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Precision BioSciences Concludes Partnership with Prevail Therapeutics and Resumes Programs

Wednesday, April 17, 2024

Precision BioSciences, Inc. (Nasdaq: DTIL), a leading gene editing company, has declared the anticipated return of three programs previously under Prevail Therapeutics Inc., a subsidiary of Eli Lilly and Company. Precision is exercising its option to reclaim rights to these programs following Prevail Therapeutics’ decision to terminate the collaboration. Utilizing its innovative ARCUS® platform, Precision specializes in developing in vivo gene editing therapies for complex genetic edits, including gene elimination, insertion, and excision. The collaboration, which began in January 2021 and underwent an amendment in June 2023, facilitated the transfer of specific preclinical research, manufacturing, and investigational new drug (IND)-enabling activities from Precision BioSciences to Prevail Therapeutics.

Michael Amoroso, President and CEO of Precision BioSciences, expressed gratitude for the productive collaboration with Prevail Therapeutics, acknowledging their role in advancing these programs toward clinical candidacy. With Precision completing its work plan for these programs, Amoroso highlighted the pivotal development decision point reached. Regaining control of these programs presents promising opportunities for Precision's pipeline, particularly in addressing congenital genetic disorders.

Jeff Smith, PhD, Co-Founder, and Chief Research Officer, emphasized the unique attributes of ARCUS that the programs aim to leverage, such as its precision, versatility, and simplicity. Plans are underway to prepare for GLP toxicology studies, followed by potential submissions for IND and clinical trial applications (CTAs). Exciting proof-of-concept data has been generated, notably in the DMD program demonstrating ARCUS gene excision efficacy and the gene insertion program showing remarkable efficiency in non-dividing cells of non-human primates.

Despite this development, Precision remains steadfast in its near-term clinical priorities, including ornithine transcarbamylase (OTC) deficiency, HBV, and PMM, with no disruption expected to its expected cash runway. Progress continues with wholly owned programs and partnerships with Novartis and iECURE, particularly with iECURE's initiation of regulatory and clinical activities worldwide for OTC deficiency.

Precision's financial position is robust, supported by recent public offerings and potential cash from cell therapy transactions, ensuring a cash runway into the second half of 2026. With several opportunities to validate ARCUS through both wholly owned and partnered programs in 2024 and 2025, Precision BioSciences remains committed to advancing gene editing therapies for unmet medical needs.



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