WEST JEFFERSON, Ohio, July 12, 2023 (Newswire.com) – AmplifyBio, a leading service provider for the commercialization of advanced modality therapeutics, such as cell and gene therapies, today announced the successful acquisition of a cutting-edge intellectual property (IP) that, among other capabilities, will allow them to offer non-viral gene-editing services to clients. The move represents a significant milestone in AmplifyBio’s mission to assemble tools and technologies that create a productive, collaborative sandbox environment for developing safe, commercially viable advanced therapies.
This newly acquired IP encompasses a comprehensive portfolio of proprietary methods and protocols for non-viral gene editing previously held by PACT Pharma and clinically validated as part of their trials for developing personalized TCR cell therapies. The technology empowers AmplifyBio to perform precise, efficient modifications, including simultaneous knock-in and knock-out of genes of interest in client cells, with exceptional accuracy and proven safety, paving the way for a broader range of transformative therapeutic applications. The platform is extensible to more complex cell editing, including tunable and inducible gene expression, knockdown through shRNA, edits to allow T cells to be local delivery agents for bioactive molecules (e.g. sIL-12 or anti-PD-1 scFV), and can accomplish dual knock-in at distinct locations in one step.
AmplifyBio’s strategic vision will, in part, be accomplished by building an ecosystem of tools, technologies and experts to address the pain points causing delays and clinical failures around the industry today. The acquisition of non-viral gene editing IP is one example of those critical tools. The ABIO ecosystem will enable clients to focus on robust product characterization, product optimization, scale-up, automation, and next-generation operational components.
“Our goal at AmplifyBio is to create a development environment where clients can leverage a wide range of tools and technology platforms while being able to tap into the expertise of our subject matter experts and those of our technology partners,” said J. Kelly Ganjei, CEO of AmplifyBio. “The opportunity to acquire a portfolio of IP that allows us to partner with clients making gene modifications, and also to enhance our ability to provide a richer picture of cell signaling and potency, is a big step forward in ensuring that R&D is done with a level of characterization and optimization that reduces clinical safety risks and interruptions in manufacturing scale-up.”
AmplifyBio’s expanded offering of non-viral gene editing services enables clients to benefit more fully from AmplifyBio’s team of experts who bring proven track records in commercializing cell and gene therapies. That expertise can now fully be applied to assist with the daunting challenges commonly encountered when developing genetically modified products, including off-target editing and integrations, mispairing of chains, and immune-driven safety issues, but more to the point to address those challenges with CMC and manufacturing scale-up in mind.
This announcement adding non-viral gene-editing and other cellular characterization capabilities closely follows two previous announcements from AmplifyBio on expanded capacity in preclinical safety testing capabilities and the addition of advanced therapy manufacturing capabilities. The company’s recent growth initiatives reinforce its commitment to becoming the leading commercialization partner for advanced modality therapeutics.