ABUS Arbutus Biopharma Corporation

2.76
+0.01  (+0%)
Previous Close 2.75
Open 2.76
52 Week Low 2.31
52 Week High 5.87
Market Cap $269,242,827
Shares 97,551,749
Float 77,395,187
Enterprise Value $285,982,204
Volume 896,055
Av. Daily Volume 1,680,277
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Upcoming Catalysts

Drug Stage Catalyst Date
AB-836
Hepatitis B
Phase 1a
Phase 1a
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Drug Pipeline

Drug Stage Notes
AB-729 and VTP-300
Hepatitis B
Phase 2a
Phase 2a
Phase 2 trial to be initiated 2H 2021.
AB-729 and ATI-2173
Hepatitis B
Phase 2a
Phase 2a
Phase 2 combination cohort to commence 2H 2021.
AB-729
Hepatitis B (HBV)
Phase 1
Phase 1
Phase 1a/b data at EASL meeting June 26, 2021 - HBsAg declines below 100 IU/ml in 75% of treated subjects. Favorable safety and tolerability profile.
AB-729 and Vebicorvir (ABI-H0731)
Hepatitis B virus (HBV)
Phase 2
Phase 2
Phase 2 trial initiation announced February 26, 2021.

Latest News

  1. WARMINSTER, Pa., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection, as well as therapies to treat coronaviruses (including COVID-19), today announced that the Company will participate in a fireside chat at the Wedbush PacGrow Healthcare Virtual Conference on Tuesday, August 10, 2021 at 4:05 PM ET.

    Arbutus Fireside Chat Presenters:

    William Collier, President and CEO; Dr. Michael Sofia, Chief Scientific Officer; Dr. Gaston Picchio, Chief Development Officer; and David Hastings, Chief Financial Officer.

    A live webcast of the fireside chat can…

    WARMINSTER, Pa., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection, as well as therapies to treat coronaviruses (including COVID-19), today announced that the Company will participate in a fireside chat at the Wedbush PacGrow Healthcare Virtual Conference on Tuesday, August 10, 2021 at 4:05 PM ET.

    Arbutus Fireside Chat Presenters:

    William Collier, President and CEO; Dr. Michael Sofia, Chief Scientific Officer; Dr. Gaston Picchio, Chief Development Officer; and David Hastings, Chief Financial Officer.

    A live webcast of the fireside chat can be accessed through the Investors section of Arbutus' website at www.arbutusbio.com or directly at Live Webcast. An archived replay of the webcast will be available on the Company's website after the conference.

    About Arbutus

    Arbutus Biopharma Corporation is a publicly traded (NASDAQ:ABUS) biopharmaceutical company primarily focused on discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple product candidates with distinct mechanisms of action that it believes have the potential to provide a new curative regimen for chronic HBV infection. Arbutus has also initiated a drug discovery and development effort for treating coronaviruses (including COVID-19). For more information, visit www.arbutusbio.com.



    Contact Information

    Investors and Media

    William H. Collier

    President and CEO

    Phone: 267-469-0914

    Email:



    Pam Murphy

    Investor Relations Consultant

    Phone: 267-469-0914

    Email:



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  2. WARMINSTER, Pa., July 29, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection, as well as therapies to treat coronaviruses (including COVID-19), today announced that it has scheduled its second quarter 2021 financial results and corporate update for Thursday, August 5, 2021. The schedule for the press release and conference call/webcast are as follows:

    2Q/2021 Press Release:Thursday, August 5, 2021 at 7:30 a.m. ET
    2Q/2021 Conference Call/Webcast:Thursday, August 5, 2021 at 8:45 a.m. ET
    Domestic Dial-In Number:(866) 393-1607
    International Dial-In Number:

    WARMINSTER, Pa., July 29, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection, as well as therapies to treat coronaviruses (including COVID-19), today announced that it has scheduled its second quarter 2021 financial results and corporate update for Thursday, August 5, 2021. The schedule for the press release and conference call/webcast are as follows:

    2Q/2021 Press Release:Thursday, August 5, 2021 at 7:30 a.m. ET
    2Q/2021 Conference Call/Webcast:Thursday, August 5, 2021 at 8:45 a.m. ET
    Domestic Dial-In Number:(866) 393-1607
    International Dial-In Number:(914) 495-8556
    Conference ID Number:2719108

    A live webcast of the conference call can be accessed through the Investors section of Arbutus' website at www.arbutusbio.com or directly at Live Webcast.

    An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling (855) 859-2056 or (404) 537-3406, and reference conference ID: 2719108.

    About Arbutus

    Arbutus Biopharma Corporation is a publicly traded (NASDAQ:ABUS) biopharmaceutical company primarily focused on discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple product candidates with distinct mechanisms of action that it believes have the potential to provide a new curative regimen for chronic HBV infection. Arbutus has also initiated a drug discovery and development effort for treating coronaviruses (including COVID-19). For more information, visit www.arbutusbio.com.

    Contact Information

    Investors and Media

    William H. Collier

    President and CEO

    Phone: 267-469-0914

    Email:



    Pam Murphy

    Investor Relations Consultant

    Phone: 267-469-0914

    Email:



    Primary Logo

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  3. Phase 2a trial to investigate the safety and anti-viral activity of AB-729 in combination with ongoing nucleos(t)ide analog (NA) therapy and short courses of Peg-IFNα-2a in subjects with chronic hepatitis B virus infection (CHB)

    WARMINSTER, Pa., July 07, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection (CHB), as well as therapies to treat coronaviruses (including COVID-19), today announced it has received authorization from the U.S. Food and Drug Administration to proceed with its Investigational New Drug (IND) application for AB-729 in a Phase 2a clinical trial. The Phase 2a proof-of-concept…

    Phase 2a trial to investigate the safety and anti-viral activity of AB-729 in combination with ongoing nucleos(t)ide analog (NA) therapy and short courses of Peg-IFNα-2a in subjects with chronic hepatitis B virus infection (CHB)

    WARMINSTER, Pa., July 07, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection (CHB), as well as therapies to treat coronaviruses (including COVID-19), today announced it has received authorization from the U.S. Food and Drug Administration to proceed with its Investigational New Drug (IND) application for AB-729 in a Phase 2a clinical trial. The Phase 2a proof-of-concept clinical trial will evaluate the safety and efficacy of AB-729 in combination with ongoing nucleos(t)ide analog (NA) therapy and short courses of Peg-IFNα-2a in subjects with CHB.

    William Collier, President and Chief Executive Officer of Arbutus, stated, "The acceptance of our IND application is an important step forward for AB-729 and supports our objective to establish its value as a cornerstone therapy for patients with CHB. We look forward to the initiation of this proof-of-concept Phase 2a clinical trial in this quarter."

    Gaston Picchio, PhD, Chief Development Officer at Arbutus, stated, "We are gratified that our IND submission for AB-729, in combination with Peg-IFN, in subjects with chronic hepatitis B viral infection has been deemed safe to proceed. This Phase 2a trial will allow us to investigate if short courses of Peg-IFN, following a pronounced HBsAg suppression and potential immune reactivation by AB-729, could contribute to achieving a functional cure in HBeAg negative chronic hepatitis B subjects."

    About the Phase 2a Clinical Trial

    This is a randomized, open label, multicenter Phase 2a trial investigating the safety and antiviral activity of AB-729 in combination with ongoing NA therapy and short courses of Peg-IFNα-2a in subjects with CHB. Pending protocol finalization, the trial is expected to enroll 40 stably NA-suppressed, HBeAg negative, non-cirrhotic CHB subjects. After a 24-week dosing period of AB-729 (60 mg SC every 8 weeks (Q8W)), subjects will be randomized into one of 4 groups:

    • A1: AB-729 + NA + weekly Peg-IFNα-2a for 24 weeks (N = 12)
    • A2: NA + weekly Peg-IFNα-2a for 24 weeks (N = 12)
    • B1: AB-729 + NA + weekly Peg-IFNα-2a for 12 weeks (N = 8)

    • B2: NA + weekly Peg-IFNα-2a for 12 weeks (N = 8)

    After completion of the assigned Peg-IFNα-2a treatment period, all subjects will remain on NA therapy for the initial 24-week follow up period, and then will discontinue NA treatment if treatment stopping criteria are met. If subjects stop NA therapy, they will enter an intensive follow-up period for 48 weeks.

    About AB-729

    AB-729 is an RNA interference (RNAi) therapeutic targeted to hepatocytes using Arbutus' novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. AB-729 inhibits viral replication and reduces all HBV antigens tested, including hepatitis B surface antigen, in preclinical models. Reducing hepatitis B surface antigen is thought to be a key prerequisite to enable reawakening of a patient's immune system so as allow it to respond to the virus. Based upon clinical data generated thus far in an ongoing single- and multi-dose Phase 1a/1b clinical trial, AB-729 has demonstrated positive safety and tolerability data and meaningful reductions in hepatitis B surface antigen.

    About HBV

    Hepatitis B is a potentially life-threatening liver infection caused by HBV. HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from chronic HBV infection. Approximately 900,000 people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options.

    About Arbutus

    Arbutus Biopharma Corporation is a publicly traded (NASDAQ:ABUS) biopharmaceutical company primarily focused on discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple product candidates with distinct mechanisms of action that it believes have the potential to provide a new curative regimen for chronic HBV infection. Arbutus has also initiated a drug discovery and development effort for treating coronaviruses (including COVID-19). For more information, visit www.arbutusbio.com.

    Forward-Looking Statements and Information

    This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Forward-looking statements in this press release include, but may not be limited to, statements about Arbutus' development plans for AB-729, including the expected trial design of the Phase 2a clinical trial, the expected number and type of subject to be enrolled in the trial and the expected dosing schedule of the clinical trial; and Arbutus' expectations regarding the potential for its product candidates to provide a curative regimen for chronic HBV infection.

    With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of preclinical studies and clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus' assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies, including uncertainties and contingencies related to the ongoing COVID-19 pandemic.

    Additionally, there are known and unknown risk factors which could cause Arbutus' actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: anticipated pre-clinical studies and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested drug candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus' products; economic and market conditions may worsen; market shifts may require a change in strategic focus; and the ongoing COVID-19 pandemic could significantly disrupt Arbutus' clinical development programs.

    A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus' Annual Report on Form 10-K, Arbutus' Quarterly Reports on Form 10-Q and Arbutus' continuous and periodic disclosure filings, which are available at www.sedar.com and at sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.

    Contact Information

    Investors and Media

    William H. Collier

    President and CEO

    Phone: 267-469-0914

    Email:

    Pam Murphy

    Investor Relations Consultant

    Phone: 267-469-0914

    Email:



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  4. WARMINSTER, Pa. and OXFORD, United Kingdom, July 06, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS) and Vaccitech plc (NASDAQ:VACC) today announced that the companies have entered into a clinical trial collaboration agreement to evaluate an innovative therapeutic combination for the treatment of subjects with chronic hepatitis B virus (HBV) infection (CHB) who are already receiving standard-of-care nucleos(t)ide reverse transcriptase inhibitor (NrtI) therapy.

    The multi-center, Phase 2a clinical trial will evaluate the safety, pharmacokinetics, immunogenicity, and antiviral activity of Arbutus's proprietary GalNAc delivered RNAi therapeutic, AB-729, followed by Vaccitech's proprietary immunotherapeutic, VTP-300, in NrtI-suppressed…

    WARMINSTER, Pa. and OXFORD, United Kingdom, July 06, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS) and Vaccitech plc (NASDAQ:VACC) today announced that the companies have entered into a clinical trial collaboration agreement to evaluate an innovative therapeutic combination for the treatment of subjects with chronic hepatitis B virus (HBV) infection (CHB) who are already receiving standard-of-care nucleos(t)ide reverse transcriptase inhibitor (NrtI) therapy.

    The multi-center, Phase 2a clinical trial will evaluate the safety, pharmacokinetics, immunogenicity, and antiviral activity of Arbutus's proprietary GalNAc delivered RNAi therapeutic, AB-729, followed by Vaccitech's proprietary immunotherapeutic, VTP-300, in NrtI-suppressed subjects with CHB. The Phase 2a clinical trial is expected to initiate in the second half of this year and will be managed by Arbutus, subject to oversight by a joint development committee comprised of representatives from Arbutus and Vaccitech. The parties retain full rights to their respective product candidates and will split all costs associated with the clinical trial. Pursuant to the agreement, the parties intend to undertake a larger Phase 2b clinical trial depending on the results of the initial Phase 2a clinical trial.

    "Based on the positive clinical results we have seen in our ongoing Phase 1a/1b clinical trial for AB-729, including recent data demonstrating increased HBV-specific immune responses, we believe AB-729 has the potential to become a cornerstone therapeutic in multiple future HBV combination regimens," stated Gaston Picchio, Chief Development Officer at Arbutus. "We are looking forward to initiating this proof-of-concept Phase 2a clinical trial, which will allow us to evaluate the combination of two promising clinical candidates with potential complimentary mechanisms of action. We believe combining AB-729, which is designed to reduce HBsAg resulting in increased HBV immune responses with VTP-300, an immunotherapeutic designed to elicit an HBV specific immune response, may offer patients with CHB a much needed and durable functional cure."

    "CHB is characterized by T cell exhaustion, driven primarily by HBsAg, that may require immune modulation," said Tom Evans, MD, Vaccitech's Chief Scientific Officer. "Current treatments can control viral replication but do not cure the disease. We believe that a combination of immunotherapy, such as VTP-300, with agents that reduce hepatitis B surface antigen is a promising approach toward a functional cure. This clinical trial will be evaluating that hypothesis. If successful, we believe that VTP-300, along with siRNA, such as AB-729, could be a foundation for CHB combination therapy."

    About the Phase 2a Clinical Trial

    Pending regulatory approval, the trial is expected to enroll 40 NrtI-suppressed, Hepatitis B e-antigen negative or positive, non-cirrhotic CHB subjects. Subjects are expected to receive AB-729 + NrtI for 24 weeks. At Week 24, subjects will be randomized 1:1 to receive either NrtI + VTP-300 or NrtI + VTP-300 sham. At Week 48, all subjects are expected to be evaluated for eligibility to either discontinue all treatments or remain on their NrtI only. Subjects are expected to be followed for an additional 48 weeks.

    About AB-729

    AB-729 is an RNA interference (RNAi) therapeutic targeted to hepatocytes using Arbutus' novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. AB-729 inhibits viral replication and reduces all HBV antigens, including hepatitis B surface antigen in preclinical models. Reducing hepatitis B surface antigen is thought to be a key prerequisite to enable reawakening of a patient's immune system to respond to the virus. Based upon clinical data generated thus far in an ongoing single- and multi-dose Phase 1a/1b clinical trial, AB-729 has demonstrated positive safety and tolerability data and meaningful reductions in hepatitis B surface antigen.

    About VTP-300

    VTP-300 utilizes Vaccitech's ChAdOx1-HBV/MVA-HBV prime-boost combination to elicit an immune response against HBV. The HBV DNA sequence contained in the viral vectors is derived from a genotype C sequence, which is the most common genotype circulating worldwide. Vaccitech's proprietary platform has demonstrated robust activation of cytotoxic CD8+ T cells (immune cells associated with clearance of HBV infected cells), which are believed to have the potential to lead to a functional cure for patients with CHB, a life-threatening disease that affects more than 250 million people worldwide. VTP-300 is currently being evaluated in ongoing Phase 1/2a clinical trial in healthy volunteers and CHB patients and a Phase 1b/2a clinical trial in CHB patients in combination with a low-dose checkpoint inhibitor.

    About HBV

    Hepatitis B is a potentially life-threatening liver infection caused by HBV. HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. CHB represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from chronic HBV infection. Approximately 900,000 people die every year from complications related to chronic HBV infection despite the availability of effective prophylactic vaccines and current treatment options.

    About Arbutus

    Arbutus Biopharma Corporation is a publicly traded (NASDAQ:ABUS) biopharmaceutical company primarily focused on discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple product candidates with distinct mechanisms of action that it believes have the potential to provide a new curative regimen for chronic HBV infection. Arbutus has also initiated a drug discovery and development effort for treating coronaviruses (including COVID-19). For more information, visit www.arbutusbio.com.

    About Vaccitech

    Vaccitech plc is a publicly traded (NASDAQ:VACC) clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer. The company's proprietary platform comprises proprietary modified simian adenoviral vectors, known as ChAdOx1 and ChAdOx2, as well as the well-validated Modified Vaccinia Ankara, or MVA, boost vector, both with demonstrable tolerability profiles and without the ability to replicate in humans. The combination of a ChAdOx prime treatment with subsequent MVA boost has consistently generated significantly higher magnitudes of CD8+ T cells compared with other technologies and approaches. The company has a broad pipeline of both clinical and preclinical stage therapeutic programs in solid tumors and viral infections and prophylactic viral vaccine programs. Vaccitech co-invented a COVID-19 vaccine with the University of Oxford, now approved for use in many territories and exclusively licensed worldwide to AstraZeneca through Oxford University Innovation, or OUI. Vaccitech is entitled to receive a share of the milestones and royalty income received by OUI from AstraZeneca.

    Arbutus Forward-Looking Statements and Information

    This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Forward-looking statements in this press release include statements about our expectations for the collaboration, including Arbutus' belief that combining the ability of AB-729 to reduce HBsAg with VTP-300, an immunotherapeutic that elicits an HBV specific immune response, may offer patients with chronic hepatitis B a much needed and durable functional cure; the timing and expected trial design of the Phase 2a clinical trial to be initiated by the parties pursuant to the agreement; Arbutus' belief that AB-729 has the potential to become a cornerstone therapeutic in multiple future HBV combination regimens; and the parties' plans for future collaboration clinical trials depending on the results of the initial Phase 2a clinical trial.

    With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of preclinical studies and clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus' assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies, including uncertainties and contingencies related to the ongoing COVID-19 pandemic.

    Additionally, there are known and unknown risk factors which could cause Arbutus' actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: the parties may never realize the expected benefits of the collaboration; anticipated clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; economic and market conditions may worsen; market shifts may require a change in strategic focus; and the ongoing COVID-19 pandemic could significantly disrupt clinical development programs.

    A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus' Annual Report on Form 10-K, Arbutus' Quarterly Reports on Form 10-Q and Arbutus' continuous and periodic disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.

    Vaccitech plc Forward-Looking Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding risks and uncertainties related to Vaccitech's expectations regarding the benefits of this collaboration, including the potential benefits of using VTP-300 in triple combination with AB-729 and an NrtI, the timing and expected trial design of the Phase 2a clinical trial to be initiated by the parties pursuant to the agreement and Vaccitech's expectations that, if the clinical trial is successful, VTP-300 together with AB-729, could be a foundation for CHB combination therapy. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to numerous risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to timing and advancement of the planned clinical trial and other risks identified in Vaccitech's SEC filings, including its Quarterly Report on Form 10-Q for the first quarter of 2021 and subsequent filings with the SEC. Existing and prospective investors are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Vaccitech expressly disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

    Arbutus Contact Information

    Investors and Media

    William H. Collier

    President and CEO

    Phone: 267-469-0914

    Email:

    Pam Murphy

    Investor Relations Consultant

    Phone: 267-469-0914

    Email:

    Vaccitech Contact Information

    Investors:

    Vaccitech Investor Relations

     

    Media:

    Katja Stout, Scius Communications (EU)

    Direct: +44 (0) 7789435990

    Email: 

    Ryo Imai / Robert Flamm, Ph.D. (US), Burns McClellan, Inc.

    212-213-0006 ext. 315 / 364

    Email:  / 

    Henry Hodge, Vaccitech

    Email: 



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  5. MENDHAM, N.J. and WARMINSTER, Pa., June 29, 2021 (GLOBE NEWSWIRE) -- Antios Therapeutics, Inc. and Arbutus Biopharma Corporation (NASDAQ:ABUS) today announced that the companies have entered into a clinical collaboration agreement to evaluate a triple combination of Arbutus' proprietary GalNAc delivered RNAi therapeutic, AB-729, Antios' proprietary active site polymerase inhibitor nucleotide (ASPIN), ATI-2173, and Viread (tenofovir disoproxil fumarate), for the treatment of subjects with chronic hepatitis B virus (HBV) infection.

    ATI-2173, AB-729 and Viread will be evaluated in combination in a single cohort in the ongoing Antios Phase 2a ANTT201 clinical trial. The multi-center, double-blinded, placebo-controlled, multiple-dose cohort will…

    MENDHAM, N.J. and WARMINSTER, Pa., June 29, 2021 (GLOBE NEWSWIRE) -- Antios Therapeutics, Inc. and Arbutus Biopharma Corporation (NASDAQ:ABUS) today announced that the companies have entered into a clinical collaboration agreement to evaluate a triple combination of Arbutus' proprietary GalNAc delivered RNAi therapeutic, AB-729, Antios' proprietary active site polymerase inhibitor nucleotide (ASPIN), ATI-2173, and Viread (tenofovir disoproxil fumarate), for the treatment of subjects with chronic hepatitis B virus (HBV) infection.

    ATI-2173, AB-729 and Viread will be evaluated in combination in a single cohort in the ongoing Antios Phase 2a ANTT201 clinical trial. The multi-center, double-blinded, placebo-controlled, multiple-dose cohort will evaluate the safety, pharmacokinetics, immunogenicity, and antiviral activity of the combination of ATI-2173, AB-729 and Viread. This cohort is expected to initiate in the second half of 2021. Antios will be responsible for the costs of adding this single cohort to its ongoing clinical trial. Arbutus will be responsible for the manufacture and supply of AB-729.

    "This collaboration with Antios advances our efforts to position AB-729 as a potential cornerstone therapeutic in future HBV combination regimens and reflects our conviction that a combination of agents with complementary mechanisms of action is needed to cure chronic HBV," stated William Collier, Chief Executive Officer at Arbutus."

    Greg Mayes, Chief Executive Officer of Antios said, "ATI-2173 has, to date, demonstrated a well-tolerated safety profile and sustained on- and off-treatment antiviral responses as a monotherapy in patients with chronic HBV. We believe that its unique mechanism of action and early evidence of clinical activity may position ATI-2173 as the backbone of a once-daily curative regimen in combination with other agents for chronic HBV. Our collaboration with Arbutus will test that hypothesis in combination with AB-729, an RNAi drug candidate, and Viread, a nucleotide analogue."

    About the Combination Clinical Trial Cohort

    The combination clinical trial cohort will include 10 subjects with chronic HBV infection assigned 8:2 to active drug (ATI-2173+AB-729) or matching placebos. The active drug (ATI-2173+AB-729) or placebo will be administered in combination with 300 mg of Viread (equivalent to 245 mg of tenofovir disoproxil fumarate). ATI-2173 and Viread will be administered once a day for 90 days. AB-729 will be administered by subcutaneous injection at Day 28 and Day 90. Following this 90 day treatment period, subjects will be followed-up for safety and sustained antiviral responses for 6 additional months.

    Any subjects whose HBV DNA remains below the limit of quantification (BLQ) at 6 months of follow-up will have HBV DNA and virology samples collected every 3 months off therapy until a detectable HBV DNA level is confirmed, or until 18 months after the 6 months of follow-up, whichever comes first.

    About AB-729

    AB-729 is an RNA interference (RNAi) therapeutic targeted to hepatocytes using Arbutus' novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. AB-729 inhibits viral replication and reduces all HBV antigens, including hepatitis B surface antigen in preclinical models. Reducing hepatitis B surface antigen is thought to be a key prerequisite to enable reawakening of a patient's immune system to respond to the virus. Based upon clinical data generated thus far in an ongoing single- and multi-dose Phase 1a/1b clinical trial, AB-729 has demonstrated positive safety and tolerability data and meaningful reductions in hepatitis B surface antigen.

    About ATI-2173

    ATI-2173 is a novel, orally-administered, liver-targeted Active Site Polymerase Inhibitor Nucleotide (ASPIN) molecule designed to deliver the 5'-monophosphate of clevudine to the liver. This L-nucleoside's active 5'-triphosphate has unique antiviral properties as a non-competitive, non-chain terminating HBV polymerase inhibitor that distorts the active site of HBV polymerase resulting in potent HBV antiviral activity and extended off-treatment suppression of HBV DNA. ATI-2173 targets the liver, delivering high levels of the unique 5'- triphosphate while limiting systemic exposure to the parent L-nucleoside. ATI-2173 has the potential to become an integral part of a curative combination regimen for chronic hepatitis B.

    About HBV

    Hepatitis B is a potentially life-threatening liver infection caused by HBV. HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection (CHB) represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from chronic HBV infection. Approximately 900,000 people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options.

    About Arbutus

    Arbutus Biopharma Corporation is a publicly traded (NASDAQ:ABUS) biopharmaceutical company primarily focused on discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple product candidates with distinct mechanisms of action that it believes have the potential to provide a new curative regimen for chronic HBV infection. Arbutus has also initiated a drug discovery and development effort for treating coronaviruses (including COVID-19). For more information, visit www.arbutusbio.com.

    About Antios

    Antios Therapeutics is a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure viral diseases. Antios is currently developing ATI-2173, aiming to provide chronic hepatitis B-infected patients with a curative combination regimen.

    Arbutus Forward-Looking Statements and Information

    This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Forward-looking statements in this press release include statements about our expectations for the collaboration; the timing and expected trial design of the Phase 2a clinical trial to be initiated by the parties pursuant to the agreement; and Arbutus' belief that AB-729 has the potential to become a cornerstone therapeutic in multiple future HBV combination regimens.

    With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of preclinical studies and clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus' assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies, including uncertainties and contingencies related to the ongoing COVID-19 pandemic.

    Additionally, there are known and unknown risk factors which could cause Arbutus' actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: the parties may never realize the expected benefits of the collaboration; anticipated clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; economic and market conditions may worsen; market shifts may require a change in strategic focus; and the ongoing COVID-19 pandemic could significantly disrupt clinical development programs.

    A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus' Annual Report on Form 10-K, Arbutus' Quarterly Reports on Form 10-Q and Arbutus' continuous and periodic disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.

    Arbutus Contact Information

    Investors and Media

    William H. Collier

    President and CEO

    Phone: 267-469-0914

    Email:

    Pam Murphy

    Investor Relations Consultant

    Phone: 267-469-0914

    Email:

    Antios Contact Information

    Investors:

    Lee Roth

    Burns McClellan



    +1 (212) 300-8331

    Media:

    Ryo Imai / Robert Flamm, PhD

    Burns McClellan

     / 

    +1 (212) 300-8315 / +1 (212) 300-8364



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