CFBV

Assembly Biosciences Provides Update on its Core Inhibitor Pipeline, Reports Fourth Quarter and Year End 2022 Financial Results and Recent Highlights

Retrieved on: 
Wednesday, March 22, 2023
PK, DNA, Interim, Assembly, Virology, HBeAg, Safety, Aes, ECG, Viral, Hepatitis B, Toxicity, Research, EC50, CFBV, Trial of the century, Simplex, Plasma, Patient, Cmin, SAN, CccDNA, Viral hepatitis, HBV, Hepatitis, Disease, Pharmaceutical industry, Vaccine

In the Phase 1a study of 4334, all single-dose cohorts and the first multiple-dose cohort of 100 mg are complete.

Key Points: 
  • In the Phase 1a study of 4334, all single-dose cohorts and the first multiple-dose cohort of 100 mg are complete.
  • No serious adverse events (AEs) or patterns of clinically significant AEs or laboratory abnormalities have been observed in either clinical study.
  • General and administrative expenses were $24.1 million for the year ended December 31, 2022, compared to $28.8 million in 2021.
  • The decrease is primarily due to a reduction in professional and consulting fees and a reduction in stock-based compensation expense.

Arbutus Reports Fourth Quarter and Year End 2022 Financial Results and Corporate Update

Retrieved on: 
Thursday, March 2, 2023
Immune system, Safety, Arm, Roivant Sciences, RNA, VBR, PD-1, Clinical trial, Research, RNA interference, Initiate, HBsAg, Patient, HBV, Technology transfer, Assembly, PD-L1, Investment, COVID-19, Nivolumab, CFBV, Virology, Therapy, Cornerstone, Hepatitis B virus, Coronavirus, SARS-CoV-2, NA, Viral, IND, Pharmaceutical industry, Vaccine, Cryptocurrency

Preliminary data from the lead-in phase of the trial further validated AB-729’s capacity to reduce HBsAg.

Key Points: 
  • Preliminary data from the lead-in phase of the trial further validated AB-729’s capacity to reduce HBsAg.
  • We expect to announce preliminary data from patients receiving the combination of AB-729, NA therapy and IFN in the first half of 2023.
  • As of December 31, 2022, we had approximately 157.5 million common shares issued and outstanding, as well as approximately 15.5 million stock options outstanding.
  • Roivant Sciences Ltd. owned approximately 25% of our outstanding common shares as of December 31, 2022.

Arbutus Announces 2023 Corporate Objectives and Provides Financial Update

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Thursday, January 5, 2023
CFBV, Clinical trial, RNA, Arm, RNA interference, NA, Degenerative disease, Patient, Severe acute respiratory syndrome coronavirus 2, Investment, Therapy, IND, HBV, Nivolumab, Virology, Pharmaceutical industry

WARMINSTER, Pa., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, today announced its 2023 corporate objectives and provided a financial update.

Key Points: 
  • In addition, we are excited to move our newly nominated pan-coronavirus Mpro compound, AB-343, into the clinic.
  • With a strong balance sheet, we are well capitalized to fund our 2023 corporate objectives and we expect our cash runway to extend into the fourth quarter of 2024.”
    Announce additional off-treatment data from AB-729-001, our Phase 1a/1b clinical trial, in the first half of 2023.
  • Announce preliminary data from patients who received AB-729, NA and VTP-300 in the second half of 2023.
  • Initiate a Phase 1 healthy subject clinical trial with AB-161 in the first half of 2023; single-ascending dose data is expected from the clinical trial in the second half of 2023.

Assembly Biosciences Announces Promising Interim Results from Two Clinical Trials Evaluating Highly Potent Next-Generation Core Inhibitor Candidates ABI-H3733 and ABI-4334

Retrieved on: 
Monday, December 19, 2022
CFBV, Hepatitis B virus, Bio, MD, PK, Completeness, DNA, Interim, Degenerative disease, Trial of the century, Patient, Plasma, CccDNA, Safety, HBeAg, Therapy, HBV, AO, RNA, Assembly, Pharmaceutical industry

Both compounds have demonstrated significantly increased potency preclinically against both mechanisms compared to first-generation core inhibitors.

Key Points: 
  • Both compounds have demonstrated significantly increased potency preclinically against both mechanisms compared to first-generation core inhibitors.
  • This increased potency, particularly against cccDNA formation, is critical to Assembly Bio’s HBV strategy to bring finite therapies and cures for those living with chronic HBV (cHBV) infection.
  • Patients were randomized 8:2 between the new tablet formulation of 3733 and placebo for a period of 28 days.
  • Dosing for the second cohort is complete and initial data from this cohort are anticipated in the first quarter of 2023.

Arbutus Completes Enrollment in its Phase 2a Clinical Trial Combining AB-729 with NA Therapy and Peginterferon alfa-2a in Patients with Chronic Hepatitis B Virus Infection

Retrieved on: 
Tuesday, December 13, 2022
RNA, Hepatitis B, Coronavirus, Patient, Drug discovery, World Health Organization, Clinical trial, Annual report, RNA interference, PD, Hepatitis, Membrane protein, N-Acetylgalactosamine, HBsAg, Hepatocyte, SE, Safety, Non-cirrhotic portal fibrosis, Degenerative disease, Death, NA, HBV, Liver cancer, Hepatitis B virus, Risk, Vaccine, Drug Quality and Security Act, HBeAg, Arbutus, Virology, Immune system, Severe acute respiratory syndrome coronavirus 2, Patent, Antigen, CFBV, Cirrhosis, COVID-19, Therapy, Conditional sentence, Pharmaceutical industry, Peginterferon-alfa

WARMINSTER, Pa., Dec. 13, 2022 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, today announced preliminary data from the AB-729 lead-in portion of its Phase 2a clinical trial combining AB-729 with nucleos(t)ide analogue (NA) therapy and Peginterferon alfa-2a (IFN). The data reinforces AB-729’s surface antigen reducing-capacity, while continuing to exhibit a generally safe and well-tolerated profile in patients with chronic Hepatitis B virus (cHBV). Given that only a few patients are in the early weeks of the IFN phase of the clinical trial, the Company intends to provide additional updated data in the first half of next year which will include preliminary results of the IFN portion of the trial.

Key Points: 
  • The data reinforces AB-729’s surface antigen reducing-capacity, while continuing to exhibit a generally safe and well-tolerated profile in patients with chronic Hepatitis B virus (cHBV).
  • Enrollment is complete in the clinical trial with 43 patients having received at least one dose of AB-729.
  • As the trial progresses, patients will be randomized into various treatment arms which include the combination of AB-729, NA therapy and short courses of IFN for either 12 or 24 weeks.
  • Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV).

Arbutus Reports Third Quarter 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, November 9, 2022
GLOBE, CFBV, Peripheral neuropathy, Investment, Cornerstone, Severe acute respiratory syndrome coronavirus 2, HBV, Nasdaq, AASLD, VBR, Mouse, Technology transfer, Degenerative disease, University, Coronavirus, RNA interference, Company, Roivant Sciences, Clinical trial, Virology, Research, Conference, NA, Patient, Discovery, Therapy, ALT, COVID-19, Assembly, Vaccine, Pharmaceutical industry, Air cargo, IND, HBsAg, Vaccitech

WARMINSTER, Pa., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, today reports its third quarter 2022 financial results and provides corporate updates.

Key Points: 
  • We reported at AASLD off-treatment data which showed that AB-729 treatment results in long-lasting control of HBV biomarker levels.
  • The Phase 2a clinical trial evaluating AB-729 in combination with NA therapy and short courses of Peg-IFN-2a (AB-729-201) in cHBV patients is continuing.
  • Total revenue was $6.0 million for the three months ended September 30, 2022 compared to $3.3 million for the same period in 2021.
  • Roivant Sciences Ltd. owned approximately 25% of the Companys outstanding common shares as of September 30, 2022.

Arbutus Presents AB-729 Clinical Data and AB-101 Preclinical Data at AASLD - The Liver Meeting®

Retrieved on: 
Tuesday, November 1, 2022
Liver, Cornerstone, HBsAg, Virology, DC, Conference, Hepatitis B virus, Clinical trial, Biomarker, GLOBE, CFBV, Nasdaq, NA, HBV, ALT, Safety, Degenerative disease, RNA interference, Conference call, Patient, AASLD, Therapy, Vaccine, Pharmaceutical industry, Medical imaging, Medical device, Cohort

All of the data will be presented as poster presentations at AASLD The Liver Meeting being held in Washington, DC, November 4-8, 2022.

Key Points: 
  • All of the data will be presented as poster presentations at AASLD The Liver Meeting being held in Washington, DC, November 4-8, 2022.
  • Three patients experienced transient HBV DNA elevations that spontaneously resolved without intervention, which further supports AB-729's potential for immunological control.
  • Dr. Gaston Picchio, Chief Development Officer of Arbutus Biopharma, stated, I remain impressed with the longer follow up data we generated from our AB-729-001 trial.
  • The results showed that monotherapy with AB-101 reduced PD-L1 in liver immune cells, confirming liver target engagement of the compound.

Arbutus Biopharma Announces Issuance of a New Key U.S. Patent Related to AB-729

Retrieved on: 
Tuesday, August 30, 2022
RNA interference, Liver cancer, CFBV, COVID-19, N-Acetylgalactosamine, HBV, RNA, Securities Exchange Act of 1934, Cirrhosis, Program, Membrane protein, Hepatocyte, Hepatitis B virus, Securities Act of 1933, Arbutus, Patent, Virology, Vaccine, Death, USPTO, Coronavirus, Risk, Hepatitis B, World Health Organization, Antigen, Goal, Degenerative disease, Severe acute respiratory syndrome coronavirus 2, GLOBE, PD, Nasdaq, Immune system, Therapy, NA, Conditional sentence, World, Drug discovery, Annual report, Forward-looking statement, Patient, Pharmaceutical industry

11,427,823, which provides composition of matter patent protection for Arbutus AB-729 RNAi therapeutic product.

Key Points: 
  • 11,427,823, which provides composition of matter patent protection for Arbutus AB-729 RNAi therapeutic product.
  • The patent is expected to provide Arbutus with exclusivity for AB-729 out to at least April 2038.
  • Furthermore, AB-729 has shown achievement of virologic control in five cHBV patients after discontinuing treatment with AB-729 and nucleos(t)ide analog (NA)-therapy.
  • Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases.

Arbutus Reports Second Quarter 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, August 4, 2022
Roivant Sciences, Virology, Journal of Clinical Oncology, Coronavirus, Annual general meeting, COVID-19, Arbutus, VBR, HBsAg, Technology transfer, RNA interference, Degenerative disease, RNA, HBV, ASCO, Patient, Company, ALT, Association, Nasdaq, Safety, Society, American Society of Clinical Oncology, Assembly, Journal, ILC, EASL, Investment, European Association for the Study of the Liver, Antibody, Research, Therapy, Achievement, GLOBE, Severe acute respiratory syndrome coronavirus 2, Â, NA, CFBV, PD-L1, Clinical trial, Vaccine, Pharmaceutical industry, Tutoring, Liver, IND, Vaccitech

WARMINSTER, Pa., Aug. 04, 2022 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, today reports its second quarter 2022 financial results and provides corporate updates.

Key Points: 
  • WARMINSTER, Pa., Aug. 04, 2022 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, today reports its second quarter 2022 financial results and provides corporate updates.
  • Finally, our financial position is strong with a projected cash runway into the second quarter of 2024.
  • The Company is on-track to report initial data in the second half of 2022.
  • The Company will provide an update with respect to the status and timing of this clinical trial in the second half of 2022.

Arbutus Biopharma Provides Update on the Phase 2A Combination Trial with AB-729 and a Capsid Inhibitor

Retrieved on: 
Wednesday, July 20, 2022
Goal, Patient, Conditional sentence, Death, N-Acetylgalactosamine, Severe acute respiratory syndrome coronavirus 2, CFBV, HBsAg, GLOBE, HBeAg, Forward-looking statement, World, Cornerstone, PD, Cirrhosis, Drug discovery, Hepatitis B virus, Securities Act of 1933, Securities Exchange Act of 1934, Risk, RNA interference, Patent, Immune system, COVID-19, Safety, World Health Organization, NA, Assembly, Virology, Hepatitis B, Clinical trial, Liver cancer, VBR, Coronavirus, Nasdaq, Pharmacokinetics, Therapy, Membrane protein, HBV, Hepatocyte, Annual report, Program, Drug Quality and Security Act, Antigen, RNA, Vaccine, Degenerative disease, Pharmaceutical industry, Arbutus

WARMINSTER, Pa., July 20, 2022 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, today announced that while its partner, Assembly Biosciences, has decided to discontinue development of its investigational hepatitis B virus core inhibitor candidate vebicorvir (VBR), it plans, in consultation with Assembly Biosciences, to continue dosing patients in the Phase 2a triple combination clinical trial evaluating its proprietary RNAi therapeutic, AB-729, VBR and nucleos(t)ide analogue (NA) therapy for the treatment of patients with chronic HBV infection (cHBV). Preliminary data from the trial are expected in the second half of 2022.

Key Points: 
  • We intend, in collaboration with Assembly, to continue the clinical trial in order to fully and accurately assess the results.
  • The results from this trial coupled with the additional data we anticipate collecting from our capsid inhibitor program will help inform our go-forward combination strategy in the development of cHBV treatments."
  • AB-729 targets hepatocytes using Arbutus novel covalently conjugated N-Acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery.
  • Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases.