Latest news with #EBV
Yahoo
16 hours ago
- Business
- Yahoo
Atara Biotherapeutics Provides Regulatory and Business Updates on Tabelecleucel (Tab-cel®)
Atara Biotherapeutics Resubmits Tabelecleucel (Tab-cel®) Biologics License Application for Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease to the U.S. FDA Approval of BLA Would Trigger $40 Million Milestone Payment from Pierre Fabre Laboratories THOUSAND OAKS, Calif., July 14, 2025--(BUSINESS WIRE)--Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced that it has resubmitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tabelecleucel (EBVALLO™ or tab-cel®) indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. There are no FDA approved therapies in this treatment setting. "The BLA resubmission for tab-cel represents the collaborative efforts with our partner, Pierre Fabre Laboratories, to address the third-party manufacturing facility observations outlined in the January 2025 Complete Response Letter," said Cokey Nguyen, President and Chief Executive Officer of Atara. "We look forward to continued engagement with the FDA throughout its review and with Pierre Fabre Laboratories as they actively prepare for the potential launch of this innovative therapy in the U.S." Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells. The BLA is supported by pivotal and supportive data covering more than 430 patients treated with tab-cel across multiple life-threatening diseases, including the latest pivotal ALLELE study data that demonstrated a statistically significant 48.8% Objective Response Rate (ORR) (p<0.0001) and favorable safety profile consistent with previous analyses. Tab-cel has been granted Breakthrough Therapy Designation for the treatment of rituximab-refractory EBV-associated lymphoproliferative disease by the U.S. FDA and has orphan drug designation for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disorders. Corporate Updates Tab-cel Transition Activities: The company is finalizing the transfer of the following clinical studies associated with tab-cel: NCT03394365: Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy (ALLELE) NCT04554914: A Study to Evaluate Tabelecleucel in Participants with Epstein-Barr Virus-associated Diseases. This study is a multicenter, multicohort, open-label, single-arm, Phase 2 study investigating the efficacy and safety of tabelecleucel for the treatment of EBV-associated diseases. Upon completion substantially all operational activities and associated costs related to tab-cel will transfer to Pierre Fabre Laboratories. The sponsorship of the BLA continues to be maintained by Atara. Cash Runway and Future Tabelecleucel (Tab-cel®) Milestone and Royalty Income: Atara projects that its cash, cash equivalents and short-term investments of approximately $22M as of June 30, 2025, combined with the cost reduction initiatives implemented in the first half of 2025, will enable funding of all currently planned operations, including one-time restructuring costs, into the first quarter of 2026, that Atara believes will be sufficient to fund the ongoing activities required to achieve potential BLA approval. Additionally, under its commercialization agreement with Pierre Fabre Laboratories, Atara is eligible to receive a $40 million milestone payment upon FDA approval of the tab-cel BLA, as well as significant double-digit tiered royalties as a percentage of net sales, and milestones related to commercial sales of EBVALLO. The estimate of our cash, cash equivalents and short-term investments as of June 30, 2025, is preliminary, has not been audited and it is subject to change upon completion of our financial statement closure procedures. Our independent registered public accounting firm has not audited or completed any procedures with respect to this estimate. Such estimates are based on assumptions and plans that are subject to change and such changes could materially impact our expected cash runway. These assumptions include the completion of specific development and regulatory activities by us and actions taken by third parties, and are, therefore, uncertain at this time. Any delay in these activities will create additional expenses and cash needs for us. We have not yet completed our quarter-end financial close process for the quarter ended June 30, 2025. This estimate of our cash, cash equivalents and short-term investments as of June 30, 2025, is preliminary and is subject to change upon completion of our financial statement closing procedures. Additional information and disclosure would be required for a more complete understanding of our financial position and results of operations as of and for the quarter ended June 30, 2025. About Atara Biotherapeutics, Inc. Atara is harnessing the natural power of the immune system to develop off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions that can be rapidly delivered to patients from inventory. With cutting-edge science and differentiated approach, Atara is the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy. Our advanced and versatile T-cell platform does not require T-cell receptor or HLA gene editing and forms the basis of a diverse portfolio of investigational therapies that target EBV, the root cause of certain diseases. Atara is headquartered in Southern California. For more information, visit and follow @Atarabio on X and LinkedIn. 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: (1) the development, timing and progress of tab-cel, including the resubmission of the BLA and potential indications, the timing for FDA review of any resubmission of the BLA, the potential characteristics and benefits of tab-cel, and the results of, and prospects for, the global partnership with Pierre Fabre Laboratories involving tab-cel, and the potential financial benefits to Atara as a result of the global partnership with Pierre Fabre Laboratories, including the receipt, timing and amount of any payments to be received by Atara thereunder; (2) Atara's estimate of its cash, cash equivalents, and short-term investments as of June 30, 2025, as well as Atara's cash runway, receipt of potential milestone payments, and operating expenses, including Atara's ability to fund its planned operations into the first quarter of 2026; and (3) Atara's planned transition of substantially all remaining activities relating to tab-cel to Pierre Fabre Laboratories and the timing thereof. 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 related with the timing of the transfer of substantially all operational activities related to tab-cel to Pierre Fabre Laboratories, with any potential delay creating additional expenses and cash needs for Atara; risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; risks related to FDA feedback and the ability of Atara, Pierre Fabre Laboratories and Pierre Fabre Laboratories third-party manufacturer to address issues identified in the Complete Response Letter (CRL); our ability to access capital, and the sufficiency of Atara's cash resources and access to additional capital on favorable terms or at all; risks and uncertainties related to Atara's financial close and audit procedures; and other risks and uncertainties affecting Atara, including those discussed in Atara's filings with the Securities and Exchange Commission, 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. View source version on Contacts Investor and Media Relations Amber DaughertySr. Director, Strategy and Operationsadaugherty@ Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Newsweek
5 days ago
- Health
- Newsweek
Common Virus Found To Increase Cancer Risk
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. Those who have a specific antibody that is produced following infection from a common virus may be at greater risk of developing certain cancers, a new study from the International Agency for Research on Cancer (IARC) has found. Individuals who test positive for Epstein–Barr virus (EBV) capsid antigen (VCA-IgA) antibodies were found to have a higher risk of developing cancers such as lung cancer, liver cancer, nasopharyngeal carcinoma and lymphoma, according to a study shared by IARC with Newsweek. Newsweek has contacted the Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Services (HHS) via email for comment. What Is Epstein-Barr Virus? The Epstein-Barr virus is one of the most common and persistent human viruses in the world, according to the CDC, and is member of the herpes virus family. EBV infects approximately 95 percent of the global population, the IARC said. It is the usual cause of infectious mononucleosis, otherwise known as "mono"—a contagious disease common among teens and adults that is usually spread through saliva, so by kissing or sharing drinks and food. After an individual is infected with EBV, the virus becomes inactive in their body, but may reactivate in some cases, with the potential for symptoms to resurface. "It's a latent virus that resides inside of certain cells," Dr. Henry Balfour Jr., a professor in the Department of Laboratory Medicine and Pathology at the University of Minnesota Medical School, told Newsweek. "So, when your immune system is challenged, let's say you get a flu shot or COVID, you're likely to see reactivation of EBV," he said. Usual symptoms of EBV include fatigue, fever, inflamed throat, swollen lymph nodes in the neck, an enlarged spleen and swollen liver, as well as others. The virus was previously classified as carcinogenic to humans, in the IARC's highest risk category (Group 1), in 1997. To date, it has been directly linked to a few specific types of cancer, with studies estimating EBV-related cases accounted for between 239,700 to 357,900 new cases of certain cancers in 2020. EBV has also been linked with rare diseases like multiple sclerosis (MS), a chronic and autoimmune neurological disorder, Lawrence Steinman, a professor of neurology and neurological sciences, and pediatrics at Stanford University, told Newsweek. He also said that EBV, as a virus, may "trigger cancer itself," but that the antibodies one gets from EBV infection, may actually fight against certain cancers. "In fact, strengthening the immune response to EBV is a way that the immune system fights the virus, and in doing so helps kill the cancer or attenuate its spread," he said. "The trade off comes with developing an autoimmune response to self proteins that may be contained in the cancer." File photo: a computer illustration of the Epstein-Barr virus (EBV). File photo: a computer illustration of the Epstein-Barr virus (EBV). Dr_Microbe/Getty Images What Did The Study Find? The IARC study evaluated the cancer risk in two cohorts in Southern China of just under 74,000 adults. Over the course of around eight to 10 years, 964 cases of cancer were identified in the Zhongshan cohort and 1,026 in the Wuzhou cohort. Researchers found that those who tested positive for EBV VCA-IgA antibodies were nearly five times as likely to develop cancer compared with individuals who tested negative. There were also higher risks of developing certain cancers—for nasopharyngeal carcinoma, EBV VCA-IgA antibody positive individuals were found to be 26 times as likely to develop the disease. Meanwhile, for lung cancer, they were 1.76 times as likely to develop the disease, for liver cancer, they were 1.70 times as likely to, and for lymphoma, they were 3.20 times as likely to. Nasopharyngeal carcinoma, a type of cancer affecting the part of the throat that connects the back of the nose to the back of the mouth, had the highest risk among the cancer types investigated. Authors of the study noted there was an increased cancer risk associated with higher levels of EBV VCA-IgA antibodies—an elevated risk that persisted even up to 10 years before diagnosis, which the IARC said suggested that EBV infection "may play a long-term role in cancer development." Overall, the study estimated that 7.8 percent of the total cancer burden in Southern China could be attributed to EBV VCA-IgA antibody positivity in individuals. Are Experts Concerned? "I am not concerned about this finding," Luis Schang, a professor of chemical virology at Cornell University, told Newsweek, because it has been "long known" that EBV is associated with certain cancers. "The major contribution of this study is linking the increase in cancer risk to likely reactivation," he said. Before this study, he said that it would be argued the risk of developing cancer was "independent" of virus reactivation. Schang said that the study could also indicate that "antiviral, or vaccine, suppressive treatment could have a protective effect against the cancers produced by EBV." Antiviral treatment can "inhibit" virus reactivation, Schang said, although it is still "extremely challenging" to treat, as the virus persists in human cells for a prolonged period. He added that a vaccine that "could elicit strong immune responses" to curtail reactivation at early stages, potentially having an impact oncogenesis, the process where cells are transformed into cancer cells. While the findings are notable, experts told Newsweek that more research still needs to be done on the issue. "Most people, almost everybody who is infected with EBV, doesn't get cancer and doesn't get multiple sclerosis, so there's something else going on," Balfour Jr said. He said that there is evidence of the effects of EBV, and its potential to cause long-term chronic diseases like cancer or autoimmune diseases, being "specific to geographical area and possibly the socioeconomic status of the people." While it is not yet clear why this is the case, he said that "over and over again, socioeconomic status and race ethnicity are associated with the prevalence of EBV." As a result, "I would be cautious in interpreting these findings to be of any concern to people in the U.S. - depending on your age and your socioeconomic status, about 90 percent of young adults and adults are positive for EBV and almost all of them are not going to get cancers or autoimmune diseases such as MS," Balfour said.
Euronews
6 days ago
- Health
- Euronews
Common virus that causes mono raises cancer risks 5-fold, study warns
One of the world's most common viruses appears to significantly raise the risk of cancer, according to a new study from the World Health Organization's (WHO) cancer research agency. Most people around the world have been infected with Epstein-Barr virus (EBV) at some point in their lives. It spreads easily through saliva and other bodily fluids and does not usually cause symptoms, but it can lead to mononucleosis, also known as 'mono' or 'the kissing disease'. Scientists already knew that EBV, which stays in the body forever, can cause certain cancers, such as lymphomas and a rare form of throat cancer. But until now, there has been little data on the broader health risks. The new study, which was published in the journal Nature Communications, found that the virus puts people at higher risk for additional cancers, years before they are diagnosed. Researchers tracked nearly 74,000 people in southern China for eight to 10 years, identifying 1,990 cancer cases. They also tested whether people had EBV antibodies, which are proteins that fight off infections and are stored in the body, serving as a sign that someone has had the virus. People with EBV antibodies were about five times as likely to develop cancer compared with people who did not have them, according to the study from the WHO's International Agency for Research on Cancer (IARC) and research centres in China. The higher the level of antibodies, the higher the cancer risk. The findings will help scientists 'understand the link between [EBV infection] and the risk of various cancer types,' said Dr Zisis Kozlakidis, one of the study's co-authors and head of IARC's laboratory support, biobanking, and services unit. The risks were highest for nasopharyngeal cancer, which is a rare cancer that affects the part of the throat that connects the back of the nose to the back of the mouth. People who had EBV were 26 times as likely to develop this form of cancer than those who were not infected. Meanwhile, EBV antibodies were also tied to an elevated risk of developing lung cancer, liver cancer, and lymphomas, which are a group of blood cancers. The study had some limitations. The results may not translate directly to different demographic groups, for example, and other risk factors, such as smoking rates, could have affected the findings. Even so, researchers said the findings shed new light on cancer-causing viruses such as EBV. They called for more investigation into how exactly the virus causes cancer. Most people who have had mono will not develop cancer because of EBV, but the virus can cause genetic changes in cells that make them more likely to become cancerous. Health experts say that if people know their risks, they can watch out for signs of cancers that may be linked to the virus.
Medscape
02-07-2025
- Health
- Medscape
Think Beyond Stroke in Sudden Facial Droop
Infectious mononucleosis (IM), also known as the kissing disease or 'mono,' is typically caused by the Epstein-Barr virus (EBV). It is a clinical condition characterised by fever, lymphadenopathy, and pharyngitis. Bell's palsy is a condition that causes sudden, temporary facial paralysis or weakness on one side of the face. It can have various aetiologies, such as congenital, neurologic, infectious, neoplastic, or traumatic. This report describes the case of a woman who was diagnosed with Bell's palsy, a rare neurologic complication of EBV-associated IM. The Patient and Her History An 18-year-old woman with a medical history of low back pain and sinusitis presented to the clinic with complaints of fever, sore throat, and left-sided facial drooping. She reported noticing these symptoms 1 week prior. The neck pain had progressively worsened and radiated to the left ear. The patient also experienced difficulty forming words and was unable to raise her left eyebrow or smile due to facial drooping. She noted no improvement with over-the-counter medications and denied recent travel. Findings and Diagnosis On physical examination, several 1-cm mobile tender anterior cervical lymph nodes were noted. Tonsillitis with white exudates and left ear tympanosclerosis with associated pain were observed. The left corner of the mouth was drooping, and the patient had difficulty making facial expressions and closing her left eye. The spleen was palpable and tender to touch. Neurologic examination showed that all other cranial nerves were grossly intact. The muscle strength was 5/5 in both the upper and lower extremities, and deep tendon reflexes were present throughout. The lungs were clear to auscultation, and pulses were palpable in all extremities. No oedema, cyanosis, or clubbing was observed. The skin was dry, and no rashes were observed. Laboratory tests showed mild leucocytosis. Rapid antigen tests for streptococci, influenza, and COVID were negative. A rapid heterophile antibody test for EBV was positive. The mononucleosis spot test was positive for reactive heterophile antibodies, a hallmark finding of IM. Immunofluorescence assays showed positive immunoglobulin M and immunoglobulin G antibodies against EBV, with the presence of immunoglobulin M antibodies indicating either a recent primary infection or a reactivated infection. On the basis of these findings, a diagnosis of left-sided Bell's palsy due to EBV infection was confirmed. The patient was prescribed prednisone 60 mg for 1 week, with a plan to taper the dose. Tylenol was recommended for pain management as needed. Artificial tears were prescribed to prevent corneal damage and dryness due to the inability to close the left eye. An ear, nose, and throat (ENT) referral was made for the evaluation of left ear tympanosclerosis and associated pain. The patient was counselled to avoid contact sports because of the risk for splenic rupture, a common complication of IM. At the 2-week follow-up, the patient reported symptoms such as runny nose, fatigue, and ongoing ear pain, pending evaluation by an ENT specialist. At that time, there was no evidence of lymphadenopathy, fever, or splenomegaly. The patient's facial paralysis had improved by approximately 70%, and her speech was also markedly improved. The patient was counselled to rest, stay hydrated, and closely monitor for new symptoms. Discussion IM, most often caused by the EBV, is a viral illness that primarily affects teenagers and young adults. It is transmitted through saliva — which is why it is often referred to as the 'kissing disease' — but can also be spread via respiratory droplets, blood, or organ transplants. Symptoms may include sore throat, fever, swollen lymph nodes, and extreme fatigue, as well as swelling of the liver and spleen. A heterophile antibody test is typically sufficient to diagnose IM. Most people recover on their own with rest, fluids, and over-the-counter pain relievers. However, in rare cases, complications such as a ruptured spleen, neurologic issues, or liver inflammation can occur. Neurologic complications, such as cranial nerve palsies, Guillain-Barré syndrome, meningoencephalitis, and mononeuritis multiplex, occur in approximately 1%-5% of all patients with acute EBV infection. In children, neurologic manifestations may be the only clinical sign that can occasionally delay diagnosis. Acute peripheral facial paralysis is the most common acute mononeuropathy and often presents a diagnostic challenge for physicians. Its incidence has been reported as 21.1 per 100,000 per year in children younger than 15 years. Paediatric facial nerve paralysis can be congenital or acquired, but the idiopathic form, known as Bell's palsy, is the most frequent, accounting for 40%-75% of cases. Bell's palsy is diagnosed by the abrupt onset of unilateral facial weakness or complete paralysis of all muscles on one side of the face. It may be accompanied by dry eyes, pain around the ear, an altered sense of taste, hypersensitivity to sounds, or decreased tearing. Recovery time varies, but complete resolution of symptoms usually occurs within 2-3 weeks. There is always a small possibility of permanent functional loss, which can result from structural damage to axons and myelin. Treatment is usually supportive, often involving a combination of steroids and, in some cases, physical therapy. Facial nerve palsy is most often idiopathic and related to microcirculatory changes but may also result from congenital defects, infections, trauma, neoplasms, or systemic illness. Infectious causes account for 5%-30% of cases and are the most common cause in young children. Common pathogens include herpes simplex virus 1, varicella-zoster virus, EBV, Borrelia burgdorferi , HIV, and influenza virus. The causes of facial palsy are classified as follows: Genetic: Hereditary myopathies, gene mutations Syndromic: Craniofacial malformations and brainstem disorders Delivery-related: Prematurity, instrumental delivery, caesarean section Infectious: Viral, bacterial, and fungal agents including chronic or acute otitis media Inflammatory: Autoimmune and vasculitis conditions Neoplastic: Tumours involving the facial nerve or surrounding structures Traumatic: Skull fractures affecting the facial nerve Iatrogenic: Injury during head and neck surgeries Idiopathic: Bell's palsy Timely diagnosis and stroke exclusion are critical to avoid permanent damage. Lyme disease should be ruled out, especially in patients with recent travel to endemic areas and a bull's eye rash.
Yahoo
12-06-2025
- Business
- Yahoo
Moderna explores outside financing for vaccine trials, shares dip
-- Moderna Inc (BMV:MRNA) (NASDAQ:MRNA) shares fell 2.2% Thursday as the company confirmed it is seeking outside investment to support its late-stage vaccine programs. The move underscores the biotech firm's effort to align capital efficiency with strategic advancement across its product pipeline amid slowing COVID-19 revenue. 'We are very actively talking to potential partners right now,' CEO Stéphane Bancel said Wednesday at the Goldman Sachs Annual Global Healthcare Conference. He added that the discussions involved both pharmaceutical companies and financial partners, enabling the company to progress stalled late-stage candidates while controlling costs. A key focus for potential funding includes its latent virus vaccine programs, such as those targeting Epstein-Barr virus (EBV), herpes simplex virus (HSV), and varicella-zoster virus (VZV). 'We are working actively with [a] pharma company on the one hand and [a] financial partner on the other hand because we want those products to get to phase three,' Bancel said. Moderna has paused internal spending for those programs, opting instead to secure external capital and avoid further capital expenditure. 'We could launch EBV without adding $1 of CapEx. We could launch HSV without adding $1 of CapEx,' Bancel said, noting that Moderna's existing facilities have sufficient capacity to support production without the need for additional investment. The company's earlier collaboration with Blackstone (NYSE:BX) on financing a flu vaccine program stands as a precedent for these new deal structures. 'We would rather wait a few months to get the best partnership than being in a hurry and destroy value for shareholders by being in a hurry,' Bancel noted. While the company has over $8.5 billion in cash on hand, Bancel indicated this financing effort is about maximizing efficiency, not bridging funding gaps. 'We want to figure out who is the best partner in terms of capabilities and in terms of value,' he said, reiterating that securing the right structure is more important than speed. The funding push comes as Moderna aims to return to profitability by 2028 while ramping its oncology and respiratory portfolios. Shares finished the day down 2.2%, reflecting cautious sentiment amid uncertainty around vaccine uptake, trial timelines, and partnering outcomes. Related articles Moderna explores outside financing for vaccine trials, shares dip Israel considers military action against Iran, sources tell ABC News Micron boosts planned U.S. investment by $30 billion amid AI-driven demand Sign in to access your portfolio
