Unum racks up yet another FDA hold as it twists its way through a restructuring, looking for a fresh start with a preclinical drug
The drumbeat of bad news at Unum Therapeutics just won’t stop.
In a filing with the SEC today, the troubled biotech reported that its experimental therapy ACTR707 — used in combination with rituximab in patients with CD20+ B cell non-Hodgkin lymphoma — may have been responsible for a possible new malignancy. The FDA slapped a partial hold on the study March 4 while the agency and the biotech explore what happened to trigger the Grade 3 SAE.
Unum’s stock, which had already sunk deep into penny stock terrain, dropped 5% Monday evening after an 8% drop over the day, leaving the stock at 46 cents. The company is helmed by Chuck Wilson and chaired by Atlas’ Bruce Booth. And they’ve had to deal with one setback after the next since filing to go public 2 years ago.
The hold came exactly 2 days after the biotech reported that it was restructuring the company, laying off 60% of the staff, and refocusing efforts away from the troublesome ACTR707 in favor of a preclinical solid tumor effort in the pipeline. At the same time, CSO Seth Ettenberg resigned after 5 years with Unum.
Last summer the biotech reported that its then premier drug — ACTR087 — was linked to serious adverse events that included grade 3 neurotoxicity and cytomegalovirus infection as well as grade 4 respiratory distress, triggering a hold. That came after the IPO, when Unum waited until it filed the S-1 to report that their drug was linked to two deaths — with 2 cases of ACTR087-related severe CRS while one patient died from ACTR087-related neurotoxicity.
That also triggered a hold which was lifted just ahead of the IPO.
Unum plans to file an IND application for BOXR1030 in late 2020 as it works to get back into the clinic. It has a long way to go, though, in restoring faith among investors.
Social image: Chuck Wilson, Unum Therapeutics