SOUTH SAN FRANCISCO, Calif., Aug. 22, 2017 (GLOBE NEWSWIRE) -- Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading "off-the-shelf" T-cell immunotherapy company developing novel treatments for patients with cancer and multiple sclerosis (MS), today announced the appointment of Kanya Rajangam, M.D., Ph.D., as Senior Vice President and Chief Medical Officer. Dr. Rajangam brings to Atara extensive global oncology clinical development experience, including advancing multiple early- and late-stage programs.
"Kanya has an exemplary track record leading clinical development and supporting regulatory submissions for several globally approved oncology products, as well as clinical experience in solid organ transplantation," said Isaac Ciechanover, Chief Executive Officer and President of Atara Biotherapeutics. "We expect she will play a key role as we prepare to initiate our two Phase 3 EBV-PTLD studies for the Company's lead oncology program, ATA129, which are anticipated to begin in the second half of 2017, and continue to advance our robust T-cell immunotherapy pipeline."
Dr. Rajangam joins Atara from Cleave Biosciences where she served as Chief Medical Officer, overseeing clinical development programs in hematologic and solid tumor malignancies. Previously, Dr. Rajangam was a Senior Medical Director at Onyx Pharmaceuticals, where she played a key role in the successful FDA and EMA submissions of the multiple myeloma product KYPROLIS® (carfilzomib). Prior to this, Dr. Rajangam was Associate Medical Director at Exelixis, where she designed early-stage oncology clinical studies, including for COMETRIQ® (cabozantinib) and COTELLIC® (cobimetinib). Throughout her career, Dr. Rajangam has worked closely with pharmaceutical partners including Amgen, Sanofi, Bristol-Myers Squibb and Genentech to advance oncology programs in all phases of clinical development.
After earning her medical degree from St. John's Medical College in Bangalore, India, Dr. Rajangam completed a surgical residency, including a master's thesis in renal transplantation, at the Postgraduate Institute of Medical Education and Research (India). She then earned her doctorate in biomedical tissue engineering from Northwestern University.
Since its discovery as the first human oncovirus, Epstein-Barr virus (EBV) has been implicated in the development of a wide range of lymphoproliferative disorders, including lymphomas and other cancers. EBV is widespread in all human populations and persists as a lifelong, asymptomatic infection. In immunocompromised patients, such as those undergoing hematopoietic cell transplants (HCT) or solid organ transplants (SOT), EBV-associated post-transplant lymphoproliferative disorder (EBV-PTLD), represents a life-threatening condition. Median overall survival in EBV-PTLD patients after HCT who have failed rituximab-based first line therapy is 16-56 days. In EBV-PTLD following SOT, patients failing rituximab experience increased chemotherapy-induced treatment-related mortality compared to other lymphoma patients. One and two-year survival in high-risk EBV-PTLD patients after SOT is 36% and 0%, respectively.
Atara's most advanced T-cell immunotherapy in development, ATA129, is a potential treatment for cancer patients with rituximab refractory EBV-PTLD as well as other EBV positive hematologic and solid tumors including nasopharyngeal carcinoma (NPC). In February 2015, FDA granted ATA129 Breakthrough Therapy Designation for EBV-PTLD following allogeneic hematopoietic cell transplant (HCT) and in October 2016, ATA129 was accepted into the EMA Priority Medicines (PRIME) regulatory pathway for the same indication, providing enhanced regulatory support. In addition, ATA129 also has orphan status in the U.S. and EU. Phase 3 studies of ATA129 in EBV-PTLD after HCT or solid organ transplant (SOT) are expected to start in 2017, and a Phase 1/2 study in NPC is planned for 2018. ATA129 is also available to eligible patients with EBV-positive tumors through an ongoing multicenter expanded access protocol (EAP) clinical study. Atara expects to submit ATA129 for conditional marketing authorization in EBV-PTLD following HCT in the EU in 2018.
About Atara Biotherapeutics, Inc.
Atara Biotherapeutics, Inc. (@Atarabio) is a leading cell therapy company developing novel treatments for patients with cancer and multiple sclerosis (MS). The Company's "off-the-shelf", or allogeneic, T-cells are engineered from donors with healthy immune function and allow for rapid delivery from inventory to patients without a requirement for pretreatment. Atara's T-cell immunotherapies are designed to precisely recognize and eliminate cancerous or diseased cells without affecting normal, healthy cells. Atara's most advanced T-cell immunotherapy in development, ATA129, is being developed for the treatment of cancer patients with rituximab refractory Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV-PTLD), as well as other EBV positive hematologic and solid tumors including nasopharyngeal carcinoma (NPC). ATA188, the Company's next generation T-cell immunotherapy for autoimmune diseases, selectively targets specific EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). A Phase 1 clinical study of autologous ATA188 in progressive forms of MS is ongoing, and a Phase 1 allogeneic ATA188 clinical study is expected to begin in the second half of 2017. Atara's clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV).
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 Company's expected initiation of Phase 3 studies of ATA129 in EBV-PTLD after HCT and SOT in the second half of 2017; the Company's belief that it continues to advance its robust T-cell immunotherapy pipeline; the Company's expected submission of a conditional marketing authorization application in EBV-PTLD following HCT in the EU in 2018; the Company's expected commencement of a Phase 1/2 trial with ATA129 in NPC in 2018; and the Company's belief that it will begin a Phase I allogeneic ATA188 clinical study in the second half of 2017. 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 those discussed under the heading "Risk Factors" in Atara Biotherapeutics' quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 7, 2017, including the documents incorporated by reference therein, and subsequent filings with the SEC. 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.
KYPROLIS® is a registered trademark of Onyx Pharmaceuticals, Inc.
COMETRIQ® is a registered trademark of Exelixis, Inc.
COTELLIC® is a registered trademark of Genentech USA, Inc.
INVESTOR & MEDIA CONTACTS:
John Craighead, Atara Biotherapeutics
Steve Klass, Burns McClellan
Justin Jackson, Burns McClellan