Hepatitis, Chronic

BOSTON, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced three upcoming poster presentations supporting the combination of bemnifosbuvir and ruzasvir as a potential treatment for Hepatitis C Virus (HCV). The combination of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, is in Phase 2 development for HCV. These data will be presented at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting 2024, being held from November 15-19, 2024 in San Diego, CA. “We look forward to presenting these important data, which support the combination of bemnifosbuvir and ruzasvir and its potential best-in-class profile for the treatment of HCV,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. “The unrelenting high incidence rate of HCV infections underscores the need for new therapies that can address the unmet needs of today’s HCV patients, particularly those with substance abuse disorders and comorbidities. We look forward to reporting results from our Phase 2 study later this year and to advancing this program into Phase 3 development.” Details for the AASLD’s The Liver Meeting presentations are as follows: Poster Number: 1467Date and Time: Friday, November 15, 1:00 p.m. – 2:00 p.m. PTLocation: San Diego Convention CenterTitle: Multiscale Modeling of Lead-in Results from a Phase 2 Study of an 8-Week Combination Regimen of Bemnifosbuvir and Ruzasvir in Patients with Chronic Hepatitis C Virus InfectionPresenter: Ruy M. Ribeiro, PhD Poster Number: 1466Date and Time: Friday, November 15, 1:00 p.m. – 2:00 p.m. PTLocation: San Diego Convention CenterTitle: Bemnifosbuvir Does Not Alter Cardiac Repolarization in Healthy Participants: Results from a Thorough QT StudyPresenter: Xiao-Jian Zhou, PhD Poster Number: 1501Date and Time: Friday, November 15, 1:00 p.m. – 2:00 p.m. PTLocation: San Diego Convention CenterTitle: Bemnifosbuvir Poses High Barrier for Resistance in both Preclinical and Phase 1b Monotherapy StudiesPresenter: Qi Huang, PhD About Bemnifosbuvir and Ruzasvir for Hepatitis C Virus (HCV) Bemnifosbuvir has been shown in in vitro studies to be approximately 10-fold more active than sofosbuvir (SOF), against a panel of laboratory strains and clinical isolates of HCV GT 1–5. In vitro studies have also demonstrated bemnifosbuvir remained fully active against SOF resistance-associated substitutions (S282T), with up to 58-fold more potency than SOF. The pharmacokinetic (PK) profile of bemnifosbuvir supports once-daily dosing for the treatment of HCV. Bemnifosbuvir has been shown to have a low risk for drug-drug interactions. Bemnifosbuvir has been administered to over 2,200 subjects and has been well-tolerated at doses up to 550 mg for durations up to 12 weeks in healthy subjects and patients. Ruzasvir has demonstrated highly potent and pan-genotypic antiviral activity in preclinical (picomolar range) and clinical studies. Ruzasvir has been administered to over 1,500 HCV-infected patients at daily doses of up to 180 mg for 12 weeks and has demonstrated a favorable safety profile. The PK profile of ruzasvir supports once-daily dosing. About Hepatitis C Virus (HCV) Hepatitis C Virus (HCV) is a blood-borne, positive-sense, single-stranded (ss)RNA virus that primarily infects liver cells. HCV is a leading cause of chronic liver disease and liver transplants, spreading via blood transfusion, hemodialysis and needle sticks. An estimated 50 million people globally live with chronic HCV infection, with approximately 1 million new infections and 242,000 deaths occurring each year. Most HCV-related deaths are due to liver scarring (cirrhosis) and liver cancer (hepatocellular carcinoma). Injection drug use accounts for around 30% of new HCV cases globally and approximately 60% in the U.S., where between 2-4 million people are estimated to have HCV. Annually, HCV diagnoses in the U.S. outpace treatment rates, as less than a third of those diagnosed with HCV receive timely treatment. About Atea Pharmaceuticals Atea is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral antiviral therapies to address the unmet medical needs of patients with serious viral infections. Leveraging Atea’s deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleos(t)ide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of serious viral diseases. Atea plans to continue to build its pipeline of antiviral product candidates by augmenting its nucleos(t)ide platform with other classes of antivirals that may be used in combination with its nucleos(t)ide product candidates. Our lead program and current focus is on the development of the combination of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, to treat HCV. For more information, please visit www.ateapharma.com. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to the anticipated date and time of the presentations at The Liver Meeting, the anticipated timing for reporting of the results from Atea’s Phase 2 trial of the combination of bemnifosbuvir and ruzasvir in the treatment of hepatitis C and the anticipated advancement of the program into Phase 3 clinical development. When used herein, words including “will,” “plans”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Atea’s current expectations and various assumptions. Atea believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Atea may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, dependence on the success of Atea’s most advanced product candidates, in particular the combination of bemnifosbuvir and ruzasvir for the treatment of hepatitis C; as well as the other important factors discussed under the caption “Risk Factors” in Atea’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Atea may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing Atea’s views as of any date subsequent to the date of this press release. Contacts Jonae BarnesSVP, Investor Relations and Corporate Communications617-818-2985Barnes.jonae@ateapharma.com Will O’ConnorPrecision AQ212-362-1200will.oconnor@precisionaq.com

– Clinical Trial Application accepted in Moldova with additional regulatory applications pending approval – PBGENE-HBV is the first in vivo gene editing program for chronic hepatitis B virus to move into global clinical trials – Company to host investor event highlighting clinical candidate safety data and plans for the Phase 1 trial prior to American Association for the Study of Liver Diseases Annual Meeting DURHAM, NC, USA I October 24, 2024 I Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS ® platform to develop in vivo gene editing therapies for sophisticated gene edits, today announced that it has received Clinical Trial Application (CTA) approval in Moldova for its lead candidate, PBGENE-HBV. PBGENE-HBV is Precision’s wholly owned in vivo gene editing program designed to cure chronic hepatitis B by eliminating cccDNA, the key source of replicating hepatitis B virus (HBV), while also inactivating integrated HBV DNA in hepatocytes. The company has opened the Phase 1 clinical program and is moving towards dosing patients. “At Precision, we remain laser-focused on execution, and our first CTA approval for PBGENE-HBV represents another significant milestone as we complete our transition to a clinical stage in vivo gene editing company. With rapid regulatory approval in hand, we are working diligently to screen and dose patients at our first clinical site in Moldova,” said Michael Amoroso, Chief Executive Officer of Precision BioSciences. “In parallel, we are leveraging our robust regulatory package, which highlights the safety and potent antiviral effects of PBGENE-HBV in a variety of models, including non-human primates, to pursue additional CTA and IND approvals globally. This multi-track approach will enable us to accelerate enrollment into the trial and generate important clinical safety and efficacy data with the aim of bringing a potentially curative treatment to the nearly 300 million patients living with chronic hepatitis B globally.” Prior to PBGENE-HBV, no other modality has been investigated in a clinical trial setting that is designed to eliminate the root cause of disease, the cccDNA. Additionally, the current standard of care requires daily chronic treatment with nucleos(t)ide analogs and only offers patients a 1-3% chance of functional cure. Through its precision cutting, compact design, and simple structure, PBGENE-HBV is engineered to target the HBV viral genome and drive functional cures for patients with chronic hepatitis B. PBGENE-HBV leverages the ARCUS ® gene editing platform by delivering an ARCUS nuclease-encoding mRNA to the liver via lipid nanoparticles. When expressed in HBV-infected hepatocytes, the ARCUS nuclease specifically cuts a highly conserved sequence in the hepatitis B viral genome and is designed to eliminate cccDNA and inactivate integrated HBV genomes. The ARCUS platform is derived from a naturally occurring enzyme and has been optimized for over 20 years into a ground-breaking and highly precise gene editing tool. “We are thrilled to receive CTA approval in Moldova given the high prevalence of chronic hepatitis B in the country and their expertise gained from multiple Phase 1 clinical trials in hepatitis B. Our clinical team, guided by our hepatitis scientific advisory board, has deep expertise in hepatitis B, and we believe that we are well-positioned to advance PBGENE-HBV towards dosing the first patient in the clinic,” added Dr. Murray Abramson, Senior Vice President, Head of Clinical Development of Precision BioSciences. “PBGENE-HBV is the first and only clinical stage approach to directly target and eliminate cccDNA, giving it the potential to achieve a functional cure. Next month, we plan to share additional information about our Phase 1 program, including the final preclinical safety package, with investigators and investors ahead of the upcoming AASLD meeting. With a clear regulatory pathway ahead of us, and our deep clinical expertise, we are focused on rapidly enrolling patients into the study and generating robust clinical data in patients with chronic hepatitis B who have for too long been unable to achieve meaningful functional cures.” Precision has submitted multiple global clinical trial applications and is on track to submit additional CTA and IND filings as part of its global Phase 1 regulatory strategy for PBGENE-HBV. The company will provide updates as it receives additional regulatory approvals to begin treating patients in those markets. The company plans to provide an update on the PBGENE-HBV program on November 15 th before the American Association for the Study of Liver Diseases (AASLD) Annual Meeting in November. Detailed information on how to join the webcast will be provided in the future. About Hepatitis B: Hepatitis B is a leading cause of morbidity in the US and death globally, with no curative options currently available for patients. In 2019, despite the availability of approved antiviral therapies, an estimated 300 million people globally and more than 1 million people in the US were estimated to have chronic hepatitis B infection. An estimated 15% to 40% of patients with HBV infections may develop complications, such as cirrhosis, liver failure, or liver cancer (hepatocellular carcinoma), which account for the majority of HBV-related deaths. Chronic hepatitis B infection is primarily driven by persistence of HBV cccDNA and integration of HBV DNA into the human genome in liver cells, the primary source of hepatitis B surface antigen (HBsAg) in late-stage disease. Current treatments for patients with HBV infection include agents that result in long-term viral suppression as indicated by reduction of circulating HBV DNA, but these therapies do not eradicate HBV cccDNA, rarely lead to functional cure, and require lifelong administration. About PBGENE-HBV: PBGENE-HBV is a potentially curative approach to treating patients with chronic HBV infection through a highly specific, novel therapeutic approach. PBGENE leverages the ARCUS ® platform and is designed to directly eliminate cccDNA and inactivate integrated HBV DNA with high specificity, potentially leading to functional cures. About Precision BioSciences, Inc. Precision BioSciences, Inc. is a clinical stage gene editing company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform that differs from other technologies in the way it cuts, its smaller size, and its simpler structure. Key capabilities and differentiating characteristics may enable ARCUS nucleases to drive more intended, defined therapeutic outcomes. Using ARCUS, the Company’s pipeline is comprised of in vivo gene editing candidates designed to deliver lasting cures for the broadest range of genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, please visit www.precisionbiosciences.com . The ARCUS ® platform is being used to develop in vivo gene editing therapies for sophisticated gene edits, including gene insertion (inserting DNA into gene to cause expression/add function), elimination (removing a genome e.g. viral DNA or mutant mitochondrial DNA), and excision (removing a large portion of a defective gene by delivering two ARCUS nucleases in a single AAV). SOURCE: Precision Biosciences

SAN DIEGO, Oct. 24, 2024 /PRNewswire/ -- SeekIn Inc, a leader in blood-based cancer early detection and monitoring technology, announced today its innovative two-step multi-cancer screening strategy at the Early Detection of Cancer Conference in San Francisco. This approach is designed to significantly alleviate the financial burden of population-wide screening, offering more affordable Multi-Cancer Early Detection (MCED) tests. SeekIn also debuted the findings from its lung cancer early detection test study, marking a significant advancement in the field of cancer screening. SeekIn's two-step multi-cancer screening strategy SeekIn proposes a two-step MCED screening approach, beginning with cost-effective initial tests like OncoSeek®, followed by advanced secondary tests such as SeekInCare® for those who test positive. This two-step approach has the potential to significantly reduce the financial burden compared to using NGS-based MCED tests for population-level screening. In a study with 1,197 participants (617 with cancer and 580 without), the two-step MCED approach achieved a remarkable 12.9-fold reduction in the false positive rate, from 9.0% to 0.7%. When applied to a hypothetical screening of five million adults, the strategy reduced total cost by 6.6-fold ($713.6 million compared to $4,745 million) and cost per cancer patient identified by 5.2-fold ($33,534 compared to $172,828), offering significant savings over an NGS-based MCED test to screen five million adults. Lung cancer early detection with LungCanSeek® SeekIn also presented its LungCanSeek® test, a blood-based, non-invasive, and cost-effective solution for lung cancer early detection. In a study of 1,814 participants (1,095 with lung cancer and 719 without cancer) from three cohorts, LungCanSeek showed 83.5% sensitivity and 90.3% specificity by combining artificial intelligence (AI) algorithms with four protein tumor markers (PTMs). Moreover, LungCanSeek can also predict the possible histological subtypes. With a 77.4% subtype classification accuracy, it could offer valuable guidance for subsequent diagnosis and treatment. For lung cancer screening, SeekIn also recommends a two-step strategy: initial screening with LungCanSeek, followed by low-dose computed tomography (LDCT) imaging for positive cases. This integrated approach leverages the strengths of both tests, reducing false positives by over 10-fold and costs by 2.5-fold compared to sole LDCT screening in high-risk populations. About OncoSeek® OncoSeek® has been developed as a multi-cancer detection test that uses artificial intelligence to distinguish between cancer patients and non-cancer individuals by calculating the probability of cancer (POC) index based on the plasma levels of seven PTMs (i.e. AFP, CA125, CA15-3, CA19-9, CA72-4, CEA, and CYFRA21-1), gender and age of the subjects. OncoSeek® is a non-invasive, efficient, and cost-effective approach for multi-cancer early detection. OncoSeek® received CE-IVD Mark in September 2022. About SeekInCare® With the mission to detect cancer while it is still curable, SeekInCare® has been developed as a pan-cancer detection test that takes a panoramic view of blood cell-free cancer signatures and a multi-omics approach incorporating genomic and epigenetic alterations in conjunction with clinically validated protein biomarkers. Equipped with proprietary AI- and big data-driven CRS algorithm, SeekInCare exhibits superior effectiveness to detect dozens of cancer types at high specificity. SeekInCare is intended for use in individuals with elevated risks of cancer such as smoking, chronic hepatitis, aging, etc., in conjunction with the approved conventional single-cancer type screening tests. SeekInCare received CE-IVD Mark in November 2021. About LungCan Seek ® LungCanSeek® was developed to distinguish lung cancer patients from non-cancer individuals and predict potential histological subtypes, lung adenocarcinoma (LUAD), lung squamous cell carcinoma (LUSC), and small cell lung cancer (SCLC). The test employs AI algorithms based on four PTMs, along with the subject's gender and age. It represents a non-invasive, efficient, and cost-effective approach for the early detection of lung cancer. About SeekIn SeekIn Inc is a biotech company founded in early 2018 in Shenzhen, China, focusing on blood-based pan-cancer early detection utilizing next-generation sequencing and artificial intelligence. Since its creation, SeekIn has been committed to providing cutting-edge and cost-effective solutions for cancer early detection, postoperative recurrence monitoring, and treatment response evaluation. SeekIn has also developed novel molecular tests for leukemia patients and its cancer early detection technology has also successfully been applied to canines. With its proprietary technical advances, SeekIn has launched a number of research and clinical studies in collaboration with top-tier hospitals in China. SeekIn envisions that, by leading a new norm for cancer early detection, the clinical outcomes of mid-/late-stage cancer patients can be reversed, and the cancer mortality rate can be reduced by 15%. For more information about SeekIn's cutting-edge technologies and products, visit . SOURCE SeekIn Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED