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Inovio Pharmaceuticals, Inc. (INO)

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7.07 +0.05 (+0.71%)
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  • j
    10/14/21: Nature Comms: INO-4800 DNA vaccine induces neutralizing antibodies and T cell activity against global SARS-CoV-2 variants.
    INO-4800 generates robust neutralizing antibodies against P.1 at levels comparable to the Wuhan strain. Despite similarities in the RBD of P.1 and B.1.351, studies have reported a reduced impact in neutralization against P.1, compared to B.1.35118,19. In sera from individuals who received the SARS-CoV-2 mRNA-1273 or the BNT162b2 vaccines, there was a 2.8 and 2.2-fold reduction in neutralization against P.1, compared to 8.6 and 6.5-fold for B.1.351, respectively18. The lower resistance to neutralization conferred by the P.1 variant suggests that changes outside the RBD, especially in the NTD, where P.1 and B.1.351 acquired and accumulated different mutations, may play a role in neutralization. INO-4800 induces cross-reactive T cell responses against B.1.1.7, B.1.351, and P.1 variants that are comparable to the Wuhan strain. Taken together, these data demonstrate maintenance of one or both cellular and humoral arms of the immune response against emerging SARS-CoV-2 variants for the INO-4800 vaccine, which will likely be critical factors to impact the ongoing COVID-19 pandemic.

    We performed a SARS-CoV-2 pseudovirus neutralization assay using sera collected from thirteen subjects two weeks after administration of a third dose of 0.5, 1, or 2 mg of INO-4800 (Supplementary Table 1). Neutralizing activity was detected against Wuhan and the emerging variants in all serum samples tested (Fig. 1b). The mean ID50 titers for the Wuhan, B.1.1.7, B.1.351, and P.1. were 643, 295, 105, and 664, respectively (Supplementary Tables 1 and 2). Compared to Wuhan, there was a 2.1 and 6.9-fold reduction for B.1.1.7 and B.1.351, respectively, while there was no difference between Wuhan and the P.1 variant. These results are consistent with other recent studies, which have demonstrated a significant reduction in neutralizing activity in vaccinated individuals towards the B.1.351 (≥6-fold reduction), while the B.1.1.7 lineage has demonstrated a reduced activity of two-fold or less4,7,8,9,17. Strikingly, while the P.1 strain presents with similar RBD mutations as B.1.351, we did not observe any reduction in neutralizing activity compared to the Wuhan strain in INO-4800 vaccinated individuals.

    13 April 2021

    06 July 2021

    14 October 2021
    npj Vaccines - INO-4800 DNA vaccine induces neutralizing antibodies and T cell activity against global...
    npj Vaccines - <ArticleTitle Language="En" xml:lang="en">INO-4800 DNA vaccine induces neutralizing antibodies and T cell activity against global...
  • c
    Despite the Incentives (Free beer/reefer/$200 gift card/million$ lottery), Threats (Imminent loss of employment), Discriminations (Loss of access to public places), Shame, fear, and intimidations (Turning the misfortunes of the unvaccinated into a Blood Sport:, only 56.7% of the US population were willing to take these semi-ineffective vaccines with frequent nasty side-effects.
    To those who posted here that "Covid is over"-- be very grateful that you weren't one of the 3,050 souls who perished yesterday.
    • COVID-19 was the No. 1 killer of Americans age 35 to 54 last month, and No. 2 overall:
    • US CV confirmed cases: 44,757,459 (+120,763 yesterday, +74,409 so far today)
    Confirmed deaths: 721,025 (+3,050 yesterday, +1,498 so far today).
    Fully vaccinated 56.7%; At least one dose 65.6%
    Positive-test rate: No longer made available.
    • US CV confirmed cases: 44,678,199 (+106,328 yesterday, +115,912 so far today)
    Confirmed deaths: 719,452 (+2,420 yesterday, +2,975 so far today).
    Fully vaccinated 56.6%; At least one dose 65.6%
    Positive-test rate: No longer made available.
    • Sources: Johns Hopkins CSSE, The COVID Tracking Project, The CDC, reported by SmartNews. Last updated 10/14/21, 17:16 PDT.
    (Some States are reporting data on a weekly basis instead of daily, which can lead to occasional spikes in total daily cases and deaths. A running 7-day total is a more reliable metric.)
  • c
    INO-4800 Phase 3: It's been 66 days since China's approvals on August 09; 49 days since Brazil's approval on August 26; 22 days since Mexico's approval on September 22, etc. And 157 days since preprint of Phase 2 results in MedRxiv on May 10.
    Assuming the US Government have decided not to block the collaboration between Inovio and Advaccine, it is becoming more plausible that Initiation of Phase 3 (First Dosing) is contingent on the peer-review publication of Phase 2 results, which is imminent, at which point the floodgate will open: First Dosing, Preorders, and maybe even additional funding(s).
  • j
    Up Next CEPI, BARDA (under HHS) funding decision for 4802 P1/2 which will start this 4Q21 Possibly in India, S. Africa.
    4/15/21 “We have begun talks with various organizations like CEPI, Barda, etc for the support of our INO-4802. Hopefully, we will receive a positive response.”

    5/12 “In terms of funding for 4800 P3 trial we are asking various parties for support and are also considering doing the P3 together with Advaccine in order to save on costs.

    Various NGOs have expressed interest in our 4802 program; now, it can be a long road from interest to actual financial support but we are trying to do everything possible to minimize our burn rate. We hope that today’s pre print is the first step on that road.

    We are working with our CRO to select and prepare required documents to agencies of various nations where we are targeting our P3 trial. We are hoping to have additional news to share with you in the coming days and weeks.”

    ”all the antibodies will wane overtime, maybe four months, maybe six months, maybe eight months. Now that doesn't mean you don't have any protection because there are memory B-cells in your immune system that can rise up again. But having T-cell responses along with the antibody responses that INO-4800 Inovio DNA vaccines can provide -- will provide a better, what I think is better protection overtime.
    And so, there is a huge potential market for the booster markets, right. So, this is potentially seasonal vaccination to boost the immune system.
    this was a DNA vaccine that was tested and gotten emergency approved in India is a similar DNA vaccine by another company called Zydus. That achieved 66% efficacy against the delta predominantly delta strain. In India, where we're Delta variant actually originated initially, now deltas are everywhere in the world, they were able to achieve 66% efficacy. It's a three dose regimen of DNA vaccines delivered with jet injection“ JK at Cantor

    “there are three those regimen is not as immunogenic as our two those regimens deliver with CELLECTRA system. But I think the success of Zydus in DNA vaccine although kudos to them, provides a great proof-of-concept for our INO-4800 deliver with a better delivery system, better immune responses against the delta, I'm very optimistic that we will be able to achieve the efficacy levels that is at least as good as Zydus. And I'm very hopeful that we will achieve efficacy that are better than Zydus has.”

    “total case for the primary endpoint is the lab confirmed COVID-19 case, symptomatic COVID-19 case. It's about 149, it's exactly 149 total cases, is the primary. So, our first analysis is going to be 50% of that. So 75 people will be when the first analysis will be made. So, with the variance, delta being predominant, most experts are saying, anywhere between 60% to 80% of efficacy is fantastic, even approved vaccines, likely will not be reaching 90 as they've demonstrated against the original one.
    So, I'm very heartened by Zydus this interim data with their 36% efficacy. I think we will be very happy, if we can match that and or even best that level with INO-4800.

    we will be talking about emergency approved COVID-19 vaccine, INO-4800, achieving the efficacy endpoint earlier in the year in '22. Looking forward to the BLA in May present for 4800.”

    “efficacy readout from our P3 REVEAL 2, meeting our endpoint of our REVEAL 2 which we were looking forward to fully enrolling that study and having the full follow-up data from REVEAL 1 by the end of this year.”
  • H
    MikeF..... the covid hysteria was last year.
    That train left the station.
    You are now holding for new lows and a valuation of $150 million or $0.70 per share.
  • S
    "WASHINGTON (AP) — U.S. health advisers endorsed a booster of Johnson & Johnson’s COVID-19 vaccine Friday, citing growing worry that Americans who got the single-dose shot aren’t as protected as those given two-dose brands."
  • R
    Apparently Forbes know something we don't...

    "After seeing promising results from its phase three clinical trials, Inovio is seeking regulatory approval for its vaccine."

    INO-4800 ?
  • J
    kimmie and Crew have 3 weeks to deliver sales and or funding...
  • M
    I commented that ENOUGH of WHERE and simply let us know WHEN Phase 3 starts and that post is deleted. What was wrong with it? I have a large amount invested in $INO since March 2020 and bought more in $20s and then bought again to average down but I guess I am being robbed here as I am still 60% down. A company focused in DNA is approved in India and this wonderful company moves like a Caterpillar.
  • D
    Why is Kimmie hyping a trial? Wasting money on a trial when almost everyone who wants to be vaccinated will be vaccinated by mid 2022 and there will be a glut of vaccines is bad news Will Inovio even have started a trial by then? Will the dispute with its exclusive manufacturer be resolved by then? Will the FDA hold be lifted by then?
  • B
    Mark last year
    $INO conversation
    "Picked up 27K in the $12.80’s" .................................................... HAHAHAHA
  • D
    42 years of failure is not worth $1.5 billion.
    I wouldn't touch the stock at a $150,000,000 valuation or $0.70 per share.
    There are so many better stocks in the $150 million range.
  • B
    Inovio was at $2 before the covid hype of a 3 hours vaccine. Shares outstanding were 100,010,328.
    Inovio produced nothing for covid and the share count increased to 209,399,260.
    Accordingly, INO should be less than $1 now.
  • C
    Forbes- INO stock has seen a rise of 5.6% in a week (five trading days). The company recently reported that a booster shot of INO-4800 significantly increased the immune responses that resulted from the second dose. After seeing promising results from its phase three clinical trials, Inovio is seeking regulatory approval for its vaccine.
  • G
    $30's are coming
    Inovio Pharmaceuticals: Implied upside of 434%
    But the crème de la crème of upside opportunity, at least on this list, is clinical-stage biotech stock Inovio Pharmaceuticals (NASDAQ:INO). According to analyst Hartaj Singh of Oppenheimer, Inovio is forecast to hit $35 a share. Based on its $6.55 closing price last week, this implies up to 434% upside in Inovio's shares.

    Most of Singh's bullishness is centered around Inovio's development of a coronavirus disease 2019 (COVID-19) vaccine. With billions of people worldwide still needing to be inoculated, there's room for additional vaccine players.

    On the other hand, Inovio's development of its COVID-19 vaccine, INO-4800, has been just as dubious as its long-term drug-development track record. Last year, it looked as if Inovio had a real shot to be one of the first developers to hit the market with a COVID-19 vaccine. Unfortunately, Inovio's plans were derailed by partial clinical holds in the United States. To boot, the U.S. eventually pulled phase 3 trial funding, which has forced Inovio to conduct its large-scale phase 3 study in Mexico and other countries around the globe.
  • P
    "Several new COVID-19 treatments are expected to become available within the next few months.
    Each drug fills a slightly different role, but together they could change the course of the illness, at least in the United States.
    An experimental antiviral from Merck and a monoclonal antibody from AstraZeneca, along with a handful of other drugs making their way through the development process, could make COVID-19 a much less fearsome disease.
    "We're at the point where if we could use these medications all to their interlocking benefits … we could really begin to control the impact this virus has on us, and in particular on the health care system," said Dr. William Schaffner, an infectious disease physician at the Vanderbilt University School of Medicine in Nashville, Tennessee."
  • w
    wilfried 2
    A) Inovio's phantom vaccine doesn't work - the DOD ran after seeing the data
    B) It can't be used because the Cellectra electrocution device is on FDA hold
    C) It can't be manufactured because of the litigation with its exclusive manufacturer
  • s
    Last paragraph of the report-

    The immune responses observed in the current trial and in our larger Phase 2 trial [4] support 

    . advancing the 2.0 mg dose of INO-4800 to a Phase 3 efficacy evaluation. This dose has elicited 

    . the highest binding and neutralizing antibody titers, the highest T cell cytokine production from 

    . both CD4+ and CD8+ T cells and the highest expression of markers associated with attenuation 

    . of severe COVID-19 on CD8+ T cells (which could be critically important for vaccine efficacy in 

    . preventing hospitalization and death in the context of the circulating Delta variant). 

    . Our demonstration in this trial that the immune responses, both antibody as well as T cell 

    . responses, elicited by a 2-dose primary series of INO-4800 could be further boosted with a third 

    . dose without safety or tolerability concerns positions INO-4800 as an important candidate for 

    . continued development as a stand-alone SARS-CoV-2 vaccine, as well as for continued 

    . examination in combination approaches. The potential ability to administer INO-4800 multiple 

    . times, with high tolerability, along with its ease of scalability and thermostability, contribute to its 

    . potential value in combatting the COVID-19 pandemic and addressing the persistence of SARS- 

    . CoV-2 as an ongoing endemic threat to global health.

  • j
    REGN+INO GBM at SITC, AACR, ESMO, and ASCO. Our next question comes from Esther Rajavelu with UBS.
    Esther Rajavelu
    Hi. Thank you for taking my questions. Can you talk a little bit about the Libtayo combo strategy with agents other than the bispecifics? I mean you have a number of Phase 2 trials ongoing with oncolytic viruses. So, curious what your thought process is there, and if we should be expecting to see any of those data readouts in the near-term?

    Israel Lowy - REGN Senior Vice President, Transitional Sciences and Oncology

    we also have – looking at DNA vaccines where we did a study with Inovio and their DNA vaccine platform in GBM. So, these are all in the early stages, exploratory stages. We hope we will be able to present data at meetings like SITC, AACR as well as ESMO and ASCO. And all I can say there is kind of stay tuned. We are pushing them all forward. And we picked these. We also have studies that we are looking at in combination with cellular therapy companies like bluebird and [indiscernible], because we believe there is opportunities for not just bispecifics, there may be reasons to try cellular therapies. So, we have a very broad outlook. We have, as a central foundation in our whole approach, have always believed that combination therapy is essential, and we have a very broad approach to that.

    Regeneron Pharmaceuticals, Inc.'s (REGN) Management Presents at Regeneron Oncology Investor Event, ESMO 2021 Conference (Transcript)
    Sep. 20, 2021 1:47 PM

    “we plan to present at a fourth quarter cancer conference, our results of OS24 but also median OS. And I don't want to take the punchline but we have been achieving better than standard of care in each of those characteristics and milestones. So we couldn't be any happier in the progress from this trial.
    We also plan to bring out what our next steps might be around that time. So as I said, Regeneron has been a wonderful partner and we look forward to executing with them this trial and potentially additional ones to come.“ 9/21/21 JK @Oppehheimer

    Inovio Pharmaceuticals, Inc. (INO) CEO Joseph Kim on Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit Conference (Transcript)
    Sep. 21, 2021 4:23 PM
    Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) Regeneron Oncology Investor Event, ESMO 2021 Conference Call September 20, 2021 08:30 AM ET Company Participants Justin Holko - Vice President,...
    Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) Regeneron Oncology Investor Event, ESMO 2021 Conference Call September 20, 2021 08:30 AM ET Company Participants Justin Holko - Vice President,...