Expanding access to off-the-shelf cell therapies by bridging the supply chain gap

Human induced pluripotent stem cell colony. [Image courtesy of NIH]

Allogeneic, or off-the-shelf, cell therapies derived from induced pluripotent stem cells (iPSCs) can be produced in a consistent, scalable manner and can significantly expand the availability and promise of this potentially curative modality. Although only autologous versions are currently approved, cell therapies are becoming an important alternative for treating many relapsed/refractory cancers and show substantial benefits over more traditional therapies.

CAR-T therapies are becoming the standard of care for some relapsed or refractory diseases, such as multiple myeloma, acute lymphoblastic leukemia, follicular lymphoma, and some forms of aggressive, non-Hodgkin lymphoma. In studies with autologous cell therapies (tisagenlecleucel and axicabtagene ciloleucel), complete response rates (CRR) ranged from 40-57%, while a mix of salvage therapies …

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Lessons in life or death logistics

Cell therapy image from Wikimedia Commons

The cell and gene therapy market continues to advance, thanks to its promise to treat cancers and other severe diseases. While the pandemic has had a negative impact on companies specializing in cell and gene therapies, it has also catalyzed interest in cold-chain logistics while also highlighting the promise of new therapy types.

Organizations interested in expanding their focus on cell and gene therapies can learn from best practices from organizations specializing in high-stake logistics.

Push for standards and collaboration

The initial focus on transporting mRNA vaccines at below-normal temperatures “highlighted the need for some sort of standardization,” said ​​Ray Hornung, senior manager, logistics and emergency preparedness at Be The Match BioTherapies (Minneapolis).

Ray Hornung

While t…

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Functional single-cell proteomics firm Isoplexis misses IPO target

Branford, Connecticut–based Isoplexis (NSDQ:ISO) made its public market debut today with an initial public offering of 8,333,000 shares of common stock initially priced at $15 per share.

ISO shares ended up selling for $11.52 apiece at the end of trading, equating to $96 million (less fees and expenses associated with the IPO). That was 23% less than its $15-per-share target, which would have raised $125 million before fees and expenses.

“We can’t control how the stock trades every day, but we can control being good at our jobs and producing revenue and growing the company,” Isoplexis co-founder and CEO Sean MacKay told Drug Discovery Trends.

The company plans to use proceeds from the IPO to invest in commercial expansion and hiring new staff.

“We grew about 103% in the first half of this year,” MacKay said. “To continue to move worldwide with our product, we need to continue to invest in the commercial teams.”

Isoplexis also plans to expan…

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