Thousand Oaks-based Atara Biotherapeutics has reached an agreement with the federal Food and Drug Administration that clears the way for the company to submit to the agency clinical trial data for its drug to treat a rare blood cancer.
Atara has developed a drug platform comprised of a type of immune cell known as a T-cell that is associated with the common Epstein-Barr virus. The aim is to create off-the-shelf therapies for difficult-to-treat cancers and immune-system disorders. The drug currently in clinical trials, called tabelecleucel, is based on this platform; it is intended to eliminate Epstein-Barr virus-infected cells in patients with rare blood cancers that occur after organ transplants.
When organs are transplanted, immunosuppression drugs are often administered to reduce the risk of the new host body rejecting the organ. But suppressing the immune system leaves the body susceptible to a wider range of harmful intruders, such as the Epstein-Barr virus. Tabelecleucel acts as a targeted immune booster, offsetting some of the effects of the immunosuppression drugs.
The agreement with the Food and Drug Administration allows Atara to submit combined clinical trial data for distinct versions of the drug that emerge from different manufacturing processes. Atara said in the announcement it intends to submit its new drug application for tabelecleucel in the second quarter of next year.
“We are pleased with the FDA’s positive assessment and conclusion of comparability, and we look forward to progressing to the next stage of preparing our BLA submission for tab-cel,” Pascal Touchon, Atara’s chief executive, said in the announcement. “Following this clarity, we can also continue to advance our U.S. partnership discussions with several parties, selecting the best possible partner to bring this potentially life-saving treatment to patients.”