TCR-Based T-Cell Therapy Cleared for Trials

Chad Robins

The FDA has cleared Genentech and Adaptive Biotechnologies’ investigational new drug (IND) application for a neoantigen-specific T-cell receptor (TCR) based T-cell therapy for oncologic indications.¹

The therapy is the first of multiple planned therapies yielding from a collaboration between the 2 companies, initiated in 2019, to advance into clinical development. The collaboration is identifying and characterizing TCRs with the use of Adaptive’s TCR discovery platform.

“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,” Chad Robins, chief executive officer and cofounder of Adaptive Biotechnologies, said in a statement.¹ “We look forward to supporting Genentech’s world-class team of scientists and drug developers to advance this potentially life-saving therapy into the clinic for patients with solid tumors.”

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Adaptive recently also announced news from its other focus on measuring minimal residual disease (MRD), which complements the use of its investigational therapies in oncologic indications. The company announced in April that it was partnering with Takeda to permit the use of its clonoSEQ® assay to measure MRD across Takeda’s clinical trials in lymphoid malignancies.

“We are thrilled to enter into a broad translational collaboration with Takeda incorporating the use of our clonoSEQ Assay technology in clinical trials to support the clinical development of groundbreaking oncological therapies,” Nitin Sood, chief commercial officer, MRD, Adaptive Biotechnologies, said in a statement at that time.² “MRD is an important measure of whether novel treatments are inducing effective and durable responses for patients, and its use as an endpoint is rapidly growing.”

The clonoSEQ assay is designed to be highly accurate, sensitive, and standardized compared to other technologies used to disease burden assessment. It is the first and only sequencing-based, next-generation MRD test authorized by the FDA for use in lymphoid malignancies. Takeda may use MRD status as measured by the clonoSEQ assay as an endpoint in certain clinical trials in the company’s lymphoid malignancy pipeline as part of the collaboration, including current and future programs.

“Innovative technology plays a critical role in informing our clinical development plans as we look to bring effective new medicines to patients with hematologic malignancies,” Christine Ward, Head, Precision and Translational Medicine, Oncology Therapeutic Area Unit, Takeda, added.² “This collaboration with Adaptive allows us to further explore the clinical relevance of MRD as we progress our pipeline of investigational medicines.”

REFERENCES
1. Adaptive Biotechnologies announces FDA acceptance of Genentech’s Investigational New Drug application for the first neoantigen-directed T-cell therapy product in oncology. News release. Adaptive Biotechnologies. May 9, 2023. https://www.globenewswire.com/news-release/2023/05/09/2664318/0/en/Adaptive-Biotechnologies-Announces-FDA-Acceptance-of-Genentech-s-Investigational-New-Drug-Application-for-the-First-Neoantigen-Directed-T-Cell-Therapy-Product-in-Oncology.html
2. Adaptive Biotechnologies Announces Translational Collaboration with Takeda to Measure Minimal Residual Disease with Its clonoSEQ® Assay Across Its Hematologic Malignancy Pipeline. News release. Adaptive Biotechnologies. April 12, 2023. https://investors.adaptivebiotech.com/news-releases/news-release-details/adaptive-biotechnologies-announces-translational-collaboration