Unum Therapeutics has been slapped with an FDA partial clinical hold on its cancer drug after a serious safety worry.
The woes keep coming for Unum: A week ago, it announced it was losing more than half of its staff and cutting several clinical assets from development as its chief scientific officer also hit the exit.
Now, it's revealed in an 8-K filing with the Securities and Exchange Commission (SEC) that it has seen its phase 1 test of ACTR707 in combination with Roche’s Rituxan (rituximab) in patients with CD20+ B cell non-Hodgkin lymphoma put on a partial hold (a situation the company is well-versed in).
“The partial clinical hold was initiated following the submission of a safety report by Unum to the FDA regarding one patient in the trial who experienced a Grade 3 serious adverse event that is being evaluated as a possible new malignancy and is considered to be possibly related to ACTR707,” it said in the filing.
“Unum plans to work closely with the study site and the FDA to further review this event. Patients who previously received ACTR707 can continue to receive rituximab infusions on study.”
It’s pretty much curtains for the experimental drug anyway, given that Unum is now looking to wind down and stop work on ACTR707. In fact, the biotech has essentially rewound back into a preclinical company after stopping work on its clinical assets.
Just two days before the SEC filing, which has only just been released, the biotech said it was wielding the ax on 43 employees (around 60% of its staffers) while its CSO, Seth Ettenberg, Ph.D., left to join cell and gene therapy biotech BlueRock Therapeutics.
This plan now is to “prioritize resources” toward advancing its preclinical program, BOXR1030, for the treatment of solid tumor cancers. BOXR1030 expresses a glypican-3-targeted CAR, and Unum has slated filing an IND application for BOXR1030 in “late 2020.”