Allogene allies with Notch to make CAR-T production more scalable – BioPharma-Reporter.com

Last year, Arie Belldegrun and David Chang, fresh from selling chimeric antigen receptor (CAR)-T pioneer Kite Pharma to Gilead Sciences, launched Allogene with $300m (271m) and a deal with Pfizer to access off-the-shelf cell therapies. The focus then, as now, was on taking CAR-T therapies mainstream by eliminating factors that could restrict them to niche status, such as the complex, costly production process.

Allogenes founding allogeneic technology moves it some way toward that goal, by enabling therapies to be made from donor cells rather than having to engineer cells taken from the patient themselves.

However, even if the allogeneic approach works as Allogene hopes, it will still require a steady supply of donor cells. When Allogene launched, it set its sights on making up to 100 doses from one donor sample.

The finite nature of donated T cells has spurred interest in induced pluripotent stem cells (iPSC), which could serve as a renewable source of materials for off-the-shelf CAR-T therapies. Notchs work to realize that potential caught the attention of Allogenes CEO, David Chang.

Chang said, We believe [it] to be a scalable and potentially more [good manufacturing practice] amenable manufacturing process. It might be amenable for large-scale manufacturing.

The early stage nature of the iPSC technology Notch is yet to enter the clinic means it is unclear whether the approach can live up to those expectations. An inability to show CAR-T doses are free from undifferentiated iPSCs and failure to generate functioning T cells from iPSCs are two potential stumbling blocks.

Allogene has seen enough potential to bet on Notch, though. The deal will see Allogene pay Notch $10m upfront, take a 25% stake in its new partner and commit to a package of milestones.

Notch will take iPSC AlloCAR T cells through preclinical development before Allogene steps in to test them in humans. Allogene will have global rights to any products resulting from the collaboration.

Other companies are also working to develop oncology cell therapies based on iPSCs. Fate Therapeutics is trialling an engineered natural killer cell therapy created from a clonal master iPSC line, while Bayer-backed startup Century Therapeutics recently raised $250m to take iPSC-derived treatments for blood cancers and solid tumors into the clinic. Takeda is also active in the space.

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Allogene allies with Notch to make CAR-T production more scalable - BioPharma-Reporter.com