Celyad Doses First mCRC Patient in the Phase 1 alloSHRINK Trial Evaluating Non-Gene Edited Allogeneic CAR-T Candidate, CYAD-101
- Category: DNA RNA and Cells
- Published on Saturday, 01 December 2018 15:53
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- Topline data from alloSHRINK trial are expected in second half of 2019
- Company regains full development and commercialization rights to CYAD-101 from ONO Pharmaceutical for Japan, Korea and Taiwan
MONT-SAINT-GUIBERT, Belgium I November 30, 2018 I Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, today announced the injection of the first patient in the Phase 1 alloSHRINK trial evaluating the Company’s non-gene edited allogeneic CAR-T therapy, CYAD-101, administered concurrently with FOLFOX chemotherapy in the treatment of patients with unresectable metastatic colorectal cancer (mCRC).
“The initiation of the alloSHRINK trial marks a critical milestone for our organization,” said Dr. Christian Homsy, CEO of Celyad. “CYAD-101 represents a potential first-in-class approach to allogeneic CAR-T therapy and continues to build up Celyad’s leadership position in the allogeneic field, which is anchored by the Company’s robust allogeneic patent estate in the United States and complemented by our novel shRNA-based non-gene edited platform.”
Dr. Frédéric Lehmann, VP of Clinical Development & Medical Affairs at Celyad, commented, “CYAD-101 represents Celyad’s second oncology program to enter the clinic for the treatment of metastatic colorectal cancer and balances the Company’s autologous clinical candidate CYAD-01, which has demonstrated encouraging preliminary results in the Phase 1 SHRINK trial. We believe investigating CYAD-101 in the alloSHRINK trial will leverage our clinical experience to date in the treatment of metastatic colorectal cancer as we look to develop novel therapies for this devastating disease.”
Celyad also announced that ONO Pharmaceutical Co., Ltd. has given notice to the Company that it will no longer pursue development of CYAD-101 in Japan, Korea and Taiwan. Celyad and ONO Pharmaceutical entered into an exclusive license agreement for the development and commercialization of CYAD-101 in these specified territories in July 2016. Based on the agreement, ONO Pharmaceutical was required to exercise an option following the initiation of the Phase 1 trial for CYAD-101. The agreement has now expired and Celyad controls worldwide development and commercialization rights to CYAD-101.
CYAD-101 and alloSHRINK Trial Design
CYAD-101 is an investigational, non-gene edited, allogeneic (donor derived) CAR-T therapy that co-expresses the chimeric antigen receptor NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands expressed on tumor cells and the novel inhibitory peptide TIM (T cell receptor [TCR] Inhibiting Molecule). TCR signaling is responsible for Graft versus Host Disease (GvHD). The expression of TIM reduces signaling of the TCR complex and could therefore reduce or eliminate GvHD in patients treated with CYAD-101.
The alloSHRINK trial (NCT03692429) is an open-label, dose-escalation trial that will assess the safety and clinical activity of CYAD-101 administered concurrently with FOLFOX chemotherapy in patients with unresectable mCRC. Patients will receive six cycles of FOLFOX chemotherapy every two weeks and three administrations of CYAD-101 every two weeks 48 hours after the initiation of chemotherapy cycles one, two and three. The three dose levels to be evaluated are 100 million, 300 million and 1 billion cells per injection, respectively.
Celyad is a clinical-stage biopharmaceutical company focused on the development of specialized CAR-T cell-based therapies. Celyad utilizes its expertise in cell engineering to target cancer. Celyad’s CAR-T cell platform has the potential to treat a broad range of solid and hematologic tumors. Its lead oncology candidate, CYAD-01 (CAR-T NKG2D), is currently being evaluated in a Phase I dose escalation clinical trial to assess the safety and clinical activity of multiple administrations of autologous CYAD-01 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 safety and clinical activity of the CYAD-01 therapy concurrently administered with standard-of-care treatments or preconditioning chemotherapy is also being assessed in a full clinical development program focused on acute myeloid leukemia and colorectal cancer. Celyad was founded in 2007 and is based in Mont-Saint-Guibert, Belgium, and New York, NY. Celyad’s ordinary shares are listed on the Euronext Brussels and Euronext Paris exchanges, and its American Depository Shares are listed on the Nasdaq Global Market, all under the ticker symbol CYAD.