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Munnybunny
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Re: Arbutus Biopharma - ABUS

Bericht door Munnybunny »

NIH-Moderna Investigational COVID-19 Vaccine Shows Promise

TOPICS:COVID-19National Institutes Of HealthPublic HealthVaccine

By NATIONAL INSTITUTES OF HEALTH AUGUST 13, 2020

Vaccine shows promise in mouse studies and is currently being evaluated in Phase 3 clinical testing.

The investigational vaccine known as mRNA-1273 protected mice from infection with SARS-CoV-2, the virus that causes COVID-19, according to research published today in Nature. Scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the biotechnology company Moderna, based in Cambridge, Massachusetts, along with collaborators from the University of North Carolina at Chapel Hill, Vanderbilt University Medical Center in Nashville, and the University of Texas at Austin conducted the preclinical research. NIAID Vaccine Research Center (VRC) scientists worked with investigators from the University of Texas at Austin to identify the atomic structure of the spike protein on the surface of the novel coronavirus. This structure was used by VRC and Moderna in the development of the vaccine candidate.

The findings show that the investigational vaccine induced neutralizing antibodies in mice when given as two intramuscular injections of a 1-microgram (mcg) dose three weeks apart. Additional experiments found that mice given two injections of the 1-mcg dose and later challenged with SARS-CoV-2 virus either 5 or 13 weeks after the second injection were protected from viral replication in the lungs and nose. Importantly, mice challenged 7 weeks after only a single dose of 1 mcg or 10 mcg of mRNA-1273 were also protected against viral replication in the lung.

The investigational vaccine also induced robust CD8 T-cell responses in mice. It did not induce the type of cellular immune response that has been linked to vaccine-associated enhanced respiratory disease (VAERD). This rare, allergic-type inflammation was seen in individuals vaccinated with a whole-inactivated respiratory syncytial virus (RSV) vaccine in the 1960s. VAERD can occur when a vaccine induces an immune response that is not strong enough to protect against infection. The investigators vaccinated mice with sub-protective doses of mRNA-1273 and then challenged the mice with SARS-CoV-2. The mice showed no evidence of enhanced lung pathology or excessive mucus production, indicating the vaccine did not cause enhanced disease, the authors write.

The authors note that the data from these studies, combined with data from studies in nonhuman primates and Phase 1 clinical testing, support the evaluation of mRNA-1273 in clinical efficacy trials. They also explain how their prior research on a candidate MERS-CoV vaccine paved the way for a rapid response to the COVID-19 outbreak. “This is a demonstration of how the power of new technology-driven concepts like synthetic vaccinology facilitates a vaccine development program that can be initiated with pathogen sequences alone,” the authors write.





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Re: Arbutus Biopharma - ABUS

Bericht door Munnybunny »

MRNA, PFE, CVAC... deze gebruiken allemaal het LNP patent van ABUS. Laat de royalties maar komen...

Moderna stands to earn $300M for quick vaccine approval, up to $6.6B for extra doses: filing

by Eric Sagonowsky | Aug 17, 2020 3:20pm
Moderna manufacturing site
A Moderna securities filing shows more specifics of the company's COVID supply deal with the U.S. (Moderna)
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Moderna's coronavirus vaccine deal with the U.S., announced last week with a $1.525 billion price tag, would be worth far more if all options are exercised—and if the mRNA biotech meets an aggressive timeline for the shot's arrival.

The company stands to gain up to a whopping $8.125 billion, according to a Moderna securities filing that details the price for follow-up doses and the windfall for an early FDA approval.

The base agreement calls for 100 million doses of the company’s COVID-19 vaccine candidate, mRNA-1273, for $1.225 billion. But the drugmaker is eligible for a $300 million bonus if it’s able to score an FDA emergency use authorization or full approval by Jan. 31, the filing shows.


The tie-up also allows the government to purchase up to 400 million additional doses through four contract options, each comprising 100 million doses.

Each 100 million-dose chunk would cost the U.S. government $1.65 billion, making those vaccine doses cost $16.50 each. If the government exercised all options, that'd be another $6.6 billion in revenues on top of the first round of $1.525 billion.

RELATED: After nearly $1B in research funding, Moderna takes $1.5B coronavirus vaccine order from U.S.

Last week's agreement builds on $955 million in R&D funding the government has already awarded to the biotech, which has entered late-stage testing with its candidate.

Also under the agreement, Moderna is entitled to “approximately $600 million” for producing documents related to production, according to the filing. And if Moderna wins an FDA endorsement for the vaccine but doesn’t fulfill the supply order, the company is obligated to help the government or a third party scale up manufacturing to produce the doses.

RELATED: Moderna has started turning out COVID-19 vaccine doses for quick shipment if approved: CEO

In addition to the Moderna deal, the government has inked supply agreements with AstraZeneca, Johnson & Johnson, Pfizer and Novavax, with all of the agreements totaling 800 million doses. Pfizer’s partner BioNTech has said the team could be in a position to seek emergency approvals by October. For his part, vaccine expert Peter Hotez recently told CNN there’s “no way” a vaccine will be available by Election Day on Nov. 3.

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Re: Arbutus Biopharma - ABUS

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Curevac muddies the Moderna/Arbutus waters further

Jacob Plieth

The markets try to figure out who really benefits from last week’s patent decision over a key mRNA technology.

It took Arbutus and Moderna almost 24 hours to comment publicly on the relevance of Thursday’s legal bust-up, which saw the former prevail in a patent ruling that could threaten the latter’s Covid-19 vaccine. Neither company looks to have covered itself in glory. The entry of Curevac into the fray complicates things further still.

Arbutus admitted that it had actually signed away much of the relevant rights two years ago, and its stock lost 20%. Moderna, meanwhile, claimed that its tech was in fact “not covered by the Arbutus patents”. In that case why did it initiate the legal action against Arbutus to begin with? And is Curevac in the clear?

The German group revealed its hand in a filing with the US SEC for a proposed $100m flotation. In the document Curevac spelled out its reliance on a lipid nanoparticle (LNP) technology developed by Acuitas, a private Canadian company with links to Alnylam, by way of a 2016 tie-up for which it pays an annual $1.1m maintenance fee.

Acuitas is at the centre of the dispute between Moderna and Arbutus, and is also the source of LNPs used by Biontech/Pfizer. The remarkable upshot of all this is that three of the major mRNA Covid-19 vaccine competitors might all in some way rely on the LNP technology in question.

Longstanding aggression

Moderna says it had challenged three relevant Arbutus patents “in response to the longstanding aggressive posture taken by Arbutus”. It also claims that its own LNP technology has advanced beyond what the Arbutus patents describe, perhaps implying that it has largely re-engineered its mRNA approach over the past two years.

Arbutus’s statement, meanwhile, should not have come as a surprise to any investors who had been paying close attention. For the sake of clarity, Arbutus might have won the legal decision, but it spells out that it has at most a 40% interest in the patent in question, US no 8,058,069.

This is because in 2018 it spun rights to the LNP technology that did not relate to hepatitis B into Genevant, a venture with Vivek Ramaswamy’s holding company, Roivant Sciences (The Covid-19 vaccine battle just got interesting, July 24, 2020). Back then no one was thinking about Covid-19, and Arbutus’s key focus was hepatitis B; the venture is 60%-owned by Roivant.

And, for Arbutus investors, it gets worse: Genevant subsequently issued convertible debt, and if this is paid off in new equity Arbutus’s shareholders “will be significantly diluted”. Arbutus says it is, however, entitled to a low single-digit royalty on sales of products derived from the ’069 patent now held by Genevant.


So, with Moderna stock down on Friday, and Arbutus coming off its Thursday blip, who could win here? Clearly Genevant’s majority owner, Mr Ramaswamy, now looks to have had remarkable foresight.

Curevac has so far not been implicated in legal action, so it must be assumed that any rights Acuitas granted it to the ‘069 patent stand. And the same goes for Biontech/Pfizer, which in 2018 struck a licensing deal with Genevant that today looks like the key to the puzzle.

Crucially, Biontech/Pfizer’s BNT162b1 and Moderna’s mRNA-1273 are fierce rivals, so in purely business terms it is in the interests of one to stop the other. But this is Covid-19, a global emergency, where the optics of a move that threatens to delay the availability of a vaccine would be disastrous.

A plain royalty looks to be the simplest answer. If Arbutus investors today look to have lost out, the real winners will emerge later.

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Re: Arbutus Biopharma - ABUS

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Brief van een aandeelhouder aan Moderna:

I'm a shareholder of both and would love to see a buyout! So I sent this to Moderna's mgmt.

Please forward to Management:

As a shareholder of Moderna, I did my extensive research on recent patent loss to Arbutus as I had no idea that there was a patent issue whatsoever when I purchased Moderna shares. As one of your shareholders, I feel that Moderna could create a much higher shareholder value based on the following research.

Arbutus “spun” out their LPN technology in 2018 and created a joint company with Roivant to form Genevant whereby Arbutus would have 40% stake but kept their Hep B research for commercialization. Genevant sublicensed this technology to BioNTech who has partnered with Pfizer for the Covid vaccine project BNT162 vaccine. In addition, Curevac who recently went public who now has a market cap of $13.6 Billion has also sublicensed the LPN technology from Acuitas who I thought Moderna had sublicensed agreement with. Acuitas in-fact has sublicense agreement with Arbutus but that sublicense is limited based on 2018 settlement with Arbutus.

I did more research on Arbutus and their Chief Scientific Officer is NONE other than Dr. Michael Sofia. That name is very familiar with me because I was a shareholder of Pharmasset back in 2010 and Gilead purchased Pharmasset for $11 Billion in 2012. Dr. Sofia was responsible for the discovery of Sofosbuvir (cure for Hep C) and when Gilead got the FDA approval, their first year of sales in 2015 soared to $10.3 Billion (world’s best-selling drug in the first year). Dr. Sofia in May of this year received the prestigious University of Edinburgh Cameron Prize for Therapeutics for finding the cure for Hep C. Arbutus has promising cure for Hep B and Dr. Sofia being the CSO, I have no doubt that they will find a cure yet again that would be another blockbuster drug to come to market. Dr. Sofia has a proven track record and speaks for itself.

While I love the fact that Moderna’s shares have gone up significantly, it could and should be worth much more based on the pipeline of promising drugs and vaccine for Covid. I’m not as smart as Moderna’s management and maybe management has already done their due diligence but why would Moderna not just buyout Arbutus? With the buyout, Moderna would not have to pay millions and possible billions in royalty payments to Genevant and would also receive royalties from BioNTech/Pfizer should their Covid vaccine come to market as 40% stakeholder of Genevant (Genevant also has promising drug discovery pipeline as well). In addition, should Curevac’s vaccine come to market for their Covid vaccine, there would be additional royalties. I have not done my DD on the licensing by Curevac but I’m sure it will be in hundreds of millions in royalties. Moderna then would also have access to a possible Hep B cure which is a multi-billion-dollar market as well. It took many tries and approx.. 5 yrs for Dr. Sofia to get FDA approval for Hep C cure and he will do it again for Hep B cure at a much faster rate with their technology.

While Moderna’s market cap has significantly increased, why not leverage that to buyout a $300 million market cap company literally cents on the dollar while you can. I strongly feel that this patent loss has put a cap on Moderna’s stock and should Moderna buyout Arbutus, that cap will be lifted which would significantly enhance shareholder value. I have no knowledge that other companies are looking at Arbutus but if an individual investor like myself can come to this conclusion, I’m sure other big pharma companies with deep pockets who can pay cash for Arbutus is now looking to do the same. Should one of these big pharma’s acquire Arbutus, that would mean even higher royalty payments for Moderna as they will want a premium for their acquisition costs of Arbutus.

In full disclosure, I am a shareholder of Moderna as well as Arbutus (just recently).
Thank you

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Re: Arbutus Biopharma - ABUS

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Goed nieuws voor ABUS 👍🏻

Moderna: Vaccine induces immunity in elderly people

BUSINESSBreaking the NewS
A coronavirus vaccine candidate developed by American biotech company Moderna produced neutralizing antibodies necessary to build immunity against the virus, the company revealed on Wednesday.

Early clinical trials performed on 20 adults aged 56 years and above showed that the volunteers produced the needed antibodies and killer T-cells, after each participant of the trial received two 100 microgram doses of the vaccine 28 days apart. The vaccine seems to be well tolerated as no serious negative effects were reported among the tested people, according to Moderna's statement.

The company is expected to hold a conference call at 4:30 pm ET today, when further details of the trial results will be revealed.

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Re: Arbutus Biopharma - ABUS

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Arbutus to Participate in Virtual Fireside Chat at H.C. Wainwright 22nd Annual Global Investment

WARMINSTER, Pa., Sept. 09, 2020 -- 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, as well as therapies to treat coronaviruses (including COVID-19), today announced that the Company will participate in a virtual fireside chat at the H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 at 10:30 am 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 virtual 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.

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Re: Arbutus Biopharma - ABUS

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Arbutus Announces AB-729 90 mg Single-Dose Week 12 Data in Chronic Hepatitis B Subjects Demonstrating Significant and Continuous Reductions in HBsAg


September 15, 2020 07:30 ET | Source: Arbutus Biopharma Corporation
Mean HBsAg reduction of 1.23 log10 IU/mL at week 12 with a favorable safety and tolerability profile

WARMINSTER, Pa., Sept. 15, 2020 (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 as well as therapies to treat coronaviruses (including COVID-19), today reports continued positive data from an ongoing Phase 1a/1b clinical trial (AB-729-001) with AB-729, its proprietary GalNAc delivered RNAi compound. These new data demonstrate that in chronic HBV subjects, a single subcutaneous injection of 90 mg of AB-729 resulted in a mean HBsAg reduction of 1.23 log10 IU/mL at week 12.

William Collier, President and Chief Executive Officer of Arbutus, stated, “The 90 mg single-dose 12-week data coupled with our previously disclosed 60 mg single-dose 12-week data mean that we now have two doses which have demonstrated meaningful reductions in HBsAg with a favorable safety and tolerability profile. We are currently dosing chronic HBV subjects in four multi-dose cohorts using both the 60 mg (every 4- and 8-weeks) and 90 mg (every 8- and 12-weeks) doses to determine the optimal dosing regimen for AB-729. We believe AB-729 will potentially offer people with chronic HBV a well-tolerated low dose treatment with a minimum of injections.”

Arbutus expects to present initial results from its ongoing Phase 1a/1b clinical trial for the 60 mg multi-dose cohorts, the 90 mg single-dose cohort in HBV DNA positive subjects, as well as longer-term follow up of the 60 and 90 mg single-dose cohorts, at an upcoming scientific meeting later this year. In addition to the ongoing 60 mg multi-dose cohorts with subjects dosed at 4- and 8-weeks, the Company has also initiated 90 mg multi-dose cohorts with subjects dosed at 8- and 12-week intervals.

Mean HBsAg changes from baseline:

60 mg Single-Dose
Cohort (B)
(N=6) 90 mg Single-Dose
Cohort (C)
(N=6)
Week 12 (day 84) mean log10 IU/mL
(Standard Error of the Mean) -0.99 (0.24) -1.23 (0.18)
Dr. Gaston Picchio, Chief Development Officer of Arbutus, stated, “The mean HBsAg decline seen in the 90 mg single-dose cohort is consistent with that seen in prior single-dose cohorts. Importantly, the data demonstrate consistent efficacy and a favorable safety profile at this intermediate dose. These findings support the continued evaluation of the 90 mg dose in the multi-dose portion of our ongoing clinical trial.”

Summary of clinical trial design

AB-729-001 is an ongoing first-in-human clinical trial consisting of three parts:
In Part 1, three cohorts of healthy subjects were randomized 4:2 to receive single-doses (60 mg, 180 mg or 360 mg) of AB-729 or placebo.

In Part 2, non-cirrhotic, HBeAg positive or negative, chronic HBV subjects (N=6) on a background of nucleos(t)ide therapy with HBV DNA below the limit of quantitation received single-doses (60 mg to 180 mg) of AB-729. An additional cohort in Part 2 included 90 mg single-dose of AB-729 in HBV DNA positive chronic HBV subjects.

In Part 3, chronic HBV subjects, HBV DNA negative first and HBV DNA positive later, are receiving multi-doses of AB-729 for up to six months.

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. In an ongoing single- and multi-dose Phase 1a/1b clinical trial, AB-729 demonstrated positive safety and tolerability data and meaningful reductions in hepatitis B surface antigen.

About HBV

Chronic hepatitis B virus (HBV) infection is a debilitating disease of the liver that afflicts over 250 million people worldwide with up to 90 million people in China, as estimated by the World Health Organization. HBV is a global epidemic that affects more people than hepatitis C virus (HCV) and HIV infection combined—with a higher morbidity and mortality rate. HBV is a leading cause of chronic liver disease and need for liver transplantation, and up to one million people worldwide die every year from HBV-related causes.

The current standard of care for patients with chronic HBV infection is life-long suppressive treatment with medications that reduce, but do not eliminate, the virus, resulting in very low cure rates. There is a significant unmet need for new therapies to treat HBV.

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Re: Arbutus Biopharma - ABUS

Bericht door Munnybunny »

Mooi hepatitis nieuws, maar de kers op de taart is toch het patent dat de covid farma’s MRNA, PFE, BNTX, CVAC gebruiken. Dit zal uiteindelijk de kassa doen rinkelen voor ABUS.

https://www.google.be/amp/s/www.evaluat ... /16048/amp
Je hebt niet voldoende permissies om de bijlagen van dit bericht te bekijken.
Mannie liked last!

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Re: Arbutus Biopharma - ABUS

Bericht door Munnybunny »

Moet sluiten boven 3,11 voor trend ommekeer.
Je hebt niet voldoende permissies om de bijlagen van dit bericht te bekijken.

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Re: Arbutus Biopharma - ABUS

Bericht door Munnybunny »

En hier zijn dan de upgrades. Target $5😃

Arbutus HBV data 'could represent a turning point,' says Chardan Arbutus Biopharma this morning announced "impressive" interim data from the Phase Ia/Ib clinical trial evaluating its lead asset, AB-729, as a treatment for chronic hepatitis B virus, Chardan analyst Keay Nakae tells investors in a research note. The data show an even greater knockdown of HBsAg compared to what was observed at 12 weeks for a single 60 mg dose, says the analyst. Nakae believes the positive results for AB-729 "could represent a turning point" for Arbutus and lead to a partnership. The analyst maintains a Buy rating on the shares with a $5 price target.

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