Summary of Invention
Treatment success in EBV-associated lymphoma using 3rd party T-cell therapy
EBV-associated lymphomas and CMV infections are associated with significant morbidity and mortality in immunosuppressed patients. MSKCC researchers have created two proprietary cell banks of fully characterized lines of EBV-specific and CMV-specific T-cells from 3rd-party donors with partially matched human leukocyte antigen (HLA). These T-cells can be used as off-the-shelf treatments and may be appropriately matched to 99% of patients with EBV-associated lymphomas and to 80-90% of patients with CMV infections.
Treatments using these T-cells have been highly successful, demonstrating response rates at 60-70%, which is similar to the response seen with donor-derived T-cells. EBV-specific T-cell therapy also may be used in treating other EBV-associated malignancies, such as nasopharyngeal carcinoma and gastric cancer, while CMV-specific T-cell therapy also may be used in treating CMV infection in other patients, such as neonates and pediatric patients.
Both cell banks, available for licensing separately or in combination, have demonstrated high response rates with durable remission and shown no graft-versus-host disease (GVHD) or allograft rejection.
- EBV-specific T cells: EBV-induced lymphomas cause morbidity and mortality in recipients of bone marrow or solid organ transplants. At an approximate price of $50,000 per patient, the total U.S. market revenue alone is estimated to be $300 million per year. Potential global market is significantly larger, with about 130,000 cases yearly of EBV+ nasopharyngeal carcinoma in South China.
- CMV-specific T cells: CMV infection remains one of the most common infections that occur in immunocompromised patients, especially post-transplantation patients, with significant morbidity and mortality. There are approximately 1,000 annual cases of post-transplantation patients with persistent CMV viremia per year, with potential additional indications of treating neonates and pediatric patients with CMV symptoms (4,000 cases). The total US market revenue alone is estimated to be $250 million per year (price per patient = $50,000).
- Clinical Trials: 4 ongoing clinical trials; 80 patients treated with EBV-specific T-cells and 21 patients treated with CMV-specific T-cells (EBV - NCT00002663 and NCT01498484; CMV - NCT00674648 and NCT01646645).
- Current Referrals: 26 regional, national, and international institutions currently refer their patients with EBV malignancies to MSKCC, given the success of these treatments.
- Inventory: Two extensive, ready-to-use, well-characterized cell banks comprising > 300 EBV-specific T-cell lines and > 100 CMV-specific T-cell lines offer a clear competitive advantage.
Richard J. O'Reilly, MD, Chair, Department of Pediatrics
Doubrovina E et al. (2012) Blood 119:2644-2656; Barker JN et al. (2010) Blood 116:5045-5049; O’Reilly RJ et al. (2007) Immunologic Research 38:237-250.
Yashodhara Dash, PhD, MBA
Senior Licensing Manager