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Moderna, Novavax, Inovio, BioNtech, 'RNA vaccin-producenten'

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MisterBlues
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MisterBlues
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Over Heat Biologics

The Current Covid situation is worse than ever, with 4 Million+ people in the US, 15 Million+ people globally infected and the US alone at 60,000-70,000 New cases a day adding, the situation will continue getting worse, in fact much worse by the day before it can ever gets better. The demand for an effective vaccine especially towards high-risk low immunity group is more desperate than ever. $HTBX (Heat Biologics) already has its existing proven GP96 platform to generate strong Tcell response which are crucial for senior citizens and high risk group generate immunity to defend against virus. HTBX's Covid human Trial program will be unique comparing to the other existing vaccine development programs, because it is not only aiming to generate antibodies like every other developer is aiming at, but it is also focusing on boosting and creating strong TCells in high-risk low immune population. This is going to be a huge breakthrough in Covid Vaccination development in my understanding of the human trial in progress with University of Miami and Manufacturing lined up with Waissman Pharmacy, I believe HTBX (Heat Biologics) is stepping in the right direction and has its unique comparative advantages over many other vaccine developers, I am also convinced that It is just a matter of time, maybe days, maybe weeks or month, before it gets further grant from government and announcing major breakthroughs. Another good thing is HTBX (Heat Biologics) had already got $7 Million from March 2020 round of fund, so there should be no stock dilution for the remaining of this year as it further its development on Covid vaccine and other immunization drugs, this another HUGE advantage that most small-mid cap vaccine developers do not have.
MisterBlues
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quote:

Goudmijntje schreef op 22 juli 2020 15:49:

twitter.com/WSJ/status/12859066634600...

BioNtech & Pfizer, akkoord voor 100m vaccins met Amerika
Dat is goed nieuws! Vooral voor BioNtech die het daar van moet hebben. Deze heb ik voor een bescheiden bedrag in bezit, vroeg ingestapt dus een heerlijke ontspannen weg voor mij tot nog toe. :)

Koers staat inmiddels over de 90,- dollar.

Jij @Goudmijntje, zit jij in deze? Welke nog meer? Nog tips?
MisterBlues
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22-7-2020 13:57:54

VS kopen 100 miljoen coronavaccins
(ABM FN-Dow Jones) De Verenigde Staten hebben 100 miljoen doses van een potentieel coronavaccin van Pfizer en BioNTech besteld. Daarvoor betaalt Washington 1,95 miljard dollar. Dit meldden beide farmaceuten woensdag.

Het gaat om kandidaatvaccin BNT162.

De VS zouden het vaccin gratis beschikbaar willen stellen aan de eigen bevolking.

De bestelling zou later nog kunnen worden verhoogd met nog eens 500 miljoen doses.

Pfizer en BioNTech denken aan het einde van dit jaar de eerste 100 miljoen doses klaar te hebben. Eind 2021 moeten er meer dan 1,3 miljard zijn.

Door: ABM Financial News.
MisterBlues
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Novavax, Inc.'s (NASDAQ: NVAX) presentation at the International Society for Vaccines virtual congress Tuesday has increased Cantor Fitzgerald's confidence in its investigational coronavirus vaccine, codenamed NVX-CoV2373.

The Novavax Analyst: Charles Duncan reiterated an Overweight rating and $148 price target for Novavax.

The Novavax Thesis: Preclinical data detailed by Novavax at the congress were encouraging, Duncan said.

The key new information, according to the analyst, was that cynomolgus macaques — a non-human primate — vaccinated with NVXCoV2373 and challenged with live virus showed lower levels of detectable viral loads in bronchoalveolar lavage samples compared to placebo animals.

This suggested that the vaccine helps reduce viral replication/load.

Benzinga is covering every angle of how the coronavirus affects the financial world. For daily updates, sign up for our coronavirus newsletter.

The analyst also noted nasal swabs from infected macaques showed there is a several log reduction in viral load in the vaccinated group as compared to the placebo group.

"We continue to be encouraged as a result of these preclinical data that provide a window into potential translatability into human efficacy, assuming that immune functionality is conserved from these non-human to human primates," Duncan wrote in the note.

If immune functionality works in human primates, the incremental preclinical data would further support the rationale for moving forward in human clinical trials, Duncan said.

Cantor remains focused on the initial immunogenicity data from the Phase 1 study due in July.

That Novavax' sPhase 1 study has enrolled a slightly higher number of participants compared to other coronavirus vaccine studies is a positive, the firm said.

In the Phase 1 update, it will look for IgG response against the spike protein, neutralizing antibody response and T-cell response, which will likely help establish a high-level perspective on the breadth and depth of the overall immune response.

Latest Ratings for NVAX
Date Firm Action From To
Jul 2020 HC Wainwright & Co. Maintains Buy
Jul 2020 Ladenburg Thalmann Downgrades Buy Neutral
Jun 2020 B. Riley FBR Maintains Buy

MisterBlues
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Why Was Novavax Awarded Almost $2 Billion in Free Money?

Operation Warp Speed (OWS) and the Coalition for Epidemic Preparedness Innovations (CEPI) both selected Novavax for their highest grant awards.

Taylor Carmichael
(TMFSaintCroix)
Jul 22, 2020 at 8:05AM

The Coalition for Epidemic Preparedness Innovations (CEPI) was established in 2017 to fund vaccine efforts to stop worldwide epidemics. Co-founded by Bill Gates, the nonprofit is the largest vaccine initiative charity in the world. In May, CEPI made headlines when it granted its largest award ever, $388 million, to tiny Novavax (NASDAQ:NVAX) to help the biotech develop a vaccine candidate for COVID-19.

Operation Warp Speed (OWS) was created after COVID-19 became a health emergency in the U.S. The idea was to fund multiple vaccine candidates and speed up the drug development process to create a working vaccine as fast as possible. In June, OWS narrowed its favorite vaccine candidates down to five companies: Moderna (NASDAQ:MRNA), Merck (NYSE:MRK), Pfizer (NYSE:PFE), Johnson & Johnson (NYSE:JNJ), and AstraZeneca (NYSE:AZN). But in July, OWS shocked the world by instead granting $1.6 billion in funding to tiny Novavax.

While other companies have received significant funding from OWS and CEPI, by far the most money was given to one of the smallest players. Why?
Several medicine vials with labels that say "Vaccine nCoV"

Image source: Getty Images
Cinderella needs a little help

In a report published July 16, The New York Times suggested that Novavax won the grants because of the company's close ties with health officials. An anonymous source told the newspaper that small biotech companies need more money than larger pharmaceutical companies to help with manufacturing costs.

While that's obviously true, it doesn't answer the question of why Novavax. After all, many small biotech companies are pursuing a coronavirus vaccine. Most of them haven't been awarded any funding at all. And the federal government's first round of funding skipped Novavax altogether.
MisterBlues
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While large pharmaceutical companies don't need financial help from the government, they certainly appreciate it. In the first round of funding, OWS named several large pharmaceutical companies (Johnson & Johnson, Merck, Pfizer) and even a foreign company (AstraZeneca) as some of the companies that would get federal funding. Only midsized Moderna would seem to qualify as a Cinderella who might need a little help.

So what changed for Novavax? Why did this small cap emerge from obscurity and receive such a large check from the federal government?
Novavax's vaccine candidate has produced a huge number of antibodies in nonhuman primates

The decision to send $1.6 billion to Novavax was not made simply because Novavax is a small company. And it was not made just because management has friendly relations with CEPI.

The simplest explanation is probably the best one. The federal government really wants a working COVID-19 vaccine. This is why it's granting such high dollar amounts in the first place. And science doesn't play favorites. Novavax was selected for a $1.6 billion grant not because it's a small company or enjoys favoritism. Novavax won that grant because its animal data is the most promising of all the vaccine candidates to date.

Back in June, Novavax announced its animal data for its vaccine candidate, NVX-CoV2373. "We are seeing neutralizing titers in the 10,000 range in nonhuman primates," said Dr. Gregory Glenn, the head of research and development at Novavax. Other companies are reporting antibody data in the 40 to 200 range in animal testing.

As a point of contrast, earlier this month Pfizer and its partner, BioNTech (NASDAQ:BNTX), announced that in a phase 1 trial, 10 micrograms of its vaccine candidate produced an average of 168 antibodies in humans, while a dose of 30 micrograms yielded 267.

While Novavax has not released its phase 1 data as applies to humans yet, a vaccine candidate that produces 10,000 antibodies in primates is very impressive.
It's likely why the company was awarded almost $2 billion in grant funding.

We're anxious to see whether this impressive result in animal testing can be reproduced in humans.
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ABUS vs. MRNA >> David vs. Goliath >> welles vs. nietes.

Ik snap even niet waarom hier niet over gerept wordt op de diverse biotechboards. Er is een patentkwestie aan de gang (betreffende LNP’s) wat het covidmedicijn van Moderna in de wielen kan doen rijden. Uitspraak afgelopen donderdag over dit punt was positief voor Arbutus wat de koers omhoog deed spuiten (+119%), Moderna verloor zo’n 10%.
Het betreft een patent van Arbutus welke gelimiteerd via Acuitas bij Moderna terecht kwam. Een beetje ingewikkeld, wordt hier beter uitgelegd:
www.evaluate.com/vantage/articles/new...
en
federallabs.org/news/patent-ruling-ag...

Ook Pfizer en BNTX (BioNYech) maken via Genevant gebruik van deze LNP-techniek voor covid. In a nutshell:
twitter.com/JacobPlieth/status/128662...

Na de forse stijging volgde een daling van 20% de volgende dag. Na eea gelezen te hebben neig ik ernaar dat ABUS (MC 342 million) Moderna (MC 28 billion) redelijk bij de ballen heeft want het verweer dusver is nog niet overtuigend. Wordt sowieso interessant dit te volgen.

Mogelijke voortgang/uitkomst/belemmeringen:
- Buy out (MNRA/PFE/BNTX?)
- Betalen van royalties (MNRA)
- Langdurige rechtsgang
- Politieke druk (in the end gaat het om HEEEL veel geld)
- Enz, enz.

Graag jullie mening want ik ben ook maar een eenvoudige boerelul ;-)
MisterBlues
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quote:

hosternokke schreef op 26 juli 2020 00:01:

ABUS vs. MRNA >> David vs. Goliath >> welles vs. nietes.

Ik snap even niet waarom hier niet over gerept wordt op de diverse biotechboards. Er is een patentkwestie aan de gang (betreffende LNP’s) wat het covidmedicijn van Moderna in de wielen kan doen rijden. Uitspraak afgelopen donderdag over dit punt was positief voor Arbutus wat de koers omhoog deed spuiten (+119%), Moderna verloor zo’n 10%.
Het betreft een patent van Arbutus welke gelimiteerd via Acuitas bij Moderna terecht kwam. Een beetje ingewikkeld, wordt hier beter uitgelegd:
www.evaluate.com/vantage/articles/new...
en
federallabs.org/news/patent-ruling-ag...

Ook Pfizer en BNTX (BioNYech) maken via Genevant gebruik van deze LNP-techniek voor covid. In a nutshell:
twitter.com/JacobPlieth/status/128662...

Na de forse stijging volgde een daling van 20% de volgende dag. Na eea gelezen te hebben neig ik ernaar dat ABUS (MC 342 million) Moderna (MC 28 billion) redelijk bij de ballen heeft want het verweer dusver is nog niet overtuigend. Wordt sowieso interessant dit te volgen.

Mogelijke voortgang/uitkomst/belemmeringen:
- Buy out (MNRA/PFE/BNTX?)
- Betalen van royalties (MNRA)
- Langdurige rechtsgang
- Politieke druk (in the end gaat het om HEEEL veel geld)
- Enz, enz.

Graag jullie mening want ik ben ook maar een eenvoudige boerelul ;-)

Interessante lead naar een nieuwe belegging (voor mij).

Eerste primaire reactie: de belangen zijn veel te groot en de financiële middelen van Moderna zijn ook ruim zodat ik denk dat het geen belemmering gaat worden. Arbutus spint er wel garen bij, zo lijkt het...

Ik denk dat het geschikt gaat worden met een goede som.

He added that the results of the lawsuit could expose Moderna to debate around its entire pipeline, including the COVID-19 vaccine, which is expected to begin Phase III clinical trials next week.
[verwijderd]
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MisterBlues
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Op het Yahoo forum gevonden:

Here the SEC filing from ABUS.... today.... and here's my question.... Genevant (partnership between ABUS and Roivant Sciences) appears to have licensed the LNP technology to BNTX as in PFE/BNTX who are currently working on COVID-19 vaccine. Can ABUS bring suit against MRNA arguing only Genevant has rights to use their LNP?? Can ABUS argue the vaccine in trial by MRNA should be invalidated??

"On July 23, 2020 the United States Patent and Trademark Office before the Patent Trial and Appeal Board ("PTAB") announced their decision in Moderna Therapeutics, Inc.'s challenge of the validity of U.S. Patent 8,058,069 ("the '069 Patent"). In this decision the PTAB determined no challenged claims were unpatentable. While Arbutus Biopharma, Inc. ("Arbutus") is the patent holder, this patent has been licensed to Genevant Sciences Ltd. ("Genevant").

As previously disclosed, in April 2018 Arbutus entered into an agreement with Roivant Sciences Ltd., its largest shareholder, to launch Genevant, a company focused on the discovery, development, and commercialization of a broad range of RNA-based therapeutics enabled by Arbutus' lipid nanoparticle ("LNP") and ligand conjugate delivery technologies. Arbutus licensed exclusive rights to its LNP and ligand conjugate delivery platforms to Genevant for RNA-based applications outside of HBV, except to the extent certain rights had already been licensed to other third parties. Arbutus retained all rights to its LNP and conjugate delivery platforms for HBV. The '069 Patent was included in this license agreement between Genevant and Arbutus.

Arbutus is entitled to receive tiered low single digit royalties on future sales of Genevant products covered by the licensed patents. If Genevant enters into a sub-license agreement, Arbutus would receive twenty percent of the revenue received by Genevant for this sublicensing of the intellectual property licensed by Arbutus to Genevant.

Arbutus owns approximately 40% of the common equity of Genevant. Genevant has issued convertible debt securities to other investors. If those securities are converted to common shares, or additional capital is invested into Genevant by other parties, Arbutus' ownership interest in Genevant will be significantly diluted. Arbutus' entitlement to receive future royalties or sublicensing revenue will not be reduced by any dilution of Arbutus' equity ownership position in Genevant".
MisterBlues
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Ook goed voor korte ritjes:

Duitse ontwikkelaar coronavaccin CureVac wil naar Wall Street

Gepubliceerd op 24 juli 2020 21:14 | Views: 3.791 | Onderwerpen: Duitsland

NEW YORK (AFN) - De Duitse biotechnoloog CureVac, die bezig is met de ontwikkeling van een vaccin tegen het coronavirus, heeft een aanvraag ingediend voor een beursgang in New York. Daarbij wil het bedrijf 100 miljoen dollar ophalen, al kan dit bedrag nog veranderen. Het geld moet onder meer worden gebruikt om onderzoek te financieren.

Volgens persbureau Bloomberg kan de beursgang 150 miljoen tot 200 miljoen dollar gaan opleveren en kan CureVac een waardering krijgen van 1 miljard dollar. De in 2000 opgerichte onderneming wil een notering aan de technologiebeurs Nasdaq onder het beurssymbool 'CVAC'. Het juridische hoofdkantoor van de biotechnoloog moet komen in Nederland.

Onlangs werd nog bekend dat de Britse farmaceut GlaxoSmithKline (GSK) voor 130 miljoen pond een belang van 10 procent in CureVac neemt. In juni werd gemeld dat de Duitse overheid voor 300 miljoen euro een belang van 23 procent heeft genomen in het bedrijf. CureVac is grotendeels in handen van miljardair Dietmar Hopp, een van de oprichters van het Duitse softwareconcern SAP en eigenaar van voetbalclub Hoffenheim.

CureVac kreeg in juni toestemming van de Duitse autoriteiten om zijn experimentele vaccin tegen het coronavirus te gaan testen op proefpersonen. De resultaten uit de eerste testfase worden dit najaar verwacht. Volgens CureVac kan het vaccin medio 2021 op de markt worden gebracht.
[verwijderd]
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What’s next?

In the typical biotech game, what would follow now is a last-ditch attempt by Moderna to still invalidate the patent by appealing the ruling. Odds are now strongly against though Moderna that they will be able to reverse last week’s ruling. In fact, the ‘069 is now stronger than ever and the above evidence will give them sufficient ammunition to sue Moderna on the presumption of infringement. Appealing the decision would, however, buy Moderna some time trying to make their smaller adversary willing to settle for more favorable terms (following the Alnylam playbook).

This, however, is happening during a pandemic and IP-related tactical games may not be viewed kindly. This also means that Arbutus would be well advised not to make a big public fuss out of what could be very valuable to them financially and continue with their low-key, matter-of-fact approach to the issue.

So in short, I don’t know when the issue will be resolved, but it certainly won’t be next week or month, but more likely at least after a first read-out of the phase 3 results before we hear about any resolution to the matter- most likely a settlement.

How much all of this is worth to Arbutus stock is anybody’s guess, too, depending, of course, mostly on the performance of mRNA-1273 in the clinic, the price Moderna could charge for its vaccine (note: Moderna is a proponent of whatever-the-market-will-bear) and whether covid19 vaccines will become an annual re-administration market. Personally, the current share price of $5 is already justified by the promising HBV-RNAi phase I results disclosed in May (update pending soon) and the optionality from the fact that Michael Sofia from Arbutus, the inventor of the most impactful HCV medicine, polymerase inhibitor sofosbuvir, has now set his sights on inhibiting the SARS-CoV-2 polymerase.

rnaitherapeutics.blogspot.com/2020/07...
MisterBlues
0
Arbutus gaat flink omhoog bij opening.

Nog een kandidaat voor korte ritjes:

VBIV will receive a Canada Government grant. It will come from $600M allocated to through the Strategic Innovation Fund to support COVID-19 vaccine and therapy clinical trials led by the private sector as well as Canadian biomanufacturing opportunities."

There are listed three companies receiving support from the federal government in COVID vaccine development:
* VBI Vaccines (** Top player IMHO)
* CanSino Biologics (now there are issues with CA government since Huawei President detention & 2 canadians in China also detained)
* The University of Saskatchewan’s (USask) Vaccine and Infectious Disease Organization-International Vaccine Centre.

NRC collaboration is special so I believe we will get substantial Canada Grant for this project.
charts.stocktwits.com/production/orig...
[verwijderd]
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@Misterblues
Klopt...maar Aburtus stond vorige vrijdag overdag zelfs +40%, om bij sluiting te eindigen op -20%.
heeft me flink wat gekost.
wait and see
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