CccDNA

JNJ-73763989 (JNJ-6379) for Chronic Hepatitis B in 6MM: Market Size, Forecasts, and Emerging Insight 2019-2023 & 2024-2032 - ResearchAndMarkets.com

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Vendredi, mai 17, 2024

"JNJ-73763989 Market Size, Forecast, and Emerging Insight - 2032" report provides comprehensive insights about JNJ-73763989 for chronic hepatitis B in the six major markets.

Key Points: 
  • "JNJ-73763989 Market Size, Forecast, and Emerging Insight - 2032" report provides comprehensive insights about JNJ-73763989 for chronic hepatitis B in the six major markets.
  • Other emerging products for chronic hepatitis B are expected to give tough market competition to JNJ-73763989 and launch of late-stage emerging therapies in the near future will significantly impact the market.
  • What are the other emerging products available and how are these giving competition to JNJ-73763989 for chronic hepatitis B?
  • Which are the late-stage emerging therapies under development for the treatment of chronic hepatitis B?

Precision BioSciences Reports First Quarter 2024 Financial Results and Provides Business Update

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Lundi, mai 13, 2024

Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, insertion, and excision, announced financial results for the first quarter ended March 31, 2024, and provided a business update.

Key Points: 
  • Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, insertion, and excision, announced financial results for the first quarter ended March 31, 2024, and provided a business update.
  • PBGENE-HBV is advancing through final toxicology studies and Precision expects to submit an IND and/or CTA for this program in 2024.
  • Cash and Cash Equivalents: As of March 31, 2024, Precision had approximately $137.8 million in cash and cash equivalents.
  • Shares: Basic weighted-average common shares outstanding for the first quarter of 2024 were 5,060,978 compared to 3,709,894 for the same period in 2023.

Excision BioTherapeutics Announces Oral Presentation Highlighting Positive Data from its HBV Program, EBT-107, at the Upcoming ASGCT 2024 Annual Meeting

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Lundi, avril 22, 2024

HBV is one of the most prevalent infectious diseases worldwide that lacks curative therapies.

Key Points: 
  • HBV is one of the most prevalent infectious diseases worldwide that lacks curative therapies.
  • While existing antiviral and immunomodulator treatments slow liver damage by reducing viral load, they fail to eliminate covalently closed circular DNA (cccDNA) that enables persistent viral infection.
  • Excision’s lead product candidate for the treatment of HBV infection, EBT-107, uses dual guide RNAs to effectively deactivate the virus and prevent the emergence of escape variants.
  • Testing a selected combination of editing nucleases and paired guide RNAs in HBV-infected cells, we observed decreased copies of total HBV DNA.

Drug Farm Announces anti-HBV immunomodulator, DF-006 is Accepted as a Late-Breaking Presentation at the 2024 European Association for the Study of the Liver Conference

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Jeudi, mai 2, 2024

Title: A phase 1, double-blinded, randomized, placebo-controlled, multicenter global study evaluating the safety, tolerability, and antiviral activity of DF-006 in chronic hepatitis B, virologically-suppressed patients.

Key Points: 
  • Title: A phase 1, double-blinded, randomized, placebo-controlled, multicenter global study evaluating the safety, tolerability, and antiviral activity of DF-006 in chronic hepatitis B, virologically-suppressed patients.
  • DF-006 is a first-in-class, orally administered ALPK1 agonist immunomodulator that potently stimulates local, innate immunity in the liver1.
  • DF-006 has a novel mechanism of action that is capable of stimulating the body’s own immune system to help clear the infection.
  • “DF-006 has demonstrated potent antiviral responses in preclinical studies, including inhibition of cccDNA and recruitment of T-cells.

Precision BioSciences Announces Late-Breaking Poster Presentation at the European Association for Study of the Liver (EASL) Congress 2024

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Mercredi, mai 1, 2024

Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, insertion, and excision, today announced that the company will present late-breaking preclinical data from its clinical candidate, PBGENE-HBV, for the treatment of chronic hepatitis B (HBV) during a poster presentation at the European Association for Study of the Liver (EASL) Congress 2024 being held June 5-8, 2024 in Milan, Italy.

Key Points: 
  • Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, insertion, and excision, today announced that the company will present late-breaking preclinical data from its clinical candidate, PBGENE-HBV, for the treatment of chronic hepatitis B (HBV) during a poster presentation at the European Association for Study of the Liver (EASL) Congress 2024 being held June 5-8, 2024 in Milan, Italy.
  • “We look forward to the opportunity to share the latest new preclinical safety data from our PBGENE-HBV clinical candidate at the EASL Congress,” said Jeff Smith, Co-Founder and Chief Research Officer at Precision BioSciences.
  • PBGENE-HBV is designed to safely eliminate cccDNA and inactivate integrated HBV DNA.
  • As we look ahead, we remain on track to file an investigational new drug (IND) and/or clinical trial application (CTA) in 2024.”
    Presenter: Emily Harrison, Senior Scientist - Hepatitis Research Leader, Precision Biosciences

Precision BioSciences Receives Pre-IND Feedback from US FDA for PBGENE-HBV as it Advances Towards Clinical Readiness

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Mercredi, février 14, 2024

Receipt of this regulatory feedback provides alignment and clarity on Precision’s final IND/CTA-enabling preclinical plans and clinical strategy for PBGENE-HBV prior to advancement into Phase 1 clinical studies.

Key Points: 
  • Receipt of this regulatory feedback provides alignment and clarity on Precision’s final IND/CTA-enabling preclinical plans and clinical strategy for PBGENE-HBV prior to advancement into Phase 1 clinical studies.
  • “Based on this feedback, we have initiated the final preclinical studies as well as site selection efforts as we move towards clinical readiness.
  • The pre-IND meeting with FDA provided feedback on overall design for the proposed first-in-human clinical study as well as feedback on the toxicology and specificity assessments.
  • “Given the constructive feedback from the FDA and other regulatory agencies worldwide, I look forward to seeing this novel modality progressing to further assessment in the clinic.”

Aligos Therapeutics Presents Positive Clinical Data at Hep-DART 2023 from Phase 1 Studies in HBV (ALG-000184) and NASH (ALG-055009)

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Jeudi, décembre 7, 2023

SOUTH SAN FRANCISCO, Calif., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, delivered oral presentations of clinical data for its capsid assembly modulator-empty (CAM-E), ALG-000184, and its thyroid hormone receptor-beta (THR-β) drug candidate, ALG-055009, at the Hep-DART 2023 meeting, held in Cabo San Lucas, Mexico, from December 3 – 7, 2023.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, delivered oral presentations of clinical data for its capsid assembly modulator-empty (CAM-E), ALG-000184, and its thyroid hormone receptor-beta (THR-β) drug candidate, ALG-055009, at the Hep-DART 2023 meeting, held in Cabo San Lucas, Mexico, from December 3 – 7, 2023.
  • The presentations can be found on the “Scientific Presentations & Conferences” section of the Aligos website ( www.aligos.com ).
  • “We’re greatly encouraged by the substantial and consistent reductions in HBV viral markers observed during prolonged dosing of ALG-000184 and are grateful for the opportunity to share these results with the scientific community at the Hep-DART 2023 meeting,” said Lawrence Blatt, Ph.D., MBA, Chairman & CEO of Aligos Therapeutics.
  • As presented at AASLD, ALG-055009 appears to have best-in-class potential.

Aligos Therapeutics Presents Positive Data at the AASLD Liver Meeting® 2023 Demonstrating that Treatment with ALG-000184 (CAM-E) Results in Significant Multi-log Reductions in Hepatitis B Antigens (HBsAg, HBcrAg and HBeAg)

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Vendredi, novembre 10, 2023

SOUTH SAN FRANCISCO, Calif., Nov. 10, 2023 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced that emerging hepatitis B antigen lowering data for its capsid assembly modulator – empty (CAM-E) drug, ALG-000184, are available as a late breaking poster at The Liver Meeting® of the American Association for the Study of Liver Diseases (AASLD), being held in Boston, Massachusetts, November 10 – 14, 2023.

Key Points: 
  • The data will be presented by Dr. Man-Fung Yuen, Chair and Professor of Gastroenterology and Hepatology at the University of Hong Kong, in Poster Hall C on Monday November 13 from 1-2 pm ET.
  • “ALG-000184 appears to have best-in-class antiviral properties which are also unique compared to other drug classes being evaluated for the treatment of chronic hepatitis B (CHB).
  • If the trends observed to date continue, ALG-000184 has the potential to become a cornerstone therapy in the treatment of CHB.
  • The antiviral effects of ALG-000184 presented at AASLD indicate that this drug is achieving significant viral suppression, likely via inhibition of cccDNA synthesis.

Tune Therapeutics Presents First Data Supporting TUNE-401: a First-in-Class Epigenetic Silencer for Hepatitis B

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Mercredi, décembre 6, 2023

Leading epigenome editing company Tune Therapeutics presented data in support of its chronic Hepatitis B Virus (HBV) program, demonstrating the ability to durably silence essential mechanisms of viral replication and persistence across a range of model systems.

Key Points: 
  • Leading epigenome editing company Tune Therapeutics presented data in support of its chronic Hepatitis B Virus (HBV) program, demonstrating the ability to durably silence essential mechanisms of viral replication and persistence across a range of model systems.
  • Importantly, the TEMPO platform does this via epigenetic processes, and without cutting, damaging, or altering genomic DNA sequences in any way.
  • “Through the richness of these data sets, we found multiple repression candidates that worked well in both contexts.
  • As such, they represent the gold standard for assessing the dose and efficacy for liver-directed therapeutics ahead of human clinical trials.

Precision BioSciences Presents Late-Breaking Data Highlighting Preclinical Efficacy and Safety of PBGENE-HBV for Chronic Hepatitis B at AASLD’s The Liver Meeting 2023

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Lundi, novembre 13, 2023

The poster highlights preclinical data demonstrating PBGENE-HBV’s ability to eliminate cccDNA and inactivate hepatitis B virus (HBV) DNA, meriting further investigation as a potentially curative treatment for chronic hepatitis B (CHB).

Key Points: 
  • The poster highlights preclinical data demonstrating PBGENE-HBV’s ability to eliminate cccDNA and inactivate hepatitis B virus (HBV) DNA, meriting further investigation as a potentially curative treatment for chronic hepatitis B (CHB).
  • The final clinical candidate nuclease demonstrated no detectable off-target editing at doses that maximized on-target editing.
  • In multiple HBV disease models, PBGENE-HBV demonstrated ability to inhibit viral markers and eliminate cccDNA in HBV-infected primary human liver cells.
  • These data are further supported by a high level of viral engagement and a 95% reduction in hepatitis B surface antigen (HBsAg) in an episomal HBV mouse model.