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 provided an update on key clinical and operational initiatives for the three-month period ended 30 September 2015.
Highlights of the 3rd quarter
Completion of dosing of the final C-Cure® patient in CHART-1 Phase III trial.
New commercial license agreement for C-Cure® in Greater China.
Reinforcement of the corporate management of the Group with the appointment of Dr. Debasish Roychowdhury as independent Director and Dr. Frédéric Lehmann as Vice- President Immuno-Oncology.
Cash position of €114.6 million as of 30 September 2015.
Dr. Christian Homsy, CEO of Celyad, said: “I am pleased to report that we have successfully met our operational milestones in both CHART-1 and our NKG2D trial. We are now in the final phase of our Phase III European clinical trial CHART-1 with data expected to be published in mid-2016. This achievement confirms our leadership in the field of regenerative therapies for the treatment of heart failure. We have also reported the first human safety data on our NKG2D CAR T-Cell therapy. These combined milestones give us further confidence in our ability to achieve our clinical development objectives for our novel pipeline.
“The fundamental position of the Company remains solid, with significant clinical achievements and a cash position which provides us with a strong cash base to propel our current development programs over the two coming years.”
Operational and financial review
At the end of July, Celyad announced the dosing of the 240th and last patient in CHART-1. This key operational milestone triggers the 9-month follow-up period which will end on 30 April 2016. The Company therefore confirms its previous projections on CHART-1 read-out for mid-2016.
In September, the Company provided the US Food and Drug Administration (FDA) with the safety data of C-Cathez® (its proprietary intra-myocardial injection catheter) that were collected from the patients treated during CHART-1 trial. In November, the briefing package was presented to the FDA in the context of a formal meeting. The conclusions of the FDA on the use of C-Cathez® in combination with C-Cure® in a US clinical trial is expected before year end, which should trigger the initiation of the CHART-2 trial in the US.
In August, Celyad entered into a new collaboration and distribution agreement with its
Hong-Kong based financial partner, Medisun International Limited (“Medisun”). Under the terms of the new license agreement, Celyad will conduct all clinical development and undertake any regulatory steps necessary for market approval in China, Hong-Kong, Taiwan and Macau (collectively “Greater China”). These activities will be funded by Medisun with a minimum investment of €20 million. Celyad expects initial clinical development activities to be initiated in Hong-Kong, together with CHART-2, with the potential addition of clinical sites in the
CHART-2 trial.
In exchange for the license, and in addition to the benefit of the funding provided by Medisun to support clinical development, Celyad will receive royalties and a profit share. The royalty rates ranging from 10% to 30% are calculated on total revenues of C-Cure® and profit sharing ranging from 20 to 25% is calculated on total revenues less royalties.
This agreement will last for an initial period of fifteen years, subject to earlier termination as specified in the agreement.
In September, Celyad appointed Dr. Frédéric Lehmann as Vice-President Immuno-Oncology and Dr. Debasish Roychowdhury as Independent Director. These two new high profile additions will significantly strengthen the Executive Management team and the Board by adding core expertise in the oncology and business development fields.
The Company ended the quarter with €114.6 million in cash. Management confirms its expectation that the treasury as of end of September 2015 is sufficient to finance the operations of the group until end of 2017.
Events SUBSEQUENT TO QUARTER-end
In October, Celyad announced the issuance of United States Patent No. 9,181,527 relating to allogeneic human primary T-Cells that are engineered to be T-Cell Receptor (TCR)-deficient and express a Chimeric Antigen Receptor (CAR). This patent significantly strengthens Celyad’s patent portfolio and leadership in the CAR T-Cell field as the granted product claims are broad and generic and not limited to specific CARs or specific methods of generating allogeneic CAR T-Cells, such as genome editing or genetic engineering. The patented products are applicable for use in treating various human disease conditions such as cancer, chronic infectious diseases and autoimmunity.
Later in November, Celyad announced the completion of the 30-day safety follow-up of the first cohort of the Phase I clinical trial evaluating the safety and feasibility of 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. This positive first human data with NKG2D CAR-T Cells triggered the recruitment of the first patient of the second cohort.
Also in November, Celyad initiated the certification procedure by the European Medicines Agency (EMA) of the non-clinical data of its lead product candidate, C-Cure®. The certification procedure involves the scientific evaluation by the European Medicines Agency's Committee for Advanced Therapies (CAT) of non-clinical data generated for C-Cure®. It aims to prepare the submission of a marketing-authorization application.