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Clinical-stage biotechnology company Celyad Oncology (NASDAQ: CYAD) recently announced that the company has voluntarily paused the CYAD-101-002 (KEYNOTE-B79) Phase 1b trial. Reasons for the decision include slower than expected recruitment and concerns about potential adverse events.
Celyad currently focuses company operations on research and development programs to support the discovery and development of chimeric antigen receptor T cell (CAR T) therapies aimed at treating cancer.
About Celyad Oncology
Celyad Oncology is a clinical-stage biotechnology company investigating novel CAR T cell therapies for cancer. Recently, the company has been investigating serious adverse events in a small number of patients treated with one of its Phase 1 candidates.
This evaluation is ongoing, and Celyad is working closely with regulatory agencies to determine next steps. As of now, the company anticipates providing additional updates on the trial in the coming weeks and months ahead.
The Company remains highly confident in the potential of CYAD-101 and is committed to exploring all options to advance this important program as quickly as possible. In the meantime, Celyad will focus on advancing its other CAR T programs, including CYAD-102 and CYAD-103.
CYAD-101-002 (Keynote-B79) Phase 1B Trial Information
The CYAD-101-002 trial is part of a collaboration with Merck Sharp & Dohme Corp. (MSD), a subsidiary of Merck & Co., Inc., through a subsidiary. The trial was designed to evaluate the company’s TCR Inhibitory Molecule (TIM)-based allogeneic NKG2D CAR T cell investigational therapy CYAD-101 administered concurrently with FOLFOX chemotherapy, followed by MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with refractory metastatic colorectal cancer. This trial was exciting news for investors as it could pave the way for future success in the treatment of metastatic colorectal cancer.
Celyad reported receiving reports of two deaths within the trial which shared similar pulmonary findings. For the safety of patients the company has decided to voluntarily pause dosing and enrollment of patients in the CYAD-101-002 trial while investigating these events.
The company’s evaluation is ongoing, and Celyad is working closely with regulatory agencies to determine next steps. As of now, they expect to provide additional updates on the trial in the near future.
Voluntarily pausing a clinical trial can be a difficult decision, but it is often done when a company feels that it is in the best interest of patients. Celyad is confident that by pausing this trial, it can improve the chances of a successful outcome for all involved.
We remind our readers that they should keep in mind the fact that clinical trials can be halted for many reasons, and it does not necessarily mean that the drug being tested is ineffective or unsafe. It is important to stay tuned for updates from Celyad as it progresses through this trial and its other CAR T programs.