Atara Biotherapeutics

Rajani Dinavahi, Atara Biotherapeutics' chief medical officer since 2024, leads clinical development, operations, and medical affairs. She spearheaded the development of Tabelecleucel, the first globally approved allogeneic T-cell immunotherapy.

Tabelecleucel (tab-cel) showed 50.7% overall response rate (ORR) and 28.0% complete response (CR) rate in patients with EBV-associated PTLD after rituximab failure, with median time to response of 1.1 months and estimated duration of response of 23.0 months. The FDA is reviewing a biologics license application for tab-cel, with a target action date of January 15, 2025.

Tabelecleucel showed 50.7% ORR, 23.0-month median DOR, and 18.4-month median OS in R/R EBV+ PTLD patients. Safety consistent with prior studies; no reports of CRS, tumor flare, ICANS, or organ rejection. BLA under priority review by FDA with PDUFA target date of January 15, 2025. If approved, tabelecleucel would be the first allogeneic, off-the-shelf T-cell therapy in the U.S. for R/R EBV+ PTLD.

DelveInsight's report highlights a robust lupus nephritis pipeline with 30+ companies developing 35+ therapies, including key players like AstraZeneca and Novartis. Promising therapies like Anifrolumab and Ianalumab are in various clinical phases, with recent updates from companies like Adicet Bio and Kyverna Therapeutics. The report provides comprehensive insights into the pipeline, therapeutic assessments, and market dynamics.

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Atara Biotherapeutics' CEO, Cokey Nguyen, will participate in a fireside chat at the 7th Annual Evercore ISI HealthCONx Conference on Dec 3, 2024. A live webcast will be available on atarabio.com, with an archived replay for 30 days.

Fujifilm Diosynth Biotechnologies completed an expansion of its cell-therapy manufacturing facility in Thousand Oaks, California, adding two new production suites and upgrading labs. The expansion increases cleanroom capacity and supports new modalities, with the site recently granted EMA approval for manufacturing sterile biological products, including Atara Biotherapeutics’ Ebvallo™. The facility is equipped for both clinical and commercial cell therapies, with experience in allogeneic T cell and CAR T immunotherapies.

FUJIFILM Diosynth Biotechnologies celebrated the expansion of its cell therapy manufacturing facility in Thousand Oaks, CA, adding two new production suites. The expansion includes upgraded labs, increased cleanroom capacity, and innovative equipment. The site received EMA GMP compliance and approval for manufacturing Atara Biotherapeutics’ Ebvallo™. The expansion supports the growing cell therapy market, expected to grow at a CAGR of 37% from 2023 to 2030.