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they're also comboing it with: 1) Barinthus VTP-300/NA/Nivolumab (EASL tomorrow) and 2) NA/Durvalumab
their 'want' is to combine Imdusiran with their proprietary small molecule PD-L1 inhibitor (AB-101) but that is probably a next year item ...
https://www.arbutusbio.com/pipeline/
ABUS, 33% is better than SOC and competitors as far as I'm aware(?) They're presenting their results of their combo trial with Barinthus tomorrow at EASL; interested for that data as well...
ABUS - Arbutus’ Imdusiran with Short Course Interferon Achieves Sustained Undetectable HBsAg, a Necessity for HBV Functional Cure
PDF Version
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-2a (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
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.
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 the potential to lead to a functional cure for HBV, our future development plans for our product candidates; the expected results of our clinical development plans and clinical trials with respect to our product candidates; our expectations with respect to the release of data from our clinical trials and the expected timing thereof; and the potential for our product candidates to achieve success in clinical trials.
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.
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 product 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.
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.
Contact Information
Investors and Media?
Lisa M. Caperelli?
Vice President, Investor Relations?
Phone: 215-206-1822?
Email: lcaperelli@arbutusbio.com
ABUS - Arbutus’ Imdusiran with Short Course Interferon Achieves Sustained Undetectable HBsAg, a Necessity for HBV Functional Cure
PDF Version
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-2a (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
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.
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 the potential to lead to a functional cure for HBV, our future development plans for our product candidates; the expected results of our clinical development plans and clinical trials with respect to our product candidates; our expectations with respect to the release of data from our clinical trials and the expected timing thereof; and the potential for our product candidates to achieve success in clinical trials.
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.
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 product 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.
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.
Contact Information
Investors and Media?
Lisa M. Caperelli?
Vice President, Investor Relations?
Phone: 215-206-1822?
Email: lcaperelli@arbutusbio.com
'this' article from 5/7 alludes to 100million doses: https://www.healthline.com/health-news/bird-flu-u-s-could-produce-and-ship-100-million-vaccine-doses-within-months
oc631, https://www.judiciary.senate.gov/imo/media/doc/2024-05-21_-_testimony_-_mossoff.pdf
"
These court decisions were reaffirmed last year in Arbutus Biopharma Corp. v. Moderna. In this
case, Arbutus sued Moderna for patent infringement in its production and sale of its COVID-19
vaccine and Moderna filed a motion to dismiss, arguing that Arbutus could only sue the
government under § 1498 given the federal government’s advance purchase contracts for COVID19 vaccine doses produced by Moderna. The court rejected Moderna’s argument and permitted the lawsuit to proceed against, holding that the government purchase contracts of vaccine doses
manufactured by Moderna were for use by and for private citizens and not just government
employees like military personnel or civil servants.
118 The court concluded that Moderna’s
“development and sale of the vaccines was for the benefit of the vaccine’s recipients,” who were
private citizens, and it was not solely for the benefit of the federal government or its employees.
119
In conclusion, § 1498 does not apply to private commercial activities in which private companies
manufacture and sell products for use by private parties in the marketplace. By its express terms,
as confirmed by its interpretation by multiple courts, § 1498 is an eminent domain statute that is
limited to unauthorized uses of patented inventions by or for the federal government, such as use
of patented inventions by the military or by federal agencies, such as the Veterans Administration.
Contrary to the argument advanced by professors and activists in a letter to Congress in 2022, and
repeated in the more recent letters by senators to administration officials, § 1498 does not apply to
circumstances in which the federal government “facilitate[s] the purchase of low-cost generics by
private entities,” even if the private entities are “reimbursed by Medicare and Medicaid.”120 In fact,
one of the sources of scholarship cited by the professors and activists in their 2022 letter
acknowledges forthrightly that § 1498 would need to be “modified” in order “to apply to
governmental payment for drugs prescribed for beneficiaries of such federal health programs as
Medicare and Medicaid.”12
"
EASL June 6-8th:
https://investor.arbutusbio.com/news-releases/news-release-details/arbutus-present-imdusiran-data-easl-congress-2024
"
HBsAg = LLOQ (lower limit of quantification) with detectable anti-HBs was observed at end-of-treatment in 28% of subjects who received 4 or 6 doses of imdusiran plus 24 weeks of IFN
"
re: Arbutus, Moderna, govt & EASL->
Govt liability ..1498..:
https://law.justia.com/cases/federal/district-courts/delaware/dedce/1:2022cv00252/78146/64/
https://www.wsj.com/articles/a-moderna-patent-bailout-would-set-a-dangerous-precedent-cb0e11d1
https://ipwatchdog.com/2023/03/08/pharma-companies-u-s-government-spar-application-section-1498-patent-infringement-claims-modernas-covid-19-vaccine/id=157459/
EASL June 6-8th:
https://investor.arbutusbio.com/news-releases/news-release-details/arbutus-present-imdusiran-data-easl-congress-2024
"
HBsAg = LLOQ (lower limit of quantification) with detectable anti-HBs was observed at end-of-treatment in 28% of subjects who received 4 or 6 doses of imdusiran plus 24 weeks of IFN
"
Even if, the issue with Moderna is it may have been willful infringement which opens the door to possible treble damages
Moderna is fighting pretty hard to shield Bancel discovery now. We will know soon-
Maybe what I assume people know is that ABUS only gets 20% of said royalties; anyone interested should DD Roivant->Arbutus->Genevant relationship
I’ll look more tomorrow but as I recall Moderna attempted to shift responsibility to the govt last year and it was denied/stalled(?)
Which numbers do you believe are inflated? The sales numbers of covid sales are factual but the royalty rate is the wildcard (again assuming Arbutus wins…etc). The lowest royalties most even consider are 3%+ and Roivant has stated low to mid teens…
re: ABUS, depends how/what you value within her: 1) cash $130mil as of 3/31 they acknowledged selling the atm in early april into the markman order results .. cash probably $150m(?) 2) the value assigned to their HBV asset (Imdusiran) which i know you place at zero lol. Honestly, though compared to competitors they seem to be at least as good as them all(?)* 3) only focusing on COVID vaccine sales in regards to their litigation, we're talking Pfizer sales of $100b+ and Moderna $40b+... not to mention future sales of covid 'and possible' other products 'possibly' infringing on their I.P. Even lowball royalties of 3% would be 'very' meaningful and Roivant has eluded to royalties in the low teens I believe.
*my notes from their 5/14 presentation on what differentiates Imdusiran from competitors:
"
what makes Imdusiran different from GSK's, Arrowhead or others..
lowest dose.. 60mg Imdusiran vs 200mg and 400mg of competitors
others do once every month, Imdusiran every 2 months
Imdusiran single trigger brings down all values whereas competitors needed 2.. Roche is single trigger but doesn't address the x-transcript(?)
"
I obviously think ABUS has room to run 'but' of course I may be wrong...
Arbutus is waking up a little following yesterday's Motion to Dismiss with Acuitas:
https://www.law360.com/ip/articles/1839088/judge-tosses-acuitas-covid-biotech-ip-suit-
other important events of late include:
1) company stating they have stopped their ATM and don't see a need to use it the rest of this year
2) the Markman order against Moderna that went in their favor:
https://investor.arbutusbio.com/news-releases/news-release-details/arbutus-biopharma-announces-claim-construction-ruling-its
3) Activist becoming involved:
https://www.morningstar.com/news/business-wire/20240517970994/whitefort-capital-publishes-open-letter-to-arbutus-biopharma-shareholders-outlining-paths-to-maximize-value
Arbutus is waking up a little following yesterday's Motion to Dismiss with Acuitas:
https://www.law360.com/ip/articles/1839088/judge-tosses-acuitas-covid-biotech-ip-suit-
other important events of late include:
1) company stating they have stopped their ATM and don't see a need to use it the rest of this year
2) the Markman order against Moderna that went in their favor:
https://investor.arbutusbio.com/news-releases/news-release-details/arbutus-biopharma-announces-claim-construction-ruling-its
3) Activist becoming involved:
https://www.morningstar.com/news/business-wire/20240517970994/whitefort-capital-publishes-open-letter-to-arbutus-biopharma-shareholders-outlining-paths-to-maximize-value
Dew, i know you don't have much love for ABUS but that doesn't mean it might not be a good play over the next 3-12months after recent activist involvement, phase 2 trial results and litigation progress/updates..etc..:
https://www.businesswire.com/news/home/20240517970994/en/
'if' anyone here cares ...
issue here, now, might be too many open $3 calls? will mm's hold her under....
mgmt killed this stock with that ATM; imo, used in a suspicious manner... ie: they put a lid on her on the markman order release at $3ish .. WHY would you do that? They could have raised same money at double the price
https://www.pacermonitor.com/public/case/48043929/Medley_LLC_Liquidating_Trust_v_RSM_US_LLP
Monday, May 13, 2024
19 court VAN-416a Order Assigning Adversary Proceeding to Mediation (Opt In Cert LR 9019-5j) Mon 05/13 12:47 PM
Amended Order Assigning Adversary Proceeding to Mediation and Setting Mediation Deadlines. Ian Connor Bifferato is Appointed as the Mediator in this Adversary Proceeding. Mediator Certificate of Completion due date: 8/12/2024. Signed on 5/13/2024. (KAR)
from Whitefort's 13D filed today: "The Reporting Persons have conveyed their view to the Issuer’s Board of Directors (the “Board”) that the current market price of the Shares does not reflect the Issuer’s intrinsic value. The Reporting Persons have requested that the Board immediately terminate the Issuer’s ATM program and explore all strategic options for the Issuer’s hepatitis B virus (HBV) portfolio. The Reporting Persons hope to continue to work constructively and collaboratively with the Board on these critical initiatives and intend to actively engage with shareholders and others regarding their views."
23-50121-KBO Medley LLC Liquidating Trust et al v. Eversheds Sutherland (US) LLP et al.. Is 'this' case different than the Evershed's settlement agreement from last October?
23-50138-KBO Medley LLC Liquidating Trust v. RSM US LLP.. last document filed was that the appointed mediator had a potential conflict of interest; assuming we're waiting on a new one
this is try to get back ~$300k from RSM of invoices paid after they should have been(?)
"Eversheds agrees to make a formal written demand against the
Debtor’s insurers on or before October 20, 2023. In the event that
demand does not lead to a resolution between Eversheds and the
Debtor’s insurers, Eversheds agrees it will file a lawsuit to collect
from the Debtor’s insurers on or before March 29, 2024. "
Of interest(?), I cannot locate any litigation involving Eversheds on Pacer.........
looking a little better today; i guess it's going to be slow and steady and not the rocket on markman day like i hoped. i think this is looking really good med-long term on the litigation from after that markman ruling
also, looking forward to EASL in june
was going to take all '3' to explode imo..
decision is out; looks like arbutus won '2' and moderna '1' .. please confirm
https://www.kccllc.net/medley/document/2110526240327000000000001 let's hope they're not too limited:
"
Entry of both the Protective Order and the Production Order is necessary to
allow the Liquidating Trust to comply with the subpoena in a cost-efficient manner, in order to
preserve the Liquidating Trust’s extremely limited financial resources
"
last doc i see regarding this is: https://www.kccllc.net/medley/document/2110526230727000000000001
assuming this is related to: "Liquidating Trust’s Request for Documents and Information" (???)
i 'thought' everything was behind us with Eversheds(?)
ugh, it 'is' more Eversheds: Court Docket: #0695
Document Name: Notice of Service of William E. Chipman, Jr. re: Defendant's Initial Disclosures Pursuant to Fed. R. Civ. P. 26(a)(1) and Fed. R. Bankr. P. 7026 (Filed by Eversheds Sutherland (US) LLP)