Atara Biotherapeutics, Inc. · NASDAQ:ATRA
Atara Biotherapeutics — JP Morgan Healthcare Conference 2022
26 slides from Atara Biotherapeutics's conference presentation, Jan 10, 2022
Slide 1: Investor Presentation, JP Morgan Healthcare Conference
Ola EBV+ PTLD Advocate ATARA BIO® Investor Presentation JP Morgan Healthcare Conference January 10, 2022 Nasdaq: ATRA
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation and the accompanying oral presentation contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this prese
Slide 3: We Are a Leading Allogeneic T-Cell Immunotherapy Company
We Are a Leading Allogeneic T-Cell Immunotherapy Company Differentiated Allogeneic Cell Therapy Platform Scalable EBV T-cell platform and technologies to develop multiple allogeneic cell therapies Tab-cel®: First-In-Kind, Late-Stage, Oncology Program MAA submitted in November 2021 with accelerated a
Slide 4: Robust T-Cell Immunotherapy Pipeline
Robust T-Cell Immunotherapy Pipeline Program Indication Target Preclinical Phase 1 Phase 2 Phase 3 Registration Next Milestone Tab-cel® tabelecleucel) RR EBV+ PTLD following HCT and SOT EBV ALLELE Study Q2 2022: BLA submission Q4 2022: EU approval Multi-Cohort: EBV+ cancers(1) EBV 2023: Ph2 Study da
Slide 5: Three Strategic Priorities Driving Long-Term Value
Three Strategic Priorities Driving Long-Term Value Tab-cel® First-in-Kind Allogeneic T-Cell Therapy with Historic Regulatory Filing BTD program for high unmet need in ultra rare population, with meaningful label expansion potential Compelling efficacy profile in Phase 2 and Phase 3 IA data with favo
Slide 6: Upcoming Key Catalysts
Upcoming Key Catalysts Tab-cel® (tabelecleucel) Planned FDA Biologics License Application (BLA) submission for patients with EBV+ PTLD Q2 2022 Anticipated EU approval of MAA for patients with EBV+ PTLD, with accelerated assessment Q4 2022 Anticipated U.S. approval of BLA for patients with EBV+ PTLD
Slide 7: Atara Strategic Priorities to Create Value: Tab-cel
Atara Strategic Priorities to Create Value: Tab-cel® Tab-cel® (tabelecleucel) Investigational T-cell immunotherapy for EBV-associated ultra-rare diseases FDA breakthrough designation and EMA PRIME for EBV+ PTLD MAA submitted in EU with accelerated assessment ATA188 CAR T A TARA B IO® 7
Slide 8: Recent Positive Regulatory Progress for Tab-cel
Recent Positive Regulatory Progress for Tab-cel® EUROPEAN MEDICINES AGENCY SCIENCE MEDICINES HEALTH Based on the requests from the FDA following our recent interactions, Atara has provided to the Agency additional analyses of CMC data we have already provided FDA has not requested additional clinica
Slide 9: Tab-cel ALLELE Data Presented at ASH 2021
Tab-cel® Phase 3 ALLELE Data Presented at ASH 2021 Demonstrate 50% ORR and Impressive Overall Survival at 1 Year Interim Analysis by IORA for Phase 3 Pivotal Study Based on data cut from Q2 2021 Includes 6-month durability of response analysis on additional patients, as requested by FDA in Q4 2020 C
Slide 10: New ASH 2021 Data Confirm Tab-cel Long-term Survival Benefit
New ASH 2021 Data Confirm Tab-cel® Long-term Survival Benefit Key Takeaways 2 year overall survival rates similar between CR and PR patients at 86% and 87%, respectively Median overall survival (OS) of ~55 months in both CR and PR groups Continued favorable safety profile: No new safety signals with
Slide 11: Atara Strategic Priorities to Create Value: ATA188
Atara Strategic Priorities to Create Value: ATA188 Tab-cel® (tabelecleucel) ATA188 EBV T-cell immunotherapy for progressive multiple sclerosis (MS) Fast Track designations in non-active PPMS and non-active SPMS CAR T A TARA B IO® 11
Slide 12: Fast Track Designation and Phase 2 EMBOLD Study for ATA188
We Have Received Fast Track Designation from FDA and are Rapidly Advancing our Phase 2 EMBOLD Study for ATA188 FDA Registrational Feedback Received Fast track designation received: FDA granted fast track designation in both non-active SPMS and non-active PPMS patient populations Patient Population:
Slide 13: Advancing Towards Planned Interim Analysis for ATA188 EMBOLD Study
We are Advancing Towards the Planned Interim Analysis for the ATA188 EMBOLD Study in Q2 2022 Planned Interim Analysis on Track for Q2 2022 We plan to conduct a formal interim analysis in Q2 2022, including efficacy and safety, to optimize the likelihood of success in Phase 2, and confirm current dev
Slide 14: Phase 1/OLE Summary of Data (ECTRIMS 2021)
Phase 1/OLE Summary of Data (ECTRIMS 2021) Updated results from the ongoing Open Label Extension (OLE) demonstrate continued safety and tolerability of ATA188 with the longest observed patients receiving up to 3 annual treatments and up to 39 months of follow up SDI with ATA188 was driven by sustain
Slide 15: ATA188 Led to Sustained EDSS Improvement in Some Patients
In the Phase 1 and OLE, Treatment with ATA188 Led to Sustained EDSS Improvement in Some Patients Suggesting a Possible Reversal of Disease Progression 3.0 (at 12 mo.) 3.0 (at 30 mo.) 3.5 (at 33 mo.) 4.5 (at 15 mo.) 4.5 (at 27 mo.) 4.5 (at 24 mo.) 4.5 (Baseline) 5.5 (Baseline) 5.5 (Baseline) 5.5 (Bas
Slide 16: ATA188 Shows Statistically Significant Increase in MTR
ATA188 Shows, For the First Time in PMS, a Statistically Significant Increase in MTR (Potential Remyelination) in Unenhancing T2 Lesions Change from baseline in MTR, mean Normal Appearing Brain Tissue (NABT) 6 Months 12 Months 0.045 0.014 0.079 0.028 p=0.44 p=0.16 (n=6) (n=14) (n=7) (n=15) Unenhanci
Slide 17: MTR Increases with ATA188 vs MTR Decreases with Siponimod
MTR Increases in Ph1 ATA188 Study (SPMS, PPMS) Suggest Remyelination vs MTR Decreases in Ph3 Siponimod Study (SPMS) Change from baseline in MTR, adj. mean Siponimod Ph3: Normal Appearing White Matter (NAWM) 12 Months p=0.14 -0.007 (n=281) -0.02 (n=162) ATA188 Ph1a Normal Appearing Brain Tissue (NABT
Slide 18: Growing Evidence that EBV Has a Major Role in MS
Growing Evidence that EBV Has a Major Role in the Pathogenesis of Multiple Sclerosis Prior EBV infection is necessary for a patient to develop MS 1,4 MS may be mediated by B cells that are infected with EBV 2 Defective elimination of EBV-infected autoreactive B cells by CD8+ T-cells results in accum
Slide 19: Atara Strategic Priorities to Create Value: CAR T
Atara Strategic Priorities to Create Value: CAR T Tab-cel® (tabelecleucel) ATA183 CAR T ATA2271/ATA3271 (Solid Tumors) ATA3219 (B-cell malignancies) Other CAR T A TARA B IO® 19
Slide 20: Atara Next-Gen CAR T Platform: Key Features
Atara Next-Gen CAR T Platform: Key Features for Efficacy and Persistence TCR is a key survival signal for T-cells1,2,7 Loss of TCR complex results in reduced persistence in vivo3,4 EBV TCR Partial HLA Matching allows TCR/MHC matching and minimizes GVHD risk8 Obviates need for genomic editing or stea
Slide 21: An Intact T-Cell Receptor is Essential for T-cell Persistence
An Intact T-Cell Receptor is Essential for T-cell Persistence Untransduced RV19BBCRTCR+ RV19BBCRTRBC- T cells in PB[%] 40 30 20 10 1 1.0 0.8 0.6 0.4 0.2 0.0 3 10 24 37 50 Days post T cell injection Loss of TCR expression results in reduced CAR T cell persistence and survival in multiple pre-clinical
Slide 22: Encouraging Preliminary Data for ATA2271 and ATA3271
Encouraging Preliminary Data for ATA2271 and ATA3271 (Mesothelin CART Programs in Solid Tumors) BAYER Clinical PK shows presence of ATA2271 CAR T cells in peripheral blood for >4 weeks Vector copy number (copies/mL) 10000 1000 100 10 1 0 2 4 6 8 10 12 Weeks since T-cell infusion ATA2271 was associat
Slide 23: ATA3219: Potential Best in Class Off-the-Shelf Allogeneic CD19 Program
ATA3219: Potential Best in Class Off-the-Shelf Allogeneic CD19 Program for B-Cell Malignancies, with IND Expected in Q4 2022 EBV TCR Matched MHC CD19 ScFv Novel 1XX costimulatory domain Investigator Sponsored Trial (MSKCC): advanced B-cell malignancy patients received partially HLA matched EBV CD19
Slide 24: ATA3219 CAR T Cells Show Superior Tumor Control in vivo
Optimized for T Cell memory, ATA3219 CAR T Cells Show Superior Tumor Control in vivo CAR T field highlights importance of memory T cell phenotype for CAR T efficacy ATA3219 is being optimized for best-in-class opportunity Modifying the ATA3219 bio-production process for stem-like T cells shows more
Slide 25: ATA3219 Differentiation to Address High Unmet Medical Need
ATA3219 Differentiation to Address High Unmet Medical Need Key Points of Differentiation in B-Cell malignancies Confirm safety of allogeneic EBV CAR T cells Demonstrate best-in-class efficacy Establish sufficient persistence for durable response Scaled up manufacturing and off-the-shelf accessibilit
Slide 26: We Are a Leading Allogeneic T-Cell Immunotherapy Company
We Are a Leading Allogeneic T-Cell Immunotherapy Company Differentiated Allogeneic Cell Therapy Platform Scalable EBV T-cell platform and technologies to develop multiple allogeneic cell therapies Tab-cel®: First-In-Kind, Late-Stage, Oncology Program MAA submitted in November 2021 with accelerated a
Atara Biotherapeutics — JP Morgan Healthcare Conference 2022 on 6ix