We are happy to report that 2018 was a big year for cellular therapy. Particularly notable were the launches of the first two CAR-T therapies, Kymriah and Yescarta; both for treatment of hematological malignancies.
 

While these launch events were heralded as a breakthrough in cancer treatment, there remains significant challenges that need to be addressed. But what are these challenges, and should we expect a superior treatment in the near future?

 

High manufacturing costs

An exploration of the data reveals that the biggest challenge lies in CAR-T manufacturing, hence the high price tag. This limits the number of patients who have access to the therapy. The severity of this problem is reflected by the large volume of research into allogeneic, off-the-shelf formulations, which are significantly cheaper, faster and easier to manufacture and administer. 

 
 
– Signals Playbook™ Insights

– Signals Playbook™ Insights

 
 

Severe safety concerns

Safety is another primary concern, which is increasingly being addressed by dual-targeting CARs, gamma/delta CARs, and activation/elimination switches, as evidenced by the growing number of data points for these solutions.

 

Poor durability

The question of durability of response is rarer in the ecosystem, but recent well-cited journal publications have exposed concerning data regarding the long-term response in Kymriah and Yescarta. CAR-T cells targeting CD19 demonstrated high relapse rates, which can be attributed in part to antigen-negative escape and no generation of immune memory.

 
 
 
 

Can one drug overcome all of these challenges?

In May 2018, TapImmune merged with Marker Therapeutics. The company, presenting at the 2018 ASH conference, demonstrated compelling results for their unique multiple-antigen targeting therapy, showing that it causes no toxicity, is much faster and easier to manufacture, and vastly reduces the relapse rate compared to current CAR-T therapies on the market. These results, coupled with the high-profile merger with TapImmune, make Marker Therapeutics a company to watch.

 
 

Marker’s response data compared to Kite’s data

 
 
 

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