Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Aldevron, the leading provider of high-quality plasmid DNA, mRNA and recombinant proteins necessary for vaccines, gene and cell therapy, gene editing and diagnostic applications, announced today that Aldevron will support the development of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD), and ARU-2801, a one-time investigational gene therapy for hypophosphatasia (HPP). Aldevron will provide good manufacturing practice (GMP)-grade plasmid for Aruvant’s upcoming ARU-1801 pivotal trial.
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.
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.
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.
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.
