Atara achieved significant progress across its three strategic priorities in 2020
Atara is well-positioned for success in anticipated tab-cel® regulatory submissions, approval and launch
Atara has had productive interactions with the FDA for ATA188 and is progressing the Phase 2 randomized clinical trial (RCT) toward an interim analysis in H1 2022
Atara Biotherapeutics, Inc. (Nasdaq: ATRA; the “Company”), 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 diseases, today announced President and Chief Executive Officer Pascal Touchon will present Atara’s 2020 progress and key upcoming milestones across the Company’s strategic priorities during a presentation at the 39th Annual J.P. Morgan Healthcare Conference, Wednesday, January 13, 1:30 p.m. PST/4:30 p.m. EST.
“Atara made significant progress in 2020 and is well-positioned for a strong 2021,” said Pascal Touchon, President and Chief Executive Officer of Atara. “As the most advanced allogeneic T-cell therapy company, nearing initiation and subsequent completion of a rolling BLA for our lead product candidate tab-cel®, we are making key investments in commercial infrastructure to ensure delivery of this potentially transformative therapy to patients in dire need. Atara also anticipates significant progress throughout 2021 on ATA188 for progressive MS with multiple data read-outs and, after recent productive interactions with the FDA, is poised to expand enrollment in the RCT and conduct an interim analysis in H1 2022.”
Anticipated key milestones across Atara’s three strategic priorities include:
Tabelecleucel (tab-cel®) for Epstein-Barr Virus-Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD)
- Complete the Biologics License Application (BLA) rolling submission to the U.S. Food and Drug Administration (FDA) for patients with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) in Q3 2021
- Present data from the Phase 3 ALLELE study in EBV+ PTLD in Q4 2021 at an appropriate congress
- Submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the European Union (EU) for patients with EBV+ PTLD in Q4 2021
- Anticipated U.S. approval of BLA for patients with EBV+ PTLD in H1 2022
- Anticipated EU approval of MAA for patients with EBV+ PTLD in H2 2022
ATA188 for Progressive Forms of Multiple Sclerosis (MS)
- Update on long-term clinical data from the open-label extension (OLE) of the Phase 1a study in an appropriate forum in H1 and H2 2021
- Conduct interim analysis to assess efficacy and safety from the Phase 2 randomized, double-blind, placebo-controlled study in progressive forms of MS in H1 2022
- Complete enrollment of the Phase 2 randomized, double-blind, placebo-controlled study in patients with progressive forms of MS in H1 2022
CAR T Programs
ATA2271/ATA3271 (Solid Tumors Over-Expressing Mesothelin)
- Present top-line Phase 1 data for ATA2271, our mesothelin-targeted autologous CAR T for patients with advanced mesothelioma in Q4 2021
- Submit next-generation off-the-shelf, mesothelin-targeted allogeneic CAR T Investigational New Drug Application (IND) for patients with advanced mesothelioma in Q2 to Q3 2022
- Advance our collaboration with Bayer in the development of the mesothelin franchise (ATA2271 and ATA3271)
ATA3219 (B-cell Malignancies)
- Submit IND for ATA3219, our next-generation off-the-shelf, allogeneic CD-19-targeted CAR T for patients with B-cell malignancies in Q4 2021 to Q1 2022
A live audio webcast of the presentation will be available by visiting the Investors and Media section of the Atara website on Wednesday, January 13, 1:30 p.m. PST/4:30 p.m. EST. 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 11, 4:30 a.m. PST / 7:30 a.m. EST.
About Atara Biotherapeutics
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-positive 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 potential benefits, safety and efficacy of tab-cel ®; data from the tab-cel®; the timing and progress of regulatory submissions of tab-cel®, the timing and progress of clinical trials of tab-cel®, and Atara’s ability to successfully advance the development of tab-cel®; the potential benefits, safety and efficacy of ATA188; data from the open-label extension study of ATA188; the timing and progress of clinical trials of ATA188, and Atara’s ability to successfully advance the development of ATA188; results and data from the Phase 1 study for ATA2271; the timing and progress of development of ATA2271 and ATA3271, Atara’s ability to successfully advance the development of its CAR T programs; the timing and progress of the development of ATA3219; and Atara’s ability to successfully advance the development of ATA3219. 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 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.