- No treatment-related safety issues reported at 30 days post-treatment of all patients in first cohort of the trial following single dose NKG2D CAR T-Cell infusion
- Triggers enrolment of first patient of the second cohort
- Expanding trial to include sites at renowned cancer research centers in U.S.
MONT-SAINT-GUIBERT, Belgium I November 10, 2015 I Celyad (Euronext Brussels and Paris and NASDAQ:CYAD), a leader in the discovery and development of engineered cell therapies, with clinical programs in cardiovascular disease and immuno-oncology, today announced the completion of the 30-day safety follow-up of the final patient enrolled in the first cohort of the Company’s Phase I clinical trial evaluating the safety and feasibility of its NKG2D CAR T-Cell therapy, in cancer patients suffering from acute myeloid leukemia (AML) or multiple myeloma (MM).
This Phase I trial aims to assess the infusion of four escalating doses of NKG2D CAR T-Cells in four consecutive patients cohorts of three patients each. Following infusion of the first dose of NKG2D CAR T-cells to the three patients of the first cohort (2 AML and 1 MM), no treatment related safety issues were reported with the treatment over the follow-up period of 30 days.
Dr. Christian Homsy, CEO of Celyad, commented, “These data mark an important step in demonstrating the safety of NKG2D CAR T-Cells infusion at single dose levels and allows us to initiate the enrolment of new patients for the second cohort of the trial. In order to boost enrolment of these new patients and also enable an extensive evaluation of this innovative approach, Celyad is extending the trial network to additional sites at renowned clinical sites in the U.S.
“These results, in addition to the positive outcome of the 30-day safety follow-up of the first patient reported last June and the recent completion of important milestones in Celyad’s C-Cure(R) and NKG2D CAR T-Cell programs, give us further confidence in our ability to achieve our clinical development objectives for our novel pipeline.”
Dr. Frederic Lehmann, VP Immuno-Oncology of Celyad, added: “This is the first time that our technology platform, which Celyad acquired in January 2015, has been tested in human subjects. The safety results to-date are encouraging for the future of the NKG2D CAR T-Cell program and we believe we are well positioned to continue our clinical programs in immuno-oncology on schedule.”
The full data readout from the Phase I trial focusing on 12 patients is expected in mid-2016. The trial is designed to assess the safety and feasibility of NKG2D CAR T-Cell as primary endpoints, with secondary endpoints including clinical efficacy.
| For more information, please contact: |
| |
For Europe : Consilium Strategic Communications
Amber Bielecka, Chris Gardner, Chris Welsh, and Laura Thornton — T: +44 (0)20 3709 5700 — celyad@consilium-comms.com |
For the U.S. : The Ruth Group
Lee Roth (Investors), and Kirsten Thomas (Media) – T: +1 646 536 7012 / 7014 — celyad@theruthgroup.com |
For France : NewCap
Pierre Laurent and Nicolas Merigeau — T: + 33(0)1 44 71 94 94 — celyad@newcap.fr |
Celyad
Christian Homsy, CEO and Marine Lhomel, Corporate Communications Manager : T: +32 (0)10 39 41 00 jgrade@celyad.com |
To subscribe to Celyad’s newsletter, visit www.celyad.com
Follow us on Twitter @CelyadSA
About CAR-NKG2D
Celyad’s lead immuno-oncology product candidate, CAR-NKG2D, is a chimeric antigen receptor (CAR) T-Cell autologous therapy to treat cancer. The CAR technology developed by Celyad uses human natural killer cell (NK cell) receptors which, unlike traditional CAR technologies such as those targeting the CD19 antigen, has the potential to target ligands present on a broad range of solid tumors and blood cancers.
The research underlying this technology was originally conducted by Dartmouth College Professor Charles Sentman, and has been published in numerous peer-reviewed publications such as Journal of Immunology in 2009, Cancer Research in 2006, and Blood in 2005. CAR-NKG2D has an active Investigational New Drug (IND) application with the FDA for a Phase I clinical trial in certain hematologic cancers.
CAR-NKG2D entered a Phase I clinical trial in April 2015. The full data readout from the Phase I dose escalation trial is expected in mid-2016. The trial is designed to assess the safety and feasibility of NKG2D CAR T-cell in certain acute myeloid leukemia and multiple myeloma patients as primary endpoints, with secondary endpoints including clinical efficacy.
About Celyad
Founded in 2007, and based in Belgium, Celyad is a leader in engineered cell therapy with clinical programs initially targeting indications in cardiology and oncology. Celyad is developing its lead cardiovascular disease product candidate, C-Cure(R), for the treatment of ischemic heart failure, and has completed enrollment of a Phase III trial in Europe and Israel. In addition, the Company is developing a novel portfolio of CAR T-cell therapies that utilize human Natural Killer cell receptors for the treatment of numerous blood and solid cancers. Its lead oncology product candidate, NKG2D CAR T-cell, entered a Phase I clinical trial in April 2015.
Celyad’s ordinary shares are listed on Euronext Brussels and Euronext Paris under the ticker symbol CYAD and Celyad’s American Depositary Shares are listed on the NASDAQ Global Market under the ticker symbol CYAD.
SOURCE: Celyad
Post Views: 191
- No treatment-related safety issues reported at 30 days post-treatment of all patients in first cohort of the trial following single dose NKG2D CAR T-Cell infusion
- Triggers enrolment of first patient of the second cohort
- Expanding trial to include sites at renowned cancer research centers in U.S.
MONT-SAINT-GUIBERT, Belgium I November 10, 2015 I Celyad (Euronext Brussels and Paris and NASDAQ:CYAD), a leader in the discovery and development of engineered cell therapies, with clinical programs in cardiovascular disease and immuno-oncology, today announced the completion of the 30-day safety follow-up of the final patient enrolled in the first cohort of the Company’s Phase I clinical trial evaluating the safety and feasibility of its NKG2D CAR T-Cell therapy, in cancer patients suffering from acute myeloid leukemia (AML) or multiple myeloma (MM).
This Phase I trial aims to assess the infusion of four escalating doses of NKG2D CAR T-Cells in four consecutive patients cohorts of three patients each. Following infusion of the first dose of NKG2D CAR T-cells to the three patients of the first cohort (2 AML and 1 MM), no treatment related safety issues were reported with the treatment over the follow-up period of 30 days.
Dr. Christian Homsy, CEO of Celyad, commented, “These data mark an important step in demonstrating the safety of NKG2D CAR T-Cells infusion at single dose levels and allows us to initiate the enrolment of new patients for the second cohort of the trial. In order to boost enrolment of these new patients and also enable an extensive evaluation of this innovative approach, Celyad is extending the trial network to additional sites at renowned clinical sites in the U.S.
“These results, in addition to the positive outcome of the 30-day safety follow-up of the first patient reported last June and the recent completion of important milestones in Celyad’s C-Cure(R) and NKG2D CAR T-Cell programs, give us further confidence in our ability to achieve our clinical development objectives for our novel pipeline.”
Dr. Frederic Lehmann, VP Immuno-Oncology of Celyad, added: “This is the first time that our technology platform, which Celyad acquired in January 2015, has been tested in human subjects. The safety results to-date are encouraging for the future of the NKG2D CAR T-Cell program and we believe we are well positioned to continue our clinical programs in immuno-oncology on schedule.”
The full data readout from the Phase I trial focusing on 12 patients is expected in mid-2016. The trial is designed to assess the safety and feasibility of NKG2D CAR T-Cell as primary endpoints, with secondary endpoints including clinical efficacy.
| For more information, please contact: |
| |
For Europe : Consilium Strategic Communications
Amber Bielecka, Chris Gardner, Chris Welsh, and Laura Thornton — T: +44 (0)20 3709 5700 — celyad@consilium-comms.com |
For the U.S. : The Ruth Group
Lee Roth (Investors), and Kirsten Thomas (Media) – T: +1 646 536 7012 / 7014 — celyad@theruthgroup.com |
For France : NewCap
Pierre Laurent and Nicolas Merigeau — T: + 33(0)1 44 71 94 94 — celyad@newcap.fr |
Celyad
Christian Homsy, CEO and Marine Lhomel, Corporate Communications Manager : T: +32 (0)10 39 41 00 jgrade@celyad.com |
To subscribe to Celyad’s newsletter, visit www.celyad.com
Follow us on Twitter @CelyadSA
About CAR-NKG2D
Celyad’s lead immuno-oncology product candidate, CAR-NKG2D, is a chimeric antigen receptor (CAR) T-Cell autologous therapy to treat cancer. The CAR technology developed by Celyad uses human natural killer cell (NK cell) receptors which, unlike traditional CAR technologies such as those targeting the CD19 antigen, has the potential to target ligands present on a broad range of solid tumors and blood cancers.
The research underlying this technology was originally conducted by Dartmouth College Professor Charles Sentman, and has been published in numerous peer-reviewed publications such as Journal of Immunology in 2009, Cancer Research in 2006, and Blood in 2005. CAR-NKG2D has an active Investigational New Drug (IND) application with the FDA for a Phase I clinical trial in certain hematologic cancers.
CAR-NKG2D entered a Phase I clinical trial in April 2015. The full data readout from the Phase I dose escalation trial is expected in mid-2016. The trial is designed to assess the safety and feasibility of NKG2D CAR T-cell in certain acute myeloid leukemia and multiple myeloma patients as primary endpoints, with secondary endpoints including clinical efficacy.
About Celyad
Founded in 2007, and based in Belgium, Celyad is a leader in engineered cell therapy with clinical programs initially targeting indications in cardiology and oncology. Celyad is developing its lead cardiovascular disease product candidate, C-Cure(R), for the treatment of ischemic heart failure, and has completed enrollment of a Phase III trial in Europe and Israel. In addition, the Company is developing a novel portfolio of CAR T-cell therapies that utilize human Natural Killer cell receptors for the treatment of numerous blood and solid cancers. Its lead oncology product candidate, NKG2D CAR T-cell, entered a Phase I clinical trial in April 2015.
Celyad’s ordinary shares are listed on Euronext Brussels and Euronext Paris under the ticker symbol CYAD and Celyad’s American Depositary Shares are listed on the NASDAQ Global Market under the ticker symbol CYAD.
SOURCE: Celyad
Post Views: 191
