Therapeutic Class

Astellas eyes AMD cell therapy trial restart after manufacturing tweaks

Astellas is set to restart trials for its age-related macular degeneration (AMD) program ASP7317 after improving production and analytical process for the embryonic stem cell-derived candidate. Astellas added ASP7317 to its pipeline through the acquisition of Ocata Therapeutics in 2015. The cell therapy, derived from pluripotent human stem cells, is being investigated as a potential treatment for people with dry AMD. But a Phase I trial enrolment was voluntarily put on hold by Astellas last year “due to the time…

Charles River looks to CGT growth to offset ‘bumpiness’ in CDMO biz

Stabilizing acquired CDMO businesses is proving “elusive and expensive” say analysts, but Charles River is confident cell and gene therapies entering the clinic will be the foundation of future growth. For the second quarter 2022, Charles River Laboratories reported revenue from its manufacturing segment of $195 million, down 1.5% on the same quarter last year. Furthermore, the company is reducing its 2022 financial guidance from revenue growth of 13.5-15.5% to 9-11% in part due to “headwinds associated with the CDMO…

Plasmid production a plus for Polyplus

Polyplus has added transgene plasmid engineering services for viral vector manufacturing, which it says allows customers to get their gene therapies to market quicker. The French biotech claims that since acquiring DNA design and production services firm e-Zyvec in February, it has focused on providing more advanced levels of solutions to support its client base. By using e-Zyvec’s technology “the plasmids are assembled de novo, from a library of DNA bricks, removing the use of standard plasmid backbones that contain…

Roche inks $110m allogeneic CAR-T deal with Poseida

Switzerland’s Roche has jumped deeper into the allogeneic cell therapy space through an off-the-shelf CAR-T collaboration and license deal with Poseida Therapeutics. Pharma giant Roche’s adventure in the cell and gene space began with gene therapies, acquiring Spark Therapeutics in 2019 for $4.3 billion and instantly adding one of just a handful of approved products. Luxturna (voretigene neparvovec), a one-time gene therapy for an inherited retinal disease, was approved by the US Food and Drug Administration (FDA) in December 2017. Having…

Further CDMO consolidation in CGT space as RoslinCT and Lykan agree to merge

The combination of the two cell and gene therapy CDMOs brings customers a transatlantic footprint and combined expertise, the companies say. UK-based cell therapy contract development and manufacturing organisation (CDMO) RoslinCT – a spinout from the Roslin Institute – has entered into a business combination agreement with Massachusetts-based Lykan Bioscience to merge. “The combination will create a global leader in process development and GMP manufacturing of advanced cell and gene therapies with transatlantic footprint in the US and UK,” a…

CGT Catapult joins personalized cell therapy consortium

Cell and Gene Therapy Catapult (CGT Catapult) has launched a consortium to advance manufacturing of personalized cell therapies. The consortium, of which UK-based advanced therapy developer Achilles Therapeutics is project coordinator, has been awarded $4.2 million by Horizon Europe to advance a bioprocessing manufacturing platform for personalized therapies. According to CGT, the existing manufacturing platforms on the market are hindered in their ability to deliver sufficient real-time dating during production, which limits overall scalability and decision making. The company said…

Core Biogenesis bags $10.5m funding to drive plant-based bioproduction

Core Biogenesis has completed a $10.5 million Series A funding round, which will be used to build a plant-based bioproduction facility. The site will be located in Strasbourg, France and the firm said it will be dedicated to manufacturing growth factors and cytokines for the cell therapy space and cellular agricultural industry and will launch early next year. The firm claims it has developed a technology platform that can express recombinant proteins from the seeds of a Camelina sativa oilseed…

Legend Bio looks to raise $250m in public offering

CAR-T firm Legend Biotech has announced plans to raise $250 million by selling American Depositary Shares (ADSs) in an underwritten public offering. In February, New Jersey-Nanjing cell therapy company Legend was approved to launch its BCMA CAR-T therapy, Carvykti, for multiple myeloma in the US, and EU approval followed in May. The company partners the drug with Johnson & Johnson’s Janssen subsidiary. At the recent ASCO convention, Legend revealed the CAR-T had not reached a median progression of disease or…

Cell and gene sector could benefit from synthetic standards for flow cytometry

Cell and gene therapy developers need better ways of validating flow cytrometry software according to researchers who say synthetic datasets could help improve product quality. The comments were included in a study published in March that looked at the current state of flow cytometry data analysis tools used in the cell and gene therapy. The key finding was that the lack of standard validation methods means many manufacturers rely on subjective assessments. “Characterization of ATMPs by automated flow cytometry data…

Solvias boosts CGT testing with Cergentis acquisition

Contract development firm Solvias has bought gene sequencing firm Cergentis to feed the expected growth in cell and gene therapy testing demand. The deal, financials of which have not been divulged, will see Swiss pharmaceutical testing and manufacturing firm Solvias absorb Utrecht, Netherlands-based Cergentis, bolstering its biologics and cell and gene therapy (CGT) testing solutions. Cergentis uses its genomic analysis platform for the characterization and QC of genetically engineered models, biopharmaceutical cell line development, and cell and gene therapy products.…