Adaptive Biotechnologies Announces FDA Acceptance of Genentech’s INDA for the First Neoantigen-Directed T-Cell Therapy Product in Oncology
Adaptive Biotechnologies Corporation recently announced the US FDA has accepted an investigational new drug (IND) application submitted by its collaborator, Genentech, a member of the Roche Group, for a T-cell receptor (TCR) based T-Cell Therapy. This is the first TCR-based therapeutic product candidate to advance into clinical development based on Adaptive’s collaboration with Genentech in oncology.
“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 Chad Robins, Chief Executive Officer and Co-founder, Adaptive Biotechnologies. “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.”
Under the terms of Adaptive and Genentech’s collaboration agreement, Genentech has responsibility for clinical, regulatory and commercialization efforts for any T-Cell Therapy product candidate. Adaptive reiterates its full year revenue guidance in the range of $205 to $215 million.
In 2019, Adaptive Biotechnologies and Genentech entered into a worldwide collaboration and license agreement to develop, manufacture and commercialize novel neoantigen directed T-cell therapies for the treatment of a broad range of cancers. The collaboration combines Genentech’s global cancer immunotherapy research and development leadership with Adaptive’s proprietary T-cell receptor (TCR) discovery platform to accelerate a transformational new treatment paradigm of tailoring cellular therapy for each patient’s individual cancer.
Adaptive Biotechnologies is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision, and speed. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business areas: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases, such as cancer, autoimmune disorders, and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient. For more information, visit adaptivebiotech.com.
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