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FDA Places Unum's Early Stage Cancer Drug Trial On Clinical Hold

FDA Places Unum's Early Stage Cancer Drug Trial On Clinical Hold

Unum Therapeutics Inc (NASDAQ: UMRX) shares were under pressure Wednesday following a clinical trial update provided by the company late Tuesday.

What Happened

The FDA has imposed a clinical hold on the Phase 1 ATTCK-20-2 trial that evaluated ACTR087 in combination with Roche Holdings AG Basel ADR (OTC: RHHBY)'s rituximab following lymphodepleting chemotherapy with fludarabine and cyclophosphamide in patients with relapsed/refractory CD20+ B cell non-Hodgkin lymphoma.

A clinical hold is an order issued by the FDA to delay an ongoing clinical trial or altogether suspend it; enrolled patients may not be given the investigational drug and new patient enrollment is halted. 

The FDA action comes after Unum submitted a safety report regarding one patient in cohort 3 of the trial who experienced serious adverse events that included Grade 3 neurotoxicity, cytomegalovirus infection and Grade 4 respiratory distress.

Why It's Important

Unum, which provides curative T-cell therapies to treat a broad range of cancer patients, went public in May 2018. 

Since closing at $12.90, a 24% premium over its IPO price of $12, the stock has lost much of its value.

In its S-1 filing ahead of the IPO, Unum disclosed two deaths in its ACTR087 trial, with one resulting from enterococcal sepsis related to the investigational drug and another from unrelated sepsis. 

The company said it has deprioritized its onetime lead product candidate ACTR087 and is now focusing on its new ACTR construct ACTR707 in combination with rituximab for the same indication.

What’s Next

Unum said the FDA has agreed that patients who previously received ACTR087 and have clinical responses may continue to receive rituximab infusions, with continued monitoring for adverse events.

The company said it will work closely with the FDA to further review these events and report data from the ATTCK-20-2 trial at the end of 2019.

Unum shares were trading higher by 4.57% at $2.29 at the time of publication Wednesday. 

Related Links:

The Week Ahead In Biotech: Pending Clinical Readouts In Focus

Attention Biotech Investors: Mark Your Calendar For These July PDUFA Dates

Posted-In: Biotech News FDA Trading Ideas General Best of Benzinga


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