4.12.22-Health-Science-Startups-Kytopen

PAULO GARCIA: Thank you, Ariadna, for that introduction and, really, the ILP for putting this event in place-- so excited to see everything that the community has achieved and still the opportunities and challenges that need to be addressed in order to continue advancing the field of engineered living medicines to help patients and eventually make it the standard of care.

I am Paolo Garcia, CEO and co-founder of Kytopen. And we are physically opening cells to new possibilities by developing technology to introduce genetic material into the cells in order to enable some of the next-generation therapies. We spun out of my co-founder's lab at MIT, Cullen Buie from Mechanical Engineering, in 2017. And we currently operate at The Engine in Central Square here in Cambridge.

We're developing technology to improve patients' lives through automated cell engineering. And our value proposition is to be able to scale seamlessly between high-throughput target discovery, process development optimization, and, eventually, cost-effective manufacturing of these very important cell therapies to reach human patients.

Our secret sauce really lies in this flow cell in the center. This is where continuous flow of cells and genes operate at the same time. And we expose them to very precise fluid flows, and also electrical signatures, in order to deliver the genetic material into the cells. This flow cell has been implemented into a high-throughput delivery system where you can think about target discovery or process development optimization at low volumes, volumes between 50 to 200 microliters per sample. But with the same flow cell, we can actually scale up with time into larger volumes that can be used in autologous and allogeneic settings in a completely closed manner, back to back, at volumes and throughputs of greater than 1 billion cells per minute.

This is new technology. This is a new mechanism that we have invented initially at MIT, exclusive licensed and further developed at Kytopen, in which we combine very precise mechanical energy from the fluid flow and electrical energy from the waveforms that we program. And if we only use mechanical energy, we actually don't get delivery. If we only use electrical energy, we don't get delivery, either. This is something different than traditional static electroporation, in which there is a synergistic effect of combining both of these modes of energy for efficient delivery for high cell functionality, for being able to do things in high throughput, and end up with better yields, the number of live cells that are successfully edited or engineered.

Initially, we did most of the development using commercially available mRNA with a GFP reporter gene. And you can see that the technology is incredibly flexible. We were able to demonstrate this across a wide variety of cell types. Where we are right now is we're actually focusing further into some of those critical cells that have-- that are most advanced into clinical settings. And this involves primary T cells, natural killer cells, and CD34 stem cells specifically addressing the knockout with CRISPR-Cas payload system. The team has done an incredible job of expanding the boundaries of our technology capabilities. And later this year, we will also venture into some of the stable knock-ins via DNA plasmid and, potentially, transposon systems as well. And we heard a little bit about that earlier in the conversations.

I'm incredibly excited to share with you that Q1 of next year, we will actually be doing a launch of our GMP-compliant Flowfect Tx system. This is the manufacturing platform that is a closed system, end to end. And we are currently seeking partners, such as many of you, to evaluate the technology specifically around those three cell types that I mentioned earlier-- T cells, natural killer cells, and CD34 stem cells with either mRNA payloads or CRISPR-Cas RMPs, North America and Europe to begin because of the regulatory components of our platform-- and happy to show you the system that we're actually exhibiting in the room next door.

Thank you very much for your time and hope that you can make connections here to really continue advancing the field. Thanks.

[APPLAUSE]