On February 8, 2021 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune diseases, reported the presentation of data supporting the proposed mechanism of action of their lead product candidate, tabelecleucel (tab-cel), and five additional poster presentations at the Transplantation & Cellular Therapy (TCT) Meeting of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR), held virtually February 8-12, 2021 (Press release, Atara Biotherapeutics, FEB 8, 2021, View Source [SID1234574740]).
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"We are pleased to present key translational data advancing the clinical development of ATA188 and tab-cel, the most advanced allogeneic T-cell immunotherapy in development. Additional data being presented at TCT also support the further development of tab-cel in EBV-driven diseases, such as EBV+ acquired and primary immunodeficiency lymphoproliferative diseases (AID-LPD and PID-LPD) for which we’re currently enrolling patients for a clinical study," said Jakob Dupont, M.D., Head of Global Research & Development at Atara. "These are diseases with few treatment options and poor prognosis, and it is our goal to ultimately bring this potentially transformative therapy to patients in need. We look forward to advancing tab-cel, remaining on track to complete the Biologics License Application in the third quarter of this year based on very encouraging clinical data from an interim analysis of our pivotal trial."
Results presented at TCT detail new findings from a comprehensive multiomic analysis of modes of activation for tab-cel. Each component of the assessment contributes to building the overall understanding of therapeutic activity, mechanisms of action and extended characteristics.
In this analysis, a subset of tab-cel lots were used to confirm and establish the consistency of the product’s profile, regardless of donor.
These results demonstrated, that upon stimulation, tab-cel exhibits a consistent activation signature at the level of gene expression, T-cell receptor engagement (TCR), and secretion of factors associated with effective T cell responses. Results further illustrated that the tab-cel manufacturing process results in complementary clonal expansion and consistent enrichment of TCRs associated with productive engagement of EBV-driven diseases.
Atara will also report additional data sets related to tab-cel, as well as preclinical findings demonstrating the potent anti-tumor activity of the Company’s next-generation CD19-based CAR T, ATA3219.
Additionally, the Company is presenting data on an innovative testing solution to detect and quantify non-engineered allogeneic T-cell therapies such as ATA188. As demonstrated in partnership with CareDx, AlloCell is a precise and reproducible method that resolves the analytical barrier for non-engineered allogeneic cell therapies, which do not have transgenes available to support standard quantitative pharmacokinetic (PK) assay development. The novel testing solution offers potential applications in clinical development for determining PK profiles and correlating with response and other clinical endpoints, including the understanding of fundamental aspects of pharmacology such as presence and expansion in the patient’s body.
"Together these analyses represent a leading edge for allogeneic cell therapy research, leveraging state-of-the-art profiling technologies and innovating new methodologies in collaboration with CareDx to support development of Atara’s programs," said Blake Aftab, Head of Preclinical Science and Translational Medicine at Atara. "These methods not only support our novel allogeneic EBV T-cell development programs, but also have potential for wide-ranging applications for patients."
Atara Poster Presentations at TCT 2021:
All posters will be available for viewing at the start of the meeting on Monday, February 8, 2021.
Title: Comprehensive activation profiling of tabelecleucel, an off-the-shelf, allogeneic EBV-specific T cell therapy
Poster #: 206
Title: A sensitive and precise universal surveillance solution for pharmacokinetic monitoring of off-the-shelf cell therapies (in collaboration with CareDx)
Poster #: 204
Title: Clinical experience of tabelecleucel in patients with EBV+ primary (PID) or acquired immunodeficiency (AID) associated lymphoproliferative disease (encore from ASH (Free ASH Whitepaper) 2020)
Poster #: 219
Title: Clinical experience of tabelecleucel in patients with life-threatening complications of Epstein–Barr virus viremia (encore from ASH (Free ASH Whitepaper) 2020)
Poster #: 223
Title: A multicenter, multicohort, open-label, single arm per cohort, Phase II study to assess the efficacy and safety of tabelecleucel in patients with EBV-associated diseases using an adaptive two-stage study design (encore from ASH (Free ASH Whitepaper) 2020)
Poster #: 532
Title: ATA3219: A potent next-generation allogeneic off-the-shelf CD19 CAR-T therapy without the need for gene editing (encore from ASH (Free ASH Whitepaper) 2020)
Poster #: 203