Therapeutic Class

Instant caRNA? Tesla touts RNA bioreactor it is developing with Curevac

Curevac and car maker Tesla claim their development RNA production tech is less labour intensive and more deployable than alternatives. The technology – described as a Bioreactor for RNA in vitro Transcription – allows the DNA templates from which the RNA is produced to be used multiple times. It is also automated, which Curevac and Tesla say will minimize handling steps and make manufacturing processes more robust. The firms contrast their technology with current systems, which involve “many separate manufacturing…

Nex-T up: Bristol-Myers using machine learning to optimize future CAR-T

Bristol-Myers Squibb says its next-generation CAR-T candidates, known as Nex-T, could offer faster and cheaper autologous cell therapies against multiple myeloma and lymphoma. Bristol-Myers Squibb (BMS) entered the chimeric antigen receptor (CAR) T-cell therapy space through the completion of its $74 billion acquisition of Celgene last November. Among the candidates BMS added to its pipeline were lisocabtagene maraleucel (liso-cel), an anti-CD19 targeting lymphoma, and idecabtagene vicleuce (ide-cel) being developed against multiple myeloma in partnership with Bluebird Bio, both in late-stage…

News of note: Sanofi’s €610 million vaccine boost

Sanofi will build a production site and an R&D facility near Lyon in efforts to make homeland France the center of its global vaccine efforts. The plant in Neuville sur Saône, north of Lyon, France, represents an investment of €490 million ($550 million). It will be modular in its design and dedicated to vaccine production and is being set up to respond to future epidemics. The R&D center in Marcy-l’Etoile, west of Lyon, represents €120 million and will look to…

Imperial College London takes RNA COVID vaccine into clinic

A vaccine candidate that allegedly turns cells in the body into ‘mini-antibody producing factories’ against COVID-19 has begun first-in-human clinical trials. The latest effort in combatting COVID-19 comes form the UK’s Imperial College London, with its vaccine candidate beginning Phase I trials this week. The vaccine is being developed through over £41 million ($51 million) of UK government funds and is based on a self-amplifying RNA technology. “The way the vaccine works is quite different from other approaches in that…

Spark on changing cell and gene regulatory expectations

Regulators are increasingly looking to industry to turn the science of cell and gene therapies into reproducible platform technologies, says Spark Therapeutics’ Diane Blumenthal. The advancements in the cell and gene therapy space were applauded throughout Xconomy’s virtual Xcelerate Philadelphia event last night as industry experts spoke about the increasing number of such therapies moving through the clinic and the hurdles that industry is rapidly knocking over. But challenges continue to exist, and in a panel focused on regulatory pathways,…

Gilead’s Kite receives EMA OK for Amsterdam CAR-T plant

The $150 million facility in The Netherlands is now fully operational and will produce CAR-T therapy Yescarta for up to 4,000 patients per year, says Kite. In 2018, Gilead Sciences, fresh from its $11.9 billion acquisition of Kite Pharma, announced plans to open a European facility to manufacture chimeric antigen receptor (CAR) T-cell therapies. Today the firm has announced the 204,514 square-foot site – the largest in Kite’s network – has received approval from the European Medicine Agency (EMA) for…

Rigenerand launches CDMO biz after gene therapy facility gains approval

Regulatory approval to make gene therapies from its site in Modena, Italy has enabled biotech Rigenerand SRL to enter the advanced therapy CDMO space. Rigenerand announced last week that the Italian Medicine Authority (AIFA) has granted authorization to produce gene therapy medicinal products for clinical purposes from its site in Modena. This will allow the advancement of the firm’s lead candidate RR001 – an autologous gene therapy being investigated to treat pancreatic cancer – into Phase I trials but will…

CSL to make ‘molecular clamp’ enabled COVID-19 vaccine for University of Queensland

A part-CEPI funded COVID-19 vaccine will be made by CSL at its site in Melbourne, Australia and will incorporate the MF59 adjuvant made by CSL subsidiary Seqirus. In January, the University of Queensland (UQ), Australia received funding of up to $10.6 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to help develop its vaccine against COVID-19, caused by the novel coronavirus (SARS-CoV-2). The candidate is based on proprietary the University’s proprietary “molecular clamp” vaccine platform, a technology that aims…

Mesoblast planning capacity hike if GVHD candidate is effective against COVID-19

Mesoblast says extra capacity will be needed to scale-up production of its GVHD candidate Ryoncil for use against COVID-19. When Australia’s Mesoblast raised $90m last month it said most of the money would be used to scale up production of its graft versus host disease (GVHD) candidate Ryoncil (remestemcel-L). CEO Silviu Itescu expanded on this last week, telling analysts the funds would be used to increase production of remestemcel-L in light of the coronavirus pandemic. “The proceeds from this offering…

Immobilize growth factors to cut cell therapy COGS say researchers

Cell therapy manufacturing costs could be reduced dramatically using immobilized growth factors in culture according to research. Industry interest in cell therapies has increased significantly in recent years. According to a report by US industry group PhRMA, there are 362 cell and gene therapies in clinical development, up from 289 in 2018. The surge in cell therapies entering the clinic is the “result of years of pioneering research by America’s biopharmaceutical research companies,” according to PhRMA. It also reflects the…