Celyad Successfully Doses First Colorectal Cancer Patient with CYAD-01 Following Preconditioning Chemotherapy

 

Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, today announced the successful injection of the first patient under the amended protocol of the THINK trial, which assesses treatment with CYAD-01 after a non-myeloablative preconditioning chemotherapy regimen of cyclophosphamide and fludarabine in refractory metastatic colorectal cancer (CRC) patients.

“The first dosing of CYAD-01 in the amended THINK trial marks another important step for our company” said Dr. Christian Homsy, CEO of Celyad. “CYAD-01 has shown promising signs of clinical activity as a standalone approach, and we are committed to maximizing the clinical benefit for patients by evaluating CYAD-01 in a range of clinical settings. We aim to evaluate the anti-tumor activity of CYAD-01 not only as a standalone approach, but also with prior preconditioning and standard of care chemotherapy in both hematological malignancies and solid tumors. These additional studies will elucidate the best clinical path forward for a patient population severely in need of new therapeutic options.”

The amended THINK is a single arm, open-label, Phase I study designed to evaluate the safety and anti-tumor activity of CYAD-01 only in metastatic CRC patients following the administration of cyclophosphamide (300 mg/m²) and fludarabine (30 mg/m²). Based on initial data from the trial, a per protocol expansion cohort may be initiated.

CYAD-01 is an investigational CAR-T therapy in which a patient's T cells are engineered to express the chimeric antigen receptor NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands expressed on tumor cells. CYAD-01 is currently in clinical development through a number of trials for hematological malignancies and solid tumors.

Note

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 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 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.

For more information about Celyad, please visit: www.celyad.com

 

 

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