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FDA Accepts IND for T-Cell Receptor Therapy by Genentech, Adaptive Biotechnologies

NEW YORK – Adaptive Biotechnologies on Tuesday said that the US Food and Drug Administration has accepted an investigational new drug application for a T-cell receptor-based therapy developed through a collaboration with Genentech.

The companies signed a worldwide collaboration and license agreement in 2019 to develop personalized neoantigen-directed T-cell therapies for a range of cancers. Adaptive agreed to use its discovery platform to find optimal T-cell receptors to target each patient's neoantigens, while Genentech engineered and manufactured the resulting cellular therapies. Adaptive received $300 million in an initial upfront payment and is eligible to receive more than $2 billion in milestone payments and royalties on product sales. Genentech is responsible for clinical, regulatory, and commercialization activities, while Adaptive has taken on patient-specific screening.

Seattle-based Adaptive's immune medicine platform combines sequencing technology, computational biology, and machine learning to identify neoantigens which could be effective targets for cellular therapies for an individual patient.

"This IND acceptance reaffirms the value of our immune medicine platform and Adaptive's ability to identify and characterize clinical-grade, therapeutic T-cell receptors, which is the cornerstone of our drug discovery capabilities," said Adaptive CEO Chad Robins.