CccDNA

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

Retrieved on: 
Wednesday, February 14, 2024
Infectious Diseases, FDA, Genetics, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Oncology, HBV, University College London, FRCS, Toxicology, Precision BioSciences, Gene editing, MD, Food, HBsAg, Precision, Feedback, CccDNA, FCP, Patient, IND, Trial of the century, CTA

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)

Retrieved on: 
Thursday, December 7, 2023
Liver, AASLD, Multiple, NASH, SHBG, HBV, MBA, SAN, Therapy, Thyroid, THR, Doctor of Philosophy, HBeAg, CccDNA, Safety, Patient, Pharmacology, Pharmaceutical industry

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)

Retrieved on: 
Friday, November 10, 2023
Hepatology, Safety, DNA, SAN, Therapy, PEI, HBsAg, AASLD, Emory University, Liver, Week, Doctor of Philosophy, B, CccDNA, Liver cancer, Hepatitis B virus, CHB, Entecavir, MBA, University, Hepatitis, Hong Kong, Physician, Poster, ETV, RNA, Vaccine, Pharmaceutical industry, HBeAg, Boston, New York University, Gastroenterology, Jacob Aligo

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

Retrieved on: 
Wednesday, December 6, 2023
Research, Infectious Diseases, Genetics, Clinical Trials, Other Health, Biotechnology, General Health, Health, Science, Other Science, DNA methylation, Chromosome, DNA, Therapy, Hepatitis B virus, Liver, Tune, Mouse, HBV, Patient, TEMPO, Chimera, Hepatocyte, PCSK9, Genome, FRG, Vaccine, Dietary supplement, Medical device, CccDNA

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

Retrieved on: 
Monday, November 13, 2023
Research, Infectious Diseases, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Oncology, Webcast, ID, Safety, DNA, Gene editing, Entrepreneurship, HBsAg, AASLD, IND, HBeAg, HBV, Conference call, Liver, CccDNA, Conference, CHB, Hepatitis, CTA, Precision BioSciences, Vaccine, Broadcasting, Boston

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.

Tune Therapeutics Reveals Epigenetic Editing Program Targeting Hepatitis B Virus

Retrieved on: 
Monday, November 13, 2023
Biotechnology, Infectious Diseases, Health, Genetics, Clinical Trials, Hepatology, DNA, Therapy, Hepatitis B virus, AASLD, Tune, HBV, Multimedia, Patient, TEMPO, CccDNA, Genome, Standard of care, University, Epigenetics, SOC, Vaccine, Medicine, Boston

Pioneering epigenome editing company Tune Therapeutics has announced it is working on a new and potentially curative approach to treating chronic HBV infection.

Key Points: 
  • Pioneering epigenome editing company Tune Therapeutics has announced it is working on a new and potentially curative approach to treating chronic HBV infection.
  • (Graphic: Business Wire)
    The Tune HBV program was unveiled by Dr. Ed Gane, Professor of Medicine at the University of Auckland and world-renowned authority on Hepatitis B Virus (HBV) at the American Association for the Study of Liver Diseases ( AASLD ) conference in Boston, MA on November 11th.
  • As Tune Therapeutics’ Chief Scientific Officer Derek Jantz elucidates, this fact was the crucial driver for a new therapeutic approach using TEMPO.
  • “We can leverage the same, exact mechanism of virus control that we observe in these functionally-cured patients by switching off the virus using a targeted epigenetic silencer.

Precision BioSciences Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Friday, August 4, 2023
Research, FDA, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, Serum, HBsAg, Congress, Development, Patient, Risk, Cell, Eli Lilly and Company, CccDNA, Infant, Hepatitis B virus, Hepatitis, Heart, Cash, University, Duchenne muscular dystrophy, Gene, Gene editing, Diaphragm, DSM-IV codes, Precision, Liver cancer, Conditional sentence, European Association for the Study of the Liver, Death, Cirrhosis, IND, Genome, Precision BioSciences, DNA, AAV, Messenger, Hepatocyte, CAR, Administration, Blood, Therapy, HBV, Hemoglobinopathy, EASL, Central nervous system, Molecular Partners, CTA, Inflammation, Skeletal muscle, State Administrative Expenses, DMD, Novartis, OTC, Sickle cell disease, NHP, Regulation of tobacco by the U.S. Food and Drug Administration, Society, Food, Pharmaceutical industry, Vaccine, Prevail, Liver

Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS®-based in vivo gene editing and ex vivo allogeneic CAR T therapies, today announced financial results for the second quarter ended June 30, 2023 and provided a business update.

Key Points: 
  • Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS®-based in vivo gene editing and ex vivo allogeneic CAR T therapies, today announced financial results for the second quarter ended June 30, 2023 and provided a business update.
  • “The first half of 2023 has been a busy time at Precision.
  • Cash and Cash Equivalents: As of June 30, 2023, Precision had approximately $137.8 million in cash and cash equivalents.
  • Weighted average shares of common stock outstanding were approximately 114.1 million for the quarter ended June 30, 2023, as compared to approximately 68.0 million for the quarter ended June 30, 2022.

Best Presentation Award at EASL Congress 2023: First-in-class Bispecific Antibodies Anti-HBs×CD3 and Anti-HBs×CD28 Showed Strong Preclinical Efficacy in HBV Cure

Retrieved on: 
Wednesday, July 12, 2023
EASL, Human, POC, Leibniz-Institute of Virology, Vaccination, CD3, CD28, Serum, HBeAg, University Medical Center, Institute of technology, Infection, Technical University of Munich, University Medical Center Hamburg-Eppendorf, Antibody, SCG, Hepatocyte, Liver cancer, Hepatitis B, HBsAg, Death, Cancer, Liver, Infant, CccDNA, Lymphocyte, HBV, Vaccine, Virology

A combination of anti-HBs×CD3 and anti-HBs×CD28 activated human lymphocytes in HBV-infected human liver chimeric mice and demonstrated potent in vivo antiviral efficacy.

Key Points: 
  • A combination of anti-HBs×CD3 and anti-HBs×CD28 activated human lymphocytes in HBV-infected human liver chimeric mice and demonstrated potent in vivo antiviral efficacy.
  • Levels of HBV pgRNA, HBV DNA, and cccDNA in the liver dropped significantly, consistent with the decrease of HBV serum parameters, indicating efficient clearance of infected hepatocytes.
  • One in three humans experiences an HBV infection during their lifetime, and almost 300 million people are chronically infected worldwide.
  • Approximately 25% of chronic HBV infections progress to liver cancer, and HBV contributes to an estimated 820,000 deaths annually.

Precision BioSciences Announces Oral Presentation of Positive ARCUS® Gene Editing Data at International Liver Congress 2023

Retrieved on: 
Thursday, June 22, 2023
Research, Infectious Diseases, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Oncology, DNA, EASL, Serum, Gene editing, Inflammation, AAV, Messenger, Hepatocyte, Precision BioSciences, Liver cancer, Congress, Conditional sentence, CAR, Patient, Risk, Blood, Entrepreneurship, European Association for the Study of the Liver, Hepatitis B virus, CccDNA, Abstract, Death, Cirrhosis, HBV, Hepatitis, Genome, Vaccine, Liver, HBsAg

Hepatitis B virus (HBV) causes inflammation and damage to the liver, leading to chronic infection and increased risk of death from liver cancer or cirrhosis.

Key Points: 
  • Hepatitis B virus (HBV) causes inflammation and damage to the liver, leading to chronic infection and increased risk of death from liver cancer or cirrhosis.
  • There is no cure for chronic hepatitis B and current treatments rarely result in functional cure, primarily due to persistence of viral DNA in the liver.
  • This integrated HBV DNA produces the viral protein, hepatitis B surface antigen (HBsAg), which is secreted in the blood.
  • Eliminating both the cccDNA and HBsAg are key parameters for achieving a functional cure of HBV,” said Jeff Smith, Co-Founder and Chief Research Officer at Precision Biosciences.

Assembly Biosciences Presents New Data Highlighting Entry Inhibitor and Core Inhibitor Programs at EASL’s International Liver Congress™ 2023

Retrieved on: 
Wednesday, June 21, 2023
DNA, EASL, NTCP, Hepatitis, Assembly, Liver disease, Biotechnology, Aes, HDV, Pharmacokinetics, Viral, Hepatitis B, SAD, VBR, Hepatitis B virus, EC50, CFBV, Doctor of Philosophy, Hepatocyte, HBsAg, Congress, Death, Plasma, Patient, SAN, Annual general meeting, MAD, Poster, European Association for the Study of the Liver, ETV, CccDNA, Sodium, Viral hepatitis, HBV, Safety, Vaccine, Pharmaceutical industry, Liver

“We are excited to share the latest data on our promising HDV/HBV entry inhibitor program and next-generation HBV core inhibitors with the scientific community,” said William Delaney, PhD, chief scientific officer of Assembly Bio.

Key Points: 
  • “We are excited to share the latest data on our promising HDV/HBV entry inhibitor program and next-generation HBV core inhibitors with the scientific community,” said William Delaney, PhD, chief scientific officer of Assembly Bio.
  • “Data presented from our entry inhibitor program, from which we expect to nominate a development candidate this year, highlight our rapid progress in developing a small molecule inhibitor of this validated mechanism.
  • ABI-H3733 (3733) and ABI-4334 (4334) are novel, structurally distinct, orally bioavailable investigational core inhibitors that exhibit nM potency against pgRNA encapsidation and covalently closed circular (ccc)DNA formation.
  • Subsequent to presentation at EASL’s International Liver Congress™ 2023, Assembly Bio intends to make the posters available on the “Events & Presentations” page in the “Investors” section of its website at www.assemblybio.com .