Therapeutic Class

Second Bluebird gene therapy approval a boon for Minaris

CDMO Minaris says it will be the commercial manufacturer for Skysona (elivaldogene autotemcel, Lenti-D), a second Bluebird Bio gene therapy approved by the European Commission. The European Commission (EC) granted marketing authorization of Skysona for the treatment of early cerebral adrenoleukodystrophy (CALD) yesterday. The one-time gene therapy uses a patient’s own hematopoietic stem cells (HSC) to treat the underlying cause of the neurologic condition CALD. SKYSONA uses ex vivo transduction with the Lenti-D lentiviral vector (LVV) to add functional copies…

Sanofi doubles down on mRNA vaccines with $475m annual booster shot

‘The mRNA story is just beginning’ says Sanofi as it builds on its partnership with Translate Bio by launching dedicated vaccine R&D centers in Massachusetts and France. The French pharma giant announced plans today to invest €400 million ($475 million) annually into what it describes as its ‘mRNA Center of Excellence’ to accelerate R&D of next-generation vaccines. The ‘Center’ will in fact be spread across two of Sanofi’s locations, Cambridge (Boston) in Massachusetts and in Marcy L’Etoile (near Lyon), France,…

$250m CAR-T startup ‘validates’ Intellia’s allogeneic and CRISPR platforms

Intellia Therapeutics, Blackstone, and Cellex have launched a CAR-T biotech aimed at developing chimeric antigen receptor (CAR) T-cell therapies. The new company will combine Intellia’s allogeneic cell platform and CRISPR cell engineering with Cellex subsidiary GEMoaB’s switchable universal CAR-T platforms – UniCAR and RevCAR – to develop a range of therapies against various cancers, including solid tumors. Blackstone Life Sciences has invested $250 million in the new venture, and the three companies – Blackstone, Intellia, and Cellex – will each…

Vectorized antibody startup VectorY to establish Dutch plant

VectorY Therapeutics will use a portion of its recent €31 ($37) million seed financing to construct a plant in The Netherlands to support its vectorized antibody gene therapy candidates. The biotech, which launched in October 2020 at the Amsterdam Science Park in The Netherlands, secured €31 million through the funding round led by a syndicate that included Forbion, BGV, and Eli Lilly and Company. The money will be used to both establish preclinical proof of the firm’s concept for vectorized…

Enzymatic DNA printer will speed R&D and COVID testing, says DNA Script

DNA Script has launched a benchtop nucleic acid printer it claims will accelerate molecular biology, genomic research, and even COVID-19 testing. The Paris, France firm unveiled Syntax this month, describing it as a fully integrated, automated printer that is able to synthesize 96 DNA oligonucleotides in parallel, comprised of up to 60 nucleotides in length. The technology uses enzymes to synthesize the DNA molecules which – unlike traditional phosphoramidite chemistry based approaches – accelerates and optimizes production and eliminates the…

Dendreon leveraging Provenge network to launch cell therapy CDMO biz

Dendreon says its experience bringing Provenge to market puts it in good stead to offer its process development, manufacturing, and patient logistics capabilities to other cell therapy makers. Dendreon has had a turbulent past. Its autologous cell therapy product Provenge (sipuleucel-T) was approved in the US in 2010 for the treatment of prostate cancer but manufacturing complexities and costs led the firm to restructure itself in 2012, including selling its Morris Plains, New Jersey to Novartis. Then in 2014 Dendreon…

Get your TOX off: Piramal looks to next generation of ADCs

Non-cytotoxic payloads, immune-stimulating antibody conjugates, and peptide-delivery mechanisms all form part of the new drug-conjugate landscape, says Piramal Pharma Solutions. It has been over 20 years since the first antibody-drug conjugate (ADC) hit the market. However, the sector has only taken off over the past three years with six US FDA approvals tallying the total number of marketed ADCs to 11, the latest being ADC Therapeutics’ Zynlonta (loncastuximab tesirine). Download our ebook ‘ADCs – Evolving Links in the Biopharmaceutical Pipeline’…

Robotic CAR? Cytiva and Multiply team on cell therapy automation

Cytiva has partnered with Multiply Labs to create a fully automated robotic system intended to support commercial-scale cell therapy manufacturing. “Cytiva and Multiply Labs want to develop a robotic system that will automate the manufacturing processes for cell therapies and drastically bring down the cost to do so,” Parker Donner, head of Business Development, Cell and Gene Therapy at Cytiva told BioProcess Insider. “While these therapies have proven to be very effective, the manufacturing workflow is overly reliant on manual…

UPenn gene therapy researchers lease space at Discovery Labs

University of Pennsylvania gene therapy researchers have leased space at Discovery Labs’ facility in King of Prussia in a deal designed to expand vector production capacity. The agreement – financial terms of which have not been disclosed – includes two dedicated floors at Discovery Labs’ campus on Swedeland Road. The leased space will house the Penn Vector Core, which is a full-service viral vector manufacturing operation. At present Penn produces viral vectors for use in gene transfer. It supplies vectors…

eBook: ADCs — Evolving Links in the Biopharmaceutical Pipeline

Antibody–drug conjugate (ADC) developers both old and new are talking about the next generation of drug candidates coming through their pipelines. In April 2021, Zynlonta (loncastuximab tesirine, from ADC Therapeutics) became the eleventh such product to receive approval from the US Food and Drug Administration (FDA). But with dozens of ADC candidates currently in clinical trials, those 11 products represent the tip of the ADC iceberg. In this eBook, Dan Stanton (founding editor of BioProcess Insider) explores ADC production history,…