing developers with access to highly precise, efficient, and next-generation genome editing tools. Xuan Yao, Ph.D., Co-founader and President of HuidaGene, emphasized the significance of this agreement, stating, "HuidaGene's expansive CRISPR intellectual property portfolio distinguishes it as a vanguard in genomic medicine, with a versatile pipeline targeting critical neurological and ophthalmological conditions. Together with Synthego, we are poised to significantly accelerate the advancement of CRISPR-based therapies and deliver life-altering genomic medicines to patients worldwide."

Craig Christianson, CEO of Synthego, expressed enthusiasm about the partnership with HuidaGene on hfCas12Max, stating, "The combination of our advanced CRISPR GMP production capabilities and regulatory expertise with HuidaGene's next-generation nuclease technology is a crucial step toward advancing transformative cell and gene therapies. This partnership underscores Synthego's commitment to CRISPR-based therapeutics, bolstered by our focused investments in GMP manufacturing and comprehensive CRISPR solutions that support therapeutic development. The integration of hfCas12Max naturally aligns with our initiative to enhance the accessibility and efficiency of CRISPR tools."

hfCas12Max, a novel CRISPR gene-editing system developed through HuidaGene's HG-PRECISE platform, stands out for its superior on-target editing efficiency and reduced off-target editing activity in mammalian cells. This novel CRISPR gene-editing system also offers the advantage of packaging into a single viral vector, an important requirement for many cell and gene therapies. The commercialization of hfCas12Max will significantly enhance the accessibility of this CRISPR gene-editing system, providing increased freedom-to-operate and facilitating the development of CRISPR-based cell and gene therapies.

This partnership reinforces both companies' positions as catalysts for innovation, advancing their shared mission of transforming genomic-based cell and gene therapies and enabling unprecedented therapeutic outcomes.