Thousand Oaks-based Atara Biotherapeutics has reached an settlement with the federal Meals and Drug Administration that clears the way in which for the corporate to undergo the company scientific trial knowledge for its drug to deal with a uncommon blood most cancers.
Atara has developed a drug platform comprised of a sort of immune cell often called a T-cell that’s related to the frequent Epstein-Barr virus. The intention is to create off-the-shelf therapies for difficult-to-treat cancers and immune-system issues. The drug at present in scientific trials, known as tabelecleucel, relies on this platform; it’s meant to eradicate Epstein-Barr virus-infected cells in sufferers with uncommon blood cancers that happen after organ transplants.
When organs are transplanted, immunosuppression medicine are sometimes administered to scale back the chance of the brand new host physique rejecting the organ. However suppressing the immune system leaves the physique prone to a wider vary of dangerous intruders, such because the Epstein-Barr virus. Tabelecleucel acts as a focused immune booster, offsetting a few of the results of the immunosuppression medicine.
The settlement with the Meals and Drug Administration permits Atara to submit mixed scientific trial knowledge for distinct variations of the drug that emerge from completely different manufacturing processes. Atara mentioned within the announcement it intends to submit its new drug software for tabelecleucel within the second quarter of subsequent yr.
“We’re happy with the FDA’s constructive evaluation and conclusion of comparability, and we look ahead to progressing to the subsequent stage of making ready our BLA submission for tab-cel,” Pascal Touchon, Atara’s chief government, mentioned within the announcement. “Following this readability, we are able to additionally proceed to advance our U.S. partnership discussions with a number of events, choosing the absolute best associate to deliver this probably life-saving remedy to sufferers.”
Originally posted 2023-10-09 07:01:00.