EC approves first allogeneic T cell therapy for rare post-transplant complication
The European Commission signed off on the continent’s first allogeneic T cell therapy Monday. And for its maker Atara Biotherapeutics, the approval marks the biotech’s first approved therapy.
Ebvallo, made by Atara Biotherapeutics, is now approved by the EMA for marketing authorization for a specific subgroup of patients with post-transplant lymphoproliferative disease who are positive for Epstein-Barr virus. The disease, also known as EBV+ PTLD for short, is a rare complication that can occur after a solid organ or hematopoietic stem cell transplant.
The biotech had in-licensed the candidate from Memorial Sloan Kettering, where it was discovered, back in 2015.
Patients aged 2 years and older who have had at least one prior therapy are eligible for the treatment. Atara and marketing partner Pierre Fabre added in a statement that in patients suffering from complications of solid organ transplants, prior therapy includes chemotherapy unless chemotherapy is deemed inappropriate.
CHMP gave a positive opinion for Ebvallo back in October, setting the stage for the approval and marking a positive turn for the biotech after it announced plans to lay off 77 employees earlier in the year as part of a slimming plan to reduce cash burn.
The price for the therapy is still confidential. Atara CEO Pascal Touchon tells Endpoints News that since Pierre Fabre is taking the lead on commercialization in Europe, Pierre Fabre will disclose the price sometime in Q1 2023. Q1 next year is also the timeline for when Touchon expects marketing in Europe to start.
That marketing deal, reached last year, gives Pierre Fabre practically all commercialization rights in the EU and several other select markets. And per an amendment to the marketing deal earlier this year, Atara will receive $30 million once a transfer of the marketing authorization occurs — which Touchon said takes about a month.
Touchon said that what Atara now has is a trio of firsts. Not only is it Atara’s first approved product, but it’s also the first approved product for PTLD and the first allogeneic T cell immunotherapy to be approved. Allogeneic T cell therapies are T cell products that use T cells derived from donors. Other approved products in the T cell therapy space use the patient’s own T cells.
Pierre Fabre, on top of negotiating prices and getting Ebvallo launched in Germany and Austria, is next working on getting the therapy approved in the UK and Switzerland, according to Touchon. For Atara, the biotech is in discussions with the FDA to align on filing requirements for a BLA on Ebvallo. The chief executive added that like its partnership in Europe, Atara will be utilizing a commercialization partner if and when Atara’s product gets the regulatory green light. However, those discussions are still ongoing.
Atara is not stopping with just the second-line indication. Touchon added that other clinical trials with Ebvallo are ongoing, including in first-line PTLD where patients are not recommended for other therapies.