Breaking News
June 22, 2018 - Researchers report unusually high levels of herpesvirus in the brains of people with Alzheimer’s disease
June 22, 2018 - Theoretical models predict how juveniles evolve to be more susceptible than adults to infection
June 22, 2018 - USC study reveals how the cell launches emergency response to repair damaged DNA
June 22, 2018 - $1.9 million grant aims to enhance behavioral health services in community-based settings
June 22, 2018 - New 3D imaging technique could improve arthritis treatment
June 22, 2018 - Cytokinetics Announces Data From Phase 2 Clinical Study of Reldesemtiv in Patients With Spinal Muscular Atrophy
June 22, 2018 - Polarized cells give the heart its fully developed form
June 21, 2018 - Stem cells appear to help fight obesity in animal models
June 21, 2018 - Harnessing Pediatric Cancer Genomic Data in the Cloud
June 21, 2018 - Training nursing students with cost-effective 3D-printed task trainers
June 21, 2018 - Study provides insight into how planned and spontaneous movements are processed in the brain
June 21, 2018 - Suicide Prevention | SAMHSA – Substance Abuse and Mental Health Services Administration
June 21, 2018 - From designer microbes to stem cells, researchers are investigating new strategies to treat bowel disease
June 21, 2018 - Study suggests state-of-the-art genomic testing for routine autopsy of stillbirths
June 21, 2018 - Christiana Care Health System opens first Epilepsy Monitoring Unit in Delaware
June 21, 2018 - CDC: Obesity Prevalence Higher in Non-Metropolitan Counties
June 21, 2018 - Youths Treated for Non-Suicidal Self Harm at Increased Risk of Suicide Within a Year
June 21, 2018 - Pediatric kidney recipients often have subclinical inflammation
June 21, 2018 - OHSU Knight Cancer Institute Director wins 2018 Tang Prize in Biopharmaceutical Science
June 21, 2018 - Researchers study broader effects of neonics on wildlife
June 21, 2018 - Study provides new insight on how antibiotics affect the gut microbiome
June 21, 2018 - InHealth Technologies becomes exclusive distributor of RENÚ Voice, RENÚ Gel in the United States
June 21, 2018 - New analysis links higher BMI to lower breast cancer risk for younger women
June 21, 2018 - Interactive preclinical PET-MR workshop demonstrates benefits of multi-modality imaging
June 21, 2018 - Gene signature could improve early diagnosis of TB
June 21, 2018 - Psychiatric Drug Lithium Tied to Birth Defect Risk
June 21, 2018 - Preclinical study suggests ARID1a may be useful biomarker for immunotherapy
June 21, 2018 - Risks of cancer and mortality found to be lowest in light drinkers
June 21, 2018 - Fetal immune cells are fast-acting first responders to microbes in adulthood
June 21, 2018 - Researchers invent medical device for proliferation, differentiation of neural stem cells
June 21, 2018 - Study explores current understanding of human physiology, pathology, trauma and surgery in space
June 21, 2018 - Scientists explore interactions between chromosomes 12 and 17
June 21, 2018 - People with severe obesity constantly try to reduce or control their weight
June 21, 2018 - Breakthrough discovery reveals brain metals that may drive progression of Alzheimer’s disease
June 21, 2018 - New methods of fragment-based lead discovery to identify potential antibiotics
June 21, 2018 - Recovery and Treatment | NIH MedlinePlus the Magazine
June 21, 2018 - Study finds cell-free DNA profiling as versatile method to monitor UTIs
June 21, 2018 - ‘Hidden’ driver discovered that helps prime the anti-tumor immune response
June 21, 2018 - Groundbreaking discovery could be key to preventing cancer metastasis
June 21, 2018 - Impulse control disorders found to be more common in people taking Parkinson’s drugs
June 21, 2018 - Study finds possible link between Type 2 diabetes and common white pigment
June 21, 2018 - Most emergency department patients wish to be involved in medical decision-making
June 21, 2018 - Study highlights growing problem of ‘iPad neck’ among young adults and women
June 21, 2018 - UT Southwestern scientists identify gene mutation linked with perplexing brain condition
June 21, 2018 - Probiotics could cut age-related bone loss in elderly women
June 21, 2018 - New study sheds light on role of vitamin D in healthy pregnancy
June 21, 2018 - Teva Provides Update on Clinical Trial of Fremanezumab for Use in Chronic Cluster Headache
June 21, 2018 - Unlocking the secrets of HIV’s persistence
June 21, 2018 - New guidelines recommend newborns with Down’s syndrome to receive leukemia test
June 21, 2018 - BetterYou’s new Magnesium Bone Lotion helps maximize bone health
June 21, 2018 - UH scientist receives grant to examine understudied part of glaucoma
June 21, 2018 - Lifestyle intervention could normalize unhealthy behaviors that lead to cancer, chronic disease
June 21, 2018 - Combining two anti-malarial vaccines could greatly reduce number of infections
June 21, 2018 - By 2030, prostate and lung cancers expected to be most common cancers among HIV population
June 21, 2018 - Researchers evaluate patient satisfaction and well-being after breast reconstruction
June 21, 2018 - Combining stem cell technology and artificial intelligence to diagnose genetic cardiac diseases
June 21, 2018 - Monash study reveals why older people have reduced immune responses to cancer therapy
June 21, 2018 - Researchers develop new microscope system that can image living tissue in real time
June 21, 2018 - Long-term estrogen therapy alters microbial composition and activity in the gut
June 21, 2018 - Study points to dangers of feeding non-dairy drink to infants
June 21, 2018 - Cannabis Use Linked to Psychosis Symptoms in Adolescents
June 21, 2018 - Inadequate sleep could cost countries billions
June 21, 2018 - Inhibiting epigenetic proteins with drugs could prevent development of breast cancer
June 21, 2018 - Study identifies factors that contribute to vaginal dryness
June 21, 2018 - Researchers employ nucleotide-based gene silencing to mitigate common ataxia
June 21, 2018 - New tool determines best treatment plan for adults with severe asthma
June 21, 2018 - Identifying gene variants that contribute to ovarian reserve may improve female fertility
June 21, 2018 - Religious involvement has no significant effect on misuse of prescription opioids, study finds
June 21, 2018 - Researchers characterize key signaling network that drives growth of triple negative breast cancers
June 21, 2018 - AHA: Big Weight Gain in 1st Pregnancy Could Boost Preeclampsia Risk
June 21, 2018 - How vaping helps even hardened smokers quit
June 21, 2018 - Gaming disorder an official disease condition says WHO
June 21, 2018 - Oxygen consumption in human BAT increases after a meal, shows research
June 21, 2018 - Research finds addictions to be diseases of the brain, not criminal behavior or personality disorders
June 21, 2018 - New study is testing safety and efficacy of glycoside in breaking up kidney stones
June 21, 2018 - Biosimilar competition may offer hope for cheaper, better psoriasis treatments in the future
June 21, 2018 - Cells form cage-like structures that trap viruses
June 21, 2018 - Wound protector use linked to significant reduction in surgical site infection
June 21, 2018 - African Americans and Latinos are more likely to be at risk for depression than Whites
June 21, 2018 - Genome study presents new way to track historical demographics of US populations
Atara Biotherapeutics Receives Rare Pediatric Disease Designation from FDA for ATA230 for Treatment of Congenital Cytomegalovirus (CMV) Infection

Atara Biotherapeutics Receives Rare Pediatric Disease Designation from FDA for ATA230 for Treatment of Congenital Cytomegalovirus (CMV) Infection

image_pdfDownload PDFimage_print

SOUTH SAN FRANCISCO, Calif., Oct. 26, 2017 (GLOBE NEWSWIRE) — Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune diseases and serious viral infections, today announced that ATA230 was granted Rare Pediatric Disease Designation for the treatment of congenital cytomegalovirus (CMV) infection by the U.S. Food and Drug Administration (FDA). ATA230, an allogeneic T-cell immunotherapy targeting antigens expressed by CMV, has been investigated in one Phase 1 and two Phase 2 clinical studies in immunocompromised patients with CMV viremia or disease who are refractory or resistant to antiviral drug treatment in the post-transplant setting.

“FDA’s Rare Pediatric Disease Designation, following the recent orphan drug designation for ATA230, further underscores the high unmet medical need in treating congenital CMV infection,” said Isaac Ciechanover, M.D., Chief Executive Officer and President of Atara Biotherapeutics. “We will continue to work closely with FDA and other global health authorities to evaluate the development of ATA230 to address this potentially life-threating disease.”

The FDA grants Rare Pediatric Disease designation to drugs or biologics intended to treat serious or life-threatening rare diseases that primarily affect individuals aged from birth to 18 years and fewer than 200,000 persons in the U.S. Under this designation, should ATA230 be approved, Atara may be eligible to receive a rare pediatric disease priority review voucher for a biologics license or new drug application for a different product.

About CMV

In patients with weakened immune systems, including bone marrow and solid organ transplant recipients, newborns with immature immune systems and those with human immunodeficiency virus (HIV), CMV can cause potentially life-threatening disease or may result in blindness, brain damage and deafness. While small-molecule antiviral drugs are approved to treat and prevent CMV infection, there remains a high unmet need due to viral resistance, modest neurodevelopmental activity and adverse effects, such as toxicity and reduction in white blood cell count impairing the ability to fight other infections, with these agents.

About ATA230

ATA230, an allogeneic T-cell immunotherapy targeting antigens expressed by CMV, has been investigated in one Phase 1 and two Phase 2 clinical studies in immunocompromised patients with CMV viremia or disease who are refractory or resistant to antiviral drug treatment in the post-transplant setting. In September 2017, Atara announced that ATA230 received orphan drug designation from the FDA for the treatment of CMV viremia and disease in immunocompromised patients, and in October 2016, the European Medicines Agency (EMA) issued a positive orphan drug designation opinion for ATA230 for the treatment of CMV infection in patients with impaired cell-mediated immunity. Atara intends to further evaluate ATA230 development plans with the FDA and other global health authorities following the initiation of ATA129 EBV-PTLD Phase 3 studies.

About Atara Biotherapeutics, Inc.

Atara Biotherapeutics, Inc. (@Atarabio) is a leading T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune diseases and serious viral infections. 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). Phase 3 studies of ATA129 in EBV-PTLD following a hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study) are expected to start in 2017, and a Phase 1/2 study of ATA129 in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA® (pembrolizumab), in patients with platinum-resistant or recurrent EBV-associated 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 hematopoietic cell transplant in the EU in 2018. Allogeneic ATA188 and autologous ATA190, the Company’s next generation T-cell immunotherapies, selectively target specific EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). A Phase 1 clinical study of autologous ATA190 in patients with progressive MS is ongoing. Atara also initiated a multinational, multicenter Phase 1 allogeneic ATA188 clinical study in patients with progressive or relapsing-remitting MS in October 2017. Atara’s clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV).

Forward-Looking Statements

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 expectation that it will continue to work closely with FDA and other global health authorities to evaluate ATA230 development plans to address this potentially life-threating disease; the possibility that, should ATA230 be approved, Atara may be eligible to receive a rare pediatric disease priority review voucher for a biologics license or new drug application for a different product; the Company’s plan to further evaluate ATA230 development plans with the FDA and other global health authorities following the initiation of the ATA129 EBV-PTLD Phase 3 studies; the Company’s expected initiation of Phase 3 studies of ATA129 in EBV-PTLD following a hematopoietic cell transplant or solid organ transplant in 2017 and a Phase 1/2 study of ATA129 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with platinum-resistant or recurrent EBV-associated NPC in 2018; and the Company’s expected submission of a conditional marketing authorization application in EBV-PTLD following hematopoietic cell transplant in the EU in 2018. 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.

Source: Atara Biotherapeutics, Inc.

Posted: October 2017

Tagged with:

About author

Related Articles