Celyad's CAR-T cleared by FDA in phase 1 Keytruda combo trial, but nature of 2 deaths still unclear

Five months after Celyad Oncology voluntarily paused a phase 1b study of its cell therapy after two patient deaths, the trial has been cleared by the FDA to restart—but the small biotech is remaining mum on the details. 

CYAD-101-002, also known as KEYNOTE-B79, is getting underway again after Belgium-based Celyad changed the eligibility requirements for patients. The company is testing CYAD-101 in combination with Merck & Co.’s blockbuster cancer drug Keytruda in patients with refractory metastatic colorectal cancer.

The FDA placed a clinical hold on CYAD-101 in March, following Celyad’s voluntary action, after two fatalities occurred in the study. Celyad did not provide any additional details on the nature of the deaths or whether CYAD-101 was linked to the events in the Monday update. However, in a first-quarter earnings update in May, Celyad noted that the two patients had similar pulmonary findings.

A spokesperson for Celyad explained that the eligibility requirements have been changed to exclude patients with bilateral lung metastases and recent prior history of anti-EGFR antibodies. 

CYAD-101 is a non-gene edited allogeneic CAR-T therapy.

In the first quarter report, Celyad noted €20.5 million ($22.9 million) in cash on hand after a first-quarter net cash burn of €9.5 million ($10.6 million). The company said that the cash on hand plus an existing equity purchase agreement should fund operations through mid-2023.

Celyad also has the allogeneic shRNA-based, anti-BCMA CAR-T therapy called CYAD-211 in phase 1 study for patients with relapsed or refractory multiple myeloma. Enrollment of additional groups in the study continues with a readout expected for the second half of the year.

Editor's Note: This story was updated at 10:30 a.m. ET on Aug. 2, 2022, to include details of the new eligibility requirements.