November 8, 2022
Kymriah and Yescarta may have finally established the commercial viability of cell and gene therapies, but it is advances in manufacturing and distribution that define the market, according to new analysis.
The research – published in the journal Cytotherapy in October – looked at innovation in cell and gene therapy research, in particular in cancer which has been a very active area for developers according to the authors.
“With the early successes of ex vivo–expanded, autologous tumor-infiltrating lymphocytes (TILs) in patients with metastatic melanoma demonstrating tumor-specific cellular immunity, the field of cellular therapy for cancer treatment, as we largely know it today, was born.
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“Since then, the field has expanded at an astonishing pace. According to the most recent reports on the global development of cancer immunotherapies, there are more than 1,300 active cell therapy trials, with chimeric antigen receptor (CAR) T cells comprising approximately one-half of those trials.”
The authors also looked at the types of cells being used and found that, in the past five years, so-called “natural killer” cells – immune cells that can kill tumors or virus infected cells – and stem cells have become a major research focus.
“Natural killer (NK) cells have emerged as a therapeutic option for hematologic malignancies, with the potential to be modified with a CAR as well to enable antigen specificity.”
And the need for NK cells has changed industry sourcing practices according to the authors, who write “induced pluripotent stem cells (iPSCs) have been employed to generate allogeneic cellular therapies via both NK cells and T cells.”
The review also looks at work being done to improve production and supply processes, which is a major hurdle for the industry.
“The specialized expertise required to manufacture these novel treatments impose a significant obstacle to delivery outside of tertiary academic medical centers. Addressing this hurdle will be critical to ensuring that novel therapies are accessible so that all patients may benefit.”
They go on to cite point-of-care (POC) as an emerging option. In POC portable technologies are used to “manufacture” cell and gene therapies at the clinic, even at the bedside.
The approach has the potential to eliminate the complex logistical steps needed to both patient specific products – those made from cells harvested from an individual – and off the shelf therapies.
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