On Tuesday July 12th, the U.S. Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC) unanimously endorsed Novartis’s anti-CD19 CAR-T therapy (tisagenlecleucel, “CTL019”). This was a significant milestone in realizing the promise of engineered T-cell therapy, and it is likely that engineered T-cells targeting CD19 could be the first gene therapy approved for human use in the U.S.
This endorsement represents not only confidence in engineered T-cell therapy as an important new therapeutic modality in oncology, but also – importantly - confidence in the potential to manufacture a T-cell therapy as a commercial product given that Novartis has enabled multi-national pivotal trials with this technology.
At Adaptimmune, we were particularly excited given the importance of the clinical data for the field of T-cell therapy, and the fact that the processes used by Novartis and Adaptimmune were both developed at the University of Pennsylvania (UPenn) and share many common elements including use of a lentiviral vector as well as proprietary use of Thermo Fisher Scientific’s CD3/CD28 DynabeadsTM. In addition, many here at Adaptimmune played important roles in the development of tisagenlecleucel including our Chief Technology Officer, Gwendolyn Binder, who was instrumental in opening the original study at UPenn, and our Senior Vice President of Bioprocessing, Mark Dudley, who led the transition of tisagenlecleucel to commercial-readiness at Novartis.
Adaptimmune’s SPEAR T-cell platform differs from the CAR-T approach by using optimized, affinity enhanced, engineered T-cell receptors (TCRs) to target intra- and extracellular cancer antigens. This potentially enables access to a broad range of difficult to treat malignancies, including solid tumors. As recently presented at ASCO, our initial clinical data in synovial sarcoma with NY-ESO SPEAR T-cells demonstrate the effect of our proprietary SPEAR T‑cell platform in a solid tumor (http://ir.adaptimmune.com/phoenix.zhtml?c=253991&p=irol-newsArticle&ID=2276855). We also have active clinical trials with our wholly-owned assets targeting MAGE-A10, MAGE-A4, and AFP, which are enrolling patients in 8 different solid tumor types including non-small cell lung cancer, ovarian cancer, and hepatocellular carcinoma with initial data expected in 2017 and 2018.
Our pipeline of products have the potential to be the next generation of engineered T-cell therapy to treat a wide-range of otherwise untreatable cancers, including solid tumors, and the recent favorable outcome for Novartis is an encouraging milestone in delivering engineered T-cell therapies to patients in need.
-James Noble, Adaptimmune CEO