ABUS RNAi Play
18.12.12 13:39
#1
macos
ABUS RNAi Play
We Make RNAi Work
Tekmira is a leader in the development of therapeutic agents based upon Nobel Prize winning breakthroughs in the field of gene silencing, known as RNA interference (RNAi). Tekmira's lead RNAi product candidates target cancer, Ebola infection, high cholesterol and other indications.
http://www.tekmirapharm.com/Home.asp
Tekmira is a leader in the development of therapeutic agents based upon Nobel Prize winning breakthroughs in the field of gene silencing, known as RNA interference (RNAi). Tekmira's lead RNAi product candidates target cancer, Ebola infection, high cholesterol and other indications.
http://www.tekmirapharm.com/Home.asp
733 Postings ausgeblendet.
05.06.24 22:57
#739
RichyBerlin
ABUS-News
https://investor.arbutusbio.com/news-releases/...n-achieves-sustained
"Arbutus’ Imdusiran with Short Course Interferon Achieves Sustained Undetectable HBsAg, a Necessity for HBV Functional Cure
Jun 05, 2024
At the end of treatment, 33.3% of patients receiving imdusiran for 48 weeks, interferon (IFN) for 24 weeks and ongoing nucleoside analogue (NA) therapy achieved undetectable levels of HBsAg that were maintained in 100% of these patients 24 weeks after completing imdusiran and IFN treatment
Of the patients who have stopped all therapy, six still have undetectable levels of HBsAg and HBV DNA, with two of these patients reaching 12 weeks off all therapy
All six patients have seroconverted and have high titers of anti-HBsAg antibodies
These new Phase 2a data were presented at the European Association for the Study of the Liver (EASL) Congress 2024
WARMINSTER, Pa., June 05, 2024 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop a functional cure for people with chronic hepatitis B virus (cHBV) infection, today announced new data from its Phase 2a clinical trial IM-PROVE I (AB-729-201) showing that imdusiran, the Company’s RNAi therapeutic, and 24 weeks of pegylated interferon alfa-2α (IFN), a standard-of-care immunomodulator, added to ongoing nucleos(t)ide analogue (NA) therapy, reduced HBsAg levels and led to sustained HBsAg loss in some patients with cHBV during and after treatment. These data were presented today in the Viral Hepatitis B and D: New therapies, unapproved therapies or strategies poster session, and will be featured during a poster tour on Thursday, June 6, 2024, at the European Association for the Study of the Liver (EASL) Congress.
Select key data from this Phase 2a clinical trial include:
Some patients who received either 48 or 24 weeks of imdusiran and 24 weeks of IFN with their ongoing NA therapy achieved undetectable HBsAg at the end-of-treatment (EOT) (33.3%, n=4/12; and 23.1%, n=3/13, respectively) that was sustained 24 weeks after completing imdusiran and IFN treatment (33.3%, n=4/12 and 15.4%, n=2/13, respectively). All six patients with sustained HBsAg loss have seroconverted with high anti-HBsAg antibody levels (43.8 to >1,000 mIU/mL suggestive of immune control) and are being followed for maintenance of both undetectable levels of HBsAg and HBV DNA for 24 weeks while off all therapy to assess for a functional cure.
Two of the six patients have reached 12 weeks off all therapy while maintaining both undetectable levels of HBsAg and HBV DNA. The remaining four patients are at various timepoints less than 12 weeks off therapy with undetectable levels of HBsAg and HBV DNA.
A total of 21 patients from across the four treatment cohorts have discontinued all therapy and are in the follow-up period. One patient that received 12 weeks of IFN treatment with imdusiran and NA therapy has maintained undetectable levels of HBsAg and HBV DNA while off all therapy for six months, thereby achieving a functional cure.
“These data are impressive with robust HBsAg response rates that are sustained after end-of-treatment in patients receiving imdusiran and IFN,” commented Professor Man-Fung Yuen, D.Sc., M.D., Ph.D., Chief of the Division of Gastroenterology and Hepatology, the University of Hong Kong, who presented the data at the Congress. “Unlike other RNAi candidates in development that have been evaluated in combination with IFN, in this trial, imdusiran was administered less frequently, at a lower dose, and when combined with a shorter 24-week course of IFN, achieved undetectable HBsAg that is sustained after end of treatment and into early off-treatment follow-up. This trial evaluated small groups of patients, yet there is reason to believe that the combination of imdusiran and IFN could potentially lead to a functional cure in those patients that remain off all therapy. These data are extremely important for the HBV community, and I look forward to continuing to follow the patients who have discontinued all treatment.”
To confirm undetectable HBsAg measured by the trial assay (lower limit of quantitation of 0.05 IU/mL), the Abbott HBsAg Next Qualitative assay, an ultrasensitive, research use only assay with a detection limit of 0.005 IU/mL, was utilized. The Next Assay confirmed HBsAg loss in six of the seven patients at EOT, and those six maintained HBsAg loss for 24 weeks after completing imdusiran and IFN treatment.
These data from the IM-PROVE I trial suggest that the combination of imdusiran and 24 weeks of IFN was generally safe and well-tolerated. There were no serious adverse events (SAEs) related to imdusiran or IFN, and no adverse events (AEs) leading to discontinuation. The most common imdusiran-related treatment emergent adverse events (TEAEs) were transient ALT elevations and injection site bruising. The IFN-related TEAEs were consistent with the known safety profile of IFN.
“There is a significant need for a functional cure for the more than 250 million patients chronically infected with HBV worldwide,” commented Dr. Karen Sims, Chief Medical Officer of Arbutus Biopharma. “These data further support our belief that lowering surface antigen with imdusiran and incorporating an immunomodulator in the treatment regimen has the potential to provide a functional cure for patients with cHBV. We look forward to following the progress of these patients as well as those in our other Phase 2a trials evaluating imdusiran with other immunomodulators.”
The poster that was presented at EASL Congress 2024 can be accessed through the Arbutus website under Publications.
IM-PROVE I Trial Details
The IM-PROVE I Phase 2a clinical trial (AB-729-201; NCT04980482) enrolled 43 HBeAg-negative, NA-suppressed patients with cHBV infection. After a 24-week lead-in with imdusiran (60 mg every 8 weeks) added to ongoing NA therapy, patients were randomized into one of the following four cohorts:
A1: Imdusiran + NA + IFN weekly for 24 weeks (n=12)
A2: NA + IFN weekly for 24 weeks (n=13)
B1: Imdusiran + NA + IFN weekly for 12 weeks (n=8)
B2: NA + IFN weekly for 12 weeks (n=10)
After completion of the IFN treatment period (Week 52 for cohorts A1 and A2 and Week 40 for cohorts B1 and B2), patients underwent a 24-week follow-up period on NA therapy alone and were then assessed for discontinuation of NA therapy. Patients with ALT levels less than two times the upper limit of normal, undetectable HBV DNA, and HBsAg <100 IU/mL at two consecutive visits at least 24 weeks after the last dose of imdusiran, qualified to discontinue all therapy and will be followed for at least 48 weeks. Safety, antiviral and immunologic assessments were obtained throughout the treatment and follow-up periods. HBsAg was assessed via Roche Cobas Elecsys HBsAg II assay (lower limit of quantitation [LLOQ] = 0.05 IU/mL) and results <LLOQ were analyzed by Abbott HBsAg Next Qualitative assay (detection limit = 0.005 IU/mL).
About Imdusiran (AB-729)
Imdusiran is an RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral proteins and antigens including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine (GalNAc) delivery technology enabling subcutaneous delivery. Clinical data generated thus far has shown single and multiple doses of imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in hepatitis B surface antigen and hepatitis B DNA. Imdusiran is currently in multiple Phase 2a clinical trials.
About HBV
Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (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 2.4 million people in the United States suffer from chronic HBV infection. Approximately 820,000 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 (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to identify and develop novel therapeutics with distinct mechanisms of action, which can be combined to provide a functional cure for patients with chronic hepatitis B virus (cHBV). We believe the key to success in developing a functional cure involves suppressing HBV DNA, reducing surface antigen, and boosting HBV-specific immune responses. Our pipeline of internally developed, proprietary compounds includes an RNAi therapeutic, imdusiran (AB-729), and an oral PD-L1 inhibitor, AB-101. Imdusiran has generated meaningful clinical data demonstrating an impact on both surface antigen reduction and reawakening of the HBV-specific immune response. Imdusiran is currently in three Phase 2a combination clinical trials. AB-101 is currently being evaluated in a Phase 1a/1b clinical trial. For more information, visit www.arbutusbio.com . "
"Arbutus’ Imdusiran with Short Course Interferon Achieves Sustained Undetectable HBsAg, a Necessity for HBV Functional Cure
Jun 05, 2024
At the end of treatment, 33.3% of patients receiving imdusiran for 48 weeks, interferon (IFN) for 24 weeks and ongoing nucleoside analogue (NA) therapy achieved undetectable levels of HBsAg that were maintained in 100% of these patients 24 weeks after completing imdusiran and IFN treatment
Of the patients who have stopped all therapy, six still have undetectable levels of HBsAg and HBV DNA, with two of these patients reaching 12 weeks off all therapy
All six patients have seroconverted and have high titers of anti-HBsAg antibodies
These new Phase 2a data were presented at the European Association for the Study of the Liver (EASL) Congress 2024
WARMINSTER, Pa., June 05, 2024 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop a functional cure for people with chronic hepatitis B virus (cHBV) infection, today announced new data from its Phase 2a clinical trial IM-PROVE I (AB-729-201) showing that imdusiran, the Company’s RNAi therapeutic, and 24 weeks of pegylated interferon alfa-2α (IFN), a standard-of-care immunomodulator, added to ongoing nucleos(t)ide analogue (NA) therapy, reduced HBsAg levels and led to sustained HBsAg loss in some patients with cHBV during and after treatment. These data were presented today in the Viral Hepatitis B and D: New therapies, unapproved therapies or strategies poster session, and will be featured during a poster tour on Thursday, June 6, 2024, at the European Association for the Study of the Liver (EASL) Congress.
Select key data from this Phase 2a clinical trial include:
Some patients who received either 48 or 24 weeks of imdusiran and 24 weeks of IFN with their ongoing NA therapy achieved undetectable HBsAg at the end-of-treatment (EOT) (33.3%, n=4/12; and 23.1%, n=3/13, respectively) that was sustained 24 weeks after completing imdusiran and IFN treatment (33.3%, n=4/12 and 15.4%, n=2/13, respectively). All six patients with sustained HBsAg loss have seroconverted with high anti-HBsAg antibody levels (43.8 to >1,000 mIU/mL suggestive of immune control) and are being followed for maintenance of both undetectable levels of HBsAg and HBV DNA for 24 weeks while off all therapy to assess for a functional cure.
Two of the six patients have reached 12 weeks off all therapy while maintaining both undetectable levels of HBsAg and HBV DNA. The remaining four patients are at various timepoints less than 12 weeks off therapy with undetectable levels of HBsAg and HBV DNA.
A total of 21 patients from across the four treatment cohorts have discontinued all therapy and are in the follow-up period. One patient that received 12 weeks of IFN treatment with imdusiran and NA therapy has maintained undetectable levels of HBsAg and HBV DNA while off all therapy for six months, thereby achieving a functional cure.
“These data are impressive with robust HBsAg response rates that are sustained after end-of-treatment in patients receiving imdusiran and IFN,” commented Professor Man-Fung Yuen, D.Sc., M.D., Ph.D., Chief of the Division of Gastroenterology and Hepatology, the University of Hong Kong, who presented the data at the Congress. “Unlike other RNAi candidates in development that have been evaluated in combination with IFN, in this trial, imdusiran was administered less frequently, at a lower dose, and when combined with a shorter 24-week course of IFN, achieved undetectable HBsAg that is sustained after end of treatment and into early off-treatment follow-up. This trial evaluated small groups of patients, yet there is reason to believe that the combination of imdusiran and IFN could potentially lead to a functional cure in those patients that remain off all therapy. These data are extremely important for the HBV community, and I look forward to continuing to follow the patients who have discontinued all treatment.”
To confirm undetectable HBsAg measured by the trial assay (lower limit of quantitation of 0.05 IU/mL), the Abbott HBsAg Next Qualitative assay, an ultrasensitive, research use only assay with a detection limit of 0.005 IU/mL, was utilized. The Next Assay confirmed HBsAg loss in six of the seven patients at EOT, and those six maintained HBsAg loss for 24 weeks after completing imdusiran and IFN treatment.
These data from the IM-PROVE I trial suggest that the combination of imdusiran and 24 weeks of IFN was generally safe and well-tolerated. There were no serious adverse events (SAEs) related to imdusiran or IFN, and no adverse events (AEs) leading to discontinuation. The most common imdusiran-related treatment emergent adverse events (TEAEs) were transient ALT elevations and injection site bruising. The IFN-related TEAEs were consistent with the known safety profile of IFN.
“There is a significant need for a functional cure for the more than 250 million patients chronically infected with HBV worldwide,” commented Dr. Karen Sims, Chief Medical Officer of Arbutus Biopharma. “These data further support our belief that lowering surface antigen with imdusiran and incorporating an immunomodulator in the treatment regimen has the potential to provide a functional cure for patients with cHBV. We look forward to following the progress of these patients as well as those in our other Phase 2a trials evaluating imdusiran with other immunomodulators.”
The poster that was presented at EASL Congress 2024 can be accessed through the Arbutus website under Publications.
IM-PROVE I Trial Details
The IM-PROVE I Phase 2a clinical trial (AB-729-201; NCT04980482) enrolled 43 HBeAg-negative, NA-suppressed patients with cHBV infection. After a 24-week lead-in with imdusiran (60 mg every 8 weeks) added to ongoing NA therapy, patients were randomized into one of the following four cohorts:
A1: Imdusiran + NA + IFN weekly for 24 weeks (n=12)
A2: NA + IFN weekly for 24 weeks (n=13)
B1: Imdusiran + NA + IFN weekly for 12 weeks (n=8)
B2: NA + IFN weekly for 12 weeks (n=10)
After completion of the IFN treatment period (Week 52 for cohorts A1 and A2 and Week 40 for cohorts B1 and B2), patients underwent a 24-week follow-up period on NA therapy alone and were then assessed for discontinuation of NA therapy. Patients with ALT levels less than two times the upper limit of normal, undetectable HBV DNA, and HBsAg <100 IU/mL at two consecutive visits at least 24 weeks after the last dose of imdusiran, qualified to discontinue all therapy and will be followed for at least 48 weeks. Safety, antiviral and immunologic assessments were obtained throughout the treatment and follow-up periods. HBsAg was assessed via Roche Cobas Elecsys HBsAg II assay (lower limit of quantitation [LLOQ] = 0.05 IU/mL) and results <LLOQ were analyzed by Abbott HBsAg Next Qualitative assay (detection limit = 0.005 IU/mL).
About Imdusiran (AB-729)
Imdusiran is an RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral proteins and antigens including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine (GalNAc) delivery technology enabling subcutaneous delivery. Clinical data generated thus far has shown single and multiple doses of imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in hepatitis B surface antigen and hepatitis B DNA. Imdusiran is currently in multiple Phase 2a clinical trials.
About HBV
Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (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 2.4 million people in the United States suffer from chronic HBV infection. Approximately 820,000 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 (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to identify and develop novel therapeutics with distinct mechanisms of action, which can be combined to provide a functional cure for patients with chronic hepatitis B virus (cHBV). We believe the key to success in developing a functional cure involves suppressing HBV DNA, reducing surface antigen, and boosting HBV-specific immune responses. Our pipeline of internally developed, proprietary compounds includes an RNAi therapeutic, imdusiran (AB-729), and an oral PD-L1 inhibitor, AB-101. Imdusiran has generated meaningful clinical data demonstrating an impact on both surface antigen reduction and reawakening of the HBV-specific immune response. Imdusiran is currently in three Phase 2a combination clinical trials. AB-101 is currently being evaluated in a Phase 1a/1b clinical trial. For more information, visit www.arbutusbio.com . "
05.07.24 15:22
#742
Planetpaprika
2 neue Artikel bei seeking alpha
https://seekingalpha.com/article/...entially-huge-litigation-wildcard
https://seekingalpha.com/article/...l-trials-a-strong-buy-opportunity
Bullisch :-))
https://seekingalpha.com/article/...l-trials-a-strong-buy-opportunity
Bullisch :-))
02.08.24 06:46
#745
schmidin01
Klinische Daten und Umstrukturierung
https://www.ariva.de/news/...ie-klinische-fortschritte-trotz-11327452
und hier die original/gesamte Presseinfo von Arbutus
https://investor.arbutusbio.com/news-releases/...inancial-results-and
und hier die original/gesamte Presseinfo von Arbutus
https://investor.arbutusbio.com/news-releases/...inancial-results-and
14.11.24 13:55
#747
schmidin01
Q3 und Business-Update
https://investor.arbutusbio.com/news-releases/...inancial-results-and
Darin zu den Lizenzthemen mit Moderna und Pfizer/Biontech
LNP Litigation Update
Expert reports and expert depositions continue in the Moderna lawsuit. A trial date has been set for September 24, 2025, and is subject to the Court’s availability.
The lawsuit against Pfizer/BioNTech is ongoing and a date for the claim construction hearing has been set for December 18, 2024.
Arbutus continues to protect and defend its intellectual property, which is the subject of the on-going lawsuits against Moderna and Pfizer/BioNTech. The Company is seeking fair compensation for Moderna’s and Pfizer/BioNTech’s use of its patented LNP technology that was developed with great effort and at a great expense, without which Moderna’s and Pfizer/BioNTech’s COVID-19 vaccines would not have been successful.
Darin zu den Lizenzthemen mit Moderna und Pfizer/Biontech
LNP Litigation Update
Expert reports and expert depositions continue in the Moderna lawsuit. A trial date has been set for September 24, 2025, and is subject to the Court’s availability.
The lawsuit against Pfizer/BioNTech is ongoing and a date for the claim construction hearing has been set for December 18, 2024.
Arbutus continues to protect and defend its intellectual property, which is the subject of the on-going lawsuits against Moderna and Pfizer/BioNTech. The Company is seeking fair compensation for Moderna’s and Pfizer/BioNTech’s use of its patented LNP technology that was developed with great effort and at a great expense, without which Moderna’s and Pfizer/BioNTech’s COVID-19 vaccines would not have been successful.
28.03.25 09:59
#748
schmidin01
Klageeinleitung gg. Moderna
https://investor.arbutusbio.com/news-releases/...itiate-international
28.03.25 10:10
#749
schmidin01
Zahlen und Business Update
https://investor.arbutusbio.com/news-releases/...r-end-2024-financial
10.09.25 16:07
#753
schmidin01
Claim Construction gg. Pfizer/Biontech
https://investor.arbutusbio.com/node/19361/html
07.10.25 14:28
#754
schmidin01
Präsentationen auf der AASLD
https://investor.arbutusbio.com/news-releases/...d-presentation-aasld
11.12.25 14:33
#755
schmidin01
CEO zu Patentklagen
Auf dem Roivant Investorentag spricht die CEO zu den Patentstreitigkeiten mit Moderna bzw. Pfizer/BioNTech. https://investor.arbutusbio.com/static-files/...11d-b14f-762a1cb81c6c
20.02.26 10:52
#756
RichyBerlin
Arbutus
Nun häng ich hier seit Jahren drin, wg. der Patentklagen. Ab und zu gibt es mal Lichtblicke, aber kein Ende in Sicht..
https://finance.yahoo.com/news/...-moderna-mrna-denied-221431653.html
"Moderna Loses 2 Defenses In Patent Fight
Moderna (NASDAQ:MRNA) just hit a legal speed bump after a federal judge in Delaware knocked out 2 major defenses in its patent battle with Arbutus Biopharma (NASDAQ:ABUS) over mRNA vaccine technology.
Judge Joshua Wolson ruled that Moderna cannot reargue its obviousness claims because it already raised, or could have raised, them during an earlier inter partes review proceeding. Since Moderna lost that review, the court said it is barred from relitigating the same arguments. The judge also rejected Moderna's issue preclusion defense, which tried to argue that Arbutus did not actually invent the disputed lipid nanoparticle technology. In the ruling, Wolson pointed to testimony from Moderna's own expert acknowledging that an Arbutus scientist encapsulated mRNA in lipid nanoparticles years before Moderna did.
Moderna does have one remaining path. The court allowed its enablement defense to move forward, meaning it can still argue that Arbutus did not adequately disclose the full scope of its claimed invention. That question could carry weight as the case progresses."
https://finance.yahoo.com/news/...-moderna-mrna-denied-221431653.html
"Moderna Loses 2 Defenses In Patent Fight
Moderna (NASDAQ:MRNA) just hit a legal speed bump after a federal judge in Delaware knocked out 2 major defenses in its patent battle with Arbutus Biopharma (NASDAQ:ABUS) over mRNA vaccine technology.
Judge Joshua Wolson ruled that Moderna cannot reargue its obviousness claims because it already raised, or could have raised, them during an earlier inter partes review proceeding. Since Moderna lost that review, the court said it is barred from relitigating the same arguments. The judge also rejected Moderna's issue preclusion defense, which tried to argue that Arbutus did not actually invent the disputed lipid nanoparticle technology. In the ruling, Wolson pointed to testimony from Moderna's own expert acknowledging that an Arbutus scientist encapsulated mRNA in lipid nanoparticles years before Moderna did.
Moderna does have one remaining path. The court allowed its enablement defense to move forward, meaning it can still argue that Arbutus did not adequately disclose the full scope of its claimed invention. That question could carry weight as the case progresses."
04.03.26 08:32
#757
schmidin01
Vergleich mit Moderna erzielt
https://investor.arbutusbio.com/news-releases/...announce-225-billion
04.03.26 09:17
#758
RichyBerlin
Arbutus
Etwas zur Gesamtlage der Struktur Genevant/Roivant/Arbutus ;
'Arbutus Biopharma hält keine direkte Mehrheitsbeteiligung an Genevant Sciences, sondern ist an einem Joint Venture beteiligt. Nach Informationen aus dem Jahr 2024 besaß Arbutus etwa 16 % des Stammkapitals (Common Equity) von Genevant.
Hier sind die Details zur Beziehung:
Joint Venture Struktur: Genevant Sciences wurde als Joint Venture zwischen Roivant Sciences und Arbutus Biopharma gegründet, wobei Roivant die kontrollierende Muttergesellschaft ist.
Wirtschaftliches Interesse:
Zusätzlich zu den rund 16 % Eigenkapital ist Arbutus vertraglich berechtigt, eine "Off-the-Top"-Bruttolizenzgebühr in Höhe von 20 % aus Einnahmen der Patentverletzungsstreitigkeiten (wie dem Vergleich mit Moderna) zu erhalten.
Wirtschaftlicher Gesamtanteil: Durch diese Kombination aus direktem Eigenkapital und Lizenzrechten wurde das wirtschaftliche Interesse von Arbutus an den Klagen gegen Moderna und Pfizer/BioNTech oft auf insgesamt etwa 33 % beziffert.
Genevant Sciences, als Tochtergesellschaft von Roivant Sciences, hält die Rechte an der Lipid-Nanopartikel (LNP)-Technologie, die von Arbutus lizenziert wurde. "
-----------
Zum leichteren Nachlesen nochmal die herutige Meldung;
https://investor.arbutusbio.com/news-releases/...announce-225-billion
"Genevant Sciences and Arbutus Biopharma Announce $2.25 Billion Global Settlement With Moderna
Mar 03, 2026
Moderna to pay Genevant and Arbutus $950 million upfront and an additional $1.3 billion contingent upon a favorable resolution of Moderna’s Section 1498 appeal
If the $1.3 billion payment is realized, this settlement will be the largest disclosed patent settlement paid in the pharmaceutical industry and the second largest in any industry
Settlement holds Moderna accountable for infringement and provides for the court to enter judgment of no invalidity on the four Genevant/Arbutus patents asserted in the case
Genevant grants Moderna a global non-exclusive license to its LNP delivery technology for SM-102-containing mRNA vaccines for infectious disease and a covenant not to sue for certain Genevant/Arbutus patents and Moderna products, ending all patent-infringement litigation against Moderna arising from its unauthorized use of the technology in its COVID-19 vaccines
Pfizer/BioNTech litigation is ongoing in the United States following a favorable Markman ruling issued in September 2025; Comirnaty sales represent ~2/3 of global COVID-mRNA vaccine sales to date
Arbutus announces that it is currently evaluating a return of capital to shareholders for the third quarter of calendar year 2026, in conjunction with the upfront payment
Roivant will host an investor call to discuss these updates today, March 3, 2026, at 4:45 p.m. ET
BASEL, Switzerland and VANCOUVER, British Columbia, March 03, 2026 (GLOBE NEWSWIRE) -- Genevant Sciences, a leading nucleic acid delivery company with world-class platforms and a robust lipid nanoparticle (LNP) patent portfolio and a subsidiary of Roivant Sciences Ltd. (Nasdaq: ROIV), and Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company focused on infectious disease, today announced that they have entered into a $2.25 billion global settlement with Moderna, Inc. to resolve all U.S. and international enforcement actions involving Moderna’s unauthorized use of Genevant’s and Arbutus’ LNP delivery technology in its COVID-19 vaccines, including Spikevax®.
As part of the settlement, Moderna will pay Genevant and Arbutus $950 million upfront in July 2026 and an additional $1.3 billion contingent upon an appellate ruling that 28 U.S.C. § 1498 (Section 1498) does not bar Genevant’s and Arbutus’ claims against Moderna for patent infringement, except as to doses characterized by the district court as having gone to U.S. government employees. In asserting that defense, Moderna argued that Section 1498 applies such that U.S. taxpayers should assume liability for its infringement of Genevant’s and Arbutus’ patents for sales made under one of its government contracts. Moderna has also consented to entry of a judgment of infringement and of no invalidity of four Genevant/Arbutus patents. Additionally, as a part of this settlement, Genevant has agreed to grant Moderna a global non-exclusive license to LNP delivery technology for infectious disease applications and a covenant not to sue for certain Genevant/Arbutus patents and Moderna products. For more information about the terms and conditions of the settlement with Moderna, including the contingent payment, please refer to Arbutus’ Current Report on Form 8-K filed with the SEC on March 3, 2026.
“We are pleased with this settlement, which allows us to put this lengthy dispute behind us and remain focused on our mission to leverage our world-class nucleic acid delivery systems to bring innovative medicines to people who need them,” said James Heyes, CEO of Genevant Sciences. “At the same time, it is enormously gratifying for the Genevant team to, at long last, be recognized for our pivotal contribution to restoring normalcy around the world in the face of a once-in-a-lifetime pandemic.”
“Nobel laureates, industry executives, and prominent researchers have long recognized that Arbutus scientists changed the drug development landscape when they invented LNP delivery technology, enabling nucleic acids including mRNA to be used for medicines and opening a new world of possibilities,” said Lindsay Androski, President and Chief Executive Officer of Arbutus. “Today, Moderna has finally acknowledged the same. This is a transformative outcome for Arbutus as a company, but more importantly, it is a long-overdue recognition that the COVID-19 vaccines would never have made it to the world without the seminal work of Ian MacLachlan, Ed Yaworski, Lloyd Jeffs, Kieu Lam, Lorne Palmer, and Cory Giesbrecht. Today, above all else, we celebrate – and in the case of Cory, remember – them.”
Investor Conference Call Information
Roivant will host a live conference call and webcast at 4:45 p.m. ET on Tuesday, March 3, 2026, to discuss Genevant’s and Arbutus’ $2.25 billion global settlement with Moderna. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call.
About Genevant Sciences
Genevant Sciences, a subsidiary of Roivant, is a leading nucleic acid delivery company with world-class platforms, a robust lipid nanoparticle (LNP) patent portfolio, and decades of experience and expertise in nucleic acid drug delivery and development. Genevant’s scientists have pioneered LNP delivery of nucleic acids for over 20 years, and Genevant’s LNP platform, which has been studied across more than a dozen discrete product candidates and is the delivery technology behind the first and only approved systemic RNA-LNP product (patisiran), enables a wide array of RNA-based applications, including vaccines, therapeutic protein production, and gene editing. For more information, please visit www.genevant.com.
About Arbutus
Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company focused on infectious disease. The company is currently developing imdusiran (AB-729) and an oral PD-L1 inhibitor (AB-101) for the treatment of chronic hepatitis B (cHBV) infection. Arbutus is also consulting closely with and supporting its exclusive licensee, Genevant Sciences, to protect and defend its intellectual property, which is the subject of an on-going lawsuit against Pfizer/BioNTech for use of Arbutus’ patented LNP technology in their COVID-19 vaccines. For more information, visit www.arbutusbio.com.
About Roivant
Roivant (Nasdaq: ROIV) is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, visit www.roivant.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 are not limited to, statements about Arbutus’ plans with respect to ongoing patent litigation matters, including the expected timing thereof and the settlement of the Moderna litigation, and Arbutus’ evaluation of a potential return of capital to its shareholders.
With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things, 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. 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: uncertainties associated with litigation generally and patent litigation specifically; economic and market conditions may worsen; and risks related to the sufficiency of Arbutus’ cash resources for its foreseeable and unforeseeable operating expenses and capital expenditures.
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 Biopharma Corporation ir@arbutusbio.com
'Arbutus Biopharma hält keine direkte Mehrheitsbeteiligung an Genevant Sciences, sondern ist an einem Joint Venture beteiligt. Nach Informationen aus dem Jahr 2024 besaß Arbutus etwa 16 % des Stammkapitals (Common Equity) von Genevant.
Hier sind die Details zur Beziehung:
Joint Venture Struktur: Genevant Sciences wurde als Joint Venture zwischen Roivant Sciences und Arbutus Biopharma gegründet, wobei Roivant die kontrollierende Muttergesellschaft ist.
Wirtschaftliches Interesse:
Zusätzlich zu den rund 16 % Eigenkapital ist Arbutus vertraglich berechtigt, eine "Off-the-Top"-Bruttolizenzgebühr in Höhe von 20 % aus Einnahmen der Patentverletzungsstreitigkeiten (wie dem Vergleich mit Moderna) zu erhalten.
Wirtschaftlicher Gesamtanteil: Durch diese Kombination aus direktem Eigenkapital und Lizenzrechten wurde das wirtschaftliche Interesse von Arbutus an den Klagen gegen Moderna und Pfizer/BioNTech oft auf insgesamt etwa 33 % beziffert.
Genevant Sciences, als Tochtergesellschaft von Roivant Sciences, hält die Rechte an der Lipid-Nanopartikel (LNP)-Technologie, die von Arbutus lizenziert wurde. "
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Zum leichteren Nachlesen nochmal die herutige Meldung;
https://investor.arbutusbio.com/news-releases/...announce-225-billion
"Genevant Sciences and Arbutus Biopharma Announce $2.25 Billion Global Settlement With Moderna
Mar 03, 2026
Moderna to pay Genevant and Arbutus $950 million upfront and an additional $1.3 billion contingent upon a favorable resolution of Moderna’s Section 1498 appeal
If the $1.3 billion payment is realized, this settlement will be the largest disclosed patent settlement paid in the pharmaceutical industry and the second largest in any industry
Settlement holds Moderna accountable for infringement and provides for the court to enter judgment of no invalidity on the four Genevant/Arbutus patents asserted in the case
Genevant grants Moderna a global non-exclusive license to its LNP delivery technology for SM-102-containing mRNA vaccines for infectious disease and a covenant not to sue for certain Genevant/Arbutus patents and Moderna products, ending all patent-infringement litigation against Moderna arising from its unauthorized use of the technology in its COVID-19 vaccines
Pfizer/BioNTech litigation is ongoing in the United States following a favorable Markman ruling issued in September 2025; Comirnaty sales represent ~2/3 of global COVID-mRNA vaccine sales to date
Arbutus announces that it is currently evaluating a return of capital to shareholders for the third quarter of calendar year 2026, in conjunction with the upfront payment
Roivant will host an investor call to discuss these updates today, March 3, 2026, at 4:45 p.m. ET
BASEL, Switzerland and VANCOUVER, British Columbia, March 03, 2026 (GLOBE NEWSWIRE) -- Genevant Sciences, a leading nucleic acid delivery company with world-class platforms and a robust lipid nanoparticle (LNP) patent portfolio and a subsidiary of Roivant Sciences Ltd. (Nasdaq: ROIV), and Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company focused on infectious disease, today announced that they have entered into a $2.25 billion global settlement with Moderna, Inc. to resolve all U.S. and international enforcement actions involving Moderna’s unauthorized use of Genevant’s and Arbutus’ LNP delivery technology in its COVID-19 vaccines, including Spikevax®.
As part of the settlement, Moderna will pay Genevant and Arbutus $950 million upfront in July 2026 and an additional $1.3 billion contingent upon an appellate ruling that 28 U.S.C. § 1498 (Section 1498) does not bar Genevant’s and Arbutus’ claims against Moderna for patent infringement, except as to doses characterized by the district court as having gone to U.S. government employees. In asserting that defense, Moderna argued that Section 1498 applies such that U.S. taxpayers should assume liability for its infringement of Genevant’s and Arbutus’ patents for sales made under one of its government contracts. Moderna has also consented to entry of a judgment of infringement and of no invalidity of four Genevant/Arbutus patents. Additionally, as a part of this settlement, Genevant has agreed to grant Moderna a global non-exclusive license to LNP delivery technology for infectious disease applications and a covenant not to sue for certain Genevant/Arbutus patents and Moderna products. For more information about the terms and conditions of the settlement with Moderna, including the contingent payment, please refer to Arbutus’ Current Report on Form 8-K filed with the SEC on March 3, 2026.
“We are pleased with this settlement, which allows us to put this lengthy dispute behind us and remain focused on our mission to leverage our world-class nucleic acid delivery systems to bring innovative medicines to people who need them,” said James Heyes, CEO of Genevant Sciences. “At the same time, it is enormously gratifying for the Genevant team to, at long last, be recognized for our pivotal contribution to restoring normalcy around the world in the face of a once-in-a-lifetime pandemic.”
“Nobel laureates, industry executives, and prominent researchers have long recognized that Arbutus scientists changed the drug development landscape when they invented LNP delivery technology, enabling nucleic acids including mRNA to be used for medicines and opening a new world of possibilities,” said Lindsay Androski, President and Chief Executive Officer of Arbutus. “Today, Moderna has finally acknowledged the same. This is a transformative outcome for Arbutus as a company, but more importantly, it is a long-overdue recognition that the COVID-19 vaccines would never have made it to the world without the seminal work of Ian MacLachlan, Ed Yaworski, Lloyd Jeffs, Kieu Lam, Lorne Palmer, and Cory Giesbrecht. Today, above all else, we celebrate – and in the case of Cory, remember – them.”
Investor Conference Call Information
Roivant will host a live conference call and webcast at 4:45 p.m. ET on Tuesday, March 3, 2026, to discuss Genevant’s and Arbutus’ $2.25 billion global settlement with Moderna. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call.
About Genevant Sciences
Genevant Sciences, a subsidiary of Roivant, is a leading nucleic acid delivery company with world-class platforms, a robust lipid nanoparticle (LNP) patent portfolio, and decades of experience and expertise in nucleic acid drug delivery and development. Genevant’s scientists have pioneered LNP delivery of nucleic acids for over 20 years, and Genevant’s LNP platform, which has been studied across more than a dozen discrete product candidates and is the delivery technology behind the first and only approved systemic RNA-LNP product (patisiran), enables a wide array of RNA-based applications, including vaccines, therapeutic protein production, and gene editing. For more information, please visit www.genevant.com.
About Arbutus
Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company focused on infectious disease. The company is currently developing imdusiran (AB-729) and an oral PD-L1 inhibitor (AB-101) for the treatment of chronic hepatitis B (cHBV) infection. Arbutus is also consulting closely with and supporting its exclusive licensee, Genevant Sciences, to protect and defend its intellectual property, which is the subject of an on-going lawsuit against Pfizer/BioNTech for use of Arbutus’ patented LNP technology in their COVID-19 vaccines. For more information, visit www.arbutusbio.com.
About Roivant
Roivant (Nasdaq: ROIV) is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, visit www.roivant.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 are not limited to, statements about Arbutus’ plans with respect to ongoing patent litigation matters, including the expected timing thereof and the settlement of the Moderna litigation, and Arbutus’ evaluation of a potential return of capital to its shareholders.
With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things, 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. 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: uncertainties associated with litigation generally and patent litigation specifically; economic and market conditions may worsen; and risks related to the sufficiency of Arbutus’ cash resources for its foreseeable and unforeseeable operating expenses and capital expenditures.
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 Biopharma Corporation ir@arbutusbio.com