On November 8, 2022 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported financial results for the third quarter 2022, recent business highlights, and key upcoming catalysts (Press release, Atara Biotherapeutics, NOV 8, 2022, View Source [SID1234623413]).
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"Receiving the positive CHMP opinion for EbvalloTM (tabelecleucel) positions our product to be the first-ever approved allogeneic off-the-shelf T-cell therapy and provides important validation for our EBV T-cell platform and portfolio," said Pascal Touchon, President and Chief Executive Officer of Atara. "We continue to generate positive forward momentum across our programs, punctuated by compelling new biomarker imaging and long-term clinical data that further reinforce our belief in the transformative potential of ATA188."
Tabelecleucel (tab-cel or EbvalloTM) for EBV-Associated Ultra-Rare Cancers
Atara received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for EbvalloTM as a monotherapy for treatment of adult and pediatric patients two years of age and older with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD)
With CHMP positive opinion, the European Commission’s (EC) potential approval of the EbvalloTM Marketing Authorization Application (MAA) is expected by the end of 2022
Atara recently held a meeting with the U.S. Food and Drug Administration (FDA) that culminated in clear guidance and agreement on specific chemistry, manufacturing, and controls (CMC) Module 3 requirements for potential biologics license application (BLA) submission
A new meeting is planned with the FDA to discuss and potentially align on clinical data package requirements to prepare for a pre-BLA meeting
Atara will present updated interim analysis and safety results of the Phase 3 ALLELE study in relapsed/refractory (r/r) EBV+ PTLD with additional patients and longer follow up at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2022
Consistent with the transformative potential of tab-cel in EBV+ PTLD, overall ORR was 51.2% (22/43, 95% CI: 35.5, 66.7), 50% (7/14, 95% CI: 23.0, 77.0) in HCT, and 51.7% (15/29, 95% CI: 32.5, 70.6) in SOT with median TTR of 1.0 month and median duration of response (DOR) of 23 months
Overall median OS was 18.4 months (95% CI: 6.9, NE), with patients who responded having longer survival versus non-responders
Additionally, Atara will present updated efficacy and safety data from two single-center, open-label studies and a multicenter expanded access program in patients with EBV+ leiomyosarcomas (EBV+ LMS), who have received at least one therapy at the ASH (Free ASH Whitepaper) Annual Meeting
Clinical benefit rate (CR, PR, SD) was 77.8% (95% CI: 56.6, 96.2), with objective response rate of 22.2% (95% CI: 6.4, 47.6); the estimated median OS (95% CI) was 77.4 months (18.0, NE)
The safety profile of tab-cel remains consistent with previously reported data with no reports of tumor flare reaction, cytokine release syndrome, transmission of infectious diseases, graft-versus-host disease, or infusion reaction related to treatment
Atara continues to seek a partner for potential U.S. commercialization
ATA188 for Progressive Multiple Sclerosis (MS)
MS is a debilitating disease affecting millions, with limited treatment options and high unmet medical need in progressive forms
Atara presented new magnetic resonance imaging (MRI) biomarker imaging and open-label extension (OLE) clinical data from the Phase 1 study of ATA188 in progressive MS at the 2022 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) conference
New MRI biomarker imaging data suggest patients who achieved confirmed disability improvement (CDI) demonstrated significantly less brain atrophy over time and increased nMTR in unenhancing lesions. These data support that brain structural changes, including potential remyelination, may underlie durable CDI associated with ATA188
Updated results from the ongoing OLE with up to 46 months total follow up in patients achieving CDI demonstrate durability of improvement once achieved. Patients with stable disease, meaning no decline in EDSS, have maintained stability for up to four years
Based on enrollment in the Phase 2 EMBOLD study at the end of July, approximately 90 patients are planned to be included in the read out of the study primary endpoint of confirmed disability improvement of EDSS at 12 months. Communication of these data is planned to occur in October 2023
CAR T Programs
ATA2271 (Solid Tumors Over-Expressing Mesothelin)
The ongoing Phase 1, Memorial Sloan Kettering Cancer Center (MSK)-conducted, and investigator led clinical study of autologous mesothelin chimeric antigen receptor (CAR) T-cell therapy, ATA2271, has resumed after a voluntary pause in enrollment earlier this year
Details on the latest findings, including clinical and safety observations, will be presented at a session titled, "Building on CAR-T Experience in Mesothelioma," at ESMO (Free ESMO Whitepaper) Immuno-Oncology on December 7, 2022
ATA3219 (B-cell Malignancies)
ATA3219 is a potential best in class off-the-shelf allogeneic CD19 program using an optimized approach to address high unmet medical need. Leveraging our next-generation 1XX CAR co-stimulatory signaling domain and allogeneic EBV T-cell platform, ATA3219 does not require TCR or human leukocyte antigen (HLA) gene editing
The ATA3219 manufacturing process optimization is progressing to ensure appropriate scale-up. Atara anticipates filing an IND in Q2 2023 following completion of process optimization and manufacturing runs in the GMP manufacturing suites of our strategic manufacturing partner, FUJIFILM Diosynth Biotechnologies
Third Quarter 2022 Financial Results
Cash, cash equivalents and short-term investments as of September 30, 2022 totaled $265.4 million, as compared to $331.3 million as of June 30, 2022
In September 2022, Atara announced an additional near-term milestone payment under an updated tabelecleucel commercialization agreement with Pierre Fabre. Under this agreement, Atara will receive an additional $30 million upon EC approval and subsequent filing of the MAA transfer to Pierre Fabre
Atara believes that its cash and investments as of September 30, 2022, together with potential cash inflows from Pierre Fabre and the expected reductions in operating cash burn, will be sufficient to fund the Company’s planned operations into Q1 2024
Net cash used in operating activities was $65.1 million for the third quarter 2022, as compared to $59.0 million for the same period in 2021
Atara reported a net loss of $84.1 million, or $0.82 per share, for the third quarter 2022, as compared to a net loss of $84.7 million, or $0.90 per share, for the same period in 2021
License and collaboration revenue was $4.5 million for the third quarter 2022, primarily consisting of revenue recognized due to the termination of the Bayer agreements, as compared to $5.4 million for the same period in 2021.
Total operating expenses include non-cash expenses of $15.4 million for the third quarter 2022, as compared to $16.0 million for the same period in 2021
Research and development expenses were $70.2 million for the third quarter 2022, as compared to $70.3 million for the same period in 2021
Research and development expenses include $8.0 million of non-cash stock-based compensation expenses for the third quarter 2022 as compared to $7.8 million for the same period in 2021
General and administrative expenses were $18.9 million for the third quarter 2022, as compared to $19.8 million for the same period in 2021
General and administrative expenses include $6.0 million of non-cash stock-based compensation expenses for the third quarter 2022, as compared to $5.9 million for the same period in 2021
Conference Call and Webcast Details
Atara will host a live conference call and webcast today, Tuesday, November 8, 2022, at 4:30 p.m. EDT to discuss the Company’s financial results and recent operational highlights. Analysts and investors can participate in the conference call by dialing 877-407-8291 for domestic callers and 201-689-8345 for international callers, using the conference ID 13733805. A live audio webcast can be accessed by visiting the Investors & Media – News & Events section of atarabio.com. An archived replay will be available on the Company’s website for 30 days following the live webcast.