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Home  /  Forum  /  Koffiekamer  /  Moderna, Novavax, Inovio, BioNtech, 'RNA vaccin-producenten'

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

819 Posts
Pagina: «« 1 ... 8 9 10 11 12 ... 41 »» | Laatste | Omlaag ↓
  1. [verwijderd] 1 oktober 2020 00:35
    quote:

    MisterBlues schreef op 30 september 2020 16:43:

    [...]

    Omdat Novavax toch wat achter ligt op de tijdlijn denk ik dat er nog een behoorlijke koopkans komt omdat de concurrentie de markt eerder bereikt. Dan zal het tegenvallen en kan Novavax scoren. Ik denk en wens dat het zo gaat lopen. Jij?
    Het gaat om een shitload of money (Big Pharma, politiek etc) in deze wereld en nu zeker. Dus met de koers kan het nog echt alle kanten op. In de aanpak/uitslagen van de trials van NVAX tov de concurrentie heb ik meer vertrouwen dus als het wat later komt, soit. Persoonlijk zou ik dan ook dit (indien goedgekeurd) vaccin kiezen mocht er gevaccineerd kunnen worden. En koopkansen komen er sowieso altijd.
  2. [verwijderd] 1 oktober 2020 14:16
    Coronavirus vaccine trial participants report day-long exhaustion, fever and headaches — but say it’s worth it
    PUBLISHED THU, OCT 1 20207:00 AM EDTUPDATED 40 MIN AGO
    @CHRISSYFARR
    Berkeley Lovelace Jr.
    @BERKELEYJR
    KEY POINTS
    High fever, body aches, headaches and exhaustion are some of the symptoms participants in Moderna and Pfizer’s coronavirus vaccine trials say they felt after receiving the shots.
    While the symptoms were uncomfortable, and at times intense, they often went away after a day, sometimes less.
    The phase three trials are a critical last step needed to get the vaccines cleared for distribution.

    www.cnbc.com/2020/10/01/coronavirus-v...
  3. forum rang 5 MisterBlues 5 oktober 2020 19:42

    Novavax to Participate in Upcoming Conferences

    Oct 05, 2020 at 9:00 AM EDT

    GAITHERSBURG, Md., Oct. 05, 2020 (GLOBE NEWSWIRE) -- Novavax Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it will participate in four upcoming investor and industry conferences. Novavax’ COVID-19 vaccine candidate, NVX-CoV2373, is expected to be discussed in each conference.

    Maryland Life Sciences Bio Innovation Conference
    Date: Monday, October 5, 2020
    Time: 10:25 -11:25 a.m. ET
    Panel title: Discussion on Pandemic & Risk Mitigation: A Focus on Preparation & Resiliency
    Three Maryland biotech leaders discuss how to prepare for the unforeseen and what is needed to pivot for the future.
    Panelist: John Trizzino, Executive Vice President, Chief Business Officer and Chief Financial Officer
    To attend: Click here to register.

    Guggenheim First Annual Vaccines and Infectious Diseases Conference
    Date: Monday, October 5, 2020
    Time: 4:15 - 4:45 p.m. ET
    Participation: Fireside chat and investor meetings
    Novavax participants: Gregory M. Glenn, M.D., President of Research and Development, and John J. Trizzino, Executive Vice President, Chief Business Officer and Chief Financial Officer
    Webcast: A replay of the session will be available within 48 hours through the events page of the Company’s website at ir.novavax.com for 90 days following the event.

    Goldman Sachs Virtual Event: Inoculating the Recovery --A Discussion on COVID-19 Vaccines, Treatments, Testing of the Economy
    Date: Thursday, October 8, 2020
    Time: 12:00 - 12:55 p.m. ET
    Panel title: Vaccines – Approaching the Light at the End of the Tunnel
    Panelist: Gregory M. Glenn, M.D. President of Research and Development
    This event is open to Goldman Sachs clients.

    BioHealth Capital Region Forum
    Date: Monday, October 19, 2020
    Time: 12:45 - 1:30 p.m. ET
    Panel title: Strengths of our Region: Combatting Infectious Disease
    Panelist: Vivek, Shinde, M.D., Vice President of Clinical Development
    To attend: Click here to register.


    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Novavax

    Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs. For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

  4. forum rang 5 MisterBlues 5 oktober 2020 20:12
    quote:

    hosternokke schreef op 1 oktober 2020 14:16:

    Coronavirus vaccine trial participants report day-long exhaustion, fever and headaches — but say it’s worth it
    PUBLISHED THU, OCT 1 20207:00 AM EDTUPDATED 40 MIN AGO
    @CHRISSYFARR
    Berkeley Lovelace Jr.
    @BERKELEYJR
    KEY POINTS
    High fever, body aches, headaches and exhaustion are some of the symptoms participants in Moderna and Pfizer’s coronavirus vaccine trials say they felt after receiving the shots.
    While the symptoms were uncomfortable, and at times intense, they often went away after a day, sometimes less.
    The phase three trials are a critical last step needed to get the vaccines cleared for distribution.

    www.cnbc.com/2020/10/01/coronavirus-v...
    Ik heb een plukje Novavax bijgekocht. Het is indrukwekkend hoe ze overal opduiken en tekst en uitleg geven over hun superieure vooruitstrevende technieken.

    BioNtech dat ik al vanaf begin had is weer on the move. Dit tot mijn grote genoeg.

    Moderna gaat het toch redden denk ik. Simpelweg omdat ze de snelste is die komt met iets dat (een beetje) werkt.
  5. forum rang 5 MisterBlues 5 oktober 2020 20:23
    Novavax heeft ook de beste papieren voor India:

    India's commitment to NVAX is just another major feather in the NVAX cap. More news of other countries (or "union") will come as results trickle out from UK and South Africa trials. Month of Oct will be a HUGE month for NVAX setting up Nov and Dec for a new 52 week high!! The real FUN then can begin in 2021 with CV approval followed closely by NF approval and official start of RSV Ph 3 re-trial.

    Novavax is the only vaccine company mentioned by name in the article.

    www.reuters.com/article/us-health-cor...
  6. forum rang 5 MisterBlues 6 oktober 2020 15:04
    quote:

    MisterBlues schreef op 5 oktober 2020 20:12:

    [...]

    BioNtech dat ik al vanaf begin had is weer on the move. Dit tot mijn grote genoeg.


    Pfizer, BioNTech Start Approval Process For Covid-19 Vaccine Candidate In Europe

    MICHAEL KREY
    08:39 AM ET 10/06/2020

    Pfizer (PFE) and BioNTech (BNTX) announced early Tuesday that they've started a "rolling submission" for the approval of their Covid-19 vaccine candidate with the European Medicines Agency. BNTX stock and PFE rose early.

    The partners are in Phase 3, or final-phase, testing of their vaccine candidate. Pfizer has said initial Phase 3 clinical trial results could be in by the end of October.

    In their news release, the two companies said they'll work with the EMA's Committee for Medicinal Products for Human Use, or CHMP, to complete the rolling review process to facilitate the final Marketing Authorization Application.

    In the rolling review, the European regulator will look at data as they become available. That way, "the CHMP can reach its opinion sooner on whether or not the investigational medicine or vaccine should be authorized," the companies said in their release.
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    Four other companies or teams also are in final-phases testing of Covid-19 vaccine candidates. Analysts widely give the lead to New York-based Pfizer and its German partner. Just behind them is Moderna (MRNA).
    European Regulators Have Started Data Review

    The vaccines being developed by BioNTech/Pfizer and Moderna use messenger RNA technology. While mRNA is a heralded technology for developing vaccines there as yet is no commercial mRNA vaccine on the market. Buoyed by billions of dollars of government spending, drug companies are working at by-far record paces to develop a vaccine as the pandemic roils economies worldwide.

    Pfizer/BioNTech, in Tuesday's release, said the CHMP already had begun evaluating data from their pre-clinical vaccine trials.

    The two companies along with Moderna and six others developing Covid-19 vaccine candidates last month pledged to follow strict safety and science tenets, in the face of increasing urgency from U.S. and other governmental leaders. The need for a vaccine was clarified last week when President Trump contracted the disease, along with a number of staff members and at least three senators.

    "It is our duty to ensure that while we are working to develop a potential vaccine at unprecedented speed to help address this pandemic, we do so with the highest ethical standards while adhering to sound scientific principles," BioNTech Chief Executive Ugur Sahin said in the release.
    Volatile BNTX Stock Jumps, Steady PFE Stock Edges High

    BNTX stock jumped 9% in premarket trading in the stock market today, rising above 88. BioNTech shares have been volatile during the race for a vaccine, but BNTX stock soared 9.5% on Monday to a one-month closing high of 80.70.

    In early March, BNTX stock peaked at 105, when the German company and drug giant Pfizer announced their vaccine partnership. BNTX stock made its U.S. initial public offering in October 2019 at 15.

    Meanwhile, the bigger PFE stock has been steadier. Shares broke out of a cup base at a buy point of 39.32 in July, but that breakout failed. Lately, PFE stock has formed a flat base, with a possible buy point of 39.55.

    In premarket trading, PFE stock rose more than 1%, near 37.15.

    Both stocks sport mediocre Composite Ratings, with BNTX stock at 70 and PFE stock at 66. That puts both stocks in top third of all stocks.

    Pfizer/BioNTech and Moderna both began Phase 3 Covid-19 vaccine trials in late July, while AstraZeneca (AZN) and its partner, the University of Oxford, began earlier that month. Last month, both Johnson & Johnson (JNJ) and Novavax (NVAX) began Phase 3 trials.

  7. forum rang 5 MisterBlues 7 oktober 2020 15:33
    BioNtech komende weken - potentieel richting 300:

    BNTX way forward for stock holders:
    Next few days and weeks will be tense for BNTX stock holders. Phase 3 results will decide our decisions. Everyone must weigh their risk:reward scenarios and decide how much they are willing to bet and hold through phase 3. Here are some of my thoughts:
    1. Phase 3 must achieve 3 big goals:
    A. Resistance to COVID-19 relative to placebo. Ideally, at-least 80% better than Placebo. I look for 100%;
    B. High antibodies relative to those who are cured
    C. Excellent T-cell response

    2. If point 1 is achieved, then FDA approval;

    3. Of point 1 and 2 happens, then this could be atleast $300+ stock.

    4. If point 1 and 2 happens, big players nay walk in to BNTX not just because of COVID-19 vaccine. But also due to the fact that this will be first ever mRNA vaccine. BNTX has many other mRNA vaccines in trial for cancer etc. so, very attractive for big players to come in due to novel breakthrough technology. In such case this will run like TSLA and even better.

    There is always risk of something going wrong in vaccine trials. I am very confident this will succeed. But you never know. Only phase 3 trials will tell you.

    COVID-19 Series 1: BNTX – The First Vaccine Candidates to Be Approved by FDA full report in pdf: uwf.instructure.com/files/5131294/dow...
    • BNTX will have the first Covid-19 vaccine candidates to be approved for Emergency Use Authorization by FDA by the end of October 2020 (96% probability).
    • BNTX is a young public biotech company with a strong potential upside ahead in the coming years. BNTX could reach gross profit $78 to $91 billion by the end of 2021. Its price would surge 4-5 times and skyrocket to $294.80 and $368.50 by the end of 2021.
  9. forum rang 5 MisterBlues 8 oktober 2020 11:39
    Should Inovio Be On Your Buy List As It Tackles A Coronavirus Vaccine?


    ALLISON GATLIN
    07:15 AM ET 10/07/2020

    Inovio Pharmaceuticals (INO) has thrown its hat into the coronavirus vaccine ring with biopharma names like Moderna (MRNA), Johnson & Johnson (JNJ) and Pfizer (PFE). But INO stock is frequently volatile on Covid-19 vaccine news, and regulators recently forced the company to delay its Phase 2/3 study.

    Biotech company Inovio is taking a different tactic compared with other coronavirus vaccine makers. It's making a vaccine using pieces of DNA. That method could be promising. In late June, Inovio said 94% of Phase 1 study participants showed an immune response after receiving two doses of its vaccine.

    But on Sept. 28, the company said the U.S. Food and Drug Administration wanted additional questions addressed before Inovio could begin a Phase 2/3 Covid-19 vaccine trial. Inovio planned to start those trials in September. A Phase 1 trial remains ongoing.

    The setback hit INO stock. After all, Inovio is going up against giants in vaccine development. It trails Pfizer, Moderna and others in the race for a coronavirus vaccine. Biotech Inovio, however, has a large pipeline of drugs in development for cancer and infectious diseases.

    So, amid the backdrop of the coronavirus pandemic, is INO stock a buy now?
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    A Look At INO Stock Fundamentals

    First, it's important to note Inovio isn't profitable and expects significant losses in the foreseeable future. For the second quarter, Inovio reported a wider loss than expected and sales that also missed Wall Street expectations. The company posted a net loss of 83 cents a share, or 20 cents minus special items. Sales almost doubled but are still negligible, at $267,000.

    Also of note, Inovio doesn't have a commercially approved product on the market. It was founded in 1983, while its DNA work dates to 2000. Its revenue is comprised of collaboration and development money. The biotech company has big biopharma partners like AstraZeneca (AZN) and Regeneron Pharmaceuticals (REGN).

    The revenue picture could change quickly if Inovio succeeds in making an effective coronavirus vaccine. The biotech also has a drug in Phase 3 testing to treat a precancerous condition of the cervix. It's partnered with privately held ApolloBio on that drug.

    Simply put, INO stock isn't lining up with CAN SLIM rules for investing in growth stocks. Savvy investors are encouraged to seek companies with at least 20%-25% recent earnings growth. Inovio stock isn't expected to get there anytime soon. (Learn more about IBD Digital to get CAN SLIM stock investing tips.)

    Analysts surveyed by FactSet expect Inovio to report an 19-cent loss per share on $3.1 million in revenue in the third quarter. Revenue would grow as losses narrow.

    Currently, INO stock has a Composite Rating of just 46 out of a best-possible 99. The Composite Rating is a 1-99 measure of a stock's key fundamental and technical growth measures. This means Inovio stock ranks in the bottom half of all stocks in terms of that metric. In its case, the strength comes overwhelmingly from INO stock technicals, not fundamentals.

    In 2019, the biotech lost $1.21 per-share on $4.1 million in sales. Losses grew year over year, while sales declined markedly. This year, analysts surveyed by FactSet call for Inovio to lose $1.47 per share on $10 million in sales.
    Inovio Stock Background

    And those technicals demand a critical look. Inovio was essentially a dollar-stock in 2019, hitting as low as 1.91 in October. Today, the biotech stock trades near 12.

    Here's its background: Inovio was founded in 1983 under another name, Genetronics. At the time, it focused on a technological platform called electroporation. Electroporation is using controlled electrical pulses to create openings in cells. In theory, that should make them more permeable to drugs and other agents.

    Then, Genetronics focused on developing drugs for cancer and dermatology. It also developed machines for electroporation to sell to research companies, according to the company's first U.S. Securities and Exchange Commission filing.

    In the 1990s, Genetronics traded on the Vancouver Stock Exchange, American Stock Exchange and the Toronto Stock Exchange. It voluntarily delisted from the Vancouver exchange in 1998. It remained on the Toronto exchange until 2003.

    Two years later, Genetronics acquired gene therapy company Inovio AS and changed its name to Inovio Biomedical. In 2006 and 2007, Inovio had to restate some of its financials. In 2009, Inovio merged with VGX Pharmaceuticals. That added a cancer vaccine to its pipeline.

    A year later, Inovio Biomedical became Inovio Pharmaceuticals.
    Gates Foundation, CEPI Award Inovio Grants

    After merging with VGX, Inovio began focusing on DNA vaccines and electroporation delivery. But, in 2016, the fervor wavered after the Food and Drug Administration placed a key cancer vaccine on clinical hold. At the time, Inovio stock was also running hot on its Zika virus and influenza vaccines.

    The next few years saw a downfall for INO stock, which plummeted to dollar-stock status.

    But shares began a turn in January 2020 when the biotech company announced that the Coalition for Epidemic Preparedness Innovations, or CEPI, awarded it $9 million to develop a coronavirus vaccine. CEPI is a group of public, private and nonprofit organizations that fund vaccine development worldwide.

    In March, the Bill and Melinda Gates Foundation awarded Inovio $5 million to scale up its coronavirus vaccine delivery system. That followed a $1.6 million grant in 2016 to back its Zika virus vaccine.

    Just 10 analysts cover INO stock, according to MarketBeat.com. One does not rate the stock. Among the others, three had buy ratings, five had hold ratings and one had a sell rating on Oct. 7. But, after the FDA put a hold on the Covid-19 vaccine Phase 3 trials, Cantor Fitzgerald lowered its price target on INO stock to 12 from 31, and Roth cut its price target to 8 from 11. Maxim Group, though, upgraded the stock to buy from hold.

    Analysts from outfits like HC Wainwright, RBC Capital Markets, Citigroup and Piper Sandler also cover Inovio stock.

    As of Sept. 30, 252 mutual funds owned 36.4 million shares of Inovio's 161 million-share public float.

    About twice as many mutual funds added to their position in the latest quarter than cut their stakes. But a number of top funds recently reduced the position, including the A+-rated Wasatch Micro Cap, an IBD Best Mutual Fund. Its position in Inovio stock shrank by more than 28% from the prior quarter, while three other funds in the Wasatch family cut their stakes by as much as 66%.
  10. forum rang 5 MisterBlues 8 oktober 2020 11:53
    VBIV een vaccinmaker voor de LT.

    Prijs voor VBI

    VBI has received a “Highly Commended” rating for Best Therapeutic Vaccine Award
    from the World Vaccine Congress.

    Not huge, but still a great start. Remember PNSL was in the same range at VBIV in March.

    www.terrapinn.com/conference/world-va...

    VBI-vaccine tegen glioblastoma

    TCR and HLA analysis of patients in a Phase I/IIa trial of a therapeutic CMV vaccine against recurrent glioblastoma (rGBM)

    1o976r1jw2eculmeoxz46ig6-wpengine.net...

    Wetenschappelijk

    Most investors are not scientifically oriented. They cannot understand the biology of synthetic eVLP vaccines (high neutralizing antibodies, few adverse effects). Other corona candidates are outdated from the get-go, though they will hit the market first (Pharma cash and political pressure). Ultimately, VBIV is likely to win, even if they don’t really need corona vaccine for company success. But it may become the tail that wags the tiger.
    Ken that’s a not even a half truth. It’s so short sighted it’s almost pathetic. I assure “half whit” they are not the same. That’s like saying all monoclonal antibodies are the same because they carry a similar description. Virus-like particles (VLPs) are non-infectious nanostructures composed of viral structural proteins morphologically resembling authentic virions. Based on the structure of viruses, VLPs can be divided into non-enveloped VLPs and enveloped VLPs (eVLPs). Virus-like particles (VLPs) are non-infectious nanostructures composed of viral structural proteins morphologically resembling authentic virions. Based on the structure of viruses, VLPs can be divided into non-enveloped VLPs and enveloped VLPs (eVLPs). Several VLP-based vaccine candidates have been shown to be efficacious in preclinical and clinical trials. Some of them have reached the market and most are targeting non-enveloped viruses. Compared to non-enveloped VLPs, eVLPs are much more complex in composition. The presence of host cell-derived membranes provides additional possibilities for the integration of heterologous antigens and adjuvants.
    Like parental viruses, virus-like particles can be either enveloped or non-enveloped and can be produced in different expression systems depending on their complexity. Enveloped virus-like particles (eVLPs) has the same size and structure as enveloped viruses and present antigens in their natural state for an improved immune response.

    Institutionele beleggers

    Black rock added 187.6k shares on 10/1 for a total of almost 12M shares! 9 of top 10 shareholders have added or took new positions at a total of 17M increase in shares while the 1 who sold only sold 36k shares. ?? I wrote this before, im just following the money. These people are way smarter than I am. Vanguard DOUBLED their position! I think it’s safe to assume they aren’t gambling. I’m happy with my 25k shares. Yes I’m down but they are unrealized losses. And all analysts have this as a buy or strong buy with an average PT of $6.75 and a high of $9. I won’t be selling. Looking to reduce my position by half at some point in the next 3-4 months and the hold the rest through 2021.
  11. forum rang 5 MisterBlues 10 oktober 2020 14:06
    CRISPR-gene-edited parasite leads to unique new vaccine

    September 30, 2020

    Researchers gene edited the Leishmania major parasite so it could be used in a vaccine without causing disease

    Every year around two million people suffer suffer from a skin disease called leishmaniasis, which is caused by the Leishmania major parasite. Humans have battled with this parasite for centuries, and some cultures have practiced a primitive form of inoculation to prevent infections.

    Called leishmanization, this ancient remedy involves deliberately infecting a person with the live parasite. The process generates a minor skin infection which one's immune system can hopefully overcome, leaving the subject with life-long immunity to the parasite. However, this traditional treatment is rarely practiced today due to the tendency of patients to suffer from skin lesions than can linger for months.

    In a wonderful example of blending an ancient treatment with cutting-edge 21st century technology, a team of scientists has gene edited the Leishmania parasite to limit its infectivity. This allows the parasite to be administered to patients in the form of a vaccine, creating long-term immunity without causing disease.

    “Live vaccines like that are the best vaccines, but there’s a potential risk of causing serious disease in some people,” explains Abhay Satoskar, co-lead investigator on the new research, from Ohio State University. “We refined the concept using modern technology, making a parasite that does not cause clinical disease but allows for induction of immunity.”

    Using CRISPR gene editing technology, the researchers removed two specific genes from the parasite to stop it producing a protein called centrin, which is responsible for supporting the parasite’s physical structure. When the parasite lacks centrin it can still enter host cells and replicate, but at a significantly slower rate that means infection does not lead to disease.

    “So we’re essentially using leishmanization. CRISPR allowed us to do that,” Satoskar says. “The parasites are unable to proliferate, so they die. But they persist in the body for eight or nine months, which is long enough to generate acquired immunity.”

    In their study, the researchers chronicle the extensive development and animal testing for this prospective novel vaccine. The study shows the CRISPR-edited parasites do not cause disease in animal models of sand flies, which spread the parasite through their bite, and mice. Plus, the mutant parasite effectively generated complete immunity in the majority of animal tests, including in mice with compromised immune systems.

    “The multiple animal tests also made sure the genome didn’t revert back to normal,” adds Satoskar. “And we found that if a sand fly were to bite at the site of the vaccine and take mutated parasites into the wild, the parasites cannot survive. So it is environmentally safe.”

    The researchers are now looking to begin Phase 1 human trials within the next two years. Satoskar also suggests the vaccine is likely to cost less than US$5 a dose, offering hope of an eventual cheap and easy roll out in those hardest hit tropical countries.

    The study was published in the journal Nature Communications.

    Source: Ohio State University
  12. forum rang 5 MisterBlues 13 oktober 2020 14:57

    Novavax Appoints Leadership Team to Advance NanoFlu through Regulatory Licensure

    Oct 13, 2020 at 8:00 AM

    Team will focus on global NanoFlu licensure and evaluation of post-pandemic influenza/COVID-19 combination vaccine with NVX-CoV2373
    Russell (Rip) Wilson promoted to Executive Vice President and NanoFlu General Manager

    GAITHERSBURG, Md., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX) Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the formation of a leadership team to advance NanoFlu to regulatory licensure and the promotion of Russell (Rip) Wilson, J.D./M.B.A., to Executive Vice President and the newly-created role of NanoFlu™ General Manager. Mr. Wilson will focus exclusively on leading efforts to advance NanoFlu, the company’s influenza vaccine candidate, through global licensure, as well as the exploration of a combined influenza/COVID-19 vaccine that could be used in a post-pandemic setting. Novavax announced results of its successful NanoFlu pivotal Phase 3 clinical trial earlier this year and intends to seek regulatory approval from the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway previously granted to the company.

    “The formation of this dedicated team enables Novavax to accelerate all activities required to file a biologics licensing application (BLA) for NanoFlu in parallel with the extensive development and manufacturing work underway for NVX-CoV2373, our COVID-19 vaccine candidate,” said Stanley C. Erck, President and Chief Executive Officer. “I have full confidence in Rip and our team, which has brought NanoFlu from inception through successful Phase 3 testing. I am excited about the potential to develop a combined influenza/COVID-19 vaccine for use after the pandemic.”

    Mr. Wilson joined Novavax in 2011 and was most recently responsible for global business development, quality and program management functions across the company’s entire pipeline. In his new role, he will lead a team that will work closely with the broader Novavax team to obtain licensure for NanoFlu from FDA and other global authorities, as well as evaluate the development of a pentavalent NanoFlu/NVX-CoV2373 vaccine.

    “Currently available flu vaccines provide inconsistent, inadequate protection against seasonal influenza,” said Mr. Wilson. “NanoFlu has already completed its pivotal Phase 3 clinical trial, in which it achieved all of its primary endpoints, so I am excited about the potential to provide this important vaccine option to the patients who need it most, the difficult-to-protect older adult population. I am committed to leading our team to licensure with a strong sense of urgency.”

    The new NanoFlu leadership team includes several Novavax veterans who led the successful development of the vaccine through completion of its successful pivotal Phase 3 clinical trial. This team has also recently completed key activities related to the development of NVX-CoV2373. In addition to Mr. Wilson, the team will be comprised of the following leaders:

    Tim Hahn, Ph.D., Senior Vice President of CMC for NanoFlu, has led all CMC activities for NanoFlu since the beginning of the program. Most recently, Dr. Hahn led the establishment of a global supply chain for Novavax’ Matrix-M adjuvant. Matrix-M is a key component of both the NanoFlu and NVX-CoV2373 vaccines.

    Vivek Shinde, M.D., Vice President of Clinical Development for NanoFlu, has served as the clinical lead for the NanoFlu program since its inception and through Phase 3. Dr. Shinde also recently led the initiation of the Phase 2b clinical trial in South Africa for NVX-CoV2373.

    The new team will establish a separate NanoFlu development unit within Novavax, building on the company’s established knowledge base in the discovery and development of innovative vaccines to prevent serious infectious diseases. The team will also benefit from joint shared services with key cross-functional departments within Novavax.

    About NanoFlu™

    NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by?Novavax?in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based Matrix-M™ adjuvant.

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    Ab
  13. forum rang 10 voda 14 oktober 2020 14:46
    Moderna weer stap dichter bij coronavaccin in Europa

    FONDS KOERS VERSCHIL VERSCHIL % BEURS
    Moderna Inc
    $ 78,34 0,00 0,00 % NASDAQ

    (ABM FN-Dow Jones) Moderna mag van EMA een aanvraag indienen voor een vergunning voor het op de markt brengen van zijn coronavaccin mRNA-1273 in de Europese Unie. Dit maakte het biotechbedrijf woensdag bekend.

    De goedkeuringsaanvraag volgt op positieve resultaten van een preklinische studie en een positieve tussentijdse analyse van een Fase 1 studie met mRNA-1273 bij gezonde volwassenen en oudere volwassenen die werd gepubliceerd in de New England Journey of Medicine. Uit deze tussentijdse resultaten blijkt het middel goed te worden getolereerd in alle leeftijdsgroepen en een snelle en sterke immuunreactie op te wekken.

    Moderna schaalt zijn wereldwijde productiecapaciteit op om vanaf 2021 ongeveer 500 miljoen doses per jaar en mogelijk zelfs 1 miljard doses te kunnen leveren.

    Door: ABM Financial News.
    info@abmfn.nl
    Redactie: +31(0)20 26 28 999

    © Copyright ABM Financial News B.V. All rights reserved.
  14. forum rang 5 MisterBlues 14 oktober 2020 17:42
    quote:

    voda schreef op 14 oktober 2020 14:46:

    Moderna weer stap dichter bij coronavaccin in Europa

    FONDS KOERS VERSCHIL VERSCHIL % BEURS
    Moderna Inc
    $ 78,34 0,00 0,00 % NASDAQ

    (ABM FN-Dow Jones) Moderna mag van EMA een aanvraag indienen voor een vergunning voor het op de markt brengen van zijn coronavaccin mRNA-1273 in de Europese Unie. Dit maakte het biotechbedrijf woensdag bekend.

    De goedkeuringsaanvraag volgt op positieve resultaten van een preklinische studie en een positieve tussentijdse analyse van een Fase 1 studie met mRNA-1273 bij gezonde volwassenen en oudere volwassenen die werd gepubliceerd in de New England Journey of Medicine. Uit deze tussentijdse resultaten blijkt het middel goed te worden getolereerd in alle leeftijdsgroepen en een snelle en sterke immuunreactie op te wekken.

    Moderna schaalt zijn wereldwijde productiecapaciteit op om vanaf 2021 ongeveer 500 miljoen doses per jaar en mogelijk zelfs 1 miljard doses te kunnen leveren.

    Door: ABM Financial News.
    info@abmfn.nl
    Redactie: +31(0)20 26 28 999

    © Copyright ABM Financial News B.V. All rights reserved.
    Beleggers moeten het nog zien. Koers doet niet veel...
  15. forum rang 10 voda 20 oktober 2020 08:03
    Moderna mikt op coronavaccin in december

    FONDS KOERS VERSCHIL VERSCHIL % BEURS
    Moderna Inc
    $ 70,92 -3,02 -4,08 % NASDAQ

    (ABM FN-Dow Jones) Moderna verwacht dat de Amerikaanse federale regering het gebruik van zijn coronavaccin al in december zal toestaan. Dit zei CEO Stéphane Bancel van Moderna tijdens een jaarlijkse conferentie van The Wall Street Journal maandagavond.

    Wel moet het biotechbedrijf eerst positieve tussentijdse resultaten in november publiceren, aldus Bancel.

    Als het vaccin bij de eerste tussentijdse evaluatie niet voldoende werkzaam is, zal het bedrijf een tweede evaluatie uitvoeren. Dit zou volgens Bancel waarschijnlijk in december gebeuren, wat elk besluit van de Amerikaanse FDA tot eind januari of begin februari zou kunnen terugduwen.

    Door: ABM Financial News.
    info@abmfn.nl
    Redactie: +31(0)20 26 28 999

    © Copyright ABM Financial News B.V. All rights reserved.
  16. forum rang 5 MisterBlues 20 oktober 2020 14:47
    quote:

    voda schreef op 20 oktober 2020 08:03:

    Moderna mikt op coronavaccin in december

    FONDS KOERS VERSCHIL VERSCHIL % BEURS
    Moderna Inc
    $ 70,92 -3,02 -4,08 % NASDAQ

    (ABM FN-Dow Jones) Moderna verwacht dat de Amerikaanse federale regering het gebruik van zijn coronavaccin al in december zal toestaan. Dit zei CEO Stéphane Bancel van Moderna tijdens een jaarlijkse conferentie van The Wall Street Journal maandagavond.

    Wel moet het biotechbedrijf eerst positieve tussentijdse resultaten in november publiceren, aldus Bancel.

    Als het vaccin bij de eerste tussentijdse evaluatie niet voldoende werkzaam is, zal het bedrijf een tweede evaluatie uitvoeren. Dit zou volgens Bancel waarschijnlijk in december gebeuren, wat elk besluit van de Amerikaanse FDA tot eind januari of begin februari zou kunnen terugduwen.

    Door: ABM Financial News.
    info@abmfn.nl
    Redactie: +31(0)20 26 28 999

    © Copyright ABM Financial News B.V. All rights reserved.
    Ik heb wat betreft de mRNA vaccin producenten meer vertrouwen in de Pfizer / BioNtech combi. Moderna heeft veel meer incidenten moeten melden, en dus lijkt meer oponthoud kansrijk.
  17. forum rang 5 MisterBlues 20 oktober 2020 14:48

    Novavax to Present COVID-19 Vaccine Data at World Vaccine Congress Europe 2020

    Oct 20, 2020 at 8:30 AM EDT

    GAITHERSBURG, Md., Oct. 20, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that Gregory M. Glenn, M.D, President of Research & Development, will present on NVX-CoV2373, the Company’s COVID-19 vaccine, at the 2020 World Vaccine Congress Europe. The Congress takes place virtually October 19 - 21, 2020.
    Presentation Title: Recombinant nanoparticle COVID-19 vaccine: Platform technology for Emerging Infectious Diseases (EID)
    Time: 14:10 CET/8:10 am ET

    About NVX-CoV2373
    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).
  18. forum rang 5 MisterBlues 20 oktober 2020 21:04
    China: “We hope BioNTech and Fosun Pharma Industrial will strengthen cooperation in developing safe and reliable vaccines against the coronavirus and innovative therapies, and carry out comprehensive cooperation in research and development, and production of biomedicines in Shanghai,” Li said.

    www.shine.cn/news/metro/2010208044/

    39,862 of 44 k vaccinated
    34,601 of 44 k second dose
    (Source: PFE website)

    To see these many numbers vaccinated, almost certain of safety. The efficacy 32 result may come anytime. That will be a game changer in all likelihood.

    Amazing low volume for such a great vaccine. Peopke are only focused on MRNA, JNJ, AZN, NVAX etc. when efficacy results come BNTX162b2 will show what it is and the volume maybe 100 times average IMHO.

  19. forum rang 10 voda 22 oktober 2020 16:13
    Moderna rondt werving deelnemers coronavaccinstudie af

    FONDS KOERS VERSCHIL VERSCHIL % BEURS
    Moderna Inc
    $ 70,72 2,35 3,44 % NASDAQ

    (ABM FN-Dow Jones) Moderna heeft de werving van 30.000 deelnemers aan zijn Fase 3 onderzoeksstudie naar een coronavaccin met succes afgerond. Dit meldde het Amerikaanse biotechbedrijf donderdag tijdens aan een adviesbijeenkomst van de FDA.

    Inmiddels hebben ruim 25.650 deelnemers aan de onderzoeksstudie twee doses van Moderna's potentiële coronavaccin gehad. Op basis van twee maanden aan veiligheidsdata zal het bedrijf uiteindelijk beslissen of het bij de FDA een aanvraag doet om het vaccin versneld goed te keuren voor noodgebruik.

    In november volgen naar verwachting de eerste tussentijdse resultaten in november van de Fase 3 studie.

    Door: ABM Financial News.
    info@abmfn.nl
    Redactie: +31(0)20 26 28 999

    © Copyright ABM Financial News B.V. All rights reserved.
  20. forum rang 10 voda 26 oktober 2020 13:34
    Moderna gaat coronavaccin leveren aan Qatar

    FONDS KOERS VERSCHIL VERSCHIL % BEURS
    Moderna Inc
    $ 70,50 0,00 0,00 % NASDAQ

    (ABM FN-Dow Jones) Moderna heeft een deal gesloten met de regering in Qatar om zijn potentiële coronavaccin aan het emiraat te leveren. Dit meldde het Amerikaanse biotecbedrijf maandag.

    Moderna praat ook met Europa en Japan om dit vaccin te leveren.

    Recent werd de werving van 30.000 proefpersonen afgerond en het bedrijf hoopt in november de eerste resultaten van zijn Fase 3 studie bekend te maken.

    Ondertussen wordt de mondiale productiecapaciteit opgeschaald zodat Moderna vanaf 2021 jaarlijks 500 miljoen tot mogelijk 1 miljard doses kan leveren.

    Door: ABM Financial News.
    info@abmfn.nl
    Redactie: +31(0)20 26 28 999

    © Copyright ABM Financial News B.V. All rights reserved.
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