ATA188 / Atara - LARVOL DELTA

EMBOLD: Phase 1/2 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis (clinicaltrials.gov) - P1/2 | N=134 | Terminated | Sponsor: Atara Biotherapeutics | Trial completion date: Sep 2027 ➔ Jan 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jul 2023 ➔ Nov 2023; Study was terminated as primary endpoint was not achieved

Trial completion date • Trial primary completion date • Trial termination • CNS Disorders • Multiple Sclerosis

Confirmed Disability Improvement and Progression in Nonactive Progressive Multiple Sclerosis Patients in a Real-World Registry (ACTRIMS Forum 2024) - "Real-world data from the German NeuroTransData (NTD) MS registry were used to describe the natural history of disability changes in an naPMS population.Objectives: Characterize confirmed disability improvement (CDI) and confirmed disability progression (CDP) over time in naPMS patients using the NTD registry. NaPMS (≥2 years without relapses and Gadolinium-enhancing lesions prior to index) patients in the registry were identified using in-/exclusion criteria from EMBOLD, a Phase 2 clinical trial of ATA188, an allogeneic Epstein-Barr virus-targeted immunotherapy in naPMS; the index date was the earliest visit with an Expanded Disability Status Scale (EDSS) after patient identification starting in 2008... This real-world study showed that the percentages of naPMS patients with a CDI were 1.9-4.3% at 6-month time intervals from 12 to 24 months for DMT-treated and untreated groups. After propensity score weighting, the percentages of untreated naPMS patients with a CDI..."

Clinical • Real-world • Real-world evidence • CNS Disorders • Epstein-Barr Virus Infections • Multiple Sclerosis

Emboldened or not: The potential fall-out of a failed anti-EBV trial in multiple sclerosis. (PubMed, Mult Scler Relat Disord) - No abstract available

Journal • CNS Disorders • Multiple Sclerosis

"Was anything discussed about ata188?" (@cjonoski)

"ATA188 > removed EBV infected B cells, stops the damage do native repair can occur. Ph 2 showing sustained disability improvements in SPMS. NervGen induces remyelination, stimulates new axons and mobilizes your stem cells, starts ph 2 in Q1 2023. Database https://t.co/GeAwwle6vn" (@SammyJoLDN)

Epstein-Barr Virus Infections • Multiple Sclerosis

Correlation between clinical and biomarker data in ATA188-treated progressive MS (AECF 2022) - "Five patients achieving CDI maintained improvement out to 39-months. CDI was associated with less severe brain atrophy at 12-months and increasing nMTR over time, suggesting that brain structural changes persist and may underlie the CDI associated with ATA188."

Biomarker • Clinical • CNS Disorders • Multiple Sclerosis

"Anne silver is on #ata188" (@DraculasDaught5)

EMBOLD: Phase 1/2 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis (clinicaltrials.gov) - P1/2 | N=134 | Active, not recruiting | Sponsor: Atara Biotherapeutics | N=265 ➔ 134

Enrollment change • CNS Disorders • Multiple Sclerosis

Atara Biotherapeutics Presents New MRI and Updated Open-Label Extension Data from Phase 1 Study of ATA188 in Progressive Multiple Sclerosis at ECTRIMS 2022 (Businesswire) - P1 | N=265 | EMBOLD (NCT03283826) | Sponsor: Atara Biotherapeutics | "Atara Biotherapeutics, Inc....announced new magnetic resonance imaging (MRI) biomarker and open-label extension (OLE) clinical data from the study of ATA188, an investigational Epstein-Barr virus (EBV)-targeted T-cell immunotherapy, in progressive multiple sclerosis (MS). These findings will be presented as a late-breaking ePoster at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) taking place October 26-28, 2022, in Amsterdam, the Netherlands."

Late-breaking abstract • P1 data • CNS Disorders • Multiple Sclerosis

"Please report on ePoster 1242 on #ATA188 by @Atarabio" (@SilverGorilla2)

Long-term disability improvement during EBV-targeted T-cell immunotherapy ATA188 is related to brain volume change and normalised magnetisation transfer ratio in T2 lesions (ECTRIMS 2022) - "Pts achieving CDI continuing in the OLE sustained CDI for up to 39 months. CDI was associated with less severe brain atrophy at 12 months and increasing nMTR in chronic T2 lesions over time, suggesting that brain structural changes, potentially including remyelination, persist over time and may underlie the CDI associated with ATA188."

IO biomarker • Late-breaking abstract • CNS Disorders • Epstein-Barr Virus Infections • Multiple Sclerosis

EMBOLD: Phase 1/2 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis (clinicaltrials.gov) - P1/2 | N=265 | Active, not recruiting | Sponsor: Atara Biotherapeutics | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2026 ➔ Sep 2027 | Trial primary completion date: Sep 2022 ➔ Jul 2023

Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

Atara Biotherapeutics, Inc. (BIO 2022) - "Atara is applying this one platform to create a robust pipeline with the goal of developing treatments that improve the quality and longevity of patients’ lives. Atara’s pipeline includes tabelecleucel in Phase 3 development for EBV-driven post-transplant lymphoproliferative disease (PTLD) and in earlier stages of development for other EBV-associated diseases, ATA188 for multiple sclerosis, and next-generation CAR T therapies for solid tumors and hematologic cancers."

CNS Disorders • Hematological Disorders • Hematological Malignancies • Immunology • Multiple Sclerosis • Oncology • Solid Tumor • Transplantation

"Why couldn’t you do ATA188?" (@TimTim6689491)

"I wanted ATA188 and had to settle with Tolebrutinib. I can totally relate with her wanting to reach for something better." (@Paul13935779)

"علاج واعد ATA188 يعيد بعض ما فقد من الوظائف العصبية في الدراسات الأولية على مجموعة من مرضى #التصلب_اللويحي #التصلب_المتعدد التطوري( التدرجي) قد يكون بسبب إعادة بناء طبقة الميالين" (@monamarwan)

"Is the article about ATA188? (behind paywall 🙄)" (@italoromeno)

"Thank you for sharing. 1st relapse in 1984 at 18. Last relapse 2016. I went on fingolimod but still progressed 2018 Ocrevus - still progressed. 2021 Dx nrSPMS and Tolebrutinib trial - still progressed. 2022 - screening for antiEBV ATA188 trial. Probably too late for me." (@SilverGorilla2)

"Yes. Yes I would. I am screening for #ATA188 which takes 5 LPs." (@SilverGorilla2)

Updated Open-Label Extension Clinical Data and New Magnetization Transfer Ratio Imaging Data From a Phase I Study of ATA188, an Off-the-Shelf, Allogeneic Epstein-Barr Virus-Targeted T-Cell Immunotherapy for Progressive Multiple Sclerosis (ACTRIMS Forum 2022) - P1/2 | "Preliminary data indicate ATA188 is safe and well tolerated. Sustained EDSS improvement drove SDI in most pts, and in all but 1 pt, once SDI was achieved, it was maintained at all subsequent timepoints. Pts with sustained EDSS improvement (vs those without) showed greater increases in nMTR at 12m, providing evidence that structural changes suggestive of remyelination are associated with prolonged sustained improvement."

Clinical data • IO biomarker • P1 data • CNS Disorders • Epstein-Barr Virus Infections • Graft versus Host Disease • Immunology • Inflammation • Movement Disorders • Multiple Sclerosis • Muscle Spasticity

"Yes. Look up the ATA188 clinical trials data. AntiEbv antiviral having positive results for Progessive MS. Reducing (!) EDSS" (@SilverGorilla2)

Clinical

"It's not necessarily for you to benefit. The ATA188 trial for progressive MS trial is underway. I am posting a video on ATA188 this coming Wednesday." (@Brandon_Beaber)

Video • Multiple Sclerosis

"What about ATA188 off the shelf antie-ebv treatment?" (@SilverGorilla2)

Epstein-Barr Virus Infections

[VIRTUAL] Design of the Phase II, Double-Blind, Placebo-Controlled Dose-Expansion Portion of a Two-Part, Phase I/II, Multicenter Trial in Progressive Multiple Sclerosis (CMSC 2021) - P1/2 | "Part 2; the randomized, PBO-controlled Phase II portion of this study, is now enrolling pts to evaluate the efficacy and safety of ATA188 in pts with PMS."

Clinical • IO biomarker • P1/2 data • P2 data • CNS Disorders • Multiple Sclerosis • MRI

Atara Biotherapeutics Presents New Magnetization Transfer Ratio Imaging Data and Two-Year Clinical Data from the Open Label Extension of ATA188 for Progressive Multiple Sclerosis at ECTRIMS 2021 (Businesswire) - "'When a patient reaches a certain level of advanced disability, it is rare for them to naturally revert, and any improvement that is sustained would not be expected from the natural history of the disease,' said Mark Freedman, MD...'With progressive MS, spontaneous remyelination without therapeutic intervention is unlikely, highlighting the impact that these MTR data provide suggesting remyelination may be driving the prolonged sustained EDSS improvement.'"

Media quote • Multiple Sclerosis