Switch models: Donor-derived to iPSC-based allogeneic
Donor-derived allogeneic cell therapies have sparked interest by successfully addressing limitations of autologous strategies, including providing wider patient access, better scalability, and greater product consistency.
Yet allogeneic cell therapies based on iPSCs can add even more value, further increasing scalability, improving manufacturability, and enhancing overall quality and characterization. Those benefits – among several others – are what have led our team at Cellistic to focus exclusively on advancing iPSC-based allogeneic cell therapies.
If your team is working with a donor-derived allogeneic candidate or, alternatively, already progressing your clinical trial but interested in shifting into an iPSC-based approach, we can help. Here are two suggested collaboration models we could pursue for tuning our Pulse™ + Echo™ Platforms to your distinct needs.
MODEL 1
Donor Cell Starting Point
For an initial comparison study with your current in vitro or in vivo data, you would provide Cellistic with your best-performing donor cell that has been gene-modified with the respective KI (e.g., CAR/TCR). Our team will then reprogram it into an IPSC, and differentiate it into the desired immune cell of choice using pre-developed differentiation protocols from our Echo™ Platform. The functionality of the cells will be characterized using product specific assays by our QC team. That way, you can easily compare your donor-derived clone with an iPSC differentiated clone having the exact same edits, and our team can propose next steps towards MCB and GMP manufacturing in our facility.
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MODEL 2
DNA Sequence Starting Point
We would start with your team sharing the DNA sequence of your CAR/TCR. Then, we would use our proprietary Pulse™ Platform for gene editing to KI at the desired locus using our off-the-shelf IPSC clinical cell lines. We would then differentiate into the desired immune cells using our Echo™ Platform. The functionality of the cells will be characterized using product specific assays by our QC team. The end result is an initial comparison between your edited allogeneic donor-derived product with an iPSC gene modified, differentiated clone. In model 2, we have designed specifically where the gene modifications are inserted. We can then propose next steps to advance into master cell bank (MCB) and GMP batch manufacturing.
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Take allogeneic a step further
Curiosity is at the inception of any successful scientific endeavor, so if you are intrigued about how an iPSC-based approach may help advance your program, let’s talk. We can share our research findings, answer questions, and give you the data you need to make an informed decision about how to shorten your road ahead.