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PHILADELPHIA--(BUSINESS WIRE)--iECURE, a gene editing company focused on mutation-agnostic in vivo gene insertion, or knock-in, editing for the treatment of liver disorders with significant unmet need, and Center for Breakthrough Medicines (CBM) today announced the companies have entered into a strategic collaboration wherein CBM will produce and supply Good Manufacturing Practices (GMP)-grade adeno-associated virus (AAV) for use in iECURE's future clinical studies to enable development of iECURE's programs with the shared mission of accelerating the availability of these potential treatments to the patients.
"Our approach to gene editing relies on highly complex manufacturing processes, and we are eager to establish partnerships to ensure a reliable supply of GMP materials for future clinical development," said Paul Firuta, Chief Operating Officer of iECURE. "CBM was able to offer us significant amount of guaranteed capacity with scheduling flexibility and we are confident that they will be a strong partner with their state-of-the-art facilities and end-to end capabilities."
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"iECURE's approach to gene editing is quite innovative and has the potential to bring significant hope to patients and families facing devastating diagnoses," said Audrey Greenberg, Chief Business Officer and Co-Founder of CBM. "Our ability to provide customizable clinical and commercial GMP manufacturing solutions integrated with industry-leading comprehensive in-process testing, quality control, and lot release programs allows us to support our partners like iECURE through the entirety of their product lifecycle and is aligned with our mission to bring life changing medicines to patients in need."
About iECURE
iECURE is a gene editing company focused on developing therapies that utilize mutation-agnostic in vivo gene insertion, or knock-in, editing for the treatment of monogenic liver disorders with significant unmet need. We believe our approach has the potential to replace and restore the function of a dysfunctional gene by knocking-in a healthy copy, regardless of mutation, to offer durable gene expression and long-term, potentially curative, therapeutic benefit. Our management team has extensive experience in executing global orphan drug and gene therapy clinical trials and successfully commercializing multiple products. We intend to leverage our team's core strength in research and development strategy to identify what we believe to be the most suitable target and modality for our product candidates to address particular liver diseases. We are collaborating with the University of Pennsylvania's Gene Therapy Program, or GTP, led by James M. Wilson, M.D., Ph.D., to utilize GTP's world-class translational expertise and infrastructure, which has helped generate our initial pipeline of potential product candidates. For more information, visit www.iecure.com and follow on LinkedIn.
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About Center for Breakthrough Medicines (CBM)
CBM is a cell and gene therapy contract development and manufacturing organization (CDMO) based in the heart of Philadelphia's Cellicon Valley. CBM offers pre-clinical through commercial manufacturing capabilities including process development, plasmid DNA, viral vector, cell therapy and a full suite of testing and analytical capabilities. Through a single-source, end-to-end solution, CBM accelerates time to market without compromising quality.
Contacts
Investors:
David Garrett
dgarrett@iecure.com
Media:
Danielle Cantey
Canale Communications
danielle.cantey@canalecomm.com
"Our approach to gene editing relies on highly complex manufacturing processes, and we are eager to establish partnerships to ensure a reliable supply of GMP materials for future clinical development," said Paul Firuta, Chief Operating Officer of iECURE. "CBM was able to offer us significant amount of guaranteed capacity with scheduling flexibility and we are confident that they will be a strong partner with their state-of-the-art facilities and end-to end capabilities."
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"iECURE's approach to gene editing is quite innovative and has the potential to bring significant hope to patients and families facing devastating diagnoses," said Audrey Greenberg, Chief Business Officer and Co-Founder of CBM. "Our ability to provide customizable clinical and commercial GMP manufacturing solutions integrated with industry-leading comprehensive in-process testing, quality control, and lot release programs allows us to support our partners like iECURE through the entirety of their product lifecycle and is aligned with our mission to bring life changing medicines to patients in need."
About iECURE
iECURE is a gene editing company focused on developing therapies that utilize mutation-agnostic in vivo gene insertion, or knock-in, editing for the treatment of monogenic liver disorders with significant unmet need. We believe our approach has the potential to replace and restore the function of a dysfunctional gene by knocking-in a healthy copy, regardless of mutation, to offer durable gene expression and long-term, potentially curative, therapeutic benefit. Our management team has extensive experience in executing global orphan drug and gene therapy clinical trials and successfully commercializing multiple products. We intend to leverage our team's core strength in research and development strategy to identify what we believe to be the most suitable target and modality for our product candidates to address particular liver diseases. We are collaborating with the University of Pennsylvania's Gene Therapy Program, or GTP, led by James M. Wilson, M.D., Ph.D., to utilize GTP's world-class translational expertise and infrastructure, which has helped generate our initial pipeline of potential product candidates. For more information, visit www.iecure.com and follow on LinkedIn.
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About Center for Breakthrough Medicines (CBM)
CBM is a cell and gene therapy contract development and manufacturing organization (CDMO) based in the heart of Philadelphia's Cellicon Valley. CBM offers pre-clinical through commercial manufacturing capabilities including process development, plasmid DNA, viral vector, cell therapy and a full suite of testing and analytical capabilities. Through a single-source, end-to-end solution, CBM accelerates time to market without compromising quality.
Contacts
Investors:
David Garrett
dgarrett@iecure.com
Media:
Danielle Cantey
Canale Communications
danielle.cantey@canalecomm.com
Filed Under: Business
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