CXCL10

CAMBRIDGE, Mass., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Omega Therapeutics, Inc. (Nasdaq: OMGA) (“Omega”), a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenomic mRNA medicines, today announced it will share new preclinical data at three upcoming scientific meetings. “These preclinical results build upon the foundation of data we have shared to date and expand our confidence in the ability of epigenomic controllers to upregulate or downregulate the expression of one or more genes,” said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. “More broadly, we believe these upcoming presentations further demonstrate the power of the OMEGA platform to prospectively engineer novel therapeutic candidates to regulate gene expression with high specificity and the potential of precision epigenomic control to offer new treatment strategies for diverse indications.” Details for the upcoming presentations are as follows: Poster at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting taking place in Houston, TX, November 8 – 10 Title: Controlled Epigenetic Upregulation of CXCL9 and CXCL10 in Hepatocellular Carcinoma Promotes T-cell RecruitmentAbstract Number: 1360Session Date and Time: Saturday, November 9, 2024, from 12:15 to 1:45 p.m. CST Poster and Flash Talk at the 12th International mRNA Health Conference taking place in Boston, MA, November 12 – 14 Title: Programmable Epigenomic mRNA Therapeutics Enable Multi-Gene Up or Down Tuning of α-globin via Regulatory Element Targeting: A Precision Approach for β- and α-Thalassemia TreatmentPaper Number: 102E-Poster Session Date and Time: Tuesday, November 12, 2024, beginning at 9:00 a.m. ESTFlash Talk Session Date and Time: Tuesday, November 12, 2024, from 4:00 to 5:00 p.m. EST Poster at the American Association for the Study of Liver Diseases’ (AASLD) 75th Annual The Liver Meeting® taking place in San Diego, CA, November 15 – 19 Title: Durable Upregulation of P1-isoform Hepatocyte Nuclear Factor 4 alpha (HNF4α) Using Novel Epigenomic ControllersPublication Number: 3228 Session Title: MASLD/MASH - Therapeutics: New AgentsSession Date and Time: Sunday, November 17, 2024, from 8:00 a.m. to 5 p.m. PST The posters will be made available on the Omega website at https://omegatherapeutics.com/science/publications/ at the same time as the respective presentations. About Omega Therapeutics Omega Therapeutics is a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenomic mRNA medicines to treat or cure a broad range of diseases. By pre-transcriptionally modulating gene expression, Omega’s approach enables precision epigenomic control of nearly all human genes, including historically undruggable and difficult-to-treat targets, without altering native nucleic acid sequences. Founded in 2017 by Flagship Pioneering following breakthrough research by world-renowned experts in the field of epigenetics, Omega is led by a seasoned and accomplished leadership team with a track record of innovation and operational excellence. The Company is committed to revolutionizing genomic medicine and has a pipeline of therapeutic candidates derived from its OMEGA platform spanning oncology, regenerative medicine, and multigenic diseases including inflammatory and cardiometabolic conditions. For more information, visit omegatherapeutics.com, or follow us on X and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our expectations surrounding the broad potential of precision epigenomic control, the versatile capabilities of the OMEGA platform, the potential of the Company’s pipeline of therapeutic candidates, and the Company’s participation in upcoming events and presentations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the novel technology on which our product candidates are based makes it difficult to predict the time and cost of preclinical and clinical development and subsequently obtaining regulatory approval, if at all; the substantial development and regulatory risks associated with epigenomic controllers due to the novel and unprecedented nature of this new category of medicines; our limited operating history; the incurrence of significant losses and the fact that we expect to continue to incur significant additional losses for the foreseeable future; our need for substantial additional financing; volatility in capital markets and general economic conditions; our investments in research and development efforts that further enhance the OMEGA platform, and their impact on our results; uncertainty regarding preclinical development, especially for a new class of medicines such as epigenomic controllers; potential delays in and unforeseen costs arising from our clinical trials; the fact that our product candidates may be associated with serious adverse events, undesirable side effects or have other properties that could halt their regulatory development, prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences; difficulties manufacturing the novel technology on which our epigenomic controller candidates are based; our ability to adapt to rapid and significant technological change; our reliance on third parties for the manufacture of materials; our ability to successfully acquire and establish our own manufacturing facilities and infrastructure; our reliance on a limited number of suppliers for lipid excipients used in our product candidates; our ability to advance our product candidates to clinical development; and our ability to obtain, maintain, enforce and adequately protect our intellectual property rights. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, and our other filings with the SEC, 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 we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

Approval from U.S. Army Medical Research and Development Command, Office of Human Research Oversight is the last scientific milestone needed for Company to receivebulk of $13.1 million grant funding Company anticipates Phase 2 trial to commence by early 2025 CARSON CITY, Nev., Sept. 16, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that the U.S. Army Medical Research and Development Command, Office of Human Research Oversight, (OHRO) has approved BioVie’s plan to evaluate bezisterim for the treatment of neurological symptoms that are associated with long COVID. FDA had previously reviewed and approved the study as Safe to Proceed in August 2024. Approval from OHRO is the last scientific review milestone needed for the Company to receive the additional $12.6 million in grant funding from the U.S. Department of Defense (DOD) and initiate Phase 2 testing in long COVID. The planned Phase 2 study is a randomized (1:1), placebo-controlled, multicenter trial in approximately 200 patients to evaluate the safety, tolerability and potential efficacy of 3 months of treatment with bezisterim to reduce the neurocognitive symptoms associated with long COVID. Long COVID is a condition in which symptoms of COVID-19, the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period of time, generally three months or more. The Centers for Disease Control recently reported that more than 17 million adults in the United States currently or previously had long COVID.1 Symptoms include cognitive dysfunction and fatigue and are debilitating. No therapies have proven effective for treatment to date. Chronic inflammation is one of the main hypotheses that researchers have proposed to explain the persistence of symptoms in long COVID.3 Specifically in individuals with “brain fog,” sustained systemic inflammation and persistent localized blood-brain-barrier (BBB) dysfunction are key physiological features.5 Bezisterim permeates the BBB and has been shown to modulate inflammation via the activation of NF-kB, thus representing a novel oral treatment targeting a suspected underlying cause of long COVID symptoms. Terms of the Department of Defense AwardThe work is supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $499,200 for the planning phase with the option, if approved, to receive an additional $12.6 million, to initiate a clinical trial once the planning phase has concluded and milestones have been met, through the Peer-Reviewed Medical Research Program (PRMRP) under Award No. HT9425-24-1-0113. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the Department of Defense. About Long COVIDLong COVID is a condition in which symptoms of COVID-19, the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period of time, generally three months or more. Common symptoms include lingering loss of smell and taste, hearing loss, extreme fatigue, and “brain fog,” though persistent cardiovascular and respiratory problems, muscle weakness, and neurologic issues have also been documented. The Centers for Disease Control recently reported that 6.8% of adults in the United States (more than 17 million individuals) currently or previously have long COVID.1 The loss in quality of life and earnings and increased medical costs has an enormous economic impact estimated to be $3.7 trillion.2 To date there are no non-pharmacological or pharmacological therapies proven effective for treatment of long COVID. Chronic inflammation is one of the main hypotheses that researchers have proposed to explain the persistence of symptoms in long COVID.3 The expression of proteins associated with inflammation (LGALS9, CCL21, CCL22, TNF, CXCL10 and CD48) and immune regulation (IL1RN and CD22) have been shown to be elevated in individuals with long COVID versus full-recovered individuals.4 Specifically in individuals with “brain fog,” sustained systemic inflammation and persistent localized blood-brain-barrier (BBB) dysfunction are key physiological features.5 Thus, drugs modulating inflammation, and that work to regulate the BBB integrity, could represent potential therapeutic mechanisms for treating neurological symptoms of long COVID. About BezisterimBezisterim (NE3107) is an orally bioavailable, BBB-permeable, insulin-sensitizer that is also anti-inflammatory. In addition, it is not immunosuppressive and has a low risk of drug-drug interaction. Bezisterim has the potential to reduce symptoms of long COVID, including fatigue and cognitive dysfunction. Persistently circulating viral spike proteins are believed to trigger TLR-4 driven activation of NFkB and the subsequent expression of inflammatory cytokines (IL-6, TNF, IFNg). NE3107 has been shown to modulate the activation of NFkB and thus modulate inflammation. Bezisterim is also being investigated for Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”). BioVie has conducted and reported efficacy data on its Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate bezisterim in patients who have mild-to-moderate AD (NCT04669028). Results of a Phase 2 investigator-initiated trial (NCT05227820) showing bezisterim-treated patients experienced improved cognition and biomarker levels were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) annual conference in December 2022. An estimated six million Americans suffer from AD. A Phase 2 study of bezisterim in PD (NCT05083260) has been completed, and data presented at the AD/PD™ 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders in Gothenburg, Sweden in March 2023 showed significant improvements in “morning on” symptoms and clinically meaningful improvement in motor control in patients treated with a combination of bezisterim and levodopa vs. patients treated with levodopa alone, and no drug-related adverse events. About BioVie Inc.BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease. In neurodegenerative disease, the Company’s drug candidate bezisterim inhibits inflammatory activation of ERK and NFkB (e.g., TNF signaling) that leads to neuroinflammation and insulin resistance, but not their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both are drivers of AD and PD. In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with FDA Fast Track status, is being evaluated and discussed with guidance received from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis. For more information, visit www.bioviepharma.com. Forward-Looking StatementsThis press release contains forward-looking statements, which may be identified by words such as “expect,” “look forward to,” “anticipate,” “intend,” “plan,” “believe,” “seek,” “estimate,” “will,” “project” or words of similar meaning. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to the Company's ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our pre-clinical or clinical studies and to obtain approval for our product candidates, our ability to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company's control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law. References1 Ford ND, Agedew A, Dalton AF, Singleton J, Perrine CG, Saydah S. Notes from the Field: Long COVID Prevalence Among Adults — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:135–136. DOI: http://dx.doi.org/10.15585/mmwr.mm7306a4. 2 Cutler, David M. 2022 The economic costs of Long COVID: An update. long_covid_update_7-22.pdf (harvard.edu) 3 Evans RA, Leavy OC, Richardson M, et al. Clinical characteristics with inflammation profiling of Long-COVID and association with one-year recovery following hospitalisation in the UK: a prospective observational study. The Lancet Respiratory Medicine. 2022;10(8):761-775. 4 Yin K, Peluso MJ, Luo X, et al. Long COVID manifests with T cell dysregulation, inflammation and an uncoordinated adaptive immune response to SARS-CoV-2. Nature Immunology. 2024;25:218-225. 5 Greene C, Connoly R, Brennan D, et al. Blood–brain barrier disruption and sustained systemic inflammation in individuals with long COVID-associated cognitive impairment. Nature Neuroscience. 2024;27:421-432. For Investor Relations Inquiries:Bruce MackleManaging Director, LifeSci Advisors, LLCbmackle@lifesciadvisors.com For Media Relations Inquiries:Melyssa WeibleManaging Partner, Elixir Health Public Relationsmweible@elixirhealthpr.com

Pre-clinical studies for intranasal RIG-101, a first in class RIG-I agonist, demonstrate potent local innate immune stimulation and pan-viral activity against human rhinovirus, influenza and RSV infections. RIG-101 is in development for the pan-viral prevention of RNA virus transmission in asthma patients to inhibit seasonal exacerbations. RIG-101 intranasal (IN) is on track to enter first in human trials in mid-2025. FARMINGTON, Conn., Sept. 09, 2024 (GLOBE NEWSWIRE) -- RIGImmune Inc., a biopharmaceutical research company developing a new class of RNA therapeutics, today announced three oral presentations demonstrating the viral prevention effects of intranasal RIG-101, their lead product development candidate, at the European Respiratory Society (ERS) Congress 2024 in Vienna, Austria. The three oral presentations highlight the impressive results from pre-clinical studies demonstrating that the company’s first in class RIG-I agonist has the ability to rapidly and substantially reduce viral loads by inducing innate immune responses when delivered directly to the respiratory tract. Intranasal RIG-101 is formulated with the company’s novel NEED™ (Nano-Emulsion Enhanced Delivery) platform, a complex designed to deliver a wide range of RNA payloads without the use of lipid nanoparticle encapsulation. The results from these studies and other company experiments demonstrate the potential for RIG-101 to inhibit the transmission of an RNA virus from an infected person to a non-infected individual and could significantly reduce viral infection-related respiratory complications in at-risk patient populations, including the immune-compromised and those with chronic respiratory diseases such as asthma and COPD. “While the nose is an obvious passageway to leverage for infectious disease prevention, inefficient uptake of previous intranasal RNA therapeutics by the nasal epithelial cells has been a barrier to infection prevention,” said the senior author of all three studies, Kazuhiro Ito, Ph.D., principal research fellow of Respiratory Molecular Pharmacology in Genomic and Environmental Medicine Section in National Heart and Lung Institute (NHLI) in the Faculty of Medicine of Imperial College London, and vice president of biology at RIGImmune. “Our study results show that RIG-101, formulated with our proprietary NEED™ technology can induce efficient uptake into the epithelium and is uniquely optimized to activate the innate immune system to fight viral respiratory diseases with local intranasal administration. The NEED™ platform allows us to effectively deliver RNA therapeutic payloads directly to the upper and lower respiratory tract and avoid the use of LNPs, which can damage the respiratory system when given locally.” “We’re excited with the study results presented by Dr. Ito at the 2024 European Respiratory Society. The data from these studies and other work conducted by RIGImmune demonstrate potent pan-viral activity for RIG-101 formulated with our NEED™ technology platform,” said Susan Sobolov, Ph.D., president of RIGImmune. “We have designed NEED™ to enable targeted delivery of a broad range of RNA therapeutics that aligns with the body’s own biological pathways, thereby minimizing toxicity risks. By validating RIG-101 in our NEEDTM formulation technology in these pre-clinical systems that have demonstrated translation to the clinical setting, we are further committed to advancing RIG-101 intranasal to our first-in-human studies in mid-2025.” Description of RIG-101 Study Results Presented at European Respiratory Society Sept 7th – 11th: Title: Pan-antiviral effects of RIG-I agonists (RIG-101) against respiratory syncytial virus and human rhinovirus in nasal epithelium in vitro and mice in vivoOverview Prophylactic intranasal RIG-101 demonstrates potent antiviral activities against human rhinovirus (HRV) and respiratory syncytial virus (RSV), potentially preventing respiratory virus-induced asthma and similar respiratory disorders. Details This study, led by Leah Daly of Imperial College London, showed that RIG-101 was able to induce interferon signaling in fully differentiated human nasal epithelium when delivered the day-prior and day-of viral exposure at apical site in air-liquid interface (ALI).In vivo testing demonstrated statistically significant reductions in HRV1B viral load and neutrophilia compared to pleconaril. Intranasal RIG-101 NEED™ (2mg/ml) was administered 4 and 1 day prior to exposure, with evaluations one day following exposure, and oral pleconaril (200 mg/kg) was administered up to one day prior to viral exposure. Title: Effects of an anti-viral interferon booster, RIG-I agonist (RIG-101), on influenza infection in vitro and in vivo Overview Prophylactic intranasal RIG-101 offers signs of viral prevention efficacy against influenza infection, and demonstrated increased immune response Details In an oral presentation, researchers, led by Hugo Ombredane, Ph.D. student at Imperial College London, demonstrated that delivering intranasal RIG-101 prophylactically offered significant induction of type I/III interferon signalling and potent antiviral effects against influenza with antiviral effect comparable or superior to oseltamivir in both in vivo and in vitro models.RIG-101 significantly reduced viral load in vivo and in vitro, as well as strongly induced CXCL10, a surrogate marker of antiviral interferon production in vitro and prevented neutrophil accumulation, a sign of inflammation, in the nasal lavage in vivo.For this study, RIG-101 was delivered 4 days and 1 day prior to viral exposure in vitro and 3 days, 1 day and 1 hour prior to viral exposure in vivo, and evaluations were conducted 48 hours post-viral exposure in vitro and 1-5 days post-viral exposure in vivo. Title: Adjutancy effects of a RIG-I agonist (RIG101) on H1N1 HA antigen intranasally vaccinated mice and human nasal epithelium/PBMCs co-culture Overview Adding prophylactic intranasal RIG-101 to the recombinant seasonal influenza hemagglutinin (rHA) vaccine more effectively reduced viral load and inflammation associated with the H1N1 HA subtype of influenza. Details RIG-101 combined with the recombinant seasonal influenza hemagglutinin (rHA) vaccine not only reduced viral load and inflammation associated with H1N1 HA, but also prevented virus-induced body weight loss compared with both HA antigen vaccination alone and the HA antigen vaccine plus CPG-ODN vaccine addition in a preclinical study led by Dr. Shyreen Hassibi of Imperial College London.An in vitro study involved peripheral blood mononuclear cells (PBMCs), which may include lymphocytes monocytes, natural killer cells (NK cells) and dendritic cells, cultured from the nasal cavity, and found that RIG-101 combined with H1N1 HA vaccination clearly enhanced the body’s natural production of immunogobulin M (IgM) antibodies, the first line of defence of the adaptive immune system, compared with H1N1 HA vaccination alone. Presentation e-posters may be accessed on the Company Presentations page under the Corporate News section of the RIGImmune website as well as the European Respiratory Society Congress website. About RIGImmune RIGImmune is a biopharmaceutical research company focused on the development of innovative RNA therapeutics to prevent or treat serious respiratory diseases with high unmet clinical needs. The company was co-founded by the prominent scientists, Drs. Akiko Iwasaki and Anna Pyle from Yale University, to advance the development of a novel class of oligonucleotides called stem-loop RNA therapeutics or “SLRs.” These SLRs were discovered in Dr. Pyle’s laboratory at Yale. In 2022, RIGImmune combined with a UK-based development company named SubIntro to develop non-lipid nanoparticle formulations for the effective delivery of a broad set of nucleic acid payloads directly to the respiratory tract. SubIntro was co-founded by the prominent research scientists and successful respiratory drug and formulation developers, Drs. Garth Rapeport, Kazuhiro Ito, and Jag Shur. RIGImmune’s lead product development candidate is RIG-101, a stem loop RNA therapeutic that targets the RIG-I pathway to enhance the innate immune response against viral respiratory diseases. RIGImmune’s second product development candidate is RIG-301, an mRNA formulated with the NEED™ technology, targeting the CFTR mutation in cystic fibrosis patients. RIGImmune has internally developed a proprietary nano-emulsion delivery technology platform named NEED™ to effectively deliver RNA compounds without the need for lipid nanoparticle encapsulation. About RIG-101RIG-101 is a potent agonist of RIG-I, which results in the induction of the interferon pathway in the respiratory epithelium when administered locally. RIG-101 is formulated with the company’s NEED™ (Nano-Emulsion Enhanced Delivery) technology and will enter a Phase 1/2a clinical program in mid-2025 for the prevention of seasonal viral exacerbations of asthma. RIGImmune is developing RIG-101 for delivery by multiple routes of administration, including intranasal (IN), a solution for inhalation for lower respiratory tract delivery, intra-muscular, and subcutaneous. In the first clinical program for RIG-101, the product development candidate will be administered by the intranasal route for delivery directly to nasal epithelium. Extensive prior research by noted investigators has shown delivery directly to the nasal epithelium can be critical for comprehensive protection from a broad range of respiratory viruses. About NEED™ (Nano-Emulsion Enhanced Delivery)NEED™ is a non-lipid nanoparticle (LNP) formulation platform developed by RIGImmune to effectively deliver RNA directly to the respiratory mucosa and avoid the limitations and potential toxicity concerns associated with LNP delivery systems. The principal novelty of the NEED™ formulation technology is the ability to transform surfactants and natural fatty acids into a proprietary nano-emulsion complex that encapsulates a nucleic acid and protects the payload while controlling particle size and charge, and facilitates intracellular uptake when administered directly to the respiratory epithelium. The first clinical presentation of the NEED™ delivery platform will be an aqueous formulation for the intranasal delivery of RIG-101 to the upper respiratory tract. RIGImmune has shown that NEED™ can also be administered by multiple routes, including a solution for inhalation to the lower respiratory tract, subcutaneous, and intra-muscular. Initial research conducted by the company has shown the NEED™ delivery platform technology could be compatible and effective with a diverse range of RNA and DNA therapeutics. Media Contact:Caren Begun TellMed Strategies908-947-0500 x723Caren.begun@tmstrat.com