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Switch models: Autologous to iPSC-based allogeneic

Instead, we put our sole focus on furthering the unique experience we have accumulated in advancing iPSC-based allogeneic cell therapies. 

If your team is in discovery with an autologous candidate or, alternatively, already progressing your clinical trial but interested in shifting into an allogeneic clinical candidate, we can help. Here are two collaboration models we could pursue for adapting our Pulse™ + Echo™ Platforms to your distinct needs.

MODEL 1

Autologous Cell Starting Point

For an in vitro or in vivo comparison study, you would provide our team with your autologous cell, already gene modified with the respective KI (e.g., CAR/TCR). We would then reprogram it into an iPSC and, using pre-developed protocols from our Echo™ Platform, differentiate it into the desired immune cell of choice. The functionality of the cells will then be characterized using product specific assays by our QC team. That way, you get a Proof of Concept comparing your autologous product with an iPSC differentiated clone having exact same edits without performing gene editing again. Our team can then propose next steps towards master cell bank (MCB) and GMP batch manufacturing.

Autologous Cell Starting Point - FNL

MODEL 2

DNA Sequence Starting Point

If you share the DNA sequence of your CAR/TCR, we can use our Pulse™ Platform 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 and 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 autologous 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.

DNA Sequence Starting Point - FNL

Understanding your options

If a switch to an iPSC-based allogeneic approach intrigues you, we should explore it further together. We can provide additional insights into the process that can help your team identify its best path forward.