Mont-Saint-Guibert, Belgium – 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 provides an update on key clinical and operational developments over the three-month period ended 31 March 2016.
Highlights of the first quarter
- Infusion and 21 day-safety follow-up of the first patient of the third cohort in NKR-2 Phase I/IIa trial conducted at the Dana Farber Cancer Institute in Boston, USA.
- Strategic partnership with Institut Curie in Paris, France, to further develop the Company’s NKR-T pipeline in cellular immunotherapies for cancer.
- First US patent relating to a method of producing allogeneic primary human T cells that are engineered to be T-Cell Receptor (TCR)-deficient and express a Chimeric Antigen Receptor (CAR).
- Appointment of 10 leading international immuno-oncology experts to the Company’s Scientific Advisory Board to help guide Celyad’s development of its NKR-T platform.
- Certification for C-Cure® non-clinical data from the European Medicines Agency (EMA) and Notification of the EMA of its intent to submit a MAA for C-Cure®.
- Reinforcement of the corporate management team with the appointment of Pierre Brynaert as Chief Human Resources Officer, Richard Mountfield as VP of Global Regulatory Affairs and Jean-Pierre Latere as VP of Regenerative Medicine and Medical Devices Franchise.
Dr. Christian Homsy, Chief Executive Officer of Celyad, commented: “The first quarter of 2016 has been a very productive period for Celyad. We successfully met our operational milestones in our NKR-2 trial and also established some key strategic collaborations and assets as we continue to make progress across our development programs.
“We are surrounding ourselves with top international experts and partners to achieve our clinical and business development aims for our novel pipeline, as well as building strong patent portfolios which we believe will position Celyad as a major player in the field of regenerative medicine and immuno-oncology.
“We now look forward to the expected announcement of the topline data from our CHART-1 Phase III trial and the safety and feasibility data on the first doses in our NKR-2 Phase I/IIa study at the end of June.”
Patrick Jeanmart, Chief Financial Officer of Celyad, added: “We are delighted to report for the first quarter of 2016 a cash position in line with our expectations. We also paid during this first quarter the first clinical development milestones related to our NKR-2 clinical trial, which demonstrates the significant progress made in the clinical development of NKR-2.”
Operational and financial review
Over the first quarter, Celyad has made significant progress in the preclinical and clinical development of its NKR-T platform. The Company successfully completed the safety follow-up of the patients of the second dose level cohort in NKR-2 T-Cells Phase I/IIa trial, a dose escalation study evaluating the safety and feasibility of the NKG2D receptor in cancer patients suffering from Acute Myeloid Leukemia (AML) or Multiple Myeloma (MM). No dose limiting toxicity was reported of the second dose level.
The Company also reported the completion of the 21-day safety follow-up of the first patient enrolled in the third dose level in the Phase I/IIa clinical trial. No treatment related safety issues were reported.
In March, the Company strengthened its patent portfolio having been granted, by the U.S. Patent and Trademark Office (USPTO), the first U.S. patent relating to a method of producing allogeneic primary human T cells that are engineered to be T Cell Receptor (TCR)-deficient and express a Chimeric Antigen Receptor (CAR). The first US patent (9,181,527) – that was granted to Celyad in November 2015 – was related to TCR deficient CAR T cells, regardless of the method used to generate them. This new patent fosters Celyad’s coverage for its proprietary CAR T cells by broadly protecting methods for making these modified allogeneic T cells, and providing them as medicines. The resulting products may benefit patients with various human disease conditions, particularly cancer. By reinforcing its patent portfolio in the CAR-T field, Celyad confirms its leadership in engineered cell therapy, and in the allogeneic CAR T space.
Celyad also announced a strategic partnership with the Inserm “Cancer and Immunity” Unit of Institut Curie in Paris, France, to further develop its NKR-T pipeline in cellular immunotherapies for cancer. Through this partnership, Celyad and Institut Curie will pool their expertise to progress Celyad’s immuno-oncology pipeline with the aim of bringing novel cellular immunotherapies to cancer patients. The partnership will build on Institut Curie’s first-in-class expertise and state of the art translational, preclinical and clinical know-how in cancer biology and immunology, as well as Celyad’s widely recognized cell therapy and cell manufacturing capabilities.
In March, Celyad notified the European Medicines Agency (EMA) of its intent to submit a Market Authorization Application (MAA) for C-Cure® in November 2016.
During the first quarter of 2016, Celyad reinforced its management team with the appointment of Pierre Brynaert as Chief Human Resources Officer, Richard Mountfield as Vice President of Global Regulatory Affairs and Jean-Pierre Latere as Vice President of Regenerative Medicine and Medical Devices Franchise.
The Company ended the quarter with €94.7 million in cash. Use of cash of the quarter amounts to €12.8 million, of which €7.4 million cash used to finance the operations of the Group. In January, the Company paid its first clinical development milestone ($5.0 million) to Celdara Medical Inc, former owner of the NKR-T technology platform. Investments made in capital expenditures over the quarter amounted to €0.8 million.
Events SUBSEQUENT TO QUARTER-end
The Company recently reiterated its market guidance regarding the availability of C-Cure® CHART-1 data. CHART-1 data readout in expected by end of June 2016.
In April, Celyad received certification for C-Cure non-clinical data from the European Medicines Agency (EMA). This certification is the second of three modules, following the certification of quality data obtained in May 2014, made in preparation for a marketing application. It provides confirmation that the Committee for Advanced Therapies (CAT), recognizes that the C-Cure® development program continues to meet the rigorous standards set by the EMA for a successful development and submission package.
Also in April, Celyad announced the appointment of 10 leading international Immuno-Oncology experts to its Scientific Advisory Board in order to develop its NKR-T platform and potentially open the path to new treatment options for cancer patients. (Dr. Hinrich Abken, Dr. Scott Antonia, Dr. Marco Davila, Dr. Stéphane Depil, Dr. Marc Ernstoff, Dr. David Edward Gilham, Dr. Sebastian Kobold, Dr. Daniel Olive, Dr. Charles Sentman and Dr. Jeffrey S. Weber).