The company developed tabelecleucel (ATA129) for people whose dormant Epstein-Barr virus can activate after a transplant. This activation can lead to post-transplant lymphoproliferative disorder, whose hallmark is a runaway surge in immune B-cells.
Doctors use immunotherapies to suppress the immune system after a blood stem cell or organ transplant so the body won’t reject it. The combination of Epstein-Barr virus and a suppressed immune system can lead to a post-transplant lymphoproliferative disorder, including lymphoma.
Atara will start the trials at three sites in the United States, and add locations in the United States, Canada and Australia later.
“Today we started 2018 on a strong path by initiating tabelecleucel Phase 3 clinical studies at multiple centers in the U.S.,” Dr. Isaac Ciechanover, the president and chief executive officer of Atara Biotherapeutics, said in a press release.
“We are ready to enroll patients and look forward to bringing a novel treatment option to people in need with EBV+PTLD [post-transplant lymphoproliferative disorder stemming from Epstein-Barr virus]. We will continue to work closely with the FDA [U.S. Food and Drug Administration] and other global health authorities to make tabelecleucel available to patients as expeditiously as possible.”
Most of the time, Epstein Barr virus infections lie dormant throughout a person’s life, causing no symptoms. But in people with a weakened immune system the infection can lead to post-transplant lymphoproliferative disorder.
The condition is life-threatening. In fact, those who fail to respond to Rituxan usually survive less than two months.
Atara said the trials will focus on different patient groups. The MATCH study will involve patients who developed post-transplant lymphoproliferative disorder after a blood cell transplant with donated cells. The ALLELE trial will cover patients who developed the condition after an organ transplant.
In contrast with many T-cell immunotherapies, tabelecleucel is made from donated immune cells and is available as an off-the-shelf treatment. Most T-cell therapies use a patient’s own cells to produce a treatment.
The FDA and the European Union have given tabelecleucel three designations designed to accelerate its regulatory approval. The FDA has dubbed it a Breakthrough Therapy, and the European Union has given it a similar status. And both regulatory agencies have designated it an orphan drug.