ATRA Atara Biotherapeutics Inc.

15.25
+0.15  (+1%)
Previous Close 15.1
Open 15.46
52 Week Low 11.81
52 Week High 21.85
Market Cap $1,371,240,594
Shares 89,917,416
Float 78,615,906
Enterprise Value $985,518,318
Volume 938,092
Av. Daily Volume 875,057
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Upcoming Catalysts

Drug Stage Catalyst Date
ATA188 - (EMBOLD)
Multiple sclerosis
Phase 1/2
Phase 1/2
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Tabelecleucel (ATA 129)
Epstein-Barr virus (EBV-PTLD) after solid organ transplant (SOT)
BLA Filing
BLA Filing
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Tabelecleucel (tab-cel)
EBV+ immunodeficiency-associated lymphoproliferative diseases (IA-LPDs)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
ATA3219
B-cell Malignancies
Phase 1
Phase 1
IND planned for 4Q 2022.
ATA3271
Solid Tumors
Phase 1
Phase 1
IND submission planned for 4Q 2022.
ATA2271
Mesothelioma
Phase 1
Phase 1
Phase 1 preliminary results showed that intrapleural administration was found to be well-tolerated at lowest dose levels with no CAR T-cell related adverse events (AEs) of Grade >2 observed and no AEs of Grade >3 to date in the study. All four patients had received at least four prior lines of therapy, noted December 9, 2021.

Latest News

  1. TOKYO, Jan. 26, 2022 (GLOBE NEWSWIRE) -- FUJIFILM Corporation (President and CEO, Representative Director: Teiichi Goto) today announced that it has entered into an agreement to acquire a cell therapy manufacturing facility from Atara Biotherapeutics, Inc. (NASDAQ:ATRA) for USD 100 million. Located in Thousand Oaks, California, the facility is readily expandable with the flexibility to produce both clinical and commercial cell therapies including allogeneic T-cell and CAR T immunotherapies.

    FUJIFILM Diosynth Biotechnologies, a subsidiary of FUJIFILM Corporation, and a world-leading contract development and manufacturing organization (CDMO) with experience in the development and manufacture of biologics, vaccines and advanced therapies, will…

    TOKYO, Jan. 26, 2022 (GLOBE NEWSWIRE) -- FUJIFILM Corporation (President and CEO, Representative Director: Teiichi Goto) today announced that it has entered into an agreement to acquire a cell therapy manufacturing facility from Atara Biotherapeutics, Inc. (NASDAQ:ATRA) for USD 100 million. Located in Thousand Oaks, California, the facility is readily expandable with the flexibility to produce both clinical and commercial cell therapies including allogeneic T-cell and CAR T immunotherapies.

    FUJIFILM Diosynth Biotechnologies, a subsidiary of FUJIFILM Corporation, and a world-leading contract development and manufacturing organization (CDMO) with experience in the development and manufacture of biologics, vaccines and advanced therapies, will operate the new site.

    Through this acquisition by FUJIFILM Corporation, FUJIFILM Diosynth Biotechnologies will solidify its leadership position as a complete solutions-manufacturing provider for advanced therapies. The 90,000 sq. ft. manufacturing facility is currently named "Atara T-cell Operations and Manufacturing (ATOM)" and is readily expandable to support cell therapy manufacturing processes, including allogeneic T-cell and CAR T immunotherapies. At closing, Fujifilm plans to offer positions to approximately 140 current highly-skilled manufacturing and quality staff at the site.

    As part of the agreement, FUJIFILM Diosynth Biotechnologies and Atara will enter into a long-term manufacturing and services agreement, which could extend to ten years to support the production of Atara's clinical pipeline, which includes tabelecleucel (tab-cel®) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+PTLD).

    The cell therapy manufacturing facility will advance FUJIFILM Diosynth Biotechnologies' global CDMO manufacturing footprint to the West Coast of the United States and complements its existing locations supporting the advanced therapy market in College Station, Texas, U.S.A., Watertown, Massachusetts, U.S.A., and its recently announced BioCampus in the United Kingdom.

    "Fujifilm is currently accelerating business growth of Life Sciences field and continues to aggressively invest in both capital and technology in its bio CDMO business," said Teiichi Goto, president and chief executive officer, representative director, FUJIFILM Corporation. "Through this acquisition Fujifilm can extend its CDMO offering to advanced cell therapies. Going forward, Fujifilm will, by providing a stable supply of high quality biopharmaceuticals, further advance establishing tomorrow's medicines that fulfill unmet medical needs."

    "We are thrilled that through this acquisition we will add approximately 140 talented staff from Atara's cell therapy manufacturing facility to the FUJIFILM Diosynth Biotechnologies family. The collective expertise of the team will further support our efforts as a world-class CDMO," added Martin Meeson, chief executive officer, FUJIFILM Diosynth Biotechnologies. "We also look forward to adding the facility to FUJIFILM Diosynth Biotechnologies' existing global footprint and to bolster the expansion of our advanced therapies CDMO business."

    "FUJIFILM Diosynth Biotechnologies is a highly respected industry-leading manufacturing and development organization that shares our pioneering culture and belief that allogeneic cell therapies will transform the future of medicine," said Pascal Touchon, president and chief executive officer, Atara. "We are incredibly proud of our world-class ATOM staff and the facility and believe that this strategic partnership will meet our long-term manufacturing needs. Our team has developed processes for our products, scaled them up, and built inventory for clinical trials and the commercial launch of tab-cel. We believe that now is the right time for a strategic relationship with FUJIFILM Diosynth Biotechnologies to give us access to the expert manufacturing capability Atara will require, when needed. We will now confidently further focus our capital resources on development and commercialization of our pipeline of first-in-kind therapeutics for severe diseases."  

    FUJIFILM Corporation will continue to expand its bio CDMO business by leveraging its strength of being able to handle a wide variety of biopharmaceutical process development and manufacturing from clinical to commercial scale for drug products, fill & finish, and packaging. Furthermore, in order to expand the business in the most advanced biopharmaceutical fields, FUJIFILM Diosynth Biotechnologies joined Landmark Bio, the industry-academia research and development consortium, to explore the application of genetically modified cell therapies.

    In its pursuit to establish itself as a comprehensive healthcare company covering prevention, treatment and diagnosis, FUJIFILM Corporation has made multiple strategic acquisitions over recent years to expand and diversify its healthcare portfolio. The ability to identify and leverage synergies between its businesses is a key strength of Fujifilm and fundamental to its growth strategy.

    This acquisition is expected to be completed in April 2022, subject to expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.

     

    About FUJIFILM Diosynth Biotechnologies

    FUJIFILM Diosynth Biotechnologies, a subsidiary of FUJIFILM Corporation, is a world-leading contract development and manufacturing organization (CDMO) with experience in the development and manufacture of biologics, vaccines and advanced therapies. FUJIFILM Diosynth Biotechnologies has existing locations in Teesside, UK, Research Triangle Park, North Carolina, USA, College Station, Texas, USA and Hillerød, Denmark, the company is currently building new facilities in Watertown, Massachusetts, USA, and Holly Springs, North Carolina, USA. FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™X cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. Mitsubishi Corporation is a 20% shareholder of FUJIFILM Diosynth Biotechnologies' UK, Research Triangle Park, North Carolina, Watertown, Massachusetts and College Station, Texas sites.  For more information, go to: www.fujifilmdiosynth.com.

    About FUJIFILM Corporation

    FUJIFILM Corporation is an operating company of FUJIFILM Holdings Corporation. FUJIFILM Holdings Corporation, Tokyo, Japan, brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, highly functional materials, document solutions and imaging products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2021, the company had global revenues of $21 billion, at an exchange rate of 106 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information, please visit: https://www.fujifilmholdings.com.



    Christine Jackman
    FUJIFILM Holdings America Corporation
    9142614959
    
    
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  2. Fujifilm to Acquire Atara's Cell Therapy Manufacturing Facility for Total Upfront Financial Consideration of USD 100 Million

    Parties to Enter Long-Term Supply Agreement for Clinical and Commercial Product Manufacturing

    Transaction Expected to Result in Reduced Operating Expenses for Atara

    Upon Closing, Atara's Cash Expected to Fund Planned Operations into Q4 2023

    Company to Host Live Conference Call and Webcast Today at 4pm PST / 7pm EST

    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, today announced that it has entered into a long term strategic agreement with FUJIFILM Diosynth…

    Fujifilm to Acquire Atara's Cell Therapy Manufacturing Facility for Total Upfront Financial Consideration of USD 100 Million

    Parties to Enter Long-Term Supply Agreement for Clinical and Commercial Product Manufacturing

    Transaction Expected to Result in Reduced Operating Expenses for Atara

    Upon Closing, Atara's Cash Expected to Fund Planned Operations into Q4 2023

    Company to Host Live Conference Call and Webcast Today at 4pm PST / 7pm EST

    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, today announced that it has entered into a long term strategic agreement with FUJIFILM Diosynth Biotechnologies (FDB), a subsidiary of FUJIFILM Corporation (Fujifilm) under which Fujifilm will acquire Atara's T-Cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California for USD 100 million upfront, retaining current manufacturing and quality staff at the site.

    The parties will also enter a long-term supply agreement, which could extend to ten years. Following completion of the transaction, FDB, a leading contract development and manufacturing organization (CDMO) in advanced therapies, will provide Atara with access to the flexible capacity and specific capability needed to manufacture clinical and commercial-stage allogeneic cell therapies for its maturing and promising pipeline, including tabelecleucel (tab-cel®), under regulatory review in Europe for EBV+ PTLD, ATA188 for multiple sclerosis, and allogeneic CAR T therapies, ATA3271 and ATA3219. FDB will also expand use of the Thousand Oaks site and leverage its talented staff to manufacture a broader portfolio of cell therapies. Atara will retain its expertise, staff, and capabilities in manufacturing process science to continue to innovate in initial manufacturing and scale up for allogeneic cell therapies.

    "FUJIFILM Diosynth Biotechnologies is a highly respected, quality-focused, industry-leading manufacturing and development organization that shares our pioneering culture and belief that allogeneic cell therapies will transform the future of medicine," said Pascal Touchon, President and CEO of Atara. "We are incredibly proud of our world-class ATOM staff and facility and believe that this strategic partnership will meet our long-term manufacturing needs. Our team has developed processes for our products, scaled them up, and built inventory for clinical trials and the potential commercial launch of tab-cel. We believe that now is the right time for a strategic relationship with FDB to provide us with expert manufacturing capabilities, as needed. Accordingly, we will further focus capital resources on the development and commercialization of our pipeline of potentially transformative therapeutics for serious diseases."

    Atara expects to report cash, cash equivalents and short-term investments of $371.1 million as of December 31, 2021. This information is preliminary, has not been audited, and is subject to change upon the audit of the company's financial statements for the year ended December 31, 2021.

    Under the terms of the deal, Atara will receive USD 100 million at closing and Fujifilm plans to offer positions to approximately 140 current highly skilled manufacturing and quality staff at the site. The agreement is expected to reduce Atara's planned operating expenses over the multiyear period. Upon closing, the upfront consideration, along with the reduction in operating expenses, in addition to Atara's existing cash, cash equivalents and short-term investments is expected to fund Atara's planned operations into Q4 2023, beyond the anticipated completion of the randomized, placebo-controlled Phase 2 study of ATA188, the Company's investigational off-the-shelf T-cell candidate that has the potential to reverse disability in progressive multiple sclerosis.

    Atara retains the recently established Thousand Oaks-based Atara Research Center (ARC), which is fully operational and will house Atara's Pre-Clinical, Translational Sciences, Manufacturing Process Sciences, and Analytical Development teams to further drive innovation by leveraging the Company's unique and differentiated allogeneic cell therapy platform. Atara will also retain a talented technical operations team to manage external manufacturing, quality, logistics and supply.

    "We are thrilled that through this acquisition we will add approximately 140 talented staff from Atara's cell therapy manufacturing facility to the FUJIFILM Diosynth Biotechnologies family. The collective expertise of the team will further support our efforts as a world-class CDMO," added Martin Meeson, chief executive officer, FUJIFILM Diosynth Biotechnologies. "We also look forward to adding the facility to FUJIFILM Diosynth Biotechnologies' existing global footprint and to bolster the expansion of our advanced therapies CDMO business."

    ATOM is a 90,000 ft cutting edge T-cell therapy manufacturing facility fully qualified to support clinical and commercial production and designed with the flexibility to expand to support various production requirements and capacities. The closing of the transaction, subject to expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions, is expected to occur in April 2022.

    Evercore Group LLC is acting as strategic advisor to Atara and Gibson Dunn & Crutcher LLP is acting as its legal counsel.

    Atara Conference Call

    In connection with this announcement, Atara will host a webcast and conference call today at 4pm PST / 7pm EST. 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: 13726583. 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 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 and currently under review to support registration in Europe, 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, which does not require TCR or HLA gene editing, 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 development, timing, progress and prospects of Atara's product candidates and regulatory filings, Atara's proposed sale of its ATOM manufacturing facility to FUJIFILM Diosynth Biotechnologies (FDB), the parties ability to consummate such transaction, including the timing thereof, the potential benefits of such transaction to Atara, including the potential financial benefits to Atara, the proposed supply agreement between the parties and the duration and benefits thereof, FDB's ability to perform under the proposed supply agreement and meet Atara's requirements, FDB's potential plans for ATOM, including the expansion thereof, Atara's ability to drive innovation, Atara's ability to retain its staff and capabilities, and the sufficiency of Atara's cash, cash equivalents, short-term investments to fund its planned operations. 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.   Aberrant Immune Response to EBV Protein Triggers the Immune System to Attack and Destroy Myelin, Leading to Onset and Progression of Multiple Sclerosis (MS)

    Findings Reinforce Potential for ATA188 to Treat the Cause of MS by Specifically Targeting EBV-Infected B cells and Plasma Cells  

    Reinforces Recent Epidemiological Analysis in Science of >10 Million Individuals Over Two Decades Providing Compelling Evidence of Causality of EBV Infection and MS

    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 lauded the second high impact study this month solidifying…

      Aberrant Immune Response to EBV Protein Triggers the Immune System to Attack and Destroy Myelin, Leading to Onset and Progression of Multiple Sclerosis (MS)

    Findings Reinforce Potential for ATA188 to Treat the Cause of MS by Specifically Targeting EBV-Infected B cells and Plasma Cells  

    Reinforces Recent Epidemiological Analysis in Science of >10 Million Individuals Over Two Decades Providing Compelling Evidence of Causality of EBV Infection and MS

    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 lauded the second high impact study this month solidifying EBV as the primary driver of the development of MS. The paper, titled, "Clonally Expanded B Cells in Multiple Sclerosis Bind EBV EBNA1 and GlialCAM," was published today in the journal Nature.

    MS is a chronic neurological illness affecting an estimated 2.8 million people worldwide, including approximately 900,000 in the U.S. MS is driven by abnormally activated immune cells and subsequent inflammation which damages and ultimately destroys the protective myelin sheath surrounding nerve fibers in the central nervous system (CNS). While genetics and environmental factors play a role, it has long been postulated that EBV triggers the patient's immune cells to erroneously attack myelin.

    The Nature study adds to the known EBV-MS epidemiological connection by providing a mechanistic basis for how EBV infection can trigger the patient's immune cells to attack self-tissue in the CNS. These findings validate molecular mimicry as one of the leading mechanisms of EBV-mediated MS, which occurs when fragments of the virus share sequence or structural similarities with certain brain proteins. The immune system may mistake these "self-proteins" for EBV. These new data reveal how EBV infection can drive the development of antibodies that target both EBV and CNS proteins, potentially leading to MS.

    The researchers identified a type of antibody isolated from MS patients' cerebrospinal fluid (CSF), which strongly binds an EBV protein, EBNA1, and cross-reacts with the central nervous system protein GlialCAM. GlialCAM is a cell adhesion molecule expressed in a variety of brain cells, including oligodendrocytes that are responsible for producing myelin, as well as on the outside of myelin sheaths. This antibody cross-reactivity between EBV and self-proteins was found to result from molecular mimicry due to key similarities between GlialCAM and EBNA1. The group also demonstrated that immunization with EBNA1 in a mouse model of MS exacerbated the disease and generated a strong antibody response against GlialCAM and EBNA1, enhancing immune cell infiltration and demyelination that are two hallmark features of human MS pathology.

    "EBV may be the only risk factor required to develop MS, given essentially 100 percent of people living with MS have been infected with EBV. Until now, we didn't have a step-by-step account of how this drives the immune system to attack a person's own myelin sheath," said Lawrence Steinman, MD, Professor of Neurology and Neurological Sciences, Pediatrics and Genetics, Stanford University, and author of the study. "This new research fills in those gaps and provides clarity into how EBV infection can cause MS. New therapies that specifically target this link are already in development, including Atara's ATA188 T-cell immunotherapy, which is actively enrolling a Phase 2 clinical study."

    The Nature paper complements findings from a second publication, "Longitudinal analysis reveals high prevalence of Epstein-Barr virus associated with multiple sclerosis," recently published in the journal Science, and collectively provide new epidemiological and molecular data confirming the role of EBV in triggering and driving the pathophysiology of MS. The cohort-based study provided compelling epidemiological evidence that EBV infection precedes the onset of MS. The study analyzed 62 million serum samples and followed >10 million individuals in the U.S. military over a 20-year period (1993-2013), showing a 32-fold increase in the risk of MS after EBV infection. Out of the 801 MS cases identified, 35 were EBV negative at baseline with all but one becoming EBV positive before the onset of their MS, yielding a 97 percent seroconversion rate versus 57 percent among individuals who did not develop MS. Serum concentrations of neurofilament light chain (sNfL), a sensitive biomarker for nerve fiber damage, only increased after EBV infection, indicating that EBV infection preceded not only symptom onset but also the time of the first detectable pathological mechanisms underlying MS. Other viral infections, like CMV, were not found to increase the risk of MS and were ruled out as a contributing factor in MS development.

    "These studies identify EBV as the leading cause of MS and provide a direct mechanistic link between the activation of the immune system caused by EBV, and the autoimmune myelin pathology observed in MS," said AJ Joshi, MD, Chief Medical Officer at Atara. "Specifically, these new data further link MS to EBV-infected B cells and plasma cells, highlighting the role of EBV antigens, including EBNA1 protein, in the development of the disease. Importantly ATA188, Atara's investigational MS therapy, targets key epitopes of these antigens, including EBNA1, with the hope of ultimately delivering a new treatment option for the millions of people currently living with MS. The actively enrolling Phase 2 EMBOLD study, with a formal interim analysis planned for Q2 this year, will be a major step toward that direction."

    The complete articles are available in digital format and can be viewed via the following links:

    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 2.8 million people living with MS worldwide, with up to ~1.2 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 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 and currently under review to support registration in Europe, 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, which does not require TCR or HLA gene editing, 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 development, timing, progress and prospects of ATA188 and clinical trials relating to ATA188, the potential benefits of ATA188, the safety profile of ATA188, the potential for ATA188 to treat multiple sclerosis, the potential market for ATA188, the mechanistic link between EBV and multiple sclerosis and the ability of ATA188 to specifically target such link. 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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  4. Significant Progress Achieved Against Strategic Priorities for ATA188, Tab-cel® and CAR T Programs in 2021

    ATA188 Granted FDA Fast Track Designation for Both Non-Active PPMS and Non-Active SPMS in Recognition of Potential to Address Significant Unmet Medical Need

    Tab-cel® on Track to be First Ever Allogeneic Off-The-Shelf T-cell Immunotherapy Approved in EU in 2022

    Presentation on Wednesday, January 12 at 5:15 p.m. EST / 2:15 p.m. PST

    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 Pascal Touchon, President and Chief Executive Officer of…

    Significant Progress Achieved Against Strategic Priorities for ATA188, Tab-cel® and CAR T Programs in 2021

    ATA188 Granted FDA Fast Track Designation for Both Non-Active PPMS and Non-Active SPMS in Recognition of Potential to Address Significant Unmet Medical Need

    Tab-cel® on Track to be First Ever Allogeneic Off-The-Shelf T-cell Immunotherapy Approved in EU in 2022

    Presentation on Wednesday, January 12 at 5:15 p.m. EST / 2:15 p.m. PST

    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 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.

    "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) 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, 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-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.

    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 and currently under review to support registration in Europe, 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, which does not require TCR or HLA gene editing, 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: (1) the potential benefits, safety and efficacy of tab-cel®; the timing and progress of tab-cel®, including (i) data and analyses from the ALLELE study, (ii) tab-cel® clinical trials, and the timing and outcome of Atara's discussions with the FDA regarding a BLA submission for tab-cel®, (iii) the timing and decision of the EMA regarding the MAA for tab-cel®, (iv) the timing of the initiation or submission of the BLA, (v) Atara's ability to successfully advance the development of tab-cel®, including for potential additional indications, (vi) Atara's activities in anticipation of potential tab-cel® approval and commercial launch in the U.S., including the timing thereof, (vii) Atara's collaboration with Pierre Fabre for commercializing tab-cel® in Europe, Middle East, Africa and other emerging markets, including the timing thereof, and (viii) the potential competition for tab-cel®; (2) the potential benefits, safety and efficacy of ATA188; the timing and progress of ATA188, including (i) data and analyses from the ATA188 OLE study, (ii) data and analyses from the EMBOLD study, including from the planned interim analysis, including the timing thereof, (iii) the timing, design and outcome of potential additional ATA188 clinical trials, (iv) Atara's ability to successfully advance the development of ATA188; and (v) partnering options for ATA188; (3) the timing and progress of its CAR T programs, including (i) ATA2271 clinical trial; (ii) ATA3271 and ATA3219 preclinical development, including the timing of regulatory submissions for such product candidates, (iii) progress of the strategic collaboration with Bayer for ATA2271 and ATA3271, and (iv) Atara's ability to successfully advance the development of its CAR T programs; and (4) Atara's research and development activities and manufacturing activities, including the development and progress thereof; (5) Atara's ability to advance development of its programs. 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 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'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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  5. Relationship Will Leverage Be The Match BioTherapies' Expertise and Expansive Donor Registry to Provide Healthy Donor Cells in Support of Atara's Allogeneic T-cell Platform

    Be The Match BioTherapies and Atara Biotherapeutics, Inc. (NASDAQ:ATRA), today announced an extension of their collaboration to provide high-quality healthy donor cells for Atara's off-the-shelf T-cell immunotherapy platform for patients with cancer and autoimmune diseases.

    This multi-year partnership leverages the capabilities of Be The Match BioTherapies to source healthy donor cells from the Be The Match Registry® with over 22 million genetically diverse human leukocyte antigen (HLA) immune profiles.

    "Atara and Be The Match BioTherapies share an aspiration to serve…

    Relationship Will Leverage Be The Match BioTherapies' Expertise and Expansive Donor Registry to Provide Healthy Donor Cells in Support of Atara's Allogeneic T-cell Platform

    Be The Match BioTherapies and Atara Biotherapeutics, Inc. (NASDAQ:ATRA), today announced an extension of their collaboration to provide high-quality healthy donor cells for Atara's off-the-shelf T-cell immunotherapy platform for patients with cancer and autoimmune diseases.

    This multi-year partnership leverages the capabilities of Be The Match BioTherapies to source healthy donor cells from the Be The Match Registry® with over 22 million genetically diverse human leukocyte antigen (HLA) immune profiles.

    "Atara and Be The Match BioTherapies share an aspiration to serve every patient, and this partnership will allow us to deliver treatments to the patient populations that our organization was founded to help," said Chris McClain, Senior Vice President, Sales and Business Development at Be The Match BioTherapies. "We are proud to provide a consistent supply of high-quality, compliant, and consented HLA-specific starting material to support Atara's tabelecleucel (tab-cel®) program, including the ongoing Phase 3 ALLELE study, and its other pipeline candidates."

    Since 2016, Be The Match BioTherapies has been a strategic supplier to Atara by providing the cellular starting material, peripheral blood mononuclear cells, from healthy donors with targeted HLA haplotypes for further manufacture and cryopreservation as inventory ready to be delivered to patients in need in just a few days. Cutting-edge bioinformatic insights into HLA genetics have supported Atara's clinical programs by ensuring that for each product, an inventory of different manufactured lots is available for partial matching to patient HLA profiles to support efficacy and safety. Be The Match BioTherapies' regulatory expertise ensures the collection of donor cells that meet FDA and varying international regulations, broadening the potential use of the therapies.

    "With our recent EU regulatory marketing authorization application submission for tabelecleucel, the first-ever off-the-shelf allogeneic T-cell therapy to be reviewed by any regulatory agency in the world, we are one step closer to bringing this potentially transformative treatment to patients," said Matt Yedwabnick, Vice President, Global Supply Chain at Atara. "Our ability to deliver investigational medicines, including tab-cel, is reliant on sourcing high-quality healthy donor cells. Be The Match BioTherapies' capabilities have been instrumental in identifying and supplying the starting materials to produce our multiple allogeneic T-cell and CAR-T immunotherapies in development."

    About Be The Match BioTherapies

    Be The Match BioTherapies is the only cell and gene therapy solutions provider with customizable services to support the end-to-end cell therapy supply chain. Backed by the industry-leading experience of the National Marrow Donor Program®/Be The Match®, and a research partnership with the CIBMTR® (Center for International Blood and Marrow Transplant Research®), the organization designs solutions that advance the development of cell and gene therapies across the globe.

    Be The Match BioTherapies is dedicated to accelerating patient access to life-saving cell and gene therapies by providing high-quality cellular source material from the Be The Match Registry®, the world's most diverse registry of more than 22 million potential blood stem cell donors. Through established relationships with apheresis, marrow collection, and transplant centers worldwide, the organization develops, onboards, trains, and manages expansive collection networks to advance cell therapies. Be The Match BioTherapies uses a proven infrastructure consisting of regulatory compliance and managed logistics experts and cell therapy supply chain case managers to transport and deliver regulatory-compliant life-saving therapies across the globe successfully. Through the CIBMTR, Be The Match BioTherapies extends services beyond the cell therapy supply chain to include long-term follow-up tracking for the first two FDA-approved CAR-T therapies.

    For more information, visit www.BeTheMatchBioTherapies.com or follow Be The Match BioTherapies on LinkedIn or Twitter.

    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, which does not require TCR or HLA gene editing, 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.

    Atara 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, Atara's ability to successfully advance the development of its programs, the potential benefits to Atara as a result of the collaboration with Be The Match BioTherapies, and Be the Match BioTherapies' ability to supply donor cells to Atara, including the characteristics thereof. 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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