Aldevron News: Clinical Grade Manufacturing/cGMP (2)

Genprex Taps Aldevron to Enable Full Commercial Scale Plasmid DNA Manufacturing Capabilities

Genprex, Inc. (NASDAQ: GNPX), is collaborating with Aldevron to secure GMP plasmid DNA manufacturing capacity for Genprex's Oncoprex™ gene therapy portfolio.

The manufacturing program supports upcoming clinical trials, including Oncoprex™ in combination with Tagrisso®, which has received FDA Fast Track Designation. The collaboration with Aldevron will enable full commercial scale plasmid DNA manufacturing capabilities. 

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Aldevron Announces GMP Gene Synthesis Service to Support Neoantigen-based Oncology Research and other Applications

Aldevron has added GMP gene synthesis to its array of services. This expanded capability will be used primarily to support Aldevron’s clients who require rapid GMP gene synthesis for novel cancer treatments based on neoantigens. The company noted the service is not suited for routine, research-grade synthesis, for which Aldevron will continue using outside providers.  

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Genprex™ Manufacturing Partner Aldevron Completes Significant Step in Manufacturing for Oncoprex™ Clinical Development Program

Newly manufactured plasmids will be used in clinical trials evaluating Oncoprex™ in combination with targeted therapies and immunotherapies

Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company, announced that its manufacturing partner, Aldevron, has successfully completed the manufacturing of the TUSC2 (Tumor Suppressor Candidate 2) plasmid DNA pursuant to the manufacturing agreement between Genprex and Aldevron that was announced in September 2018.

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Aldevron Releases GMP-Grade SpyFi™ Cas9 Nuclease

Product is the result of a partnership with Integrated DNA Technologies, Inc., and provides clinical stage clients with a critical raw material 

Aldevron is announcing the release of GMP SpyFi Cas9 Nuclease for clinical and commercial applications. SpyFi Cas9 Nuclease, the trade name for Aldevron’s research grade and GMP products, is the direct result of a partnership with Integrated DNA Technologies, Inc. (IDT). The advantages of SpyFi Cas9 Nuclease include reduced off-target effects combined with clinically relevant on-target activity.

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New Standardized Plasmids Available for Lentiviral Manufacturing

Novel Packaging and Expression Plasmids Promise to Reduce Gene Therapy Manufacturing Costs and Delivery Times

Miami, FL - Aldevron announced from Phacilitate Leaders World in Miami the immediate availability of standardized plasmids for lentiviral production through a license agreement with Oxford Genetics.

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Sarepta Therapeutics Enters into Long-term Strategic Relationship with Aldevron

Agreement provides Sarepta with committed capacity and dedicated manufacturing slots for GMP-grade plasmid production for its micro-dystrophin Duchenne muscular dystrophy (DMD) gene therapy program, as well as plasmid capacity for future gene therapy programs 

Cambridge, Mass., January 2, 2019 - Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases and Aldevron, the leading producer of custom nucleic acids, proteins, and antibodies for the biotechnology industry, announced today that they have entered into a long-term strategic relationship for the supply of plasmid DNA to fulfill Sarepta’s needs for its gene therapy clinical trials and commercial supply.

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Genprex™ Taps Aldevron to Supply TUSC2 Plasmid DNA for Oncoprex™ Clinical Development Program

Newly manufactured plasmids will be applied in clinical trials evaluating Oncoprex in combination with targeted therapies and immunotherapies

Austin, Texas, Cambridge, Mass. and Fargo, N.D. – September 26, 2018 – Genprex, Inc. (NASDAQ: GNPX), a clinical stage gene therapy company developing a new approach to treating cancer based upon a novel proprietary technology platform, has signed an agreement with Aldevron, a leading contract manufacturing organization, to supply TUSC2 (Tumor Suppressor Candidate2) plasmid DNA for use in Genprex’s clinical development program evaluating its immunogene therapy Oncoprex for the treatment of non-small cell lung cancer.

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Aldevron to Provide New GMP Cas9 Nuclease Through Agreement with Integrated DNA Technologies

Aldevron and Integrated DNA Technologies, Inc. (IDT), a supplier of custom nucleic acid and genome editing products, have announced a license agreement whereby Aldevron will manufacture and distribute a S. pyogenes Cas9 variant—known as SpyFiTM Cas9 Nuclease—which is patented by IDT. The product will be manufactured for research, clinical, and commercial use.  

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