PHILADELPHIA, PA, USA and OXFORD, UK I November 09, 2016 I Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, today announced that the U.S. Food and Drug Administration has removed the partial clinical hold on the planned study of its NY ESO SPEAR™ (Specific Peptide Enhanced Affinity Receptor) T-cell therapy in MRCLS.
Under a revised protocol, Adaptimmune will initiate a study in up to 15 MRCLS patients. Patient screening is expected to begin in 4Q 2016. Results from this study will inform a potential future registration trial.
The Company will provide an overview of the removal of the partial clinical hold during its conference call to discuss the third quarter ended September 30, 2016, scheduled for 8:00 a.m. EST (1:00 p.m. GMT) on Thursday November 10, 2016. The live webcast of the conference call will be available via the events page of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available after the call at the same address. To participate in the live conference call, if preferred, please dial (877) 280-2296 (U.S.) or +44(0)20 3427 1906 or 0800 279 4977 (United Kingdom). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (3960227).
About Adaptimmune
Adaptimmune is a clinical stage biopharmaceutical company focused on novel cancer immunotherapy products based on its SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform. Established in 2008, the Company aims to utilize the body’s own machinery – the T-cell – to target and destroy cancer cells by using engineered, increased affinity TCRs as a means of strengthening natural patient T-cell responses. Adaptimmune’s lead program is a SPEAR T-cell therapy targeting the NY-ESO cancer antigen. Its NY-ESO SPEAR T-cell therapy has demonstrated signs of efficacy and tolerability in Phase 1/2 trials in solid tumors and in hematologic cancer types, including synovial sarcoma and multiple myeloma. Adaptimmune has a strategic collaboration and licensing agreement with GlaxoSmithKline for the development and commercialization of the NY-ESO TCR program. In addition, Adaptimmune has a number of proprietary programs. These include SPEAR T-cell therapies targeting the MAGE-A10 and AFP cancer antigens, which both have open INDs, and a further SPEAR T-cell therapy targeting the MAGE-A4 cancer antigen that is in pre-clinical phase with IND acceptance targeted for 2017. The Company has identified over 30 intracellular target peptides preferentially expressed in cancer cells and is currently progressing 12 through unpartnered research programs. Adaptimmune has over 250 employees and is located in Oxfordshire, U.K. and Philadelphia, USA. For more information: http://www.adaptimmune.com.
SOURCE: Adaptimmune
Post Views: 108
PHILADELPHIA, PA, USA and OXFORD, UK I November 09, 2016 I Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, today announced that the U.S. Food and Drug Administration has removed the partial clinical hold on the planned study of its NY ESO SPEAR™ (Specific Peptide Enhanced Affinity Receptor) T-cell therapy in MRCLS.
Under a revised protocol, Adaptimmune will initiate a study in up to 15 MRCLS patients. Patient screening is expected to begin in 4Q 2016. Results from this study will inform a potential future registration trial.
The Company will provide an overview of the removal of the partial clinical hold during its conference call to discuss the third quarter ended September 30, 2016, scheduled for 8:00 a.m. EST (1:00 p.m. GMT) on Thursday November 10, 2016. The live webcast of the conference call will be available via the events page of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available after the call at the same address. To participate in the live conference call, if preferred, please dial (877) 280-2296 (U.S.) or +44(0)20 3427 1906 or 0800 279 4977 (United Kingdom). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (3960227).
About Adaptimmune
Adaptimmune is a clinical stage biopharmaceutical company focused on novel cancer immunotherapy products based on its SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform. Established in 2008, the Company aims to utilize the body’s own machinery – the T-cell – to target and destroy cancer cells by using engineered, increased affinity TCRs as a means of strengthening natural patient T-cell responses. Adaptimmune’s lead program is a SPEAR T-cell therapy targeting the NY-ESO cancer antigen. Its NY-ESO SPEAR T-cell therapy has demonstrated signs of efficacy and tolerability in Phase 1/2 trials in solid tumors and in hematologic cancer types, including synovial sarcoma and multiple myeloma. Adaptimmune has a strategic collaboration and licensing agreement with GlaxoSmithKline for the development and commercialization of the NY-ESO TCR program. In addition, Adaptimmune has a number of proprietary programs. These include SPEAR T-cell therapies targeting the MAGE-A10 and AFP cancer antigens, which both have open INDs, and a further SPEAR T-cell therapy targeting the MAGE-A4 cancer antigen that is in pre-clinical phase with IND acceptance targeted for 2017. The Company has identified over 30 intracellular target peptides preferentially expressed in cancer cells and is currently progressing 12 through unpartnered research programs. Adaptimmune has over 250 employees and is located in Oxfordshire, U.K. and Philadelphia, USA. For more information: http://www.adaptimmune.com.
SOURCE: Adaptimmune
Post Views: 108
