Ceylad, a Belgian company in the discovery and development of engineered cell therapies, has been approved in Belgium to initiate the THINK clinical trial. THINK is the second clinical trial of its NKR-2 product candidate, a CAR-T cell therapy using NKG2D ligands as a target, to evaluate safety and efficacy in seven cancer indications including both solid and hematological malignancies.
THINK ( TH erapeutic I mmunotherapy with NK R-2) is a multinational open-label Phase Ib study to assess the safety and clinical activity of multiple administrations of autologous NKR-2 T-cells in seven refractory cancers including five solid tumors; colorectal, ovarian, bladder, triple-negative breast and pancreatic cancers, and two hematological tumors: acute myeloid leukemia and multiple myeloma.
The company said the trial will be conducted in the US and in Europe. It contains a dose escalation and an extension stage. The dose escalation will be conducted in parallel in the solid tumor and in the liquid cancer groups, while the extension phase will evaluate in parallel each tumor independently.
The seven indications evaluated in the THINK trial were selected based on evidence generated in the pre-clinical settings and in the first study recently completed at Dana Farber Cancer Institute in Boston, MA, USA.
Dr. Christian Homsy, CEO of Celyad said: “We are extremely happy to be able to start this next phase of the clinical development program of NKR-2, building on the successful outcome of the single dose, dose escalation trial, to be presented at ASH. We now look forward to treating the first patients in Belgium, and to receiving FDA clearance to initiate the trial at our US-based sites.”
Dr. Frédéric Lehmann, VP Clinical Development and Medical Affairs at Celyad added: “We are excited to initiate this multiple tumor study with key cancer institutions in Belgium. While immunotherapy is rapidly transforming the treatment of patients with cancer, there remains a significant unmet medical need for more effective therapies. It is our hope that Celyad’s NKR-2 T-cells have the potential to be truly disruptive in the way we treat cancer and this study is one more step towards that goal.”
Q3 financial report
On Friday, Ceyald announced its financial results according to which the company ended the quarter with €87 million in cash including the first payment of €10 million from ONO. Use of cash over the quarter amounted to €9 million. The company said it expects that existing cash and cash equivalents and short term investments will be sufficient to fund operating expenses and capital expenditure requirements, based on the current scope of activities, until the middle of 2019.
CEO Homsy commented: “The third quarter of 2016 saw us increase our focus on the development of our NKR-T platform in line with our strategy. We continued to deliver on our development objectives for NKR-2 and reached important safety outcomes with the successful completion of our Phase I trial. We also saw reports of unexpected clinical benefits which were encouraging. We now look forward to reporting the outcome of this trial at ASH in December, and starting THINK, our multiple dosing umbrella trials testing NKR-2 in five solid and two blood malignancies.”
Patrick Jeanmart, CFO at Celyad, added: “Thanks to the first payment associated to the ONO partnership and a strong management of our operational cash drain, we ended the third quarter of 2016 with EUR 87 million. This cash position will allow the Group to finance all of its operations and clinical development program until the middle of 2019.”