Gene and cell therapy developers are contending with the implications of the evolving regulatory environment while trying to progress programs as quickly as possible to address unmet needs and secure first-mover advantage in competitive indications. Regulators are facilitating efforts to truncate development timelines through a series of designations that can expedite programs while also making efforts to implement standardization.
In the News: AAVCOVID Partner Mass Eye and Ear Releases Preclinical Data on Single-Dose, Room Temperature-Stable COVID-19 Vaccine, and Announces Grant Award.
Aldevron is excited to share an update on our partner's progress regarding their AAVCOVID vaccine program. Mass Eye and Ear's novel gene-based vaccine strategy utilizes an adeno-associated virus (AAV) vector.
In the News: Aldevron Partner, Genprex Completes Manufacturing Technology Transfer for Novel Gene Therapy
Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, announced today that it has successfully completed the technology transfer of its manufacturing process for the production of REQORSA™ immunogene therapy, the company’s lead drug candidate.
Plasmid DNA was key to the development of biologic drug manufacturing. Today, it plays a critical role in the production of next-generation cell and gene therapies and vaccines. With its plasmid DNA manufacturing expertise, Aldevron has helped facilitate the advance of these important therapeutics. The company continues to invest in additional capacity and novel capabilities to support biopharma manufacturers into the future.
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.
Aldevron, Nature Technology Corporation Team up to Offer Nanoplasmids™ for Gene Therapy Manufacturing
Aldevron has announced the immediate availability of NanoplasmidsTM and antibiotic-free RNA-OUT technology for use in gene therapy manufacturing. Through a license agreement with Nature Technology Corporation (NTC), Aldevron can now provide its clients the option of using NTC’s plasmid technology to provide a more efficient system for manufacturing viral vectors used in gene and cell therapy.
PTC Therapeutics Establishes Strategic Collaboration with Aldevron to Support GMP Plasmid Manufacturing
PTC Therapeutics, Inc., is collaborating with Aldevron to secure GMP manufacturing capacity for PTC's gene therapy portfolio. This portfolio includes the Friedreich ataxia and Angelman syndrome programs in PTC's gene therapy pipeline.
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.