Celyad, a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, has announced highlights from the company’s NKG2D-based CAR-T clinical candidates for the treatment of metastatic colorectal cancer (mCRC), including its novel, off-the-shelf cell therapy CYAD-101 and alloSHRINK dose-escalation Phase 1 trial. Results were presented at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting, held in Washington D.C. from November 6-10, 2019.
Founded in 2007, located in Mont-Saint-Guibert, Belgium and New York City, USA, Celyad leverages unique know-how in taking cell-based therapies from bench to Phase III, as well as the manufacturing and logistical infrastructure for such complex products. Celyad builds it business model on partnering with prominent research institutions such as Dartmouth College, and develops those programs from bench to commercial applications.
Results from ongoing, dose-escalation alloSHRINK Phase 1 trial demonstrate absence of graft-versus-host disease for first-in-class, non-gene edited allogeneic CAR-T candidate, CYAD-101, when administered concurrently with FOLFOX chemotherapy
Best overall response in alloSHRINK trial in refractory metastatic colorectal cancer (mCRC) patients who had previously received prior oxaliplatin-based chemotherapy, which includes two patients with partial response (PR) and seven patients with stable disease (SD), with 50 percent (6 out of 12) of patients experiencing a decrease in tumor burden
Enrollment completed in dose-escalation segment of alloSHRINK trial with additional results expected in first half 2020; expansion segment of trial anticipated to begin in mid-2020
“We are encouraged by the latest results from the alloSHRINK trial in metastatic colorectal cancer patients previously exposed to oxaliplatin- and irinotecan-based chemotherapies, including the tolerability profile and early antitumor activity of CYAD-101 with prior FOLFOX preconditioning chemotherapy. In particular, the lack of clinical and laboratory evidence of graft-versus-host-disease for CYAD-101, which incorporates our proprietary T-cell receptor inhibitory molecule to reduce signaling of the TCR complex, establishes proof-of-concept for this industry-leading, off-the-shelf CAR-T approach. In addition, any host-versus-graft reaction against the allogeneic CAR-T product candidate appears to be controlled by the non-myeloablative FOLFOX chemotherapy. Overall, these encouraging data from the alloSHRINK trial warrant further evaluation of CYAD-101.” – Dr. Frédéric Lehmann, VP of Clinical Development & Medical Affairs at Celyad
“Treatment of advanced metastatic colorectal cancer patients beyond the second line of metastatic chemotherapy remains a high unmet medical need. Our confidence in CYAD-101 has continued to build as data from the alloSHRINK trial have emerged over the past year. We look forward to the planned expansion segment of the alloSHRINK trial to further evaluate the CAR-T product candidate for refractory mCRC patients as we continue to execute on the company’s vision for the treatment of patients with advanced solid tumors with allogeneic CAR-T therapies.” – Filippo Petti, CEO of Celyad