HBV

Drug Farm Doses First Patient in Part 3 of Phase 1 Chronic Hepatitis B Trial

Retrieved on: 
Tuesday, September 26, 2023

Drug Farm, a clinical-stage biopharmaceutical company, announced today that it has dosed the first chronic hepatitis B patient in Part 3 of its Phase 1 clinical trial (ANZCTR Trial ID: ACTRN12621000592842 ).

Key Points: 
  • Drug Farm, a clinical-stage biopharmaceutical company, announced today that it has dosed the first chronic hepatitis B patient in Part 3 of its Phase 1 clinical trial (ANZCTR Trial ID: ACTRN12621000592842 ).
  • This trial is evaluating Drug Farm’s first-in-class ALPK1 agonist, DF-006, as a monotherapy and in combination with standard-of-care nucleos(t)side reverse transcriptase inhibitors in treatment-naïve and virologically suppressed patients with chronic hepatitis B infection.
  • Drug Farm is a private biotechnology company developing innovative treatments targeting innate immunity for hepatitis B, heart and kidney diseases, and ROSAH (retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis and headache) syndrome.
  • Using the IDInVivo platform, Drug Farm has identified novel innate immunity pathways and targets and is now rapidly advancing multiple first-in-class drug candidates into clinical development.

Bluejay Therapeutics expands management team and hired Christopher Holterhoff as senior Vice President, head of business development

Retrieved on: 
Thursday, September 21, 2023

He will be a member of Bluejay’s Executive team, reporting to Keting Chu, Founder and CEO of Bluejay Therapeutics.

Key Points: 
  • He will be a member of Bluejay’s Executive team, reporting to Keting Chu, Founder and CEO of Bluejay Therapeutics.
  • “I am delighted to welcome Chris to the senior leadership team at Bluejay”, stated Mrs. Chu.
  • “Chris has an outstanding track record in business & corporate development with both public and private biotech and pharma companies.
  • Before joining Bluejay, he served as VP, Business & Corporate development at LEXEO Therapeutics, where he led all business development, strategic transactions and played a significant role in the company’s capital raising activities.

Assembly Biosciences to Highlight Pipeline Progress in HBV and HDV at the 2023 International HBV Meeting

Retrieved on: 
Tuesday, September 19, 2023

SOUTH SAN FRANCISCO, Calif., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today announced that the company will present new preclinical data from multiple hepatitis B virus (HBV) and hepatitis D virus (HDV) pipeline programs at the 2023 International HBV Meeting taking place in Kobe, Japan, September 19-23, 2023.

Key Points: 
  • At the meeting, one oral presentation will highlight progress in the company’s HBV/HDV oral entry inhibitor program including activity, selectivity and pharmacokinetic (PK) data that support advancement towards development candidate nomination.
  • A second oral presentation reports new data for ABI-4334 (4334), Assembly Bio’s most potent capsid assembly modulator (CAM) with a potential best-in-class profile, describing the prevention of HBV DNA integration in vitro.
  • The poster presentation, from the company’s interferon-α receptor (IFNAR) agonist program, characterizes small molecule IFNAR agonists that closely mimic interferon-α’s signaling.
  • In patients with chronic HBV infection, HBV DNA integration has been linked to the development of liver cancer.

Global Chemiluminescence Immunoassay Industry Research Report 2023: Increasing Incidence of Diseases and Technological Advancements to Drive Market Expansion to 2028 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, September 20, 2023

The "Global Chemiluminescence Immunoassay Market by Product (Instrument, Consumable), Technology (Chemiluminescence Enzyme, Microparticle Chemiluminescence), Sample (Blood, Urine), Application (Infectious Disease, Oncology), End User - Forecast to 2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Chemiluminescence Immunoassay Market by Product (Instrument, Consumable), Technology (Chemiluminescence Enzyme, Microparticle Chemiluminescence), Sample (Blood, Urine), Application (Infectious Disease, Oncology), End User - Forecast to 2028" report has been added to ResearchAndMarkets.com's offering.
  • The global chemiluminescence immunoassay market, valued at approximately USD 13.2 billion in 2023, is expected to experience significant growth, reaching USD 19.0 billion by 2028, with a notable CAGR of 7.5%.
  • This comprehensive report provides valuable insights for both established market leaders and newcomers, offering precise revenue estimations for the overall market and its subsegments.
  • Oncology testing segment is expected to grow at the highest rate within the chemiluminescence immunoassay market.

Vaccitech to Host KOL Webinar on Seeking a Functional Cure for Chronic Hepatitis B on September 20, 2023

Retrieved on: 
Wednesday, September 13, 2023

Details are as follows:

Key Points: 
  • Details are as follows:
    To register for the event, click here .
  • The Vaccitech management team will provide a clinical overview of VTP-300, the first antigen-specific immunotherapy that has been shown to induce sustained reductions in Hepatitis B surface antigen, a marker of the disease.
  • Vaccitech is studying VTP-300, including in combination with siRNA and low-dose anti-PD-1 antibodies, as part of the search for a regimen that could lead to a potential functional cure for HBV.
  • A live Q&A session will follow the formal presentations.

Arbutus Announces Pipeline Updates and Dosing of the First Subject in the Phase 1a/1b Clinical Trial with AB-101; Cash Runway Extended

Retrieved on: 
Monday, September 11, 2023

WARMINSTER, Pa., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, today announced pipeline updates including its continued focus on its hepatitis B virus (HBV) assets, imdusiran (AB-729) as a cornerstone therapy in a functional cure treatment regimen for patients with chronic hepatitis B virus (cHBV), as well as its oral PD-L1 inhibitor, AB-101. In addition, the Company is discontinuing development of its oral RNA destabilizer, AB-161, due to a pre-clinical toxicology finding not related to peripheral neuropathy. There were no safety issues reported in the healthy subjects that received single doses of AB-161 in the Phase 1 clinical trial. The company is also discontinuing its efforts to identify and develop a coronavirus combination therapy that included AB-343 its Mpro candidate, due to an unfavorable PK profile noted in the IND-enabling studies, and a potential nsp12 polymerase inhibitor. These pipeline changes are expected to extend the Company’s cash runway through Q3 2025.

Key Points: 
  • There were no safety issues reported in the healthy subjects that received single doses of AB-161 in the Phase 1 clinical trial.
  • These pipeline changes are expected to extend the Company’s cash runway through Q3 2025.
  • “Imdusiran has a strong foundation of safety and efficacy data, and we are actively advancing multiple ongoing Phase 2a combination clinical trials.
  • Initial data from part one of the clinical trial are expected in the first half of 2024.

Precision BioSciences Hosts Virtual R&D Day Highlighting its Proprietary ARCUS Technology and Recent In Vivo Gene Editing Program Developments

Retrieved on: 
Tuesday, September 12, 2023

Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies, today announced that the Company plans to highlight its current development programs, pipeline updates, and underlying ARCUS platform technology during a virtual R&D Day to be held today at 9:00 AM ET.

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, today announced that the Company plans to highlight its current development programs, pipeline updates, and underlying ARCUS platform technology during a virtual R&D Day to be held today at 9:00 AM ET.
  • “At Precision, we are moving forward with a renewed identity and focus on our core foundational strength as a gene editing company.
  • “In addition to illustrating where we see a clear advantage for ARCUS, we will drill down on the novel attributes of ARCUS that inform our development program strategy.
  • “Together with PBGENE-HBV, we believe that both of these programs are emblematic of the unique advantages of our ARCUS technology.

VBI Vaccines Partner Brii Biosciences Announces Topline Interim Results of Phase 2 Study Evaluating BRII-179 (VBI-2601) in Combination With PEG-IFNα for the Treatment of Chronic Hepatitis B

Retrieved on: 
Wednesday, September 6, 2023

VBI Vaccines Inc. (Nasdaq: VBIV) (“VBI” or the “Company”) today announced that its strategic hepatitis B (HBV) partner, Brii Biosciences (Brii Bio) (Stock code: 2137.HK), announced topline cohort-level unblinded Week 36 data from interim analysis of a randomized, placebo-controlled and double-blinded Phase 2 study of BRII-179 (VBI-2601), a first-in-class Pre-S1/Pre-S2/S therapeutic vaccine, in combination treatment with pegylated interferon-alpha (PEG-IFNα) in chronic hepatitis B virus (HBV) patients compared with PEG-IFNα only treatment.

Key Points: 
  • VBI Vaccines Inc. (Nasdaq: VBIV) (“VBI” or the “Company”) today announced that its strategic hepatitis B (HBV) partner, Brii Biosciences (Brii Bio) (Stock code: 2137.HK), announced topline cohort-level unblinded Week 36 data from interim analysis of a randomized, placebo-controlled and double-blinded Phase 2 study of BRII-179 (VBI-2601), a first-in-class Pre-S1/Pre-S2/S therapeutic vaccine, in combination treatment with pegylated interferon-alpha (PEG-IFNα) in chronic hepatitis B virus (HBV) patients compared with PEG-IFNα only treatment.
  • VBI and Brii Bio reported in previous studies that BRII-179 (VBI-2601) induced broad antibody and T-cell responses against Pre-S1, Pre-S2, and S epitopes in HBV patients.
  • Brii Bio’s detailed press release can be found here: https://www.briibio.com/en/media/press-release/20230906/ .
  • “We share Brii Bio’s excitement about this data and congratulate them on their continued ability to move quickly and execute clinical programs as they seek to deliver higher hepatitis B functional cure rates,” said Jeff Baxter, President and CEO of VBI.

AusperBio Announces FDA Clearance of IND Application of AHB-137 in Chronic Hepatitis B Treatment

Retrieved on: 
Friday, August 25, 2023

This milestone is a pivotal juncture for AusperBio.

Key Points: 
  • This milestone is a pivotal juncture for AusperBio.
  • "The FDA's clearance of our IND application to initiate clinical evaluation of AHB-137 in CHB patients in the United States brings us one step closer to introducing a potential functional cure for people living with HBV."
  • said AusperBio CEO and Co-founder Dr. Guofeng Cheng, "This milestone is a pivotal juncture for AusperBio, underscoring our consistent and outstanding execution in driving innovative therapies towards a functional cure for CHB."
  • "Our focus now is on working closely with key opinion leaders to initiate the CHB patient study in the US."

VBI Vaccines Reports Second Quarter 2023 Financial Results

Retrieved on: 
Monday, August 14, 2023

Cost of Revenues: Cost of revenues was $3.5 million in the second quarter of 2023 as compared to $2.5 million in the second quarter of 2022.

Key Points: 
  • Cost of Revenues: Cost of revenues was $3.5 million in the second quarter of 2023 as compared to $2.5 million in the second quarter of 2022.
  • Research and Development (R&D): R&D expenses for the second quarter of 2023 were $3.3 million as compared to $5.6 million for the second quarter of 2022.
  • Impairment for the second quarter of 2023 was $20.0 million as compared to $0 for the second quarter of 2022.
  • Foreign exchange loss for the second quarter of 2023 was $5.9 million as compared to $21.9 million for the second quarter of 2022.