HuidaGene Therapeutics ("HuidaGene") and Synthego Corporation ("Synthego") have unveiled a pioneering licensing agreement for the high-fidelity Cas12 CRISPR nuclease (hfCas12Max). This strategic collaboration underscores the profound clinical potential of hfCas12Max, synergizing seamlessly with Synthego's expertise in cutting-edge GMP manufacturing capabilities.

Under the terms of this agreement, the specifics of which remain undisclosed, HuidaGene grants Synthego manufacturing and commercialization rights for the hfCas12Max nuclease and optimized gRNA for research purposes. Additionally, HuidaGene extends to Synthego the right to sublicense the nuclease for therapeutic applications, heralding a new era of collaborative innovation in the realm of CRISPR-based therapies.

Central to this partnership is the promise of streamlining the development of CRISPR-based therapeutic interventions, furnishing developers with access to a suite of highly precise, efficient, and next-generation genome editing tools. Xuan Yao, Ph.D., Co-founder 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, born from HuidaGene's HG-PRECISE platform, emerges as a standout CRISPR gene-editing system, distinguished by its unparalleled on-target editing efficiency and minimized off-target editing activity in mammalian cells. Moreover, this innovative gene-editing system offers the distinct advantage of packaging into a single viral vector, meeting a critical requirement for numerous cell and gene therapies. The commercialization of hfCas12Max is poised to democratize access to this CRISPR gene-editing system, offering enhanced freedom-to-operate and expediting the development of CRISPR-based therapeutic interventions.

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