Therapeutic Class

Celyad going to clinic with tweaked CAR-T manufacturing platform

Celyad expects to treat the first patients with its autologous CAR-T therapy CYAD-01 using the updated manufacturing process by the end of September. CYAD-01 is an autologous chimeric antigen receptor (CAR) T-cell therapy in development by Celyad for hematological malignancies and solid tumors. The immunotherapy has the ability to bind to eight different ligands that are naturally expressed by cancer cells. In July, the firm announced regulators accepted a proposal to change the candidate’s manufacturing process to use its proprietary…

Lineage granted stem cell production patent for cancer vax

The patent validates a system for production of antigen presenting dendritic cells from human embryonic stem cells (hESCs), used in Lineage Cell Therapeutics’ cancer immunotherapy program VAC2. The United States Patent and Trademark Office (USPTO) issued Patent No. 10,344,262, entitled ‘Differentiation of primate pluripotent stem cells to hematopoietic lineage cells,’ to Lineage Cell Therapeutics in July. The patent was filed by Asterias Biotherapeutics in February 2017. Asterias was acquired by clinical-stage biotech BioTime in March 2019, and since then BioTime…

Why freezing should be a hot topic for cell therapy sector

Cell therapy firms need to think about freezing earlier in process development according to an expert, who says optimized cryopreservation is key. Cell therapies have the potential to revolutionize medicine. For example, products like Yescarta and Kymriah can treat cancers more effectively and with fewer side effects than even the best chemotherapies. But unlike chemotherapies, cell therapies are highly susceptible to the temperature fluctuations that occur during transportation. To address this, developers protect their products using various methods, with cryopreservation…

Moderna talks vaccines, from mRNA to Zika

Moderna, Inc has received US FDA Fast Track designation for its investigational Zika vaccine based on its messenger RNA (mRNA) technology. The US Food and Drug Administration (FDA) has been granted to mRNA-1893, a vaccine intended to treat Zika currently in Phase I clinical studies. The Fast Track designation is designed to speed up development and review of therapies and vaccines needed to fill an unmet medical need. “Our Zika program is part of Moderna’s broader commitment to improving global…

US Gov provides Merck extra $23m for Ebola vaccine

The Health and Human Services (HHS) funding will support continued development of V920, a live viral vectored vaccine designed to protect against Zaire Ebola virus, says Merck. Merck & Co. began developing a vaccine to protect against the Ebola virus following the 2014-2016 Ebola outbreak in West Africa. In 2017, the firm received a definitive contract funded by the Office of the Assistant Secretary for Preparedness and Response of the HHS, originally worth $126 million (€114 million), to aid development…

Pfizer pumps $500m into NC gene therapy site

The expansion in North Carolina will create 300 jobs and is the latest investment by Pfizer in its burgeoning gene therapy network. The $500 million (€450 million) investment in Sanford, North Carolina will see the Big Pharma firm construct a facility to support production of its recombinant adeno-associated virus (rAAV) vectors for use in its gene therapies and vaccines. Mike McDermott, president of Pfizer Global Supply, said the Sanford expansion will “strengthen Pfizer’s leadership in gene therapy manufacturing technology” and…

Orchard to open CA plant in 2021 to support gene therapy pipeline

Orchard Therapeutics says it will balance its existing CMO network with a planned facility in Fremont to create the infrastructure needed to commercialize its gene therapies. Orchard’s pipeline of ex vivo autologous gene therapies include the former GSK hematopoietic stem cell (HSC) gene therapy Strimvelis – approved by the EMA in 2016 – and five clinical stage programs. The firm has been reliant on its network of contract manufacturing organizations (CMOs) to produce these therapies, but late last year it announced it…

Lonza to simplify vein-to-vein supply chain with Vineti partnership

The cell and gene therapy industry is at a global inflection point says Lonza as it teams with logistics firm Vineti to remove the supply chain hurdles affecting the space. The non-exclusive partnership will see contract development and manufacturing organization (CDMO) Lonza incorporate Vineti’s real-time end-to-end supply chain platform into its cell and gene therapy offering. “The Vineti and Lonza partnership is a preferred business collaboration to drive manufacturing efficiencies in the C&GT [cell and gene therapy] manufacturing process by…

Bio-Techne: $50m reagent plant will support cell & gene therapies

Plans for a $50 million GMP reagent facility in Minnesota are materializing at Bio-Techne as it looks to support the burgeoning cell & gene therapy sector. In its third quarter FY2019 financial call, life sciences services and consumables firm Bio-Techne spoke of intentions to build a $40 million (€36 million) GMP facility in Minneapolis, Minnesota to produce reagent proteins for use in cell and gene therapy applications. Three months on, the firm has said plans are now laid to invest…

COGS crisis: Cell therapy sector must rethink CMC says expert

The cell therapy sector faces a cost of goods sold (COGS) crisis and needs to get beyond the “product is the process” mind-set says Anthony Davies, CEO of Dark Horse Consulting. Cell and gene therapies have attracted a lot of attention in recent years. In part this is because drugs like Yescarta, Kymriah and Zolgensma have been approved as one-off cures. However, their cost – $373,000, $475,000 and $2.1m per vial in the US, respectively – has also seen them…