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August 8, 2025 42 mins

This week, we talk about drug discovery with Shinya Yuki, co-founder and CEO of Elix Inc., and Teresa Whalen, CEO of CytoAgents, about CAR-T therapies, cytokine release syndrome, and the FDA.

Interview times:

03:53 Elix

20:58 CytoAgents

Elix drug discovery platform

AI drug discovery company Elix, Inc. and the Life Intelligence Consortium (LINC) have announced that for the first time in the world, an AI drug discovery platform has been commercialized that incorporates multiple AI models trained using federated learning on data provided by 16 pharmaceutical companies.

The key to AI drug discovery lies in high-quality and sufficiently large datasets. Diverse and abundant data are indispensable for building superior AI models; however, pharmaceutical companies are generally limited to utilizing their own proprietary data and public datasets, resulting in significant data shortages that have posed major challenges to progress.

Federated learning technology provides a solution to this challenge. Elix, in partnership with the Department of Biomedical Data Intelligence, Graduate School of Medicine, Kyoto University, developed the federated learning library kMoL, enabling multiple companies to collaboratively develop a suite of AI models without disclosing their confidential data externally. Sixteen pharmaceutical companies participated in building these learning-based models, which are now implemented on Elix Discovery, Elix’s proprietary AI drug discovery platform.

By introducing Elix Discovery, users can leverage these newly developed models, and several pharmaceutical companies have already adopted the platform. The initiative marks the world’s first commercialisation of an AI drug discovery platform in partnership with numerous pharmaceutical companies utilising federated learning.

Our conversation is with Shinya Yuki, co-founder and CEO of Elix.

CAR-T, CRS and the FDA

FDA Commissioner Marty Makary marked his first 100 days with a media tour and series of “bold” announcements.

One was that the FDA has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for six CAR T-cell (CART) immunotherapies, citing growing evidence that the treatments can be safely managed without additional regulatory oversight.

While many support this decision since it has the potential to broaden the use of CART therapies, the black box warning for the risks of cytokine release syndrome (CRS) and neurological toxicities remains. CRS continues to have a massive impact on patients and poses a threat to widespread uptake of CART therapy. CRS develops in up to 95% of cancer patients treated with CART therapies and up to 50% of those patients are at risk of developing Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) leading to extended hospital stays, inability for systems to onboard additional patients, and significant expense to care for these patients.

CytoAgents is a company focused on the development of innovative pharmaceutical products for the treatment of life-threatening symptoms associated with CRS.

We have a conversation with Teresa Whalen, CEO of CytoAgents, about CAR-T therapies, cytokine release syndrome, and the FDA announcement.

To get in touch with guest suggestions, or to sponsor or advertise on the podcast, please email jim@deeptechdigest.com

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