Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, today provided an update in context of the COVID-19 (coronavirus) pandemic.
"While this is an unprecedented time in history, Atara is working hard to ensure operational continuity to serve patients whose lives are affected by severe diseases," said Pascal Touchon, President and Chief Executive Officer of Atara Biotherapeutics. "The COVID-19 pandemic is evolving rapidly, and we are closely monitoring it to both ensure the safety and well-being of our employees, patients and communities as well as assess the potential impacts to our business so we can continue delivering transformative medicines to patients in critical need."
Atara believes that it remains on track to initiate a tab-cel® biologics license application (BLA) submission for patients with EBV+ PTLD in the second half of 2020. While clinical study operations and the opening of additional Phase 3 study sites in U.S., Canada and Europe have been impacted by the spread of COVID-19, at this time most sites remain open to enrollment for patients with this life-threatening condition who have no other approved therapeutic options.
ATA188 for Multiple Sclerosis (MS):
We continue to monitor patients in our Phase 1a clinical study of off-the-shelf, allogeneic ATA188 in patients with progressive MS across clinical sites in the U.S. and Australia. Atara expects to present in an appropriate forum the ATA188 Phase 1a six-month clinical results for cohorts 1-4 and 12-month results for cohorts 1-3 in Q2 2020. We are also allowing for re-treatment in the open-label extension (OLE) of the Phase 1a in an appropriate setting and as determined by the treating physician and patient. We have decided to temporarily pause the screening and enrollment of patients in our Phase 1b randomized controlled study to ensure sites can focus on meeting the needs of patients with COVID-19 and to protect the safety of study participants, investigators, and staff. This will also help preserve the study and data integrity as there are numerous assessments that require a specific clinical setting.
Atara continues to deliver product to patients from our inventory of off-the-shelf, allogeneic EBV T cells.
Prior to the COVID-19 outbreak, as part of our routine supply planning and operational risk management strategies, the Company had already manufactured significant inventories of tab-cel® and process intermediates and procured the required starting materials needed to maintain long-term product supply across tab-cel®, ATA188 and other programs.
Operationally, in response to the spread of COVID-19, we have taken steps designed to protect our employees and comply with guidance from federal, state and local authorities including limiting travel and implementing work-from-home policies for non-essential staff and adhering to social distancing and enhanced cleaning procedures in our manufacturing and lab sites. Management continues to monitor the situation and will resume normal operations once it is prudent to do so. In the meantime, Atara has adopted remote working tools and various staff support programs to ensure minimal disruption and enable achievement of existing goals and objectives.
We are monitoring the COVID-19 pandemic as it continues to rapidly evolve and continue to assess the impact and timing of potential changes to our business, operations and other clinical and preclinical studies.
About Atara Biotherapeutics
Atara Biotherapeutics, Inc. (@Atarabio) is a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases. Atara’s technology platform leverages research collaborations with leading academic institutions with the Company’s scientific, clinical, regulatory and manufacturing expertise. Atara’s pipeline includes tab-cel® (tabelecleucel), which is in Phase 3 development for patients with Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) as well as in earlier stage development for other EBV-associated hematologic malignancies and solid tumors, including nasopharyngeal carcinoma (NPC); T-cell immunotherapies targeting EBV antigens believed to be important for the potential treatment of multiple sclerosis; and next-generation chimeric antigen receptor T-cell (CAR T) immunotherapies. The Company was founded in 2012 and is co-located in South San Francisco and Southern California. Our Southern California hub is anchored by our state-of-the-art manufacturing facility in Thousand Oaks, California. For additional information about the company, please visit atarabio.com.
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 anticipated impact and timing of the COVID-19 pandemic on our business, research and clinical development plans and timelines; Atara’s ability to deliver on key milestones, including the timing of BLA submissions for tab-cel® for patients with EBV+ PTLD; the potential benefits and efficacy of Atara’s drug candidates; and the timing, enrollment and results of additional data from Atara’s clinical trials. 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 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 the sections titled "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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200402005242/en/
INVESTOR & MEDIA:
Kerry Beth Daly
Head, Corporate Communications
John Craighead, Ph.D.
Vice President, Investor Relations & Corporate Communications