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DNA-Based Vaccines
DNA vaccine, yet another type of nucleic acid vaccine, is made from DNA encoding antigen protein. Unlike traditional vaccines, DNA vaccines are designed to inject a specific naked DNA code of the pathogen directly into the human body (219, 238). Once inside, it can be transcribed into mRNA in the nucleus and translated into antigen in the cytoplasm, thereby inducing the body to produce an immune response (239). Thus, vaccinated individuals obtain corresponding immune protection and disease prevention capabilities (240). Interestingly, its rapid technological development may create a whole new generation of immunologic tools. Multiple DNA vaccines are currently under development, including malaria, influenza, rotavirus, HIV, and so on. Furthermore, many of them have already entered CTs (241–243). DNA vaccination offers more potential advantages, compared to traditional vaccines, including stimulation of the B and T cell immune responses, stabilization of the vaccine, avoidance of any infectious agents, and ease of large scale production (244). More importantly, a large-scale COVID-19 vaccination is under rapid execution around the world, and the “stability” that determines whether a vaccine is convenient for transportation, and storage is a major indicator of vaccine feasibility (245). Compared to RNA vaccines, DNA vaccines can be stored for a longer period of time at the same refrigeration temperature, or even for a longer time at room temperature (246). Once successfully developed and put into use, this will likely bring great convenience to the mass production of vaccines. However, DNA vaccines usually exhibit low immunogenicity, and must be inoculated through delivery devices (such as, electric perforators) to be effective, which also limits their use.
Due to the COVID-19 pandemic outbreak, numerous DNA vaccine candidates entered CTs. According to the information from ICTRP, three of them entered phase III CTs, namely INO-4800, AG0302-COVID19, and, ZyCoV-D. INO-4800, developed by INOVIO Pharmaceuticals, is a DNA vaccine candidate for the prevention of the new coronavirus (243, 247). After the new coronavirus gene sequence was released, INOVIO employed a proprietary DNA drug platform to quickly design the INO-4800 vaccine (247). Pre-CT revealed that INO-4800 strongly induces SARS-CoV-2 specific antibody and T cell responses in mice and guinea pigs, hence, it was quickly approved for CTs (248). Based on the phase I CT results, INO-4800 is immunogenic in all subjects, and effectively produces humoral immune and/or cellular responses (145). Currently, the INO-4800 vaccine is simultaneously in both phase II/III CTs, and its safety and effectiveness reports are worthy of attention. AG0301-COVID19, a DNA vaccine developed by Osaka University/AnGes/Takara Bio, expresses the full-length S protein upon host cell entry. In a pre-CT, AG0301-COVID19, with an aluminium-containing adjuvant, strongly stimulated neutralizing antibody production, and enhanced T cell responses in rats, with no toxic response to body organs. Yet another COVID-19 DNA vaccine candidate is AG0301-COVID19, also developed by the Osaka University/AnGes/Takara Bio. The safety and effectiveness of the AG0301-COVID19 vaccine was examined in phase I/II CTs, but the results are not yet reported (243). It is worth noting that the phase III CTs are in progress at the present time. Recently, India urgently authorized and approved the listing of a DNA COVID-19 vaccine ZyCov-D that consists of a DNA plasmid vector harboring the S protein genetic code. A pre-CT study revealed that ZyCov-D elicits marked antibody and Th-1 responses, as demonstrated by augmented IFN-c expression (249). In a phase I CT, the ZyCov-D vaccine, which is administered by pressing a needle-free device on the skin, was reported to be safe, well tolerated, and immunogenic (142). The device creates a tiny stream of high-pressure liquid that pierces the skin surface, thus causing less pain for the recipient. ZycoV-D is currently conducting a large-scale phase III CT in India, involving tens of thousands of subjects, but the data is not public yet. However, due to its high efficiency and safety, India urgently authorized the application of ZycoV-D. Thus far, this is not only the first DNA vaccine for COVID-19, but also the first DNA vaccine in the world. Till date, no DNA vaccine completed phase III trials or received approval.
https://www.frontiersin.org/articles/10.3389/fimmu.2022.843928/full
Fauci says U.S. is transitioning out of 'pandemic phase'
……..
https://www.nbcnews.com/news/amp/rcna26236
INO It is very important for investors, especially newbees, to made aware of what a scam INO has been these many years. And that Inovio's Mr Everything, Avtar Dhillon, according to government charges, is a huge scammer.
I feel very validated after years of being one of the few speaking out against Inovio.
INO has caused so much financial heartache for often desperate people, lured in by Inovio's slick PR machine, that Inovio should have been delisted years ago, in my opinion.
MG
Father of The Inovio Scam Expose
NOWHERE in this article does it mention any reference to Avtar Dhillion or Inovio Pharmaceutical Co. Just because you didn't score $$ on this stock you've decided to continually bash it. MOVE ON !!
Sounds like Kim - raising funds, selling shares…
……..
https://emerald.life/emerald_leadership/avtar-dhillon/
INO News story about Avtar Dhillon,
Dhillon was an Inovio (INO) Founder as well as Inovio President, Inovio CEO, Inovio Director and Inovio Chairman & highly Paid Consultant to 2019.
https://biv.com/article/2021/11/time-ticking-vancouver-man-charged-1-billion-international-stock-fraud-scheme
INO, the company which claimed to be uniquely positioned to solve an array of world pandemics, closed today at the low of day, $2.82.
$2.82 equates to eighteen cents (.18) a share, when the most recent two reverse split are accounted for.
Inovio (INO) has never originated an approved product in its forty-three (43) corporate years of fleecing Newbees of their hard earned money with slick, misleading PRs, hundreds and hundreds and hundreds of them. No reputable pharma acts that way. Jim Cramer described Inovio as "publicity rich."
A small consolation for investors who were duped is the knowledge that one of Inovio's founders, Inovio President, Inovio CEO, Inovio Director and Inovio Chairman & highly Paid Consultant to 2019, Avtar Dhillon, was arrested in August 2021 by a joint force, charged with multiple counts of Stock Fraud, Conspiracy and Obstruction of Justice related to other stocks he was also pumping.
Stay far away from INO, perhaps the longest running stock scam in the stock market.
MG
Father of The Inovio Scam Expose
Years Railing Against This Scam
https://cannabislifenetwork.com/vancouver-dr-avtar-singh-dhillon-billion-dollar-fraud-case/
INOVIO to Report First Quarter 2022 Financial Results on May 10, 2022
This ought to be another big disappointment.
This company really sucks. With all this company is supposedly doing and the share price sits in the $2-3 range. Garbage
Lakers, everything / news as been very quite from Inovio. Are you hearing of any new developments or anything of interest? Thanks in advance.
Any update on this?
Japan officially approves Novavax COVID-19 vaccine
……….
https://www3.nhk.or.jp/nhkworld/en/news/20220419_19/amp.html
………
Just a memory: https://www.reuters.com/article/idCNL4N2IJ37E
INO My message to the SEC- "Delist this scurrilous pump & dump! "
INO Broke under $3.00,. Now $2.98, LOD.
Pump and Dump.
All were amply warned by moi.
MG
Father of The Inovio Scam Expose
INO Inovio is hit .1875 (eighteen & three quarters cents) today, when two most recent R/S are accounted for.
Stay away from this Pump & Dump. Bag holders are legion. INO investors have died waiting 43 years for Inovio to produce one, single approved drug, vaccine or therapy.
And there are plenty of sore, disgruntled holders still alive. You don't want to be one of them.
MG
Father of The Inovio Scam Expose
False information
INO Oh, he most certainly was one of Inovio's founders. You could also say notorious Dhillon was an architect of Inovio. You could even go so far as to say he is the Father of 43 Year Scam Inovio, just as you may call me the Father of The Inovio Scam Expose.
I'll repeat my post in case you stumbled over the wording. I said Dirty Dhillon was a Founder.
All along your DD has been porous on Inovio and is now, too.
Avtar Dhillon never was Inovio’s founder. Telling this is spreading false information.
UPenn Researchers Enrolling BRCA1/2 Carriers into Inovio hTERT Cancer Vaccine study
Apr 11, 2022 | Caroline Hopkins
NEW ORLEANS — Researchers at the University of Pennsylvania in collaboration with the drugmaker Inovio have launched a Phase I clinical trial assessing whether a cancer vaccine, dubbed INO 5401, can prevent high-risk breast cancer patients with BRCA1/2 germline mutations from relapsing and healthy individuals with these mutations from developing cancer at all.
Susan Domchek, executive director of the Basser Center for BRCA at the University of Pennsylvania, presented the trial details during the American Association for Cancer Research's annual meeting on Saturday. The study is enrolling participants to two groups: Cohort A includes 16 patients with BRCA1 or BRCA2 mutations who have had a prior diagnosis of invasive breast or ovarian cancer, pancreatic cancer, or prostate cancer and have completed adjuvant therapy with no clinical evidence of disease. Cohort B will include 28 healthy participants carrying BRCA1 or BRCA2 mutations.
The immuno-interception strategy that Domchek and her team are evaluating in the trial involves Plymouth Meeting, Pennsylvania-based Inovio's INO 5401, a DNA plasmid encoding hTERT, WT-1, and PSMA, alone or together with INO-9102, which encodes the gene for IL-12.
Following the vaccine, participants are given a small electric charge via an electroporation device called the Cellectra 2000 to increase the amount of vaccine taken up by muscle. Both cohort A and cohort B are separated into two treatment arms: one arm will receive INO 5401 followed by electroporation and one arm will received INO 5401 and INO 9102 together followed by electroporation.
Positive data from both the metastatic breast cancer setting and from a Phase I clinical trial of the strategy for solid tumor patients at a high risk of relapse offered the rationale for the Basser Center study to assess the feasibility for non-surgical prevention.
That earlier study, dubbed TRT-001, was published recently in the Journal for Immunotherapy of Cancer. Among 93 patients with breast, ovarian, and pancreatic cancers, among others, an earlier iteration of the Inovio vaccine, INO-1400, was not only immunogenic, but also safe. Immune responses were observed across all tumor types, and the vaccine increased a CD8-positive phenotype associated with improved overall survival in pancreatic cancer patients. Patients experienced very few side effects, save local injection site reactions, which was a key consideration for moving the vaccine into trials of healthy individuals.
At Basser, Domchek and colleagues have already completed enrolling cohort A part one and are actively enrolling cohort B. "Soon, we will be vaccinating healthy BRCA1 and BRCA 2 carriers," she said, adding that there "seems to be great interest from healthy carriers who want to come on this study." Cancer vaccines typically have not been tested in early-stage or adjuvant trials, let alone intervention trials for germline mutation carriers who are at high risk of developing cancer, but who do not actually have a diagnosis.
Clinical trials evaluating drugs as a means to prevent or intercept, rather than treat, cancers are challenging and lengthy. Because the endpoints for these trials are often related to whether a patient goes on to develop malignancies far down the line, the trials can take decades or more. For this reason, prevention trials often lack adequate funding and drugmaker support. But researchers like those in Domchek's lab are increasingly determined to tackle them.
The Inovio-UPenn vaccination study is designed to evaluate the cancer vaccine's safety and dose-limiting toxicities as well as antigen-specific immune response over a period of two years, though it will take much longer to show the intervention's ability to prevent cancer development.
"We've considered cancer interception for years, but now I would argue that we actually have the tools to translate it," Domchek said during a plenary session at the meeting on Saturday. "There are multiple viable strategies for non-surgical prevention in BRCA1 or BRCA2 carriers that are being tested or have a good opportunity to be tested."
Because BRCA1 and BRCA2 carriers are at high-risk for a number of the most common malignancies, including breast, ovarian, pancreatic, and prostate cancer, proving the success of an interception strategy could not only have sweeping implications, but also be generalizable to future efforts in other high-risk populations and cancer types, Domchek suggested.
Moving PARPi into the prevention space
Other interventional possibilities could be on the horizon, too, when it comes to breast cancer prevention. For example, Merck and AstraZeneca's PARP inhibitor Lynparza (olaparib) has demonstrated efficacy in the adjuvant treatment setting for early-stage, high-risk breast cancer patients harboring BRCA1 or BRCA2 mutations. The drug recently secured US Food and Drug Administration approval for the adjuvant treatment of HER2-negative, high-risk BRCA1/2-positive breast cancer, based on an event-free survival benefit seen in the large, Phase III randomized OlympiA trial.
As Domchek suggested during her presentation, the fact that the PARP inhibitor has been effective for preventing recurrence following initial treatment for this high-risk, early-stage patient population raises the possibility that Lynparza might be an alternative to prophylactic surgery for healthy BRCA1/2 carriers.
As is the case across much of drug development, Merck and AstraZeneca began by evaluating Lynparza in the metastatic disease setting and then gradually moved the agent into earlier treatment lines from there. "We've gone from metastatic to adjuvant," Domchek said of PARP inhibitors. "Can we go to prevention? I don't know."
She pointed to several early "clues" that the strategy may be worth pursuing. For example, patients in the OlympiA trial who received Lynparza were less likely to develop second primary cancers than patients in the control arm. Indeed, 19 patients receiving Lynparza developed second primary cancers versus 32 patients who received a placebo. The numbers are not statistically significant, and it will take more time to see if the trend continues, but the signal is encouraging, Domchek said.
Within cancer prevention trials it is critical to balance potential benefit against the risk of toxicities. The fact that Lynparza in OlympiA did not appear to cause secondary cancers such as myelodysplastic syndromes or acute myeloid leukemia, as some other treatments do, and had a relatively manageable toxicity profile, is also encouraging for the potential of PARP inhibitors to be used for prevention.
"Compared to placebo [in OlympiA], there was no overall effect on quality of life with olaparib," Domchek added. "There are some differences with nausea and fatigue, but [managing that] is really a question of what should a schedule look like and what is considered tolerable for patients."
"We need to answer many of these questions," she continued. "There are a lot of people thinking about these issues and how we can move forward."
While drugmakers have not announced any concrete plans to evaluate Lynparza as a cancer interception strategy for healthy BRCA1/2 carriers, Domchek seemed to suggest that such a trial does not seem out of the realm of possibilities, especially in light of the high cost and quality-of-life implications of prophylactic mastectomies, oophorectomies, and other such invasive procedures too often presented as the sole option for high-risk BRCA1/2 carriers.
"I admit that large-scale interception studies are difficult, even in high-risk patients," she acknowledged. "They are large, they take a long time … but that does not mean we shouldn't do them. At the end of the day, this is what we want to do: intercept cancers and change people's lives."
https://www.precisiononcologynews.com/cancer/upenn-researchers-enrolling-brca12-carriers-inovio-htert-cancer-vaccine-study?utm_campaign=Precision+Oncology+News+Welcome+Email&utm_medium=email&CSAuthResp=1649718133700%3A0%3A2514068%3A0%3A24%3Asuccess%3A40EC667EE29FABF7195C9F6B1DFF7A91&_ga=2.8889842.658874540.1649717985-1590207770.1649717985&adobe_mc=MCMID%3D58018332632319430302833232159497549527%7CMCORGID%3D138FFF2554E6E7220A4C98C6%2540AdobeOrg%7CTS%3D1649718003&utm_source=Sailthru&CSAuthReq=1#.YlSzeiVHYlQ
What ever happened to general Gus Perna and Inovio?
“the maker of the Medigen vaccine looked towards the results of the World Health Organization’s Solidarity Trial Vaccines clinical study—a test to evaluate the effectiveness of vaccines around the world. The results are scheduled to be published in early April.” 4/6/22
That should include INO-4800 as well.
psuvanguard.com/medigen-vaccine-controversial-or-helpful/
“Medigen is now waiting for the results of the WHO’s Solidarity Trial Vaccines clinical study, which evaluates the effectiveness of vaccines from around the world.
If the trial proceeds as scheduled, the results are expected by the end of next month or in early April, Medigen chief executive officer Charles Chen said”
taipeitimes.com/News/front/archives/2022/02/16/2003773205
INO And there's the dump. Adding bagholders, already legion in number.
Inovio (INO) is a 43 year, pump & dump that has not originated a single approved product in all its years..
Avtar Dhillon, an Inovio founder, as well as its past President, CEO, Director, and Chairman & highly Paid Consultant to 2019 is currently charged with Stock Fraud as well as Obstruction of Justice.
Only the unscrupulous play this P&D penny stock*.
MG
Father of The Inovio Scam Expose
* when the most recent two Reverse Splits are factored for, INO is presently valued at at .22/SH (22 cents a share).
UCSF Brain Tumor Center: This clinical trial will evaluate the safety and efficacy of INO-5401, INO-9012, and cemiplimab, alongside radiation therapy and temozolomide (TMZ), in treating patients with newly diagnosed glioblastoma.
INO-5401 and INO-9012 are comprised of DNA molecules, or plasmids, and are injected intramuscularly and then delivered using electroporation – a technique using electric pulses to push the DNA plasmids into cells. The cells that are electroporated will begin producing specific molecules based on the instructions in the DNA plasmid. For example, cells electroporated with INO-5401 will begin producing antigens that are common in many cancer cells (including WT1, PSMA, and hTERT). Production of these antigens helps activate T-cells to better recognize cancer cells. INO-5401 is therefore considered a T-cell activating immunotherapy.
INO-9012 is another immunotherapeutic agent, a DNA plasmid encoding the human interleukin-12 (IL-12) gene. Cells electroporated with INO-9012 will begin producing IL-12, a protein that promotes the activation of natural killer cells, among other immune-stimulating effects.
Cemiplimab is an antibody-based immunotherapy, administered intravenously, that also targets the immune system and activates it to stop cancer growth and/or kill cancer cells. More specifically, cemiplimab works by binding and inhibiting PD-1, a protein that normally protects the body from attacking itself. Normally, PD-1 works by detecting a molecular signal (called PDL-1) made by various cells across the body. Some cancer cells take advantage of this protection mechanism making the protective signal themselves. Blocking PD-1 with cemiplimab allows the immune system to activate its T-cells and recognize these tumors as cells to be attacked.
Eligible participants will be separated into two cohorts, depending on MGMT promoter methylation status. Both cohorts will receive the INO-5401, INO-9012, and cemiplimab at the same doses and schedule, in addition to radiation therapy and TMZ, if clinically indicated:
Experimental Cohort A (Unmethylated MGMT Promoter): INO-5401 + INO-9012 + Cemiplimab + RT + TMZ
Experimental Cohort B (Methylated MGMT Promoter): INO-5401 + INO-9012 + Cemiplimab + RT + TMZ
Actual Study Start Date :
May 31, 2018
Estimated Primary Completion Date :
June 30, 2022
Estimated Study Completion Date :
June 30, 2022
21 study locations
United States, California
City of Hope
Duarte, California, United States, 91010
Stanford University, School of Medicine
Palo Alto, California, United States, 94304
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Florida
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, New Jersey
Rutgers University - Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
New York University Langone Medical Center; Perlmutter Cancer Center
New York, New York, United States, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Columbia University Medical Center The Neurological Institute of New York
New York, New York, United States, 10032
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States, 10065
United States, North Carolina
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States, 27599
United States, Oklahoma
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania Health System: Penn Medicine
Philadelphia, Pennsylvania, United States, 19104
UPMC Cancer Center Neuro-Oncology; UPMC Cancer Pavilion
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Texas Oncology
Austin, Texas, United States, 78705
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Monday, April 04, 2022, at 18:53- Colombia Conducts Trials to Determine Effectiveness of New COVID-19 Vaccine. The World Health Organization (WHO) has been working with a group of experts in order to select from all the vaccines that are in phases of research I and II, those that have the greatest results in efficacy and safety. "The objective has been to be able to carry out a trial that allows them to be compared with each other and to have immunizers that are effective towards variants of the virus that are now and that may appear later," Carlos Álvarez, national coordinator of studies on COVID-19 in Colombia, said on previous occasions. The Ministry of Health and Social Protection (MinSalud) has announced that it is accompanying the study in eight cities in the country. Many of the current vaccines are found with patents that do not allow their adequate distribution in the world. It should be remembered that, the WHO has been developing a vaccine to bring it to the world in an equitable way. In this way, once we are all vaccinated, this pandemic can be terminated. Likewise, the Clinical Study 'Vaccine Solidarity' is being evaluated in the eight cities of the country evaluating through volunteers, how safe the new vaccines against COVID-19 are, with the accompaniment of MinSalud. "This new vaccine is safe. It has been verified with most of the participants we have had in Bogotá. Of 80 people, some have had a headache or malaise that resolves spontaneously. We have had no serious or severe adverse effects. And no one has had to be taken to the emergency room," said Freddy Carreño, a researcher at the Solidarity Study.
12/15/21 Inovio vaccine arrives in Veracruz, with immunity in 24 hours
from the 1st dose
The biological Inovio arrives in Veracruz as a high-tech and effective alternative against Covid-19, for this reason, Training for Comprehensive Consulting for the Clinical Research Center (FAICIC) will have 250 antigens to apply to the same number of 18-year-olds in forward that they have never been vaccinated against the coronavirus, nor are they pregnant or currently breastfeeding; as well as those who suffer from chronic diseases such as: diabetes, hypertension, cancer, HIV, obesity, allergies, among others.
The general director of the Faicic Clinical Research Center, Sharzy Molina Guízar, explained that it is a very safe antigen, which has the characteristic that it is not injected, but through a shot in the arm that will impact at the cellular level, through a electrode, since it has a very different molecular composition that makes it different from those already known, because it travels at the cellular level, causing immunity in 24 hours, for longer and with greater efficiency.
“Previous vaccines were given through an injection in the arm; this also goes on the arm, but it is done by means of a device that is like a small pistol, which what it does is that here in the arm, in the muscle, a shot is fired that does not cut, that does not open the skin, it does not hurt, it is painless and this allows it to travel to the cellular level and how is it that we achieve immunity in 24 hours? We achieve it because it travels so fast in the cells that what it does is reproduce, they cause an excitation to the cells that makes one infect the other very quickly and, then, we can go from one to 10, from 10 to 100 , from 100 to a thousand and not only do we cause immunity for a longer time, but also, much more effectively”.
He explained that Inovio decided to do it this way, since the existing vaccines that are applied in the injected arm, their route at the muscular level generated immunity from 28 to more than 40 days, depending on the organism, due to its composition and its journey in the body, which also caused other allergic reactions or altered some parts of the body, while Inovio causes immediate immunity.
Likewise, Molina Guízar recognized that, based on studies carried out, Inovio has proven high efficacy against the Omicron variant, although investigations continue, so it is added to the list of qualities of this antigen.
“This vaccine, so far, is showing an efficacy of 95.5% in the first application that is given at 24 hours. This vaccine consists of two doses (two applications): on day zero, which is the day the vaccine is applied, and on day 28”, stated the interviewee.
The general director of Faicic admitted that there are side effects similar to those of injected vaccines, such as: headache, nausea, dizziness, weakness, fever, among others, which are treatable and will be treated by the medical staff of the center of research.
In this sense, he recognized that there is still a large amount of population not vaccinated against this disease for various reasons, such as: fear, resistance, lack of information, among others.
“After two years, we already have a lot of experience, we have seen how to improve it and we invite the population that was afraid to come because now we have a very safe vaccine; It is also aimed at those people who, for example, are allergic, who have chronic-degenerative diseases”.
Sharzy Molina highlighted that they will be working every day for the Inovio application, including holidays such as December 25 and January 1, 2022, for which she invited citizens with these characteristics to sign up for this application, since It will serve the population of Veracruz and foreigners, where in the case of the latter, they will be supported with the transfer, therefore, they require social leaders who support with this process the population of marginalized areas whose expenses are assumed by Faicic.
He added that in addition to the support for the transfer to the Faicic headquarters, patients will be provided with: medical, nutritional, psychological consultation, laboratory studies and for a year and a half they will remain in contact with them, with open consultation for any symptom or subsequent condition that they may present.
He recalled that Faicic is a research center that seeks to improve people's health and lives, through studies and in coordination with recognized pharmaceutical companies.
https://www-eldictamen-mx.translate.goog/noticias-de-veracruz/boca-ver/llega-a-veracruz-vacuna-inovio-con-inmunidad-en-24-horas-desde-la-1a-dosis/?_x_tr_sl=auto&_x_tr_tl=en&_x_tr_hl=en
4/4/22 Prime-boost vaccination regimens with INO-4800 and INO-4802 augment and broaden immune responses against SARS-CoV-2 in nonhuman primates
Inovio Pharmaceuticals, Plymouth Meeting, PA, 19462, USA
Vaccine and Immunotherapy Center, The Wistar Institute, Philadelphia, PA, 19104, USA
Received 2 November 2021, Revised 2 March 2022, Accepted 23 March 2022, Available online 4 April 2022.
Abstract
The enhanced transmissibility and immune evasion associated with emerging SARS-CoV-2 variants demands the development of next-generation vaccines capable of inducing superior protection amid a shifting pandemic landscape. Since a portion of the global population harbors some level of immunity from vaccines based on the original Wuhan-Hu-1 SARS-CoV-2 sequence or natural infection, an important question going forward is whether this immunity can be boosted by next-generation vaccines that target emerging variants while simultaneously maintaining long-term protection against existing strains. Here, we evaluated the immunogenicity of INO-4800, our synthetic DNA vaccine candidate for COVID-19 currently in clinical evaluation, and INO-4802, a next-generation DNA vaccine designed to broadly target emerging SARS-CoV-2 variants, as booster vaccines in nonhuman primates. Rhesus macaques primed over one year prior with the first-generation INO-4800 vaccine were boosted with either INO-4800 or INO-4802 in homologous or heterologous prime-boost regimens. Both boosting schedules led to an expansion of T cells and antibody responses which were characterized by improved neutralizing and ACE2 blocking activity across wild-type SARS-CoV-2 as well as multiple variants of concern. These data illustrate the durability of immunity following vaccination with INO-4800 and additionally support the use of either INO-4800 or INO-4802 in prime-boost regimens.
https://www.sciencedirect.com/science/article/pii/S0264410X22003681
(Repost) Summary by @StockHound Posted on November 01, 2021.
"In short, compared to our competitors, 4802 as a booster is displaying amazing numbers. No wonder why the WHO has chosen as 1 of 2 vaccines in the Solidarity trial.":
Here's my take on the article from BioRxiv on the INO-4800 and INO-4802 boosters.
Inovio originally conducted a Pre-Clinical study on Mice and Guinea Pigs to advance to P1 human trials. They also did a study on Non-Human Primates Rhesus Macaques monkeys. These monkeys elicit similar immune responses as humans do. During this study they found the following antibody responses:
• GMT Binding Antibodies = 258,032 @ 6 weeks (Convalesent (Covid Recovered patients) had a GMT BA = 142,140)
• GMT Neutralizing Antibodies = 175 @ 6 weeks (Convalesent had an approx. GMT NA = 150)
These numbers were also seen in the Phase 2 clinical trials using the 2 mg dose. It's noted that the Binding Antibody measurement had changed at this point, unfortunately it will be hard to compare to other vaccines providers at this point. I'm concluding that since the neutralizing antibodies were similar between the monkey study and P2, I can assume that Binding Antibodies of 258,032 from the monkey study should be close to the Binding Antibodies of P2 of 2210. INO 4800 P2 results:
• GMT Binding Antibodies = 2210
• GMT Neutralizing Antibodies = 150
Neutralizing Antibodies of a Convalesent patient was nearly 150 and Binding Antibodies of 142,140. Comparing to mRNA vaccines at this time, their GMT NA was about 343-900 (MRNA). MRNA also produced GMT Binding Antibodies of 782,719 for the 100ug dose.
Coming back to the most recent booster article, here are the numbers at weeks 43-64, essentially 1 year since the 2nd dose on these monkeys.
4800:
• GMT Binding Antibodies: Wild Card=3077, Beta=2338, Gamma=2077, Delta=21,044
• GMT Neutralizing Antibodies: Wild Card=2286, Beta=1199, Gamma=1596, Delta=785
4802:
• GMT Binding Antibodies: Wild Card=6285, Beta=6285, Gamma=6285, Delta=6285
• GMT Neutralizing Antibodies: Wild Card=3712, Beta=1452, Gamma=4389, Delta=1434
It is controversial which antibody is more important as both have an important role within the immune system and response to a pathogen. Neutralizing antibodies defend the cell and can result in lifelong immunity to the target infection. Binding Antibodies bind to the pathogen and trigger the immune system to attack it with white blood cells.
What this article is telling me, boosting the INO-4800 as a primary vaccine with either INO-4800 or INO-4802 as a booster 1 year later shows significant increases in Neutralizing Antibodies especially with INO-4802 and increase in Binding Antibodies well past what Convalescent patients have displayed. The significantly higher number Neutralizing antibodies providing an advantage to long term protection. It's worth noting that mRNA vaccine booster will also increase their Neutralizing Antibodies to an approximate GMT of 2000 or 800 for Delta. Though these numbers are similar to INO, it is good in the fact that we can achieve the same and slightly better results of a leading EUA vaccinev while providing a superior safety profile, thermo stability and shelf life.
This also doesn't include INO advantage with the production and sustainment of T, B, CD4 and CD8 cells.
In short, compared to our competitors, 4802 as a booster is displaying amazing numbers. No wonder why the WHO has chosen as 1 of 2 vaccines in the Solidarity trial.
World Vaccine Congress Washington 2022, WASHINGTON DC, Apr 21 09:40
Inovio’s DNA COVID vaccine update
COVID & Beyond - M4, Independence Salon D
Joseph Kim,Chief Executive Officer, Inovio Pharmaceuticals
Apr 18 14:00
ANTIBODIES FOR INFECTIOUS DISEASES 2pm - 5pm - M4, Liberty Salon O
ANTIBODIES FOR INFECTIOUS DISEASES - Liberty Salon O
Mark Esser,Vice President, Early Vaccines and Immune Therapies, AstraZeneca
Flonza Isa,Associate Medical Director, Regeneron Pharmaceuticals
Alina Baum,Director, Infectious Diseases, Regeneron Pharmaceuticals
Apr 20 09:00
Chair’s opening remarks
Emerging and Infectious Diseases - M4, Liberty Salon M
David Weiner,VP, Director of Vaccine & Immunology Center, The Wistar Institute
Apr 21 11:30
GT-EPIC platform to target advanced hepatocellular cancer in a patient specific manner
Cancer and Immunotherapy - M4, Liberty Salon I-K
Niranjan Sardesai,President & Chief Executive Officer, Founder, Geneos Therapeutics
Apr 20 17:10
Panel: Advances in our understanding of the key parameters of tumor epitope immunogenicity
Cancer and Immunotherapy - M4, Liberty Salon I-K
Niranjan Sardesai,President & Chief Executive Officer, Founder, Geneos Therapeutics
Apr 20 17:10
Panel: What are the risks to self-spreading viruses?
Veterinary - M4, Supreme Court Room
Stanley Plotkin,Emeritus Professor, University of Pennsylvania School Of Medicine
3/28/22 Geneos Therapeutics, a clinical stage biotherapeutics company spun out of Inovio Pharmaceuticals, raised $17 million in a private stock sale.
The 6-year-old Plymouth Meeting company's Series A2 financing was led by Flerie Invest, a European venture capital firm based in Stockholm and London that specializes in backing life sciences companies tackling major medical challenges. Existing Series A investors Santé Ventures, Korea Investment Partners Global Bio Fund, and Inovio (NASDAQ: INO) also participated. Geneos closed its initial $12 million Series A round in March 2021.
Geneos plans to use the bulk of the proceeds to expand the clinical trials for its lead new drug candidate GNOS-PV02 from 24 to 36 patients. The personalized cancer vaccine is under development as a treatment for patients with advanced hepatocellular carcinoma, a type of liver cancer.
The experimental treatment is a tumor-specific DNA plasmid-based product that is designed and manufactured for each patient based on their unique tumor mutations. The mutations are identified by sequencing each patient’s tumor. The company's GT-EPIC platform targets unique neoantigens or abnormal mutations produced by cancer cells.
The investment money will also be used to expand the company's pipeline into a new, undisclosed cancer indication. The remaining funds will be used for general company operations.
In February 2021, Geneos completed a second closing of the Series A-1 preferred stock financing, in which the Company did not participate. Following this transaction, the Company held approximately 35% of the outstanding equity, on an as-converted to common stock basis.
The Company continues to exclusively license its SynCon® immunotherapy and CELLECTRA® technology platform to Geneos to be used in the field of personalized, neoantigen-based therapy for cancer. The license agreement provides for potential royalty payments to the Company in the event that Geneos commercializes any products using the licensed technology. The Company is not obligated to use any of its assets to fund the future operations of Geneos.
“I think INO will become the standard of care for glioblastoma patients. If we’ve already extended the lives of methylated glioblastoma patients by AT LEAST 6 months median (that is what we know so far and the study is not yet over).
13,000 people diagnosed with GB each year and I know for a fact Keytruda costs $125,000 per year per patient. So if patients are living AT LEAST 2.5 years that is 32,500 patients being treated per year x $125,000 potential revenue per year (maybe we would even charge more since our treatment is more effective than what is currently being used). That is an extra $4 billion per year in revenue. That also only takes care of USA patients.
$4 billion per year revenue x .20 profit margin x 35 (PE ratio) = over $16 billion to our market cap. That’s a 10x return only for one product.” By JuliekLily5410
Patients can apply for Compassionate Use with FDA to get 5401 GBM treatment immediately.
https://www.terrapinn.com/conference/world-vaccine-congress-washington/agenda.stm?utm_source=email&utm_medium=pardot&utm_campaign=UK_10550_WVC+DC+2022_CONFPROM&utm_term=email
Lakers-W.....Great Posts....Shareholders Appreciate!
INO closed up 5.85% at $3.8 on 4/1. Able to find support at 50-dma. Bullish!
50-Day $3.52
100-Day $4.77
200-Day $6.40 likely tested in 2Q22
2Q22 Catalysts:
? Advaccine’s Homologous and Heterologous pGx9501 booster 2,4,6,8 wks Interim Readout. EUA. Preorder.
? WHO’s STV Interim Readout. Apply EUL. COVAX preorders.
? INNOVATE resumes in Philippines ????, Colombia ????, Brazil ????, Mexico ???? , starts in India ????, Rwanda ????, Tunisia ????, Thailand ????
? RRP 3107 P3 IND approval
? GBM 5401 OS36, median OS MGMT-methylated
? COVID-19 dMAb® P1 starts in May
AZD5396, AZD8076
? Report INO-4500 Lassa P1b data
“We believe this is an important
step for dMAb program. This has to do with announcement we had made in December 2020 regarding dMAbs to treat Covid19. We are working with many collaborators on this project as you know. We are hoping that this can lead to benefits not just for Covid but for our dMAbs program, in general.
Thank you
Investor Relations” 3/25/22
STV Primary outcome measure:
Virologically confirmed COVID-19 disease, through SARS-CoV2 RNA isolation and RRT-PCR amplification in oro-nasopharyngeal specimen, regardless of disease severity, at 14, 180, 365 days after the last dose.
isrctn.com/holding
INNOVATE primary endpoint changes from prevention of virologically confirmed COVID-19 disease to prevention of severe disease due to COVID-19.
Before the amendment, INNOVATE was a duplicate of STV. In the Omicron BA-1 and BA-2 era, all other vaccines have much lower infection prevention efficacy.
3/1 Hartaj Singh: Sanofi and GSK reported a vaccine efficacy of 58%, right? And they ended their trial before Omicron really hit. They’re looking for approval. Their severe disease endpoint looked pretty good. Moderna’s already talking about bivalent vaccines against Omicron.
So, it seems you’re getting proactive in trying to get ahead of what Omicron can do to current vaccines in development or approvals.
How are you thinking if you were to get that protocol amendment? Would you essentially market the vaccine on that disease severity endpoint, hospitalization endpoint, plus the risk benefit profile, the actual product profile of the vaccine?
Dr. Joseph Kim
Yes. Hi Hartaj, absolutely. That’s the view that we have. Obviously, the Omicron has thrown a curveball to all vaccine developers, with reduction in antibody responses from the original ancestral strain targeted vaccine, which, all of the approved vaccines and some of the ones in testing, including INO-4800 is. What’s great about our Omicron data as described by Kate and myself earlier is that our T cell responses, including CD8 killer T cells were fully maintained against Omicron. So, that really leads us to believe that whether we’re targeting the original variants Alpha, Beta, Gamma, Delta, or even Omicron, or even what’s next, right, the stealth Omicron or the next variant, we have full faith that our CD8 T cell responses and our overall T cell responses generated from INO-4800 is going to persist and be maintained.
So, with that in mind, we are taking a proactive step knowing that our probability of success in demonstrating prevention of severe disease with our vaccine against COVID-19 virus is high. And that’s the label that we would look for and all of the other attributes and target profile that we have mentioned earlier. We believe our INO-4800 has a strong position once we get the Phase 3 data, and once we get the emergency and full licensure to demonstrate this -- benefits as a vaccine against SARS-CoV-2.
Hartaj Singh
Yes, great. Joe, I mean, your in vitro data matches up pretty well against some of the commercial and vaccines in approval.
3/15 Hartaj Singh: Any updates on 4802 timeline? Any updates on the S. Korea trial?
JK: That was the 4800 P1. They were completed. And they were P1 trials. So, both P1 trials in S. Korea and China had results similar to our U.S. trial. It was a similarly or identically designed trial. So, we published under U.S. We would also look to publish those results along with our collaborators IVI in S. Korea and in China. We are in P3, so a lot more interest in the later stage program.
For 4802, 4803, we have a pan Covid program that we have published, completed the preclinical trials. We put the pause in 4802 in clinic, just b/c 4800 was so cost effective, both in the animal testing and clinical sample testing compared to 4802. Of course, the Omicron changed - it was a big shift until Omicron. And now we have an Omicron match construct, that’s being tested preclinically.
So, there are many research constructs that we have designed. But our lead horse is 4800. We think we have a vaccine that can provide protection across all different variants in protecting against severe diseases. And we look forward to testing that thesis from our INNOVATE trial but also demonstrate 4800’s ability to serve as a booster.
The as we develop out COVID-19 platform, once we get our first product approved, we would be able to utilize the bridging strategy that many regulators have been deploying to bridge into the new variants as necessary. But our current focus is really in getting 4800 tested and approved through emergency and full approval where appropriate.
“It is my understanding that Advaccine is reengaging the IPO pathway. I also believe they will be able to share data on their boost trial in not too distant future since enrollment had been completed.
Thanks
Investor Relations” 4/2/22
Key 2021 Company highlights included:
• Completed dose selection from Phase 2 data and initiated global Phase 3 trial for INO-4800, our COVID-19 vaccine candidate;
• INO-4800 selected by the World Health Organization ("WHO") to be included in Solidarity Trial Vaccines;
• Established manufacturing consortium and developed a proprietary manufacturing process for production of plasmids
• Presented efficacy data for REVEAL1 (cervical dysplasia) and completed enrollment for REVEAL2 (confirmatory trial) Phase 3 trials for product candidate VGX-3100;
• Identified and advanced the development of pre-treatment biomarker for VGX-3100;
• Presented additional efficacy data for product candidate INO-5401 + cemiplimab in glioblastoma multiforme (GBM) participants;
• Completed enrollment for recurrent respiratory papillomatosis ("RRP") Phase 1/2 clinical trial (product candidate INO-3701);
• Completed enrollment for infectious disease vaccine programs: Phase 1b clinical trial for Lassa fever (INO-4500),Phase 1b clinical trial for Ebola (INO-4201 as a booster), and the first portion of Phase 2 clinical trial for MERS (INO-4700); and
• Advanced Zika dMAb trial with side-port needles.
2020 Performance-Based PSUs: Rigorous Milestone Goals for COVID-19 Vaccine Candidate
The 2020 PSUs, which were intended to cover a multi-year performance period, have performance conditions related to the development and commercialization of INO-4800, our vaccine candidate for COVID-19. Given the multi-year nature of the goals described below, performance has not yet been achieved and will continue to be assessed through the full performance period.
Portions of the PSUs will only vest, if at all, upon the achievement of:
• full enrollment in our planned Phase 2/3 trial of INO-4800;
• non-dilutive, third-party funding for clinical development and manufacturing of INO-4800;
• manufacture of 100 million doses of INO-4800 and a specified number of delivery devices; and
• U.S. FDA approval, with no more than a specified number of other COVID-19 vaccines having previously received such approval. The target achievement date for each of the goals is within three years from the grant date in August 2020.
Annual Cash Incentive: Rigorous, Pre-Set Clinical, Regulatory and Corporate Goals, Strong Performance Achievement and Annual Incentive Plan Payouts Reflecting Pay for Performance Alignment
COVID-19 Vaccine Candidates:
• 15% for completing dose selection from Phase 2 data and initiating the global Phase 3 trial for INO-4800;
• 12% for advancing INO-4802 addressing variant of concern and conducting a Phase 1/2 trial for INO-4800; and
• 8% for manufacturing of DNA plasmid, devices and arrays to deliver INO-4800 and INO-4802.
VGX-3100:
• 12% based on presentation of top line efficacy data for our REVEAL1 Phase 3 trial;
• 12% based on enrollment levels and numbers of patients dosed in our REVEAL2 Phase 3 trial; and
• 6% for advancing the development of the miRNA biomarker in vitro diagnostic ("IVD") platform with Qiagen and analyzing the research level data of REVEAL 1 clinical samples for miRNA signatures.
Advancing Oncology Programs:
• 6% to conduct additional efficacy and tolerability assessments and conduct clinical data review with Regeneron for GBM-001; and
• 6% based on enrollment levels and numbers of patients dosed in our RRP trial.
Advancing Infectious Disease Programs:
• 4% for development activities associated with our Zika dMAb trial; and
• 6% in the aggregate based on enrollment and numbers of patients dosed in our Lassa fever and MERS trials.
Additional Corporate Objective:
• 13% to maintain a strong balance sheet via a combination of new funding and control of expenses to end the year with no less than 2 years cash runway based on the current approved budget.
In 2021, our performance against the corporate objectives resulted in a corporate score of 96.4%, calculated as follows, compared to a 2020 corporate performance score of 110%.
• We partially met the goals surrounding INO-4800 and INO-4802, collectively yielding 24% credit of the possible 27%;
• We partially met the goals surrounding the manufacturing of DNA plasmid, devices, and arrays, yielding 5% credit of the possible 8%;
• We achieved our goals with respect to REVEAL-1 Phase 3 efficacy data readout target and REVEAL-2 Phase 3 dosing target, collectively yielding 24% credit;
• We exceeded our goal to advance the development of the miRNA biomarker IVD platform, yielding 7.5% credit (which was 125% of the target weighting of 6% credit);
• We achieved our goal for GBM-001, yielding 6% credit;
• We exceeded our goal surrounding RRP-001 dosing, yielding 7.5% credit (which was 125% of the target weighting of 6% credit);
• We successfully submitted a proposed amendment to the RRP Phase 3 trial design, yielding 2% credit;
• We partially met our goal for Lassa fever trial dosing, yielding 1.5% credit of the possible 3%;
• We significantly exceeded our goal with respect to MERS dosing, yielding 4.5% credit (which was 150% of the target weighting of 3% credit;
• We met our goal related to the Zika dMAb trial, yielding 4% credit; and
• We partially met our other corporate objectives, yielding 10.4% credit of the possible 13%.
4/1/22 DNA-based, needle-free Covid vaccine ZyCoV-D 67% effective in Phase 3 trial, Lancet study finds
Vaccine ZyCoV-D contains a small DNA molecule that can replicate independently; it does not need a SARS-CoV-2 virus strain.
New Delhi: The phase 3 clinical trial of the world’s first DNA-based vaccine ZyCoV-D have shown that the needle-free, three-dose vaccine has an efficacy of 66.6 per cent, according to the results published Friday in The Lancet journal.
Although Indian regulatory authorities have approved Zydus Lifesciences’ (formerly known as Cadila Healthcare) ZyCoV-D for children over 12, the vaccine is yet to be rolled out in the country.
Developed in 2020, preliminary animal study demonstrated that the vaccine induces antibody response including neutralising antibodies against SARS-CoV-2. Subsequent phase 1 and phase 2 trials in 1,048 human volunteers found the vaccine to be safe.
The vaccines contain a genetically engineered plasmid — a small DNA molecule that can replicate independently. The plasmid is engineered to produce the spike protein of the virus, which then triggers a protective immunological response.
DNA-based vaccines do not need a SARS-CoV-2 virus strain, unlike the inactivated vaccines that require viruses in killed or inactivated forms. This makes developing the virus much simpler as it can be manufactured under minimal biosafety requirements.
In the absence of any infectious agent in the vaccine, it can be manufactured with ease, under minimal biosafety requirements (BSL-1).
ZyCoV-D is delivered using a needle-free injection device.
The trial of the vaccine, conducted in India, is the first phase 3 trial globally to deliver a DNA vaccine using a needle-free delivery device, and the first time that a COVID-19 vaccine is being tested in the age group of 12–17 years in India.
Overall, the study demonstrated that intradermal injection of ZyCoV-D vaccine is safe and feasible and might achieve successful prevention of COVID-19 diseases in a large population.
“Additionally, the DNA vaccine is based on a plasmid DNA platform, which allows rapid generation of new constructs; the ZyCoV-D vaccine can therefore pave the way for next-generation DNA vaccines capable of handling mutant strains,” the authors wrote in their study.
“We anticipate that the major implication of this study will be the introduction of DNA-based prophylactic therapy against highly infectious diseases such as SARS-CoV-2,” they said.
The study showed that a three-dose regimen of ZyCoV-D, administered intradermally via a needle-free injection system, was found to be 66.6 percent effective against Covid-19.
The study was conducted during the peak of the second wave of COVID-19 in India, which was mainly due to the B.1.617.2 (delta) variant.
As many as 27,703 volunteers participated in the trial, of which 13,851 were given the vaccine, while the rest were given a placebo.
The team, which included doctors from Grant Government Medical College, Sir J J Group of Hospital in Mumbai, N R R Hospital in Bangalore, and Cadila Healthcare, conclude that the ZyCoV-D vaccine is effective against the delta variant.
“Considering that no severe or moderate COVID-19 cases were reported in the ZyCoV-D group, and based on the interim analysis results, the vaccine was found to be 100% effective against severe and moderate COVID-19 cases and 64·9% effective against mild COVID-19 cases,” the researchers said.
“Therefore, it is possible that the severe and moderate cases that might result in fatalities and put enormous pressure on health-care systems could be prevented to a great extent with full vaccination using the ZyCoV-D vaccine,” according to the study.
https://theprint.in/health/dna-based-needle-free-covid-vaccine-zycov-d-67-effective-in-phase-3-trial-lancet-study-finds/897941/
SHANGHAI, April 1 (Reuters) - China's commercial hub of Shanghai ground to halt on Friday after the government locked down most of the city's 26 million residents to stop the spread of COVID-19, even as official numbers put local cases falling for the second day in a row.
The city government late on Thursday extended an existing lockdown in eastern districts, just as western parts of the city were shut down as scheduled.
Fresh official guidance indicated that many in China's most populous city will now be required to stay home as long as it takes to control the outbreak - instructed not to cross their doorsteps even to dispose of rubbish or walk their dogs.
The lockdown, designed to stop an outbreak of the highly transmissible Omicron variant that started about a month ago, began on Monday and was originally due to last 10 days in total.
Areas east of Shanghai's Huangpu River were to be closed for five days, before reopening as western districts began a five-day shutdown.
But the city government said it would lift the curbs in east Shanghai in stages instead. read more
This means the majority of districts are now under a lockdown that covers the office towers of the Lujiazui district, China's answer to Wall Street, and factories including Volkswagen's (VOWG_p.DE) joint venture with SAIC Motor (600104.SS) and U.S. automaker Tesla's (TSLA.O) plant.
https://www.reuters.com/world/asia-pacific/shanghai-expands-covid-lockdown-life-hold-city-26-million-2022-04-01/?utm_source=Sailthru&utm_medium=newsletter&utm_campaign=global-healthcare&utm_term=Health%20Report%20-%202021%20-%20Master%20List
April 1 (Reuters) - Russia's total number of COVID-related deaths have reached almost 778,000 since the start of the pandemic in April 2020, Reuters calculations based on new data from the Rosstat state statistics service showed on Friday.
Rosstat said that 43,201 people had died from COVID or related causes in February, up from 35,807 in January.
The death toll hit a record monthly high of nearly 90,000 in November, propelling Russia into second place for the highest number of fatalities worldwide after the United States, which has more than twice the population. read more
Reuters calculations also showed Russia recorded more than 958,000 excess deaths since the beginning of the pandemic in April 2020 to the end of February, when compared to average mortality in 2015-2019.
Some epidemiologists say that calculating excess deaths is the best way to assess the true impact of a pandemic.
https://www.reuters.com/world/europe/russias-total-number-covid-related-deaths-hits-nearly-778000-2022-04-01/?utm_source=Sailthru&utm_medium=newsletter&utm_campaign=global-healthcare&utm_term=Health%20Report%20-%202021%20-%20Master%20List
$10M C2K Procurement Contract will be recognized as revenue, 100% margin in 1Q22, or 2Q22
10-K, pg 97: Additionally, in June 2020, the Company was awarded a fixed-price contract (the “Procurement Contract”) from the DoD for the purchase of the Company’s intradermal CELLECTRA 2000 device and accessories. The CELLECTRA 2000 devices will be used to inject INO-4800 in the Company’s later-stage clinical trials. The total purchase price under the Procurement Contract is expected to be approximately $10.7 million. As of December 31, 2021, the Company determined that the Procurement Contract falls under the scope of ASC Topic 606 as the contract is with a customer and the Company is able to satisfy its obligations under the arrangement as the Phase 3 clinical trials of INO-4800 are underway. Performance obligations under the Procurement Contract consist of the delivery of a specified number of CELLECTRA® 2000 devices and accessories. The total transaction price was allocated to the individual performance obligations based on the determined standalone selling price for the devices and accessories. The Company will recognize revenue on the consolidated statement of operations upon shipment of the purchased devices and accessories. During the year ended December 31, 2021, the Company recorded revenue of $755,000 from the Procurement Contract. This revenue was recognized at a 100% margin as the sale was for products whose related inventory had previously been written down to zero.
Upon good STV Iterim Readout which meets or exceeds Primary Endpoint 50% efficacy of prevention of virologically confirmed COVID-19 disease, even before WHO granting EUL, Ino can start talking to LMICs for 4800, C2K Pre-orders. The WHO will quickly grant EUL as they OWN trial data.
pGx9501 booster EUA may trigger large Biologic, device orders in China and from Chinese government for Vaccine Diplomacy.
In April 2021, the Company announced that the DoD had notified the Company that it will discontinue funding for the Phase 3 segment of the Company's clinical trial of INO-4800 in the United States, while continuing funding under the OTA Agreement and Procurement Contract.
3/1 JK: “STV is run and sponsored by the WHO. They have full control. We have full confidence that they will be able to execute the trial as they see most appropriately. So far, everything is moving as they had stated in the fall.
Vaccine homologous and heterologous boost trials, that’s fully enrolled. Advaccine expects to have data in the second quarter of this year.”
3/6/22 Expect STV Interim Readout April 2022. “According to the STV team, the Philippines has already reached the primary outcome of the trial wherein 133 participants tested positive for Covid-19 after completing the two-dose schedule of the first study vaccine,”
According to DOST, the Philippines, Mali, and Colombia have reached the target number of primary endpoints and are currently validating and analyzing the initial data.
Under the OTA Agreement, the Company intends to develop the CELLECTRA 3PSP device and arrays for use in the U.S. military population and the U.S. population as a whole, subject to approval of the device by FDA. The OTA Agreement is also expected to support large-scale manufacturing of the CELLECTRA
3PSP device, as well as large-scale DNA plasmid production for manufacture and supply of a specified number of doses of INO-4800 in support of FDA approval of the device. The total amount of funding being made available to the Company under the OTA Agreement is $54.5M. The Company will record contra-research development expense on the consolidated statement of operations in the same period that the underlying expenses are incurred.
https://mb.com.ph/2022/03/06/7083-participants-of-who-solidarity-trials-get-first-dose-of-covid-19-jabs/
http://www.chictr.org.cn/showproj.aspx?proj=131321&fbclid=IwAR1AVdMvFu74Nx8-pOSgRo4VjZMy7l0knDclViZlyOK_rPbfPJwTi2OfN64
Cellectra 3PSP, is handheld and battery operated. It can deliver about a hundred doses on a single charge and has a life-span of about 5,000 uses, due to battery limitations.
50K*5K=250M doses. EUL requires a sufficient device quantity For COVAX. So does China EUA.
Each use requires a disposable tip. As with more conventional vaccines, the injection site is the upper arm. Vaccination starts with an intradermal injection of the vaccine dose?a shot that's only skin deep. Then, the tip of the Cellectra device is pressed against the skin, directly over the location of the shot. Electrodes about 3 mm in length administer a series of four square-wave electrical pulses that last 42 milliseconds each, at 0.2 amperes.
The recipient feels a brief twinge, similar to the level of pain people experience from a flu shot. Recipients rated it at an average of about 2.5 on a 0-to-10 pain scale?although the feeling is said to be like a buzzing sensation, rather than the prick and pressure of a shot.
The pulses cause nearby cells to temporarily open channels through which the vaccine can enter. As soon as the electrical pulses finish, those channels close. “Now this DNA molecule is trapped inside the cells," says Inovio's Broderick. The DNA then “acts like a code, so your cells become a factory for producing the vaccine," she explains. Electroporation is generally 10 to 100 times as efficient at provoking an immune response as the same DNA vaccine given by a conventional needle injection alone, says Lu of the University of Massachusetts.
Over the last decade, Inovio's DNA vaccines have been tested against HIV, Ebola, MERS, Lassa fever, and human papillomavirus (HPV), each delivered with some form of electroporation. In total, more than 3,000 people have received one of Inovio's electroporated medicines, largely through phase 1 and 2 studies, Broderick says.
https://spectrum.ieee.org/inovios-electrical-device-zaps-a-covid19-vaccine-into-the-body
3/15 JK at Oppenheimer: “We are gearing up our CELLECTRA 3PSP both for regulatory approvals, but also for our potential emergency use. Once our INNOVATE and SOLIDARITY trials, once we can demonstrate efficacy and safety, of course, our endgame is to apply for emergency approval and then the full approval.
So, we have been solving the scaling up of device manufacturing. It’s one of those platform things. It does slow us down of our clinical device from going from P1, P2, P3 for COVID vaccine. But we have solved for these issues. And the beauty of this platform is that once you solve for them, you don’t have to deal with the same issues again. So, our inventories are very strong.
We have CELLECTRA 2000 that we are using for our clinical trials. We have extensive inventory to execute all of our trials, including COVID-19. We have CELLECTRA 5PSP that is currently being used in REVEAL1 and REVEAL2.
We have also used them in some of our Vulvar trial as well in P2. And we have plenty of inventory. We are actually gearing up commercial inventory, studying that as we prepare to wrap up REVEAL2 and potentially have the package in preparation for our feature commercialization.“
INO New viewers: Avoid this stock like the plague. It's a 43-year pump & dump. Not a single approved product originated in all that time.
One of its key founders, Avtar Dhillon, served as Inovio President, Inovio CEO, Inovio Director and Inovio Chairman & highly Paid Consultant to Inovio to 2019.
He was taken out of his LA home by a multi-agency task force in August of 2021. Dhillon is charged with stock fraud, conspiracy and obstruction of justice.
Avtar Dhillon is serial penny stock promoter, He is possibly the most reviled individual ever in the stock market. So many people are incensed and livid with him that he'd probably be better off in jail.
Inovio (INO) is Dhillon's baby and all readers would do very well to stay far away from this penny stock* (* when the most recent two reverse splits are accounted for, INO has a present value of 23 cents a share).
Bag holders are legion here. Don't become one, too. Don't fall for the clever, misleading Press Releases. Dhillon could do a master class on deceptive, misleading PRs. Don't be lured in- you are the mark of the unscrupulous pumping that surrounds this stock. It's been an ATM for years for those who who prey on newbie's.
MG
Father of The Inovio Scam Expose
No position whatsoever in over a half dozen years
Was not burnt by Inovio
50,000 online stock posts of integrity- all as MiamiGent
This is my pro bone work for a wonderful life in stocks
https://cannabislifenetwork.com/vancouver-dr-avtar-singh-dhillon-billion-dollar-fraud-case/
https://news.bloomberglaw.com/white-collar-and-criminal-law/cannabis-and-biotech-board-chair-arrested-for-securities-fraud
Institutional Investment Is Now 105,043,090 Shares. According To Fintel.....Blue Chip Institutional Investors Keep Buying More INOVIO Shares.....They Do Wharton/Harvard Style Due Diligence!
Sad story hopefully to be addressed by INO HPV vaccine.
The case of a 27-year-old woman, who died a day after being diagnosed with cervical cancer and after claiming she wasn't listened to by doctors, has been described as "shocking and traumatic" by a coroner.
Porsche McGregor-Sims, an events manager from the U.K. city of Portsmouth, died at Queen Alexandra Hospital on April 14, 2020, a day after being diagnosed with stage 4 cervical cancer, Hampshire Live reported. Prior to her diagnosis she had suffered from abdominal pain and bleeding for 15 m
Rhodes-Kemp said: "We see hundreds and hundreds of cases every year—and I have done about 6,000 inquests—but this one is particularly sad."
The inquest found that McGregor-Sims died of natural causes.
McGregor-Sims' family doctor referred her to a specialist after she complained of abdominal pain and vaginal bleeding in December 2019.
In January 2020, McGregor-Sims saw gynecology consultant Dr. Peter Schlesinger, who decided not to examine her. He told the inquest that he thought she was experiencing symptoms from hormonal contraception, endometriosis, or irritable bowel syndrome.
Schlesinger said it was "very rare" for someone to experience symptoms of aggressive cancer after having a recent negative smear test and ultrasound, as McGregor-Sims had.
Dr. Dirk Brinkmann, a gynecological cancer surgeon who briefly saw McGregor-Sims before her death, told the inquest that in the best-case scenario she would have had a 70 percent chance of living for a further 24 months had she been diagnosed at Schlesinger's appointment 11 weeks earlier.
The family said in a statement read in court that it was not in McGregor-Sims' character to complain, but she felt she was "not listened to," according to BBC News.
Her mother Fiona Hawke is now calling for the age that women are offered cervical cancer screening to be dropped to 16.
"We need to understand that this is a disease that can affect young women of any age," she told ITV .
In the U.K., an HPV test—where cervical samples are tested for the human papillomavirus virus (HPV) that can cause cervical cancer—is available for people with a cervix aged 25 to 49 every three years, and every five years for those aged 50 to 64 years old.
In the U.S., the CDC recommends Pap tests, or smears, which look for precancerous cells, from the age of 21. Those aged 30 to 65 are advised talk to their doctor about getting a Pap test or HPV test, or a combination of the two. A doctor may advise those over 65 to no longer get screened if they have had a normal result for several years, or had their cervix removed.
Newsweek has contacted Portsmouth Hospitals University NHS Trust for comment from Schlesinger and Brinkmann.
Liz Rix, chief nurse at Portsmouth Hospitals University NHS Trust, said in a statement to ITV: "On behalf of Portsmouth Hospitals University NHS Trust, I would like to express our condolences to the family of Porsche McGregor-Sims.
"When we were aware of concerns around her care, we immediately investigated these and ensured we learnt from the experience of Porsche and her loved ones.
"I would like to reassure patients that their safety is of utmost importance to us and should they have any concerns or questions regarding their care, encourage them to raise these with the team caring for them. Our thoughts are with Porsche's family at this difficult time."
Plumline Approval of Phase 3 Plan for Dog DNA Immunotherapy
Aim to reduce recurrence rate by combining chemotherapy and 'PLS-D5000' for blood cancer in dogs Reporter Lim Jeong-yo | Public 2022-03-24 13:59:27
This article was published on March 24, 2022 at 13:59 The Bell Paid Page .
Plumline Life Sciences announced on the 24th that the Ministry of Agriculture, Food and Rural Affairs has approved the Phase 3 clinical trial plan for 'PLS-D5000', a DNA immunotherapy for dogs.
In this phase 3 clinical trial, Plumline Life Sciences will confirm the efficacy and safety of PLS-D5000 against malignant lymphoma (hematologic cancer).
Malignant lymphomas are caused by malignant changes in lymphocytes in the lymphoid tissues constituting the immune system. If left untreated, the dog dies within 3-4 months.
Currently, the most preferred treatment modality is CHOP combination chemotherapy (vincristine, doxorubicin, cytoxane, L-asparaginase, and prednisone), but only temporary tumor remission is possible. The majority of cases recur, and even if they gradually fail to respond to chemotherapy and receive treatment, the average dog survives for about 12 months.
PLS-D5000 is a dog-only DNA immunotherapy that targets the TERT protein, which is overexpressed in 90% of canine cancers. The company explains that it can strongly induce cellular immunity that can attack and kill malignant blood cancer as it has been developed as a platform technology that is differentiated compared to the previously known dog breed TERT DNA. Unlike chemotherapy, which is a cytotoxic substance, the possibility of side effects is very low and it can be used continuously.
According to an IRBM oncology paper, when TERT DNA immunotherapy and chemotherapy are combined, the total survival period is extended by more than 250% (100 weeks vs 40 weeks) compared to conventional chemotherapy.
Since dog lymphoma is a 100% incurable cancer, the goal of lymphoma treatment is to prolong the total survival time and minimize side effects during treatment. In the phase 3 clinical trial of PLS-D5000, the experimental group to which PLS-D5000 was applied after chemotherapy was compared with the control group treated only with the existing chemotherapy method to determine the total survival time and recurrence rate.
An official from Plumline Life Sciences said, “About 150,000 dog chemotherapy cases are counted annually in the US market alone, and more than $10,000 is paid for dog chemotherapy. It is possible, and it has a technological advantage that can induce high cellular immunogenicity, which is related to the survival rate of dogs with cancer.”
https://m-thebell-co-kr.translate.goog/m/newsview.asp?svccode=00&newskey=202203241006130400108585&_x_tr_sch=http&_x_tr_sl=auto&_x_tr_tl=en&_x_tr_hl=en
Along with everybody else.
Facing omicron 'curveball,' Inovio seeks endpoint switch amid fear it will strike out against original goal
…..
https://www.fiercebiotech.com/biotech/facing-omicron-curveball-inovio-seeks-endpoint-switch-amid-fear-it-will-strike-out-against
3/25 Researchers studied 141 people infected with the virus in the first half of 2020 who provided blood samples 12 months later. None of them had been vaccinated in the interim. Most individuals still had low levels of antibodies, and most of those younger than 60 still had some antibodies that could neutralize the virus, according to a report published on Wednesday in The Lancet Microbe. But in everyone - regardless of age or severity of the original infection, and including patients who had lost their neutralizing antibodies - responses by so-called memory B cells and memory T cells were still evident "and were not disrupted by new variants," the researchers said. These defenses do not prevent infection but they do help to prevent severe disease.
"Current SARS-CoV-2 vaccines are mainly focused on neutralizing antibodies," the researchers noted. "These data underline the importance of broad B-cell and T-cell immunity for future vaccine strategies targeting SARS-CoV-2."
https://www.reuters.com/business/healthcare-pharmaceuticals/some-immune-system-memory-persists-year-after-infection-covid-omicron-also-less-2022-03-25/
https://www.thelancet.com/action/showPdf?pii=S2666-5247(22)00036-2
We exceeded our goal to advance the development of the miRNA biomarker IVD platform, yielding 7.5% credit (which was 125% of the target weighting of 6% credit);
We exceeded our goal surrounding RRP-001 dosing, yielding 7.5% credit (which was 125% of the target weighting of 6% credit);
We successfully submitted a proposed amendment to the RRP Phase 3 trial design, yielding 2% credit;
We significantly exceeded our goal with respect to MERS dosing, yielding 4.5% credit (which was 150% of the target weighting of 3% credit;
We met our goal related to the Zika dMAb trial, yielding 4% credit
We partially met the goals surrounding the manufacturing of DNA plasmid, devices, and arrays, yielding 5% credit of the possible 8%;
To start P1 dMAbs for Prevention of COVID-19 May 2022
Estimated Study Start Date : May 2022
Estimated Study Completion Date : May 2023
This May exceed initial goal of 2H22.
Inovio Flu - 2013 - what happened?
……..
https://www.wsj.com/video/end-of-the-flu/DA7088C7-FA43-4F32-BCC0-92C92AE70D84.html
March 25 (Reuters) - The U.S. health regulator said on Friday the current authorized dose of GlaxoSmithKline (GSK.L) and Vir Biotechnology's (VIR.O) antibody-based COVID-19 treatment is unlikely to be effective against the Omicron BA.2 variant.
The agency pulled its authorization for the therapy in much of the U.S. northeast where the subvariant is dominant.
It updated its emergency use authorization factsheet on sotrovimab and also updated its website to exclude the drug's use in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant.
The U.S. Centers for Disease Control and Prevention (CDC) has identified that the BA.2 variant is now circulating with a frequency exceeding 50% in Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont, New Jersey, New York, Puerto Rico, and the Virgin Islands.
As a result, the Office of the Assistant Secretary for Preparedness and Response said it would pause distribution of sotrovimab to these states.
GSK and Vir said on Friday they are preparing a package of data in support of a higher dose of the therapy for the BA.2 subvariant and will be sharing the data with regulatory authorities around the world for discussion.
The currently authorized dosage for sotrovimab is 500 mg. It is authorized for adults and children 12 years of age and older, and who are at high risk for progression to severe COVID-19.
3/25/22 “We believe this is an important step for dMAb program.
This has to do with announcement we had made in December 2020 regarding dMAbs to treat Covid19. We are working with many collaborators on this project as you know. We are hoping that this can lead to benefits not just for Covid but for our dMAbs program, in general.
Thank you
Investor Relations”
P1 dMAbs for Prevention of COVID-19
https://clinicaltrials.gov/ct2/show/NCT05293249?term=Dmabs&draw=2&rank=1
Recombinant monoclonal antibodies represents the largest segment of pharmaceutical markets today with more than $100B in sales.
In 2020, the Company received a $10.7M sub-grant through Wistar, which was amended in 2021 to $13.5M, for the preclinical development and translational studies of dMAbs as countermeasures for COVID-19, with funding through September 2022. The sub-grant also includes an option for an additional $6.0M in funding through September 2024, of which $3.3M has been exercised as of December 31, 2021.
Moderna stock falls 8% as SVB Leerink lowers price target; sees 55% downside
#MRNA has never managed to field a product where AEs (and pretty much the same set of AEs) did not produce more risk and harm than the pathogen they were targeted against. The company has been seeking progressively more deadly diseases to work with to change the risk equation and still couldn't field a finished drug or turn a profit since its inception, losing 100-200m annually until 2021.
Covid has been their only fielded product, period, and you know how that went - same sets of AEs.
The lipid nanoparticles are problematic. The adenovirus vector is problematic. These are the fundamental components of their product; changing the package contents is irrelevant when the container is what kills you.
https://stocktwits.com/Brooxsie/message/447121894
Though new orders from Japan and Colombia helped Moderna boost its expected revenue from Covid vaccines this year from $19 billion to $21 billion, the firm also shared phase 2 trial data for its flu vaccine candidate that showed only “similar” efficacy to standard flu shots, making it difficult to say whether the candidate is “necessarily better,” Jefferies analysts said Friday.
Other analysts were harsher on the data, with SVB Leerink’s Mani Foroohar calling the results a “nonstarter for the influenza market,” both commercially and clinically, and saying any further development of the candidate would be a “poor use” of Moderna’s resources.
Though several analysts praised Moderna’s efforts to develop vaccines against latent (also known as dormant) viruses—including cancer, multiple sclerosis and congenital deafness—a few acknowledged investors are still focused on the firm’s Covid offerings.
Morgan Stanley, which holds a price target of $170 for Moderna shares, pointed out it’s unlikely the UN’s Covax will exercise its option to purchase additional doses by an April 1 deadline, while lawmakers in the U.S. struggle to secure additional Covid funding.
Nearly 77% of Americans ages five and older have received at least one COVID-19 vaccine dose so far, according to the Centers for Disease Control & Prevention (CDC). The number is even higher -- 88% -- for adults ages 18 and older. But these doses were free to all Americans. If there had been even a nominal cost, the percentages would almost certainly be significantly lower.
Also, the costs of vaccines will increase in a private market. Bancel acknowledged on Thursday, "In an endemic setting, I believe Moderna's average price for the vaccine will be higher than it's been over the past two years." You can expect BioNTech (along with its partner, Pfizer) and Novavax to take a similar stance.
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