Scailyte, a leader in AI-driven single-cell biomarker discovery, today announced the results of a successful, in-depth collaboration with Sanofi. The project, now published on the bioRxiv preprint server, directly addresses one of the most significant hurdles in cell therapy: predicting manufacturing success.
The allogeneic Natural Killer (NK) cell therapy field is challenged by the high variability of donor starting material. Unpredictable expansion yields lead to a high risk of batch failures, resulting in significant costs, manufacturing delays, and a critical bottleneck in therapeutic development.
The joint Scailyte-Sanofi teams, including Sanofi’s Single-Cell Biology and NK Manufacturing units, set out to solve this problem. The study revealed that standard computational analysis methods were unable to find any significant predictive signals to distinguish high-expanding from low-expanding donors.
However, when applied to the same complex single-cell dataset, Scailyte’s proprietary ScaiVision™ AI platform successfully generated a high-accuracy predictive model (AUC up to 0.89).
The impact of this collaboration is two-fold:
- Solved a High-Value Problem: ScaiVision™ succeeded where standard methods failed, identifying a complex predictive signature that was otherwise hidden in the data. This provides a direct solution to a multi-million dollar manufacturing challenge.
- Delivered an Actionable, Translatable Solution: The platform distilled this complex single-cell discovery into a simple, 100-gene signature. This provides a clear path toward a scalable, cost-effective clinical assay (like a qPCR panel) that can be used to screen and select high-potential donors before the expensive manufacturing process begins.
“This project with Sanofi is a perfect example of our core mission,” said Peter Nestorov, CEO at Scailyte. “‘It demonstrates ScaiVision’s unique ability to succeed where standard methods fail, solving high-value, real-world problems for our pharma partners. We didn’t just find an interesting biological signal; we delivered an actionable, translatable solution that can directly improve the speed and reduce the cost of cell therapy manufacturing.'”
While the AI-driven discovery also uncovered novel, unexpected biology—identifying a B cell phenotype as the key predictor, which was subsequently validated by Sanofi’s labs—the primary breakthrough is the creation of a robust, translatable tool to de-risk the cell therapy pipeline.
This work underscores the power of Scailyte’s AI platform to derive actionable, predictive biomarkers that solve critical R&D and manufacturing challenges. The full manuscript, “Single-cell neural network classifiers reveal that PM21 NK cell expansion is dependent on B cell signaling,” is available on bioRxiv.
About Scailyte
Scailyte is a Swiss-based artificial intelligence company that uncovers hidden novel biological insights. Leveraging its proprietary ScaiVision™ platform, Scailyte discovers AI single-cell medicine biomarkers for preclinical and disease in precious stable solutions.