Atara Therapeutics’ pipeline has hit another obstacle after the US Food and Drug Administration (FDA) halted clinical trials evaluating two of the company’s T-cell immunotherapies, after receiving a complete response letter (CRL) last week.
The clinical hold by the FDA is on active investigational new drug applications for Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) treatment Ebvallo (tabelecleucel), and ATA3219, a candidate for the treatment of non-Hodgkin’s lymphoma and systemic lupus erythematosus.
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Screening and enrolment of new participants in both programmes have been halted, whilst those who have the potential to gain clinical benefit from the drugs may continue treatment.
Shares in the US company were down 4.1% at market open on 21 January following the announcement and closed a further 3.8% lower at market close. Atara has a market cap of $34.8m.
Atara stated that the FDA’s decision was based on an inspection of a third-party manufacturing site conducted as part of a pre-licence inspection for Ebvallo. The FDA found there were inadequately addressed good manufacturing practice (GMP) compliance issues at the third-party facility. Whilst ATA3219 drug product is manufactured at a separate facility, the drug was still implicated in the clinical hold because its starting materials are affected by the compliance issues at the same third-party facility.
Atara said it has discussed and agreed with the FDA “upon the actions necessary to release the clinical holds”.
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By GlobalDataAtara’s CEO Cokey Nguyen said: “We intend to work closely with the FDA to address these issues as expeditiously as possible.
“We are encouraged with ongoing correspondence with the agency and a potential path to submitting the necessary data to release the clinical hold. Patient safety remains our priority and maintaining the highest standards for our programmes.”
Atara reassured concerns over its other third-party manufacturer – Fujifilm Diosynth Biotechnologies – whose facility in California is unaffected by the issues which caused the CRL and clinical hold. This site was recently approved by the European Medicines Agency (EMA) to manufacture Ebvallo, which was approved in Europe in December 2022.
Atara’s shares also took a hit last week when the FDA rejected the approval of Ebvallo for EBV+ PTLD in the US. Atara reiterated that the CRL was solely due to the issues at the third-party manufacturing site and not related to clinical safety or efficacy.
Given as an injection over several 35-day cycles, Ebvallo became the first allogenic T-cell immunotherapy following its European approval. The treatment is forecast to become a blockbuster drug by 2028 and could generate $1.5bn in sales by 2030, according to GlobalData’s Pharma Intelligence Center.
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