UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| ITEM 8.01 | Other Events. |
On February 18, 2022, Atara Biotherapeutics, Inc., a Delaware corporation (the “Company”), announced that it had been informed by its collaborator Memorial Sloan Kettering Cancer Center (“MSK”), the holder of the investigational new drug application for ATA2271, a next-generation, autologous chimeric antigen receptor T-cell therapy program targeting mesothelin, that (i) on February 15, 2022, MSK notified the U.S. Food and Drug Administration (the “FDA”) of the occurrence of a fatal serious adverse event (SAE) associated with a patient treated in MSK’s ongoing Phase 1, open label, single-arm, dose-escalation study (NCT04577326) for patients with malignant pleural mesothelioma (the “Study”) and (ii) MSK voluntarily paused enrollment of new patients in the Study pending further investigation and review of the event by MSK and MSK’s Institutional Review Board. The FDA has notified MSK of its agreement with MSK’s decision to voluntarily pause enrollment of new patients in the Study and requested additional information regarding the event. MSK and the investigator are in the process of further evaluating the occurrence, including the extent of the relationship of such event to ATA2271 and any potential changes to the patient informed consent form and/or clinical trial protocol.
Forward-looking Statements
This Current Report contains forward-looking statements. Forward-looking statements include, but are not limited to, statements that express the Company’s intentions, beliefs, expectations, strategies, predictions or any other statements related to the Company’s future activities, or future events or conditions, including those relating to ATA2271 and the Study. These statements are based on current expectations, estimates and projections about the Company’s business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors, including those risks discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission (the “SEC”) on March 1, 2021, and in other documents that the Company files from time to time with the SEC, including but not limited to its Quarterly Reports on Form 10-Q. Any forward-looking statements speak only as of the date on which they are made, and the Company does not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of this report, except as required by law.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Atara Biotherapeutics, Inc. | ||
| By: | /s/ Amar Murugan | |
| Amar Murugan | ||
| Senior Vice President, General Counsel | ||
Dated: February 18, 2022
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