ATRA Atara Biotherapeutics Inc.

15.88
+0.07  (+0%)
Previous Close 15.81
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Market Cap $1,345,949,910
Shares 84,757,551
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Enterprise Value $970,343,126
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ATA2271
Mesothelioma
Phase 1
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Tabelecleucel (ATA 129)
Epstein-Barr virus (EBV-PTLD) after solid organ transplant (SOT)
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ATH-1017
Alzheimer’s Disease
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ATA188 (EMBOLD)
Multiple sclerosis
Phase 1/2
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Latest News

  1. Patients who Achieved Sustained Expanded Disability Status Scale (EDSS) Improvement at any Time Showed Significant Increase in Magnetization Transfer Ratio (MTR) from Baseline at 12 Months, Suggestive of Remyelination

    7 of 8 Patients Achieving Sustained Disability Improvement (SDI) Maintained Improvement at all Subsequent Timepoints up to 33 Months, with Most SDI Responses Driven by EDSS

    Interim Analysis from Randomized Phase 2 EMBOLD Study on Track for H1 2022

    Conference Call and Webcast Today, October 13, 2021, at 8:30 a.m. EDT

    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…

    Patients who Achieved Sustained Expanded Disability Status Scale (EDSS) Improvement at any Time Showed Significant Increase in Magnetization Transfer Ratio (MTR) from Baseline at 12 Months, Suggestive of Remyelination

    7 of 8 Patients Achieving Sustained Disability Improvement (SDI) Maintained Improvement at all Subsequent Timepoints up to 33 Months, with Most SDI Responses Driven by EDSS

    Interim Analysis from Randomized Phase 2 EMBOLD Study on Track for H1 2022

    Conference Call and Webcast Today, October 13, 2021, at 8:30 a.m. EDT

    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, today announced new translational data based on magnetization transfer ratio (MTR) and updated Phase 1 open-label extension (OLE) clinical data in patients with progressive multiple sclerosis (MS) treated with ATA188 for up to 39 months.

    ATA188 is an investigational, off-the-shelf, allogeneic T-cell immunotherapy that targets Epstein-Barr virus (EBV)-infected B cells and plasma cells. Following treatment, Phase 1 clinical data indicate that ATA188 continues to be well-tolerated with no new safety findings in this patient population. Additionally, patients may achieve sustained disability improvement (SDI), with most driven by EDSS, at a higher rate and longer duration than would be expected based on the natural history of progressive MS, with MTR analysis providing evidence that structural changes suggestive of remyelination may be driving sustained EDSS improvements.

    "There is growing robust evidence that EBV-infected B cells and plasma cells play a critical role in the pathogenesis of multiple sclerosis," said AJ Joshi, MD, Chief Medical Officer at Atara. "These data on ATA188 in progressive MS, the population with highest unmet need, underscore the potential to halt or reverse disability progression by precisely targeting what may be a root cause of MS. Importantly, an increase in MTR imaging signal suggestive of remyelination was seen in patients that achieved sustained EDSS improvement which may provide a potential biological basis for the clinical improvements observed with ATA188 treatment."

    Of 24 patients who received ATA188, and in which efficacy was evaluated in the initial 12-month period, 18 patients chose to participate in the OLE and were followed for up to 39 months as of August 2021. Efficacy from the 12-month dose escalation portion of the trial was previously reported.1

    Of the 18 total patients in the OLE, nine patients achieved SDI either in the initial 12-month period (n=7) or in the OLE (n=2) and of these, seven patients had sustained EDSS improvement. A relationship between dose-escalation and increasing clinical response was observed, with seven of nine patients that achieved SDI receiving the two highest doses either initially or in the OLE versus two of nine receiving the two lower doses. Eight patients that achieved SDI participated in the OLE, and seven of these maintained SDI at all subsequent timepoints. The median time for which SDI was maintained in these eight patients was 18 months (range 0.03–27.0 months). One patient with secondary progressive multiple sclerosis (SPMS) who had achieved SDI experienced a non-treatment related relapse at 18 months, occurring approximately six months after the last ATA188 dose, and elected to discontinue the study. As of August 2021, inclusive of the OLE, no fatal adverse events, grade >3 events, dose-limiting toxicities, cytokine release syndrome, or graft versus host disease were observed.

    In multiple sclerosis, a person's own immune system erroneously attacks the fatty layer of insulation (myelin) that helps nerve fibers in the central nervous system communicate with each other. MTR, a measure of myelin density, has emerged as a promising imaging biomarker of myelin loss (demyelination) or myelin repair (remyelination).

    Patients treated with ATA188 who achieved sustained EDSS improvement, versus those who did not, showed a significant increase (p value: 0.0213) from baseline in MTR for nonenhancing T2 chronic brain lesions at 12 months, which may be indicative of remyelination. Compared to baseline, MTR increased at 12 months for nonenhanced T2 lesions and normal-appearing brain tissue in patients with sustained EDSS improvement (median change of 0.134 and 0.082 MTR units, respectively), whereas MTR remained unchanged in those patients without sustained EDSS improvement (median change of –0.030 and 0.005 MTR units, respectively). In general, a trend supporting a correlation between increase in MTR signal and improvement in EDSS score was observed across patients as early as six months.

    "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, Professor of Neurology, University of Ottawa. "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."

    In a separate ePoster, Atara also presented encore data profiling and evaluating the functionality and proliferation potential of ATA188 following antigen exposure. This comprehensive analysis of ATA188 lots produced from diverse human leukocyte antigen (HLA) donors demonstrates a robust manufacturing process showing consistent functional activation and productive effector responses.

    Atara continues to enroll EMBOLD, a randomized, placebo-controlled Phase 2 clinical study of ATA188 in the treatment of patients with progressive MS, across clinical sites in the U.S. and Australia with a planned interim analysis in the first half of 2022.

    Poster Presentation Details:

    Title: 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

    Presenting Author: Douglas L. Arnold, MD, Montreal Neurological Institute, McGill University and NeuroRx Research, Montreal, Canada

    Date & Time: Wednesday, October 13, 2021, at 16:45 CEST / 10:45 a.m. EDT / 7:45 a.m. PDT

    Poster Session & Number: eP31 - Immunomodulation/Immunosuppression, P638

    Title: Comprehensive profiling of ATA188, an off-the-shelf, allogeneic Epstein-Barr virus-specific T-cell immunotherapy for progressive multiple sclerosis

    Presenting Author: Monica Moreno, Ph.D., Atara Biotherapeutics, Thousand Oaks, United States

    Date & Time: Wednesday, October 13, 2021, at 16:45 CEST / 10:45 a.m. EDT / 7:45 a.m. PDT

    Poster Session & Number: eP31 - Immunomodulation/Immunosuppression, P644

    Atara Conference Call and Webcast Information

    Additionally, the Company will hold a conference call on Wednesday, October 13 at 8:30 a.m. EDT / 5:30 a.m. PDT for analysts and investors to review the data that will be presented. The call will include:

    • Pascal Touchon, President and Chief Executive Officer, Atara Biotherapeutics
    • Jakob Dupont, MD, Executive Vice President and Global Head of Research and Development, Atara Biotherapeutics
    • AJ Joshi, MD, Senior Vice President and Chief Medical Officer, Atara Biotherapeutics
    • Douglas L. Arnold, MD, Montreal Neurological Institute, McGill University and NeuroRx Research, Montreal, Canada
    • Gavin Giovannoni, MBBCh, Ph.D., Centre for Neuroscience and Trauma, Barts and The London School of Medicine and Dentistry, London, England

    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 13722755. 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.

    About Progressive Multiple Sclerosis

    Multiple sclerosis (MS) is a chronic, debilitating, and potentially disabling autoimmune disease of the central nervous system (CNS) that affects myelin, a protein that helps nerves in the brain and spinal cord communicate. There are an estimated 2.3-2.8 million people living with MS worldwide, with approximately 1 million living with progressive forms of the disease, marked by continuous clinical decline and worsening disability. While the exact triggers of MS are not fully established, inflammation driven by environmental and genetic factors is suspected. There is growing evidence that EBV, carried by more than 90 percent of the population that infects a particular type of immune cell called the B cell, may have a role in MS and in fact may be the only risk factor identified necessary to cause MS. With few treatment options available for progressive MS and the ability of these treatments to fundamentally alter disease progression, there remains a critical unmet need.

    About ATA188

    Epstein-Barr virus (EBV) is associated with a wide range of hematologic malignancies and solid tumors, as well as certain autoimmune conditions such as multiple sclerosis (MS). T cells are a critical component of the body's immune system which normally target EBV-infected B cells. ATA188, Atara's investigational off-the-shelf T-cell candidate, has the potential to target EBV-infected B cells and plasma cells in the central nervous system that may catalyze autoimmune responses and MS pathophysiology. Atara is currently enrolling EMBOLD, a Phase 2 clinical study of ATA188 in the treatment of patients with progressive MS, across clinical sites in the U.S. and Australia.

    About Atara Biotherapeutics, Inc.

    Atara Biotherapeutics, Inc. (@Atarabio) is 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 disease. With our lead program in Phase 3 clinical development, Atara is the most advanced allogeneic T-cell immunotherapy company and intends to rapidly deliver off-the-shelf treatments to patients with high unmet medical need. Our platform leverages the unique biology of EBV T cells and has the capability to treat a wide range of EBV-associated diseases, or other serious diseases through incorporation of engineered CARs (chimeric antigen receptors) or TCRs (T-cell receptors). Atara is applying this one platform to create a robust pipeline including: tab-cel® in Phase 3 development for Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD) and other EBV-driven diseases; ATA188, a T-cell immunotherapy targeting EBV antigens as a potential treatment for multiple sclerosis; and multiple next-generation chimeric antigen receptor T-cell (CAR-T) immunotherapies for both solid tumors and hematologic malignancies. Improving patients' lives is our mission and we will never stop working to bring transformative therapies to those in need. Atara is headquartered in South San Francisco and our leading-edge research, development and manufacturing facility is based in Thousand Oaks, California. For additional information about the company, please visit atarabio.com and follow us on Twitter and LinkedIn.

    Forward-Looking Statements

    This press release contains or may imply "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding: the potential benefits; safety and efficacy of ATA188; translational and biomarker data for ATA188, including magnetization transfer ratio (MTR) data and MTR's potential link with remyelination; data from ATA188 OLE study; timing and progress of clinical trials of ATA188; and Atara's ability to successfully advance the development of ATA188. Because such statements deal with future events and are based on Atara Biotherapeutics' current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara Biotherapeutics could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; the ongoing COVID-19 pandemic, which may significantly impact (i) our business, research, clinical development plans and operations, including our operations in South San Francisco and Southern California and at our clinical trial sites, as well as the business or operations of our third-party manufacturer, contract research organizations or other third parties with whom we conduct business, (ii) our ability to access capital, and (iii) the value of our common stock; the sufficiency of Atara's cash resources and need for additional capital; and other risks and uncertainties affecting Atara's and its development programs, including those discussed in Atara Biotherapeutics' filings with the Securities and Exchange Commission (SEC), including in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings and in the documents incorporated by reference therein. Except as otherwise required by law, Atara Biotherapeutics disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.

    _____________________________

    1 Atara Biotherapeutics, Inc. (2020, September 11). Atara Biotherapeutics Announces All Progressive Multiple Sclerosis Patients with Sustained Disability Improvement at Six Months Confirmed Improvement at 12 Months in the Phase 1a Study of ATA188 [Press Release]. https://investors.atarabio.com/news-events/press-releases/detail/206/atara-biotherapeutics-announces-all-progressive-multiple

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  2. Pierre Fabre to Commercialize Tab-cel® for Epstein-Barr Virus (EBV)-Positive Cancers in Europe, Middle East, Africa, and Other Select Emerging Markets

    Atara to Receive Upfront Payment of USD 45 Million, and Up to Approximately USD 320 Million in Total Milestones, Plus Significant Double-digit Tiered Royalties as a Percentage of Net Sales

    Atara Retains Full Commercialization Rights to Tab-cel® in the United States and Other Major Markets

    Tab-cel®, Recently Granted EMA Accelerated Assessment, Remains On-Track for European MAA Filing in November 2021

    Atara to Host Conference Call on Monday, October 4 at 8:30 a.m. EDT

    Atara Biotherapeutics, Inc. (NASDAQ:ATRA) and Pierre Fabre today announced an exclusive commercialization agreement for tabelecleucel…

    Pierre Fabre to Commercialize Tab-cel® for Epstein-Barr Virus (EBV)-Positive Cancers in Europe, Middle East, Africa, and Other Select Emerging Markets

    Atara to Receive Upfront Payment of USD 45 Million, and Up to Approximately USD 320 Million in Total Milestones, Plus Significant Double-digit Tiered Royalties as a Percentage of Net Sales

    Atara Retains Full Commercialization Rights to Tab-cel® in the United States and Other Major Markets

    Tab-cel®, Recently Granted EMA Accelerated Assessment, Remains On-Track for European MAA Filing in November 2021

    Atara to Host Conference Call on Monday, October 4 at 8:30 a.m. EDT

    Atara Biotherapeutics, Inc. (NASDAQ:ATRA) and Pierre Fabre today announced an exclusive commercialization agreement for tabelecleucel (tab-cel®) in Europe, Middle East, Africa, and other select emerging markets for Epstein-Barr virus (EBV)-positive cancers. Atara will retain full rights to tab-cel® in other major markets, including North America, Asia Pacific, and Latin America.

    Under the terms of the agreement, Atara will receive an upfront payment of USD 45 million, and up to approximately USD 320 million in additional regulatory and sales milestone payments, plus significant double-digit tiered royalties as a percentage of net sales. Atara will continue to be responsible for the pivotal ALLELE study in PTLD as well as submitting the EU Marketing Authorization Application (MAA) for tabelecleucel in patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), which is on track for November 2021. Atara will also remain responsible for the Phase 2 multi-cohort study, which is evaluating tab-cel® in six additional patient populations with the goal of label expansion in EBV-driven cancers. Pierre Fabre will lead all commercialization and distribution activities in the territories, as well as medical and regulatory activities after the anticipated MAA approval in Europe. As part of the transaction, Atara will also provide manufacturing services for tab-cel® to be paid by Pierre Fabre.

    Atara is a leader in T-cell immunotherapy, leveraging its first-in-kind allogeneic off-the-shelf EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases. Tab-cel® is the Company's lead candidate in development for EBV-positive cancers, including EBV+ PTLD, where it is currently being investigated in adults and children in the Phase 3 ALLELE study. Tab-cel® has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) designation by the European Medicines Agency (EMA).

    "Pierre Fabre is a science-driven company that brings significant commercialization expertise through its integrated Oncology Business Unit, its deep knowledge of Bone Marrow Transplant centers and a track record of successful launches through partnerships," commented Pascal Touchon, President and CEO of Atara. "Our Companies' complementary capabilities will expand access to tab-cel®, a potentially transformative investigational allogeneic off-the-shelf T-cell immunotherapy, to patients worldwide who suffer from EBV+ PTLD and other EBV-driven cancers."

    Pierre Fabre enjoys a 35-year long experience in oncology covering innovation, development, manufacturing and commercialization. Its Medical Care division has declared oncology as its main R&D and commercial priority, focusing on targeted therapies, biotherapies, and immuno-oncology. Its therapeutic areas include high unmet medical needs and cover colorectal, breast, lung cancers, melanoma, and pre-cancerous conditions like actinic keratosis. The company has also developed a strong know-how in leveraging global partnerships with biotechnology and pharmaceutical companies, as demonstrated by several successful collaborations in oncology.

    "Tab-cel® is a highly innovative immunotherapy with the potential to serve patients with high unmet need in rare conditions. This partnership with Atara epitomizes our corporate purpose: ‘every time we take care of one single person, we make the world better,'" said Eric Ducournau, CEO of Pierre Fabre. "We expect strong synergies with our existing capabilities in oncology across regulatory, distribution, medical, marketing and sales and look forward to bringing this advanced product to patients."

    PJT Partners served as the exclusive financial advisor to Atara.

    Atara Conference Call

    In connection with this announcement, Atara will host a webcast and conference call today at 8:30 a.m. EDT. 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 13723585. A live audio webcast can be accessed by visiting the Investors & Media – News & Events section of www.atarabio.com. An archived replay will be available on the Company's website for 30 days.

    About Tabelecleucel

    Tabelecleucel (tab-cel®) is an off-the-shelf, allogeneic T-cell immunotherapy in development for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). EBV+ PTLD is a type of lymphoma (cancer) that may occur after a solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT). There are currently no approved treatments indicated to treat PTLD and if left untreated, PTLD can have life-threatening consequences.

    Tab-cel® is currently being investigated in the Phase 3 ALLELE study to assess efficacy and safety for the treatment of EBV+ PTLD in SOT and HCT after failure of standard of care.

    Tab-cel® has been granted Breakthrough Therapy Designation for EBV+ PTLD following allogeneic HCT by the U.S. Food and Drug Administration (FDA) and PRIME designation by the European Medicines Agency (EMA) for the same indication. Tab-cel® has orphan drug designation in the U.S. and EU.

    About Pierre Fabre

    Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies. Its portfolio ranges across several medical franchises and international brands, including Pierre Fabre Oncology, Pierre Fabre Dermatology, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive and Pierre Fabre Oral Care. In 2020, Pierre Fabre generated €2.3 billion in revenues, 65% of which came from international sales.

    Established in the South-West area of France since its creation, and manufacturing over 95% of its products in France, the Group employs some 10,000 people worldwide. Its products are distributed in about 130 countries. Pierre Fabre is 86%-owned by the Pierre Fabre Foundation, a government-recognized public-interest foundation, and secondarily by its own employees through an international employee stock ownership plan. In 2020, Ecocert Environment assessed the Group's corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard for the 2nd consecutive year and confirmed its "Excellence" level. For further information, please visit the Pierre Fabre website at www.pierre-fabre.com.

    About Atara Biotherapeutics, Inc.

    Atara Biotherapeutics, Inc. (@Atarabio) is 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 disease. With our lead program in Phase 3 clinical development, Atara is the most advanced allogeneic T-cell immunotherapy company and intends to rapidly deliver off-the-shelf treatments to patients with high unmet medical need. Our platform leverages the unique biology of EBV T cells and has the capability to treat a wide range of EBV-associated diseases, or other serious diseases through incorporation of engineered CARs (chimeric antigen receptors) or TCRs (T-cell receptors). Atara is applying this one platform to create a robust pipeline including: tab-cel® in Phase 3 development for Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD) and other EBV-driven diseases; ATA188, a T-cell immunotherapy targeting EBV antigens as a potential treatment for multiple sclerosis; and multiple next-generation chimeric antigen receptor T-cell (CAR-T) immunotherapies for both solid tumors and hematologic malignancies. Improving patients' lives is our mission and we will never stop working to bring transformative therapies to those in need. Atara is headquartered in South San Francisco and our leading-edge research, development and manufacturing facility is based in Thousand Oaks, California.

    For additional information about the company, please visit atarabio.com and follow us on Twitter and LinkedIn.

    Forward-Looking Statements

    This press release contains or may imply "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding tab-cel®: the timing of, and Atara's plans for, and potential decision by, the EMA regarding the MAA submission for EBV+ patients with PTLD, the development, timing and progress of tab-cel®, the potential characteristics and benefits of tab-cel®, and the progress and results of, and prospects for, any collaboration involving tab-cel®, the commercial prospects and business opportunity for tab-cel® in the territories licensed to Pierre Fabre, and the potential financial benefits to Atara as a result of the collaboration with Pierre Fabre. Because such statements deal with future events and are based on Atara's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; the COVID-19 pandemic, which may significantly impact (i) our business, research, clinical development plans and operations, including our operations in South San Francisco and Southern California and at our clinical trial sites, as well as the business or operations of our third-party manufacturer, contract research organizations or other third parties with whom we conduct business, (ii) our ability to access capital, and (iii) the value of our common stock; the sufficiency of Atara's cash resources and need for additional capital; and other risks and uncertainties affecting Atara's and its development programs, including those discussed in Atara's filings with the Securities and Exchange Commission (SEC), including in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings and in the documents incorporated by reference therein. Except as otherwise required by law, Atara disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.

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  3. New Magnetization Transfer Ratio (MTR) Imaging Biomarker Data and Two-Year Clinical Data from Open-Label Extension (OLE)

    Patients Achieving Sustained Expanded Disability Status Scale (EDSS) Improvement Show Increase in MTR at 12 Months Which May Suggest Remyelination

    Company to Host Live Conference Call and Webcast to Review Full Results on Wednesday, October 13, 2021, at 8:30 a.m. EDT

    Atara Biotherapeutics, Inc. (NASDAQ:ATRA), today announced the upcoming full release of new translational data and two-year open-label extension (OLE) clinical data from the study of ATA188 in progressive multiple sclerosis (MS). The findings will be presented as an ePoster at the 37th Congress of the European Committee for Treatment and Research in Multiple…

    New Magnetization Transfer Ratio (MTR) Imaging Biomarker Data and Two-Year Clinical Data from Open-Label Extension (OLE)

    Patients Achieving Sustained Expanded Disability Status Scale (EDSS) Improvement Show Increase in MTR at 12 Months Which May Suggest Remyelination

    Company to Host Live Conference Call and Webcast to Review Full Results on Wednesday, October 13, 2021, at 8:30 a.m. EDT

    Atara Biotherapeutics, Inc. (NASDAQ:ATRA), today announced the upcoming full release of new translational data and two-year open-label extension (OLE) clinical data from the study of ATA188 in progressive multiple sclerosis (MS). The findings will be presented as an ePoster at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) taking place virtually October 13-15, 2021.

    The presentation includes new imaging data on magnetization transfer ratio (MTR), a key biomarker of myelination status that may be tied to improvements in expanded disability status scale (EDSS) as seen with ATA188. Atara is 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, including MS.

    "ATA188 has a novel mechanism of action, and our clinical program is generating new insights into how the targeting of EBV-infected B cells and plasma cells can potentially benefit people living with progressive multiple sclerosis," said AJ Joshi, MD, Chief Medical Officer at Atara. "At ECTRIMS, we will be presenting new MTR imaging data suggestive of remyelination that provide a potential biologic basis for the clinical EDSS improvements observed with ATA188 treatment in the Phase 1 and OLE studies."

    As reported in the full abstract available today on the ECTRIMS website, the data demonstrate that ATA188 continues to be well-tolerated. Of 24 patients evaluated for efficacy in the initial 12-month period, 18 chose to participate in the OLE and as of April 2021, have been followed for up to 33 months. Nine patients met sustained disability improvement (SDI) criteria, a composite scale combining confirmed improvement in either the EDSS score or timed 25-foot walk test in the initial 12-month period (n=7) or in the OLE (n=2). Of these nine patients, seven achieved SDI via sustained EDSS improvement. Eight patients that achieved SDI at any point in the study participated in the OLE. A relationship between dose-escalation and increasing clinical response was observed, with a higher proportion of patients achieving SDI at higher doses. No grade >3 adverse events (AE), dose-limiting toxicities, cytokine release syndrome, graft versus host disease, or infusion-related reactions were observed.

    Changes in MTR, reflecting myelination status, may provide insights into the mechanism of EDSS improvement in our clinical assessment of ATA188 and was assessed in all patients. At 12 months, the seven patients achieving SDI by EDSS showed increases in MTR versus those that did not have EDSS improvement. The increase in MTR suggests increased myelin density in the central nervous system of patients receiving ATA188.

    Updated OLE data of up to 33 months follow-up continue to support the durability of disability improvement following ATA188 treatment. Of the eight patients who achieved SDI and entered the OLE, seven maintained SDI at all subsequent timepoints. One patient with secondary progressive multiple sclerosis (SPMS) achieved SDI at 15 months and experienced a non-treatment related relapse at 18 months, occurring approximately 6 months after the last ATA188 dose, and elected to discontinue the study.

    Further detail on the MTR data, as well as updated safety and efficacy data for up to 39 months follow-up in the OLE will be presented on October 13 in the ePoster presentation.

    In a separate ePoster, Atara will also present encore data profiling and evaluating the functionality and proliferation potential of ATA188 following antigen exposure. This comprehensive analysis of ATA188 lots produced from diverse human leukocyte antigen (HLA) donors demonstrates a robust manufacturing process showing consistent functional activation and productive effector responses.

    Poster Presentation Details:

    Title:
    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

    Presenting Author: Douglas L. Arnold, MD, Montreal Neurological Institute, McGill University and NeuroRx Research, Montreal, Canada

    Date & Time: Wednesday, October 13, 2021, at 16:45 CEST / 10:45 a.m. EDT / 7:45 a.m. PDT

    Poster Session & Number: eP31 - Immunomodulation/Immunosuppression, P638

    Title: Comprehensive profiling of ATA188, an off-the-shelf, allogeneic Epstein-Barr virus-specific T-cell immunotherapy for progressive multiple sclerosis

    Presenting Author: Monica Moreno, PhD, Atara Biotherapeutics, Thousand Oaks, United States

    Date & Time: Wednesday, October 13, 2021, at 16:45 CEST / 10:45 a.m. EDT / 7:45 a.m. PDT

    Poster Session & Number: eP31 - Immunomodulation/Immunosuppression, P644

    Atara Conference Call and Webcast Information

    Atara will hold a conference call on Wednesday, October 13 at 8:30 a.m. EDT / 5:30 a.m. PDT for analysts and investors to review the data that will be presented. The call will include:

    • Pascal Touchon, President and Chief Executive Officer, Atara Biotherapeutics
    • Jakob Dupont, MD, Executive Vice President, Global Head of Research and Development, Atara Biotherapeutics
    • AJ Joshi, MD, Senior Vice President and Chief Medical Officer, Atara Biotherapeutics
    • Douglas L. Arnold, MD, Montreal Neurological Institute, McGill University and NeuroRx Research, Montreal, Canada

    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 13722755. 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.

    About ATA188

    Epstein-Barr Virus (EBV) is associated with a wide range of hematologic malignancies and solid tumors, as well as certain autoimmune conditions, such as multiple sclerosis (MS). T cells are a critical component of the body's immune system which normally target EBV-infected B cells. ATA188, Atara's investigational off-the-shelf T-cell candidate, has the potential to target EBV-infected B cells and plasma cells in the central nervous system that may catalyze autoimmune responses and MS pathophysiology. Atara is currently enrolling EMBOLD, a Phase 2 clinical study of ATA188 in the treatment of patients with progressive forms of MS, across clinical sites in the U.S. and Australia.

    About Atara Biotherapeutics, Inc.

    Atara Biotherapeutics, Inc. (@Atarabio) is 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 disease. With our lead program in Phase 3 clinical development, Atara is the most advanced allogeneic T-cell immunotherapy company and intends to rapidly deliver off-the-shelf treatments to patients with high unmet medical need. Our platform leverages the unique biology of EBV T cells and has the capability to treat a wide range of EBV-associated diseases, or other serious diseases through incorporation of engineered CARs (chimeric antigen receptors) or TCRs (T-cell receptors). Atara is applying this one platform to create a robust pipeline including: tab-cel® in Phase 3 development for Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD) and other EBV-driven diseases; ATA188, a T-cell immunotherapy targeting EBV antigens as a potential treatment for multiple sclerosis; and multiple next-generation chimeric antigen receptor T-cell (CAR-T) immunotherapies for both solid tumors and hematologic malignancies. Improving patients' lives is our mission and we will never stop working to bring transformative therapies to those in need. Atara is headquartered in South San Francisco and our leading-edge research, development and manufacturing facility is based in Thousand Oaks, California. For additional information about the company, please visit atarabio.com and follow us on Twitter and LinkedIn.

    Forward-Looking Statements

    This press release contains or may imply "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding: the potential benefits; safety and efficacy of ATA188; translational and biomarker data for ATA188, including magnetization transfer ratio data; data from ATA188 OLE study; timing and progress of clinical trials of ATA188; and Atara's ability to successfully advance the development of ATA188. Because such statements deal with future events and are based on Atara Biotherapeutics' current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara Biotherapeutics could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; the ongoing COVID-19 pandemic, which may significantly impact (i) our business, research, clinical development plans and operations, including our operations in South San Francisco and Southern California and at our clinical trial sites, as well as the business or operations of our third-party manufacturer, contract research organizations or other third parties with whom we conduct business, (ii) our ability to access capital, and (iii) the value of our common stock; the sufficiency of Atara's cash resources and need for additional capital; and other risks and uncertainties affecting Atara's and its development programs, including those discussed in Atara Biotherapeutics' filings with the Securities and Exchange Commission (SEC), including in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings and in the documents incorporated by reference therein. Except as otherwise required by law, Atara Biotherapeutics disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.

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  4. Designation recognizes therapeutic innovation and potential to address significant unmet patient need

    Atara on track to submit MAA in November 2021

    Phase 3 ALLELE study analysis supporting tab-cel MAA to be presented in Q4 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 cancer and autoimmune diseases, today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated assessment to the Company's lead product candidate, tabelecleucel (tab-cel®), for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease…

    Designation recognizes therapeutic innovation and potential to address significant unmet patient need

    Atara on track to submit MAA in November 2021

    Phase 3 ALLELE study analysis supporting tab-cel MAA to be presented in Q4 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 cancer and autoimmune diseases, today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated assessment to the Company's lead product candidate, tabelecleucel (tab-cel®), for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).

    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 2-3 months after failure of initial therapy. There are currently no EMA- or FDA-approved treatments indicated for these patients.

    "We believe the granting of accelerated assessment by the EMA recognizes the potential of tab-cel as a first-in-kind new therapy addressing significant unmet need in EBV+ PTLD patients facing poor prognosis with no approved treatment options," said Jakob Dupont, MD, Executive Vice President and Global Head of Research and Development at Atara. "We look forward to working closely with the EMA to bring tab-cel, the first ever allogeneic, off-the-shelf T-cell therapy to be reviewed by a regulatory agency, to patients as quickly as possible."

    Accelerated assessment is granted by the CHMP when a medicinal product is expected to be of major public health interest and therapeutic innovation. The CHMP and Committee for Advanced Therapies (CAT) can reduce the time frame to review a marketing authorization application (MAA) to 150 days if the applicant provides sufficient justification for an accelerated assessment, although an application initially designated for accelerated assessment can revert to the standard procedure during the review for a variety of reasons. The decision to grant accelerated assessment has no impact on the eventual CHMP and CAT opinion on whether a marketing authorization should be granted.

    Tab-cel also has Orphan Drug status in Europe and was previously granted PRIME designation by the EMA. Following recent successful interactions with the EMA, Atara has completed the necessary regulatory and compliance steps needed to submit an MAA for tab-cel, which is on track for submission in November 2021. With the granting of accelerated assessment, Atara anticipates a decision regarding approval in the second half of 2022.

    The MAA submission will include data from the ongoing Phase 3 ALLELE study assessing the efficacy and safety of tab-cel in patients with EBV+ PTLD following solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT).

    Atara will present a new analysis from the ALLELE study at an appropriate congress in Q4 2021. Top-line data with additional patients confirm a strong objective response rate (ORR) in line with prior results while demonstrating durability. There were no new safety signals, consistent with previously published findings.

    About tabelecleucel

    Tabelecleucel (tab‐cel®) is an off-the-shelf, allogeneic T-cell immunotherapy in development for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). EBV+ PTLD is a type of lymphoma (cancer) that may occur after a solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT). There are currently no approved treatments indicated to treat PTLD and if left untreated, PTLD can have life-threatening consequences.

    Tab-cel is currently being investigated in the Phase 3 ALLELE study to assess efficacy and safety for the treatment of EBV+ PTLD in SOT and HCT after failure of standard of care.

    Tab-cel has been granted Breakthrough Therapy Designation for EBV+ PTLD following allogeneic HCT by the U.S. Food and Drug Administration (FDA) and PRIME designation by the EMA Priority Medicines for the same indication. Tab‐cel has Orphan drug designation in the U.S. and E.U.

    About Atara Biotherapeutics, Inc.

    Atara Biotherapeutics, Inc. (@Atarabio) is 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 disease. With our lead program in Phase 3 clinical development, Atara is the most advanced allogeneic T-cell immunotherapy company and intends to rapidly deliver off-the-shelf treatments to patients with high unmet medical need. Our platform leverages the unique biology of EBV T cells and has the capability to treat a wide range of EBV-associated diseases, or other serious diseases through incorporation of engineered CARs (chimeric antigen receptors) or TCRs (T-cell receptors). Atara is applying this one platform to create a robust pipeline including: tab-cel® in Phase 3 development for Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD) and other EBV-driven diseases; ATA188, a T-cell immunotherapy targeting EBV antigens as a potential treatment for multiple sclerosis; and multiple next-generation chimeric antigen receptor T-cell (CAR T) immunotherapies for both solid tumors and hematologic malignancies. Improving patients' lives is our mission and we will never stop working to bring transformative therapies to those in need. Atara is headquartered in South San Francisco and our leading-edge research, development and manufacturing facility is based in Thousand Oaks, California. For additional information about the company, please visit atarabio.com and follow us on Twitter and LinkedIn.

    Forward-Looking Statements

    This press release contains or may imply "forward-looking statements"' within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding: the potential benefits, safety and efficacy of tab-cel; the timing and progress of tab-cel, the timing of the submission of the MAA for tab-cel, the timing of a decision regarding approval of tab-cel in the EU; and Atara's ability to successfully advance the development of tab-cel in the EU. Because such statements deal with future events and are based on Atara Biotherapeutics' current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara Biotherapeutics could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; the ongoing COVID-19 pandemic, which may significantly impact (i) our business, research, clinical development plans and operations, including our operations in South San Francisco and Southern California and at our clinical trial sites, as well as the business or operations of our third-party manufacturer, contract research organizations or other third parties with whom we conduct business, (ii) our ability to access capital, and (iii) the value of our common stock; the sufficiency of Atara's cash resources and need for additional capital; and other risks and uncertainties affecting Atara's and its development programs, including those discussed in Atara Biotherapeutics' filings with the Securities and Exchange Commission (SEC), including in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings and in the documents incorporated by reference therein. Except as otherwise required by law, Atara Biotherapeutics disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.

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  5. 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 cancer and autoimmune diseases, today announced that Pascal Touchon, President and Chief Executive Officer, will participate in a panel discussion titled, "Autologous, Allogeneic CAR-T, CAR-NK & More - Exploring the State of Play in Cell Therapy," at the Citi 16th Annual BioPharma Virtual Conference on Thursday, September 9, 2021 at 7:40 a.m. PDT/10:40 a.m. EDT.

    A live webcast of the panel will be available by visiting the Investor Events and Presentations section of atarabio.com. An archived replay of the webcast will be available on the Company's website for…

    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 cancer and autoimmune diseases, today announced that Pascal Touchon, President and Chief Executive Officer, will participate in a panel discussion titled, "Autologous, Allogeneic CAR-T, CAR-NK & More - Exploring the State of Play in Cell Therapy," at the Citi 16th Annual BioPharma Virtual Conference on Thursday, September 9, 2021 at 7:40 a.m. PDT/10:40 a.m. EDT.

    A live webcast of the panel will be available by visiting the Investor Events and Presentations section of atarabio.com. An archived replay of the webcast will be available on the Company's website for 30 days following the live presentation.

    About Atara Biotherapeutics, Inc.

    Atara Biotherapeutics, Inc. (@Atarabio) is 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 disease. With our lead program in Phase 3 clinical development, Atara is the most advanced allogeneic T-cell immunotherapy company and intends to rapidly deliver off-the-shelf treatments to patients with high unmet medical need. Our platform leverages the unique biology of EBV T cells and has the capability to treat a wide range of EBV-associated diseases, or other serious diseases through incorporation of engineered CARs (chimeric antigen receptors) or TCRs (T-cell receptors). Atara is applying this one platform to create a robust pipeline including: tab-cel® in Phase 3 development for Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD) and other EBV-driven diseases; ATA188, a T-cell immunotherapy targeting EBV antigens as a potential treatment for multiple sclerosis; and multiple next-generation chimeric antigen receptor T-cell (CAR T) immunotherapies for both solid tumors and hematologic malignancies. Improving patients' lives is our mission and we will never stop working to bring transformative therapies to those in need. Atara is headquartered in South San Francisco and our leading-edge research, development and manufacturing facility is based in Thousand Oaks, California. For additional information about the company, please visit atarabio.com and follow us on Twitter and LinkedIn.

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