Atara Biotherapeutics, Inc. 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 received notification of Bayer's intention to end the exclusive worldwide licensing agreement for next-generation mesothelin-directed CAR T-cell therapies.
The collaboration included the funding and development of ATA3271, an armored allogeneic T-cell immunotherapy, and an autologous version, ATA2271, for high mesothelin-expressing tumors such as malignant pleural mesothelioma and non-small-cell lung cancer. Both ATA2271 and ATA3271 incorporate Atara's novel inclusion of armoring in the form of a PD-1 DNR construct to overcome checkpoint inhibition and a 1XX costimulatory domain on the CAR to enhance expansion and functional persistence of the CAR T-cells. ATA3271 leverages Atara's EBV T-cell platform and is currently in IND (Investigational New Drug)-enabling studies.
"We acknowledge Bayer's decision to end our collaboration following Bayer's strategic review and asset-level prioritization of its pipeline, including cell and gene therapy," said Jakob Dupont, M.D., Head of Global Research & Development at Atara. "Based on the clinical and pre-clinical data generated to date, we remain confident in the potential of ATA2271 and ATA3271 to address patient need in solid tumors and are re-assessing our strategy on how best to generate value from the programs moving forward."
Upon termination of the agreement in September 2022, the rights and licenses granted by Atara to Bayer under the collaboration will be returned to Atara, and Atara will have full rights to continue the clinical development and future commercialization of its programs worldwide. Atara will continue to support the ongoing ATA2271 Phase 1 study, which is being conducted by Memorial Sloan Kettering Cancer Center (MSK) who has voluntarily paused enrollment of new patients in the study on a temporary basis. Atara and MSK expect to provide a Phase 1 data update for ATA2271 in H2 2022. Atara will also continue to lead IND-enabling studies and process development for ATA3271.
"Atara remains focused on the upcoming interim analysis of our Phase 2 EMBOLD study of ATA188 in June, and we look forward to continued progress with tab-cel® including EMA's review in Europe and further engagement with FDA on an appropriate BLA pathway," said Pascal Touchon, President and Chief Executive Officer of Atara. "Given the exciting developments on ATA188 and tab-cel, and our continued progress toward submitting an IND for ATA3219 in Q4 2022, we plan to focus our resources accordingly while we re-assess our strategy for our mesothelin CAR T program. Consequently, we will postpone the anticipated IND filing for ATA3271 beyond the fourth quarter of 2022. We are also maintaining our cash runway guidance into Q4 of 2023."
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® (tabelecleucel) in Phase 3 development for Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD); 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.
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 timing and progress of (i) the ATA2271 and ATA3271 programs; (ii) the ATA2271 clinical trial and preliminary clinical data; (iii) ATA2271 and ATA3271 preclinical development and preclinical data; (iv) the safety and efficacy of Atara's product candidates, including ATA2271 and ATA3271; (v) MSK's ability to successfully advance the development of ATA2271; and (vi) Atara's ability to successfully advance the development of its CAR T programs, including ATA2271 and ATA3271. 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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