On January 10, 2022 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported Pascal Touchon, President and Chief Executive Officer of Atara, will present the Company’s 2021 accomplishments across strategic priorities and key upcoming catalysts at the 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12 at 2:15 p.m. PST / 5:15 p.m. EST (Press release, Atara Biotherapeutics, JAN 10, 2022, View Source [SID1234598521]).
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"Atara made significant progress in 2021, including presentation of positive data from our pivotal Phase 3 ALLELE study and EU regulatory submission for tab-cel; new data confirming our conviction for ATA188 as the first investigational therapy to potentially reverse disability in progressive multiple sclerosis, now further validated by FDA Fast Track designation; and promising early safety and persistence data for our potentially best-in-class allogeneic CAR T portfolio that does not require TCR or HLA gene editing," said Pascal Touchon, President and Chief Executive Officer of Atara. "With the interim analysis from our EMBOLD study of ATA188, a planned BLA submission and the potential groundbreaking EU approval for tab-cel, the first ever allogeneic, off-the-shelf T-cell therapy to reach this stage, 2022 will be an exciting year for Atara and patients in significant need."
Tabelecleucel (tab-cel) for Post-Transplant Lymphoproliferative Disease (PTLD)
Continued progress with the U.S. Food and Drug Administration (FDA), including productive engagement with CBER and a Type B CMC meeting scheduled for Q1 2022
Atara plans to complete the Biologics License Application (BLA) submission for patients with EBV+ PTLD in Q2 2022
U.S. approval of BLA for patients with EBV+ PTLD anticipated in H1 2023
Following successful interactions with EMA, Atara submitted a Marketing Authorization Application (MAA) for tab-cel in patients with EBV+ PTLD, the first ever for an allogeneic, off-the-shelf T-cell therapy, in November 2021. With the granting of Accelerated Assessment, the Company anticipates a decision regarding EU approval in Q4 2022
First presentation of positive data from the pivotal Phase 3 ALLELE study, reinforcing the transformative potential of tab-cel, as an oral session at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021
Data demonstrated a 50% objective response rate (ORR) and durability of response with 89% of patients responding to treatment surviving after one year, compared with 32% in non-responders
In a second oral presentation at ASH (Free ASH Whitepaper), longer term data from Phase 2 and Expanded Access Protocol (EAP) studies showed two-year survival benefit of over 86% in responders whether they achieved a complete response (CR) or partial response (PR) and median OS of 54.6 months
Continued favorable tab-cel safety profile and no new safety signals with more than 180 PTLD patients treated to date
EBV+ PTLD is a rare and potentially life-threatening cancer that may occur following a solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT). For patients with EBV+ PTLD, the median survival is only 0.7 to 4.1 months after failure of initial therapy. There are currently no EMA- or FDA-approved treatments indicated for these patients
Tab-cel for Potential Additional Indications
Enrollment is continuing at sites in the potential label expansion multi-cohort Phase 2 study evaluating six patient populations within EBV+ immunodeficiency-associated lymphoproliferative diseases (IA-LPDs) and other EBV-driven diseases
First data from the multi-cohort study planned to be presented in 2023
ATA188 for Progressive Multiple Sclerosis (MS)
FDA has granted Fast Track designation for ATA188 in non-active primary progressive multiple sclerosis (PPMS) and non-active secondary progressive multiple sclerosis (SPMS), two populations with high unmet medical need and limited treatment options
A Fast Track designation expedites the review of drugs filling an unmet medical need to treat serious conditions to get important therapies to patients faster; once received, this designation allows early and frequent communication with FDA throughout the development and review process
Atara is continuing to make good progress enrolling the Phase 2 randomized, double-blind, placebo-controlled dose-expansion EMBOLD study evaluating the efficacy and safety of ATA188 in patients with progressive MS
A formal interim analysis is planned for Q2 2022, including efficacy and safety, to optimize the likelihood of success in Phase 2 and confirm current development strategy
Following the interim analysis, the Company will communicate next steps for the program, including rationale, while still maintaining the integrity of the study
Atara plans to conduct pivotal Phase 3 studies at the conclusion of the Phase 2 study and is actively exploring partnership opportunities
One Phase 3 study will focus on non-active SPMS, for which no approved therapies currently exist in U.S. or EU
A separate study will focus on non-active PPMS, which has very few treatment options in most countries and approved therapies are of limited efficacy
The vast majority of people with PPMS and SPMS have non-active disease
Overall, increasing research activity and support within the academic community for the hypothesis of EBV as a driver of MS pathogenesis
CAR T Programs
Atara continues to advance our CAR T programs in liquid and solid tumors, which include a differentiated approach to allogeneic cell therapy, with no gene editing of the T-cell receptor (TCR) and next generation CAR technologies to enhance expansion and persistence of functional T cells
ATA2271/ATA3271 (Solid Tumors Over-Expressing Mesothelin)
Global strategic collaboration for ATA2271 and ATA3271 with Bayer continues to progress well with advancement of the mesothelin-partnered CAR T immunotherapy programs
Data presented at ESMO (Free ESMO Whitepaper)-IO in December 2021 showed promising early safety and persistence of armored CAR T, ATA2271, in patients with advanced mesothelioma; infusions for the first two patient cohorts have now been completed
Atara is continuing to make progress on IND-enabling studies for ATA3271, an off-the-shelf, allogeneic CAR-T therapy targeting mesothelin using next-generation PD-1 dominant negative receptor (DNR) and 1XX CAR co-stimulatory signaling domain technologies for patients with advanced mesothelioma, and expects a filing in Q4 2022
ATA3219 (B-cell Malignancies)
Atara continues to advance development of ATA3219, a potential best-in-class allogeneic CD19 CAR T therapy that does not require TCR or human leukocyte antigen (HLA) gene editing, leveraging our next-generation 1XX CAR co-stimulatory signaling domain and allogeneic EBV T-cell platform
New pre-clinical data (on file) demonstrated optimized version of ATA3219 with an enhanced memory phenotype, leads to both strong proliferative potential and potent antitumor activity supporting a best-in-class profile
Atara expects to submit an IND for B-cell malignancies in Q4 2022
A live audio webcast of the presentation will be available by visiting the Investors & Media – News & Events section of atarabio.com on Wednesday, January 12, at 5:15 p.m. EST / 2:15 p.m. PST. An archived replay of the webcast will be available on the Company’s website for 30 days following the live presentation. A new corporate presentation will be available on Monday, January 10 at 8:30 a.m. EST / 5:30 a.m. PST.