Cevec launches ELEVECTA platform

At the time of Cevec Pharmaceuticals’s announcement, US researchers reported that AAV gene therapy might be the most promising way to bridge the therapeutic gap until a COVID-19 vaccine is available.

Cevec Pharmaceuticals GmbH‘s patent-protected ELEVECTA^® platform is the only commercially available AAV gene therapy vector manufacturing technology on the basis of fully stable producer cell lines. The platfrom, which will be presented in detail on occasion of a webinar, allows to manufacture Adeno-associated viral or AAV vectors at large scale, a current bottleneck in gene therapy supply. ELEVECTA can be scaled to 2,000 litres and more, ten times more than current platforms can deliver,  Nicole Faust, CEO of CEVEC Pharmaceuticals, told European Biotechnology. Thus, the Cologne-based CDMO can supply preclinical and clinical gene therapy programmes of biotech and pharma developers.

CEVEC’s producer cell lines integrate all elements required for AAV production – a big progress as AAV manufacturing up to today required costly transfection reagents and cGMP-grade plasmids. ELEVECTA works for any combination of serotype-specific capsid and therapeutic gene of interest. The stable integration of these components into the cell results in cell lines designed to produce functional AAV vectors. According to Cevec, the technology can easily be implemented in bioprocess development and large-scale GMP manufacturing facilities running standard suspension bioreactor equipment widely used  for production of therapeutic antibodies and proteins.

“The launch of ELEVECTA forms a milestone on the way into a new era of viral vector manufacturing as it provides a solution for one of the major challenges in gene therapy development. By closing the production gap and providing the necessary quantities of viral vectors, it paves the way to address more common indications such as Alzheimer’s, Parkinson’s, or rheumatoid arthritis as well as therapies that require larger doses,” said Nicole Faust, CEO of CEVEC Pharmaceuticals.

Researchers highlight passive COVID-19 immunisation by AAV gene therapy

Most recently, researchers headed by Ralph Barric at the University of North Carolina at Chapel Hill highlighted AAV vector-based gene therapy as most promising technology  for in vivo therapeutic antibody delivery to combat SARS-CoV-2 outbreak and the future emergence of severe CoVs. As further highly pathogenic coronavirus strains may emerge through zoonotic reservoirs and as the rececptor-binding domain of the viral S-protein is not highly conserved, the US researchers argue, the diversity of S-protein will "render vaccines and neutralising antibodies (nAbs) unlikely to be cross-protective between existing and emerging CoVs." According to the researchers, passive immunisation of AAV can be developed as a platform technology in which the nAb can be quickly exchanged to target specific pathogens. Multiple studies have shown passive immunisation using AAV is effective against viral infectious diseases such as HIV, Ebola, influenza, and others.

Currently, there is no AAV vector-based programme in clinical development against COVID-19 albeit an AAV-based vaccine targeting the receptor-binding region of the viral S-protein showed sufficient immunogenicity and prevented infections with SARS-CoV. For adenovirus-based vaccine delevopment, which is more prominent in COVID-19 vaccine development, Cevec provides its CAP platform, which prevents formation of replication competent adenoviruses.