Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
P1PR might be published in NEJM on weds 12/9, 12/16, 12/23. It will be this Dec considering that the
Manuscript was submitted 7/31 (4 months + 1 week so far on 12/5).
mRNA took slightly less than 4 months.
DoD funding may be announced approximately 6578 participants * $50K/per = $328.9M after $740.5B NDAA 2021 is passed by Congress within the next 2 weeks with veto-proof margin.
$950B Stimulus plan including $16B for CV vaccine dev may be passed too as bi-partisan Congress wants to push the two together. If Ino-4800 becomes top 3 winner of OWS NHP challenge, it may get OWS funding for second gen vaccine.
DoD always Budgets projects even for Black Ops. Ino-4800 is not top-secret like Black Ops. Thus, INO-4800 budget will be divulged pending NDAA 2021 approval.
3PSP Update which might lift P3 device partial hold and release CEPI funding.
More global manufacturing partner such as SII (Serum Institute of India), largest in the world, and/or Shenzhen SiBiono GeneTech Co., Ltd may be Announced.
Ino already signed with 2 top players in the world in TMO, Kaneka Eurogentec S.A
Competitive Landscape:
FUJIFILM Diosynth Biotechnologies, Kaneka Eurogentec S.A, Fin vector, Spark therapeutics, Cobra biologics, Cell and gene therapy catapult, Renova Therapeutics, Shenzhen SiBiono GeneTech Co., Ltd, Thermo Fisher Scientific, Inc, 4D Molecular Therapeutics are the major players in the Viral vector and plasmid DNA manufacturing market. Capacity expansion and increasing global reach.
In 2019, Aldevron, a U.S. based plasmid DNA manufacturer, entered into a long-term agreement with a leader in precision genetic medicine for rare diseases treatment, Sarepta Therapeutics, Inc. As per the agreement, Aldevron is liable to supply plasmid DNA to Sarepta for commercial supply as well as its gene therapy clinical trials and.
Capacity expansion:
On 7th August 2020, a clinical-stage gene therapy company, MeiraGTx, announced plans to build a multi-million euro facility at Shannon Free Zone, Ireland. The new facility will be focused on increasing the manufacturing of viral vectors and plasmid DNA for gene therapies. The viral vector manufacturing facility is expected to be operational by the end of 2021, while the plasmid production facility will start operations by the end of 2020.
Similarly, in 2017, Brammer Bio invested over USD 50 million for the expansion of its production capabilities in Boston and Florida.
reportsanddataDoTcom/report-detail/viral-vector-and-plasmid-dna-manufacturing-market
Results from AstraZeneca's late-stage U.S. vaccine trial will likely roll in by late January, Operation Warp Speed chief Moncef Slaoui said. That's important, because the large set of contrasting data from trials in the U.K. and Brazil may not be enough to convince the FDA to grant the British drugmaker an emergency nod, Slaoui said. AZ recently reported that its vaccine was 90% effective when given as a half-dose primer followed by a full-dose booster, while the intended two-dose regimen charted efficacy around 70%.
Meanwhile, Anthony Fauci, the U.S.' top infectious disease expert, slammed the U.K. for its speedy authorization of Pfizer and BioNTech's vaccine. “If you go quickly and you do it superficially, people are not going to want to get vaccinated,” Fauci told Fox News. The U.K. did not review its shot as carefully as the FDA plans to do, he said. "They got a couple of days ahead. I don’t think that makes much difference."
England's National Health Service and Medicines and Healthcare Products Regulatory Agency are scrambling to figure out how to deploy Pfizer's vaccine, which must be stored at a frigid minus 94 degrees Fahrenheit, in care homes, Reuters reports, citing deputy Chief Medical Officer Jonathan Van-Tam. There;s "no absolute assurance" the U.K. can get the shot to those residents, Van-Tam said, arguing, "one thing we can’t do is... end up with a vaccine that’s been handled incorrectly, and then isn’t properly viable at the end of the distribution chain.”
Pfizer is committed to working with the Indian government to make its vaccine available in-country, the Hindustan Times reports, citing a company spokesperson. Back in November, V K Paul, who heads the country's COVID-19 task force, warned it might take months for Pfizer's shot to arrive in India, with cold chain arrangements the biggest hurdle the nation needs to overcome.
UPDATED: Wednesday, Dec. 2 at 3:17 p.m. ET
A quintet of top vaccine makers are set to split around $38.5 billion in sales next year—and Pfizer, freshly armed with a U.K. approval, is in line for a $14.3 billion slice of the pie, Bernstein analysts figure. Moderna should expect to reap $10.9 billion, followed by $6.4 billion for AstraZeneca, $3.9 billion for Novavax and $3 billion for Johnson & Johnson. The analysts further predicted $23.1 billion in total vaccine sales in 2022, $12.6 billion in 2023 and $8.5 billion in 2024 before the market settles at around $6 billion in 2025. Story
Merck & Co. on Tuesday said it had divested its stake in Moderna, fueling "a small fourth-quarter gain." It's unclear how much Merck stands to make, but it's likely to be significant: Moderna went public in December 2018 at a price of $23 per share, while Tuesday's closing price was $142. Merck first pumped $100 million in cash and stock into Moderna in 2015 to partner on five preclinical mRNA projects, later investing another $125 million in 2018. Story
The Trump Administration aims to vaccinate 100 million people by February—enough to cover all healthcare workers and the country's at-risk population, Operation Warp Speed (OWS) officials said Wednesday. Twenty million people are expected to get a shot by year-end, followed by 30 million people in January and another 50 million by February, Warp Speed chief Moncef Slaoui said.
The European Union is none too pleased with the U.K.'s rapid fire authorization of Pfizer and BioNTech's vaccine, Reuters reports. Through an emergency approval process, the U.K.'s drug regulator was able to temporarily OK the shot only 10 days after starting its review of data from large-scale trials. The European Medicines Agency argued its longer approval process is better suited to the task, because it calls for more data and involves more checks than the U.K.'s emergency procedure.
The European Medicines Agency (EMA) on Tuesday kicked off a rolling review of Johnson & Johnson's recombinant vector vaccine candidate. The hastened process will allow Europe's health regulator to assess J&J's shot in real time as data trickles in. The EMA previously initiated rolling reviews on shots from AstraZeneca, Moderna, and Pfizer and BioNTech.
The CDC's Advisory Committee for Immunization Practices (ACIP) voted 13-1 Tuesday to recommend healthcare workers and long-term care residents get first dibs on an authorized COVID-19 vaccine. ACIP also recommended vaccinating nursing home staffers alongside residents. The committee is due to meet again after a Dec. 10 advisory committee review of Pfizer's shot hopeful, where it will vote to recommend whether an authorized shot should go out to the public.
While the leading slate of vaccines have been well-tested in adults, there's a dearth of information on how those shots might work in younger children. Now, pediatricians are urging drugmakers to step up their game. The American Academy of Pediatrics, for instance, has called on researchers to expand clinical trials to include children of all ages as soon as possible. Others argue that a vaccine that works in children is a critical step to reopening classrooms. Pfizer, for its part, started including children ages 12 and older in its trial this fall.
CEPI-and-COVID-19-VACCINE-June 9, 2020 Slide-10-showed-Eurogentec,Belgium-as-Ino-mfgr-partner
Nicole Lurie, MD, MSPH
Strategic Advisor to the CEO and Incident Manager, COVID response team CEPI
https://www.hhs.gov/sites/default/files/nvac_june2020_panel1.pdf
Slide 10 shows Ino’s
Locations of large scale mfg (DS)
(1) Richter Helm, Germany; (2) Eurogentec, Belgium, (3) Inovio San Diego.
Incomplete Durability of Responses after SARS-CoV-2 mRNA-1273 Vaccination
December 3, 2020
DOI: 10.1056/NEJMc2032195
TO THE EDITOR:
We recently reported the results of a phase 1 trial of a messenger RNA vaccine, mRNA-1273, to prevent infection with SARS-CoV-2; those interim results covered a period of 57 days after the first vaccination.1,2 Here, we describe immunogenicity data 119 days after the first vaccination (90 days after the second vaccination) in 34 healthy adult participants in the same trial who received two injections of vaccine at a dose of 100 µg. The injections were received 28 days apart. The recipients were stratified according to age (18 to 55 years, 56 to 70 years, or ≥71 years), and the assays used have been described previously.1,2
Although correlates of protection against SARS-CoV-2 infection in humans are not yet established, these results show that despite a slight expected decline in titers of binding and neutralizing antibodies, mRNA-1273 has the potential to provide durable humoral immunity. Natural infection produces variable antibody longevity3,4 and may induce robust memory B-cell responses despite low plasma neutralizing activity.4,5 Although the memory cellular response to mRNA-1273 is not yet defined, this vaccine elicited primary CD4 type 1 helper T responses 43 days after the first vaccination,2 and studies of vaccine-induced B cells are ongoing. Longitudinal vaccine responses are critically important, and a follow-up analysis to assess safety and immunogenicity in the participants for a period of 13 months is ongoing. Our findings provide support for the use of a 100-µg dose of mRNA-1273 in an ongoing phase 3 trial, which has recently shown a 94.5% efficacy rate in an interim analysis.
https://www.nejm.org/doi/full/10.1056/NEJMc2032195?query=featured_home
INNOVATE P2 updated 12/3 with Recruiting Status
NCT04642638
Recruitment Status : Recruiting
First Posted : November 24, 2020
Last Update Posted : December 3, 2020
Actual Study Start Date :
November 30, 2020
Following sites now have Recruiting status:
United States, Kentucky
AMR Lexington Recruiting
Lexington, Kentucky, United States, 40509
Contact: Program Manager Ginger Switzer amrlexington@amrllc.com
Principal Investigator: Mark Adams
United States, Missouri
AMR Kansas City Recruiting
Kansas City, Missouri, United States, 64114
Contact: Program Manager Barbara Bradshaw clinicaltrialsKC@amrllc.com
Principal Investigator: John Ervin
DM Clinical Research Recruiting
Tomball, Texas, United States, 77375
Contact: Prinicipal Investigator Vickie Miller drmiller@dmclinicalresearch.com
https://clinicaltrials.gov/ct2/history/NCT04642638?A=1&B=2&C=Side-by-Side#StudyPageTop
MIT-machine-learning-models-find-gaps-in-coverage-by-Moderna,Pfizer,other-Warp-Speed-COVID-19-vaccines
Vaccine makers need to take into account genetic diversity explicitly in clinical trials or risk missing coverage for some individuals, says MIT scientists.
Tiernan Ray
By Tiernan Ray | December 2, 2020 -- 20:09 GMT (12:09 PST) | Topic: Coronavirus: Business and technology in a pandemic
Vaccines to block COVID-19 that are in development by Moderna, Pfizer, AstraZeneca and others, and that are currently in Phase III clinical trials, may not do as well covering people of Black or Asian genetic ancestry as they do for white people, a study released Wednesday by the Massachusetts Institute of Technology indicated.
"There are obviously many other factors to consider, but our preliminary results suggest that, on average, people of Black or Asian ancestry could have a slightly increased risk of vaccine ineffectiveness," one of the authors of the report, David K. Gifford, who is with MIT's Computer Science and Artificial Intelligence Laboratory (CSAIL), said in a press release issued by MIT.
The report, entitled "Predicted Cellular Immunity Population Coverage Gaps for SARS-CoV-2 Subunit Vaccines and their Augmentation by Compact Peptide Sets," was posted on the Bioarxiv pre-print server and has not yet been peer-reviewed, which means its findings must be taken with an extra degree of caution.
Enthusiasm has surged in recent weeks as Moderna, Pfizer and AstraZeneca all announced initial results from Phase III trials in human patients that showed surprisingly powerful rates of immunity, with tests subjects given the drugs being 94% to 95% less likely than people given a placebo to contract COVID-19.
Those three vaccine efforts are only the most prominent in a vast array of efforts. There are fifty-one vaccines in clinical trials in total, according to the World Health Organization. There are another one hundred and sixty-three vaccines in a pre-clinical stage of evaluation.
Curves of coverage show varying percentages of people by genetic ancestry that are likely to gain an immune response to COVID-19, for different mixes of alleles and viral peptide combinations.
Liu et al
Many of the vaccines, including those from Moderna and Pfizer and AstraZeneca, share the same weakness, the MIT report contends, which is that they do not use a sufficiently diverse set of viral particles to stimulate the same level of immune response in all people in the population, depending on genetic makeup.
The report draws on in silico computer models. Gifford and co-authors Ge Liu and Brandon Carter, two PhD students with MIT's CSAIL, used machine learning models to predict, based on patient data and models of proteins in the immune system, how likely vaccines would be to have a "hit," meaning, to successfully stimulate an immune response, in different population groups based on self-reported ethnic type or genetic ancestry.
The work in the paper builds on work done this summer by the group to develop two computer models that predict vaccine coverage. One, called OptiVax, predicts a vaccine's stimulation of immune responses. A second, called EvalVax, maps that immune response to the biochemistry of population groups by ethnic or genetic ancestral status.
The vaccine mechanism is modeled by the programs. When an invading organism enters the body, such as a virus, some of the bits of virus, short strings of perhaps 8 to 25 amino acids, known as peptides, fit into a groove in the surface of a person's cells. The cell is then able to present the bits of the virus to the body's T cells as a signal of the invasion. The T cells begin a process of killing off such infected cells.
Vaccines in development. Gifford and colleagues contend all drugs in the U.S. Operation Warp Speed program, including those from Moderna and Pfizer and AstraZeneca, have the same weakness, which is that they cluster around a vary narrow selection of viral peptides to stimulate immune response, which deprives them of sufficient diversity to ensure the broadest population coverage.
Liu et al
That's how natural human immunity works, and vaccines mimic that process by using a bit of the virus specially engineered to artificially simulate the cell's response.
In the report this summer, Gifford and team had warned that not using enough different parts of the virus could leave gaps in coverage. That is because humans have different "alleles," versions of genes, in what's called the major histocompatibility complex, the area of the human genome that encodes the cell-surface receptors that are supposed to match the viral peptides. Some alleles produce cell receptors that will bind more or less reliably to some viral peptides.
The researchers relate several instances where their models show that the lack of greater peptide diversity leads to widely varying coverage:
Based on our prediction, the receptor binding domain (RBD) subunit had no MHC class II peptides displayed in 15.12% of the population (averaged across Asian, Black, and White self-reporting individuals) […] We note that the uncovered population of RBD with no predicted display of MHC class II peptides ranges from 0.811% for the popu- lation self-reporting as White, to a high of 37.287% for the population self-reporting as Asian.
ZDNet reached out to Moderna, Pfizer, and AstrZeneca for comment and will update the article with any response.
The authors have a couple of suggestions for the drug makers. One is to take into account genetic ancestry explicitly. "Clinical trials need to carefully consider ancestry in their study designs to ensure that efficacy is measured across an appropriate population," they write.
Second, as they did in de novo vaccine synthesis over the summer, Gifford and collaborators were able to tweak vaccine designs to include a greater diversity of peptides.
Their computer model of the drug designs suggests the proportion of people who would be covered would substantially improve if a greater mix of peptides is included, the authors write:
The computed sets of augmentation peptides were predicted to substantially reduce the populations predicted to be insufficiently covered by each subunit. Post augmentation the predicted uncovered population for RBD with no peptide-MHC hits is reduced to 0.003% (MHC class I) and 4.351% (MHC class II) with MIRA positive peptides only, and 0.0% (MHC class I) and 0.309% (MHC class II) with all filtered peptides from SARS-CoV-2. (Table S1).
The authors note that their code and data is freely available on GitHub.
https://www.google.com/amp/s/www.zdnet.com/google-amp/article/mit-machine-learning-models-find-gaps-in-coverage-by-moderna-pfizer-other-warp-speed-covid-19-vaccines/
Predicted Cellular Immunity Population Coverage Gaps for SARS-CoV-2 Subunit Vaccines and their Augmentation by Compact Peptide Sets
Ge Liua,b, Brandon Cartera,b, David K. Gifforda,b,c,*
aMIT Computer Science and Artificial Intelligence Laboratory, Cambridge, MA, USA bMIT Electrical Engineering and Computer Science, Cambridge, MA, USA cMIT Biological Engineering, Cambridge, MA, USA
https://www.biorxiv.org/content/10.1101/2020.08.04.200691v2.full.pdf
Pfizer,BioNTech-to-Reportedly-Scales-Back-COVID-19-Vaccines-Target-for-2020-Due-to-Supply-Chain/Issues
BY MT Newswires
— 4:11 PM ET 12/03/2020
04:11 PM EST, 12/03/2020 (MT Newswires) -- Pfizer (PFE) has trimmed its COVID-19 vaccine rollout targets and now plans to ship half of the 100 million vaccines it had originally planned for the year on the back of supply-chain problems, The Wall Street Journal reported Thursday, citing a company spokeswoman.
Pfizer and Germany-based partner BioNTech SE ( BNTX ) now plan to roll out 50 million vaccines this year. The vaccine received emergency-use authorization from the UK on Wednesday. The partnership is, however, on track to roll out 1.3 billion doses in 2021, WSJ noted.
Lieven-Janssens,Eurogentec-CEO-shares-deal-detail:Liège-biotech-factory-makes-INO-4800
JAN DE SCHAMPHELAERE
Today at 17:38
Eurogentec, part of Kaneka, Japan, is starting to produce vaccines for Inovio on a large scale in Liège. Similar deals will follow. An investment plan of 15 million euros is on the table.
'There is something special in the air here, right?' Says Lieven Janssens. He is CEO of Eurogentec, a spin-off from the University of Liège. Wallonia, with companies such as GSK, Novasep and Univercells, plays an important role in the production of corona vaccines. Eurogentec is now added to this.
The company was managed and financed for many years by Jean-Pierre Delwart, an important member of the Solvay family. He sold it to Kaneka, Japan in 2010. Since then, Eurogentec, which produces all kinds of biological materials on behalf of pharmaceutical companies, has gained momentum. The pandemic has put a turbo on that.
Bill Gates
Eurogentec has closed a deal for the corona vaccine from Inovio Pharmaceuticals. This is financially supported by the Bill & Melinda Gates Foundation and the United States Department of Defense.
'They contacted us in March. We have finalized the production process and are now ready to produce the vaccine on a large scale, 'says Janssens. The efficacy of the Inovio vaccine is currently being evaluated in a clinical study. In the best scenario, it will take more than six months before it is released to the market. But in the meantime, Inovio keeps a stock to be able to switch quickly when the time comes.
Inovio talks about the production of hundreds of millions of vaccine doses in 2021. "We are not alone," says Janssens. 'We are part of a network of four production partners. But I can tell you that we play a crucial role. The intention is to make a large part of our production capacity available. ' The CEO does not give figures.
That Inovio is behind on other vaccines is no problem for him. "Different vaccines are needed," he says. 'This vaccine can be stored at room temperature. That can be a big advantage. Besides, how strong is the immune response with each vaccine? What type of immunity is elicited? How long does the protection last? What about the side effects? You have to look at all those factors. '
Inovio, worth $ 2 billion on Nasdaq, is one of the forerunners in the world of DNA drugs and DNA vaccines. It works on treatments for prostate cancer, human papillomavirus-related diseases and vaccines for Zika fever, Lassa fever, HIV and MERS.
More vaccine deals
"Inovio is the first customer whose name we are allowed to release, but we do more than that," says Janssens. Eurogentec has completed production runs for two other vaccines, including an mRNA vaccine. Final preparations are underway for two other deals.
Eurogentec can deploy its brand new installation for Inovio: a 2,200 liter fermentation reactor. In recent years, this has accounted for an investment of more than 40 million euros, which explains the substantial growth in the workforce: from 200 to 360 employees in four years. 'It is going fast. We have 20 vacancies and 80 will be added in the coming months', it sounds.
Eurogentec seems to be on the way to 80 million euros in turnover this year - a third more than last year - and more than 10 million euros in operating profit (EBIT). 'Our intention is to quickly switch to even higher figures. Our ambition is great. '
Extra investment
To reinforce this ambition, it will invest 15 million euros in additional production capacity for mRNA corona vaccines, among other things. It seems as if Eurogentec only owes its success to the pandemic, but nothing could be further from the truth. 'Even without it, we would have easily filled our new installation with orders,' says Janssens.
Hotspots
The company has positioned itself in a number of hotspots in medicine: gene therapy, mRNA and DNA. These advancing technologies make possible what was unimaginable ten years ago. Not only for cancer, but also for all kinds of rare genetic diseases and vaccines.
Such treatments are hardly available commercially, but the number of clinical trials is enormous. 'We are involved in many,' says Janssens. Big pharma, including Pfizer, GSK and Sanofi, has also plunged into that world. Covid has given credibility to these new technologies. That gives a boost to other projects in development, 'Janssens concludes.
https://www.tijd.be/ondernemen/farma-biotech/luikse-biotechfabriek-maakt-amerikaans-coronavaccin/10269482.html
Translated to English
https://translate.googleusercontent.com/translate_c?depth=1&hl=en&nv=1&pto=aue&rurl=translate.google.com&sl=auto&sp=nmt4&tl=en&u=https://www.tijd.be/ondernemen/farma-biotech/luikse-biotechfabriek-maakt-amerikaans-coronavaccin/10269482.html&usg=ALkJrhhkqWznTNN8YTcHtb3LSU2oFl0CTw
To-be-sure, the-U.S.-and-the-U.K.-review-vaccines-differently. Pfizer had been submitting data on its vaccine with BioNtech on a “rolling basis” to the U.K., meaning regulators there were able to review the data in real-time and do so until there was enough evidence to support a formal authorization. A rolling review is a tool that regulators use to speed up the assessment of promising drugs or vaccines.
In the U.S., the FDA will go through every aspect of the data submitted in the application, including reviewing all safety data “to make sure there are no cracks” and everything is “solid,” said Dr. Paul Offit, a voting member of the Vaccines and Related Biological Products Advisory Committee, which is scheduled to review Pfizer’s vaccine on Dec. 10.
“I don’t know what data the U.K. was working with. I know when data is submitted to the FDA, it’s voluminous,” said Offit, also director of the Vaccine Education Center at Children’s Hospital of Philadelphia. “When you talk about a 44,000-person trial, that’s a lot of clinical data.”
He said when Merck submitted its data from its 70,000-person rotavirus vaccine trial, the pages that were generated could have exceeded the height of the Sears Tower. Sears Tower, now known as Willis Tower, is a 1,450-foot skyscraper in Chicago. “The point being: It’s a lot of data,” Offit said.
Pfizer submitted its vaccine data to the FDA on Nov. 20. The FDA has indicated it would authorize a vaccine that’s safe and at least 50% effective. The flu vaccine, by comparison, generally reduces people’s risk of getting influenza by 40% to 60% compared with people who aren’t inoculated, according to the Centers for Disease Control and Prevention.
The agency’s review of the vaccine is expected to take a few weeks.
Offit said he doesn’t think a U.S. authorization about a week after the U.K. makes a difference when you’re talking about vaccinating hundreds of millions of people. Immunizing everyone who wants a vaccine is likely going to take more than a year, he added.
Additionally, the U.K. has been sharply criticized for approving Pfizer’s vaccine so quickly. Dr. Anthony Fauci, the nation’s leading infectious disease expert, told Fox News that the U.K. did not review Pfizer’s data “carefully.”
“We have the gold standard of a regulatory approach with the FDA. The U.K. did not do it as carefully and they got a couple of days ahead,” he said. “I don’t think that makes much difference. We’ll be there. We’ll be there very soon.”
Drugmakers and states are gearing up to distribute a vaccine starting in mid-December. The Federal Aviation Administration said it supported the “first mass air shipment” of vaccines last week. United Airlines carried Pfizer’s Covid-19 vaccine from Brussels to Chicago O’Hare International Airport on Friday, people familiar with the matter told CNBC.
President Donald Trump has previously accused the FDA, without proof, of working to slow the Covid-19 vaccine development process. Earlier this week, White House Chief of Staff Mark Meadows summoned FDA Commissioner Dr. Stephen Hahn to discuss why the agency hasn’t moved faster to authorize Pfizer’s vaccine, a person familiar with the matter confirmed to NBC News.
Axios first reported the meeting, along with a preemptive statement from Hahn, who told Axios: “Let me be clear — our career scientists have to make the decision and they will take the time that’s needed to make the right call on this important decision.”
Kaneka Eurogentec will manufacture INOVIO’s DNA vaccine candidate against COVID-19
03 DECEMBER 2020
We will support INOVIO to produce, manufacture and scale their COVID-19 candidate, INO-4800
INOVIO has assembled a global coalition of collaborators, partners and funders to rapidly advance the development of INO-4800, a DNA vaccine against the novel coronavirus SARS-CoV-2.
INOVIO’s President & CEO, Dr. J. Joseph Kim, said, “Our partnership with Kaneka Eurogentec, one of the world’s largest and most experienced plasmid manufacturers, provides additional scale to our growing global manufacturing coalition. Kaneka Eurogentec will be a crucial member of INOVIO’s global manufacturing consortium, supporting our plans to produce, manufacture and scale our COVID-19 candidate, INO-4800.”
Dr. Lieven Janssens, Kaneka Eurogentec’s President and CEO, said, “We are excited to join INOVIO’s growing global manufacturing consortium and look forward to supporting the manufacturing needs of DNA medicines and vaccines across INOVIO’s platform. We are pleased that our large-scale manufacturing technologies are well recognized by INOVIO, a leading player in the DNA plasmid field.”
We will manufacture large quantity of DNA vaccine against COVID-19
KANEKA EUROGENTEC is considered as the world leader in Kg-scale biomanufacturing of GMP DNA plasmid for gene and cell therapies. DNA plasmid is the active pharmaceutical ingredient of DNA vaccines, as well as the key starting material of mRNA, new generations of vaccines.
INOVIO’s Senior Vice President of Biological Manufacturing and Clinical Supply Management, Robert J. Juba Jr., said, “Kaneka Eurogentec brings a wealth of DNA plasmid manufacturing expertise and innovation to INOVIO’s global consortium to manufacture INO-4800. We look forward to working with them to utilize their state-of-the-art, large-scale manufacturing capabilities towards our goal of producing hundreds of millions of doses of INO-4800 for worldwide distribution.”
We will manufacture INO-4800 - DNA vaccine in our new state-of-the-art GMP facilities. These contain a brand new 2200 L fermentor to achieve high volumes of vaccine.
Clinical trials in progress
INOVIO is conducting a Phase 2 segment of its planned Phase 2/3 clinical trial for INO-4800, its COVID-19 vaccine candidate. The planned Phase 2/3 clinical trial, called INNOVATE (Inovio INO-4800 Vaccine Trial for Efficacy), is a randomized, blinded, placebo-controlled safety and efficacy trial of INO-4800 to be conducted in adults in the U.S. The INNOVATE trial will be funded by the U.S. Department of Defense.
New jobs opportunities will be open. We plan to recruit up to 80 new colleagues to support the production activities related to COVID-19 vaccines.
About INOVIO
INOVIO is a leading company in DNA medicines with 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases.
INOVIO has extensive experience working with coronaviruses and was the first company with a Phase 2 vaccine for a related coronavirus that causes Middle East Respiratory Syndrome (MERS).
https://www.eurogentec.com/en/news/41_kaneka-eurogentec-will-manufacture-inovios-dna-vaccine-candidate-against-covid-19
As-UK-awaits-first-Covid-19-vaccine-doses, Fauci-and-others-criticize-its -‘hasty'-decision
Nicole DeFeudis
Associate Editor
A day after the UK made history by authorizing Pfizer and BioNTech’s Covid-19 vaccine, NIAID chief Anthony Fauci joined others in the EU in scrutinizing the country’s swift decision.
“The way the FDA is, our FDA, is doing it is the correct way,” Fauci said in a Fox News interview. “We really scrutinize the data very carefully to guarantee to the American public that this is a safe and efficacious vaccine.”
European regulators and lawmakers have also criticized Britain’s move as “hasty.” In a statement to Reuters, the EMA said its longer procedure is more appropriate, as it takes into account more evidence and involves more checks. The agency expects to decide by Dec. 29.
But the MHRA stood by its decision, and BioNTech execs said the UK agency sought the same level of detail as their international counterparts. Pfizer and BioNTech began a rolling submission with the MHRA in late October, after beginning its submission with the EMA.
Over in the US, FDA commissioner Stephen Hahn told the Wall Street Journal that his people are working around the clock to review Pfizer’s data. An outside advisory committee is scheduled to discuss the application for emergency use on Dec. 10. Meanwhile, a disgruntled Chief of Staff Mark Meadows called Hahn to the White House to ask why the FDA isn’t moving faster.
“I think if we did any less, we would add to the already existing hesitancy on the part of many people to take the vaccine because they’re concerned about safety or they’re concerned that we went too quickly,” Fauci told Fox.
“So, it’s almost a damned if you do and you’re damned if you don’t, because if you go quickly and you do it superficially, people are not going to want to get vaccinated,” he said.
Doses are suspected to be en route to the UK right now, reportedly traveling in unmarked lorries through the Eurotunnel. England’s deputy chief medical officer Jonathan Van-Tam told the BBC’s “Five Live” radio show that he expects the doses to arrive “very shortly in the UK, and I do mean hours, not days,” per a CNN report.
The country already has a deal in place for 40 million doses, and is planning a phased delivery over the next year or so. According to guidance from the Joint Committee on Vaccination and Immunisation, older adult residents in a care home and care home workers would be the first to receive the vaccine.
Moderna has also submitted for emergency authorization with both the FDA and EMA. The FDA has scheduled an advisory committee meeting to discuss the Cambridge, MA-based biotech’s vaccine on Dec. 17, and the EMA says its scientific committee for human medicines (CHMP) should conclude its assessment in a meeting on Jan. 12 at the latest.
During the Fox interview, Fauci said the US would need about 70% to 75% of Americans to get vaccinated in order to achieve what he called “that umbrella of herd immunity” that would put the country on a path to some degree of normalcy. “By April, May and early June, we could be there,” he said.
“We have the gold standard of a regulatory approach with the FDA,” Fauci said. “The UK did not do it as carefully, they got a couple of days ahead. I don’t think that makes much difference. We’ll be there. We’ll be there very soon.”
This-is how-Bernstein-divvies-up-a-$40B-Covid-19-vaccine-market-among-the-leaders-in-the-race-to-an-approval
The frenzied race to regulatory approvals this year is coming down to the finish line. The winners can immediately pivot to the competition for the mega-blockbuster revenue gains to come as the starting gun is fired for the global race to seize market share.
Pfizer $PFE and their development partners at BioNTech have seized a clear — though small — lead in the race to win FDA approval for the first Covid-19 vaccine. And the analyst team working with Bernstein’s Ronny Gal says the pharma giant also has the muscle to seize a clear advantage in winning the biggest slice of the $40 billion market that lies in wait for the leading players next year.
While the market is likely to shrink as herd immunity is achieved, Bernstein’s team still sees the top 5 gaining $23 billion in 2022, with billions more on the table as vaccination campaigns spread globally and subsequent booster shots are begun in 2023.
Bottom line, this is how Bernstein, where the team is openly skeptical about the antibody therapies we’ve seen so far, sees the race for market share playing out:
We assume supply will flow to developed markets first with emerging markets given supply as demand ebbs in developed ones. The resulting model suggests that US should reach herd immunity by June and other developed markets (UK, EU, Canada, Japan) by August/September. Net-net, this looks like a ~$40B market in 2021 with a steady-state closer to $6B in the out years (assuming boosting every three years). If non-LNP vaccines falter, this will be a real long-term opportunity for Pfizer which could end up with something like $1.5B sales in 2025 and beyond.
The size of this market underscores the huge stakes that were clear to some once the Covid-19 outbreak spread out of China and started to burn around the globe. If it plays out anything close to what Bernstein has outlined, the windfall will clearly be to the mRNA players’ advantage in the competition over the world’s vaccine markets. Moderna can emerge as a fully-fledged commercial player on par with a top performer like Regeneron, with clear proof that they can achieve remarkable goals with this tech. And Pfizer can be happy with its decision to put a billion dollars at risk to make this happen.
Not clear yet is how the battle for market share will play out with the public. Big Pharma had pitched the pandemic R&D response as a chance to redeem itself with a public that has a low opinion of drug makers. Their quick success, ironically, could spike any chance of that from happening.
Looking at the top 5 players in his book, the Bernstein team sees Pfizer grabbing $2 billion in sales during the next 3 months, building that to $4.7 billion in Q3 as they round out the year with $14.3 billion for the year. That’s based on sales of a billion doses, despite questions over the ultra low temperatures it has to be shipped in.
For the full 5 years, the market should be worth $25 billion for Pfizer.
Moderna, which has more cautiously projected its ability to provide 500 million to a billion doses next year, comes in right behind the multinational, with $1.5 billion in Q1 growing to $3.5 billion in Q3, as the world’s most affluent countries achieve herd immunity. Gal posts Moderna’s revenue from its first approved product at an impressive $11 billion — giving the biotech upstart a mega-market product right out of the commercial gate. And that’s all built on an assumption the biotech can provide 750 million doses.
For the full 5 years, Bernstein estimates that Moderna will gain close to $20 billion from their vaccine.
AstraZeneca, right at third place in this regulatory race, looks to finish the year in 3rd place on the market, with $6.4 billion on the sale of a billion doses, less than half of what Pfizer expects to grab with the same level of sales. AstraZeneca’s vaccine is also stuck with a much lower efficacy rate — unless they can prove the initial half dose approach works — though it will be much easier to transport.
For the 5 years, Bernstein estimates $16.3 billion in sales.
Then comes Novavax with $3.8 billion on 436 million doses, followed by 5th place market finisher J&J, with $3 billion for the year and 420 million doses.
December 3, 2020 09:17 AM EST
https://endpts.com/this-is-how-bernstein-divvies-up-a-40b-covid-19-vaccine-market-among-the-leaders-in-the-race-to-an-approval-pfizer-and-moderna-are-way-out-front/
“Robert mentioned what we already know and stated that they are continuing discussions with global manufacturers.
Robert reiterated Richter-Helm, Thermo Fisher, and Ology Bioservices for manufacturing. He stated that when manufacturing DNA vaccines and cures, it is easy and straightforward with consistent outcome when manufacturing.” See my post about World Vaccine Immunotherapy West Coast 12/1 Robert J.Juba Sr VP Biological Manufacturing yesterday 12/2/20.
https://www.eurogentec.com/en/
With its Phase II trial finally underway, Inovio has enlisted another key manufacturing partner to hit its goal of hundreds of millions of doses of its DNA vaccine — if it manages to force its old contract manufacturer into starting tech transfer.
Japan’s Kaneka Eurogentec is tasked with plasmid production, for which Inovio has previously relied on Korean-owned VGXI. It joins a consortium Inovio has assembled that includes Thermo Fisher Scientific, Richter-Helm BioLogics and Ology Bioservices.
Inovio is still engaged in a bitter legal feud that dated back to June, when it sued VGXI for refusing to release the tech to third-party manufacturers after saying they don’t have the capacity to make the 1 million doses of INO-4800 they were asked to.
VGXI is apparently so offended by Inovio’s recruitment of new manufacturers that it filed a complaint against Ology in response.
In its quarterly report posted last month, the biotech admitted the battle was a long way from being finished:
On October 1, 2020, we filed a notice of discontinuance of appeal with the Pennsylvania Superior Court. A trial date for the litigation has not been set.
None of this is dampening CEO Joseph Kim’s characteristic (some would say notorious) optimism about his vaccine candidate and DNA technology, despite not getting a single product approval over 40 years.
“Our partnership with Kaneka Eurogentec, one of the world’s largest and most experienced plasmid manufacturers, provides additional scale to our growing global manufacturing coalition,” he said in a statement.
Getting VGXI to provide the requested manufacturing methods to other manufacturers would only solve one of the problems holding up Inovio, though. The FDA still has a partial clinical hold on the Phase III portion of Inovio’s vaccine trial, due to remaining questions about the device that will be used to deliver the shot directly to the skin. Inovio is hoping to resolve those questions during the Phase II trial. — Amber Tong
https://endpts.com/covid-19-roundup-who-researchers-raise-new-questions-on-remdesivir-fda-chief-stephen-hahn-defends-the-agencys-vaccine-approval-process/
World-Vaccine-Immunotherapy-West-Coast-12/1 Robert-J.Juba-Sr-VP-Biological-Manufacturing-on-3PSP, Jeffrey-Skolnik-Sr-VP-Immuno-Oncology
11:00 Rapid manufacture of vaccines for pandemic response – are we prepared for commercial manufacture of SARS-CoV-2 vaccines
Tuesday 1st December Agenda (PACIFIC TIME ZONE)
Unique challenges associated with different vaccine platforms, DNA, RNA, non-replicating viral vector, recombinant protein etc.
• Considerations for moving from clinical to commercial production
• Scale-up strategies - how long it will take to produce vaccines at sufficient scale to meet global demand?
• Currently available capacity and potential future capacity required for the suite of vaccine platforms and
technologies Moderator: Dr David Robinson, Deputy Director, CMC Vaccines Development and Surveillance, BGMF
Dr Andreas Kuhn, Senior Vice President RNA Biochemistry & Manufacturing, BioNTech
Dr Vikram Paradkar, EVP, Head of Technical Operations, Biological E. Ltd.
Robert J. Juba Jr., Senior Vice President, Biological Manufacturing & Clinical Supplies Management, Inovio
Robert mentioned what we already know and stated that they are continuing discussions with global manufacturers.
Robert reiterated Richter-Helm, Thermo Fisher, and Ology Bioservices for manufacturing. He stated that when manufacturing DNA vaccines and cures, it is easy and straightforward with consistent outcome when manufacturing.
4 different companies being asked questions in the same meetings.
Robert stated the CELLECTRA 2000 device is their early stage work horse and that the new CELLECTRA 3PSP was made to be extremely portable using batteries, cleanable, re-usable, for intradermal doses. The device is being made to used globally with different labels and languages.
A comment by one of the other speakers, he mentioned that they still do not understand why or how the virus affects people differently whether symptomatic or asymtomatic.
Robert stated that there are no issues getting booster vaccines. He mentioned some patients for GBM received 10-11 booster doses with no issues.
He also stated that after a patient receives DNA doses, the vaccine is cleared out of the body in a very short period time, less than a couple days.
The questioned was asked if INOVIO has been looking at using nanoparticle DNA vaccines. The answer was no, because electroporation is a very very effective and efficient method. For cancers, the cure is injected in larger doses intramuscularly, and for vaccines into the skin intradermally.
Robert mentioned that they have had a tremendous validation of their DNA platform and there has been a tremendous response within the industry.
The session was closed.
Cancer Immunotherapy
Tuesday 1st December – Cancer vaccines & Neoantigens
4:30 DNA cancer vaccines for HPV & non-HPV associated cancers
Dr Jeffrey Skolnik, Senior Vice President of Clinical Development, Immuno-Oncology, Inovio Pharmaceuticals
https://www.terrapinn.com/conference/world-vaccine-immunotherapy-congress-west-coast/index.stm
Congress-advances-$740.5B-defense-bill, bucking-Trump’s-veto-threats. DoD-may-announce-$328.9M-grant-to-Ino after NDAA 2021 is passed.
Ino-4800 P2/3 Estimated Enrollment :
6578 participants times $50K/per = $328.9M
WASHINGTON ? Congress is moving ahead with its annual defense policy bill without repealing a prized legal shield for social media companies, testing President Donald Trump’s threat to veto the bill.
Neither chamber’s version of the 2021 National Defense Authorization Act includes legislative language addressing the protections, enshrined in the Section 230 of the 1996 Communications Decency Act, three congressional aides confirmed Wednesday.
“We worked hard to craft a bipartisan defense bill that actually focuses on national defense. It would be irresponsible of President Trump to hold the well-being of our troops hostage because he doesn’t like what’s trending on Twitter.” Sen. Jack Reed, D-R.I., the top Democrat on the Senate Armed Services Committee, said in a statement to Defense News.
Senate Armed Services Committee Chair Jim Inhofe. R-Okla., reportedly said that while he agrees with Trump on Section 230, the provision “has nothing to do with the military.”
“You can’t do it in this bill. That’s not a part of the bill,” Inhofe told Politico, adding that he has conveyed that belief to Trump.
The bill finalized Wednesday contains language Trump had previously threatened to veto requiring several bases named after Confederate leaders be renamed, according to an aide to Massachusetts Democratic Sen. Elizabeth Warren, who crafted the Senate version of the renaming provision.
House Speaker Nancy Pelosi, D-Calif., and Senate Majority Leader Mitch McConnell, R-Ky., are moving to bring the defense authorization bill for a vote in both chambers, Bloomberg Government reported. The Senate on Wednesday morning agreed to proceed to conference on the defense bill by unanimous consent.
Pelosi was ready to bring the bipartisan bill to the floor, said a senior Democratic aide who asked not to be named in order to discuss plans.
It’s unclear whether Senate Republicans have prevailed on Trump not to veto the bill, which would create a politically fraught showdown ahead of a Senate runoff elections in Georgia that will determine control of the chamber during the first two years of President-elect Joe Biden’s tenure. The House and Senate passed their bills by veto-proof margins.
The $740.5 billion authorization bill cements decisions about troop levels, new weapons systems and military personnel policy. Senate Republicans had been trying to improvise a compromise proposal to change Section 230 short of a wholesale repeal. Trump’s 11th hour demand came just as lawmakers were finalizing a compromise on the 60th NDAA in a row.
Section 230's protections have served as a bedrock for unfettered speech on the internet, but Trump and other politicians, including Democrats (though for different reasons than Republicans) argue that Twitter, Facebook and other social media platforms have abused that protection and should lose their immunity from lawsuits.
But industry groups are wary of efforts to erode protections, and both lawmakers and congressional aides said this week that the issue was too complicated practically and politically to solve on the fly and drop into a bill without a full vetting from Congress.
https://www.navytimes.com/congress/2020/12/02/congress-advances-defense-bill-bucking-trumps-veto-threats/
CEPI-will-provide-up-to $56M-over-5-years to-support-Inovio-through-P2-development-of-INO-4500, its Lassa fever vaccine, and INO-4700, its MERS candidate. The groups hope clinical safety and immunological data, plus investigational stockpiles to be funded by additional grants, will be ready in time for efficacy testing during outbreaks.
Inovio is developing the two candidates based on its DNA vaccine platform called ASPIRE. The technology incorporates optimized antigenic genes, which can be translated into protein in cells to trigger both T-cell and antibody responses.
The company expects to read out data from VGX-3100 Phase 3 clinical trial REVEAL 1 in the first half of 2021. INOVIO plans to report the data from anal intraepithelial neoplasia (AIN) and vulvar intraepithelial neoplasia (VIN) Phase 2 clinical trials in the fourth quarter of 2020. Additionally, for VIN/AIN, the company expects to apply for rare and orphan disease designation in the first half of 2021.
Identifier: NCT04588428
Official Title:
Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers
Estimated Study Start Date :
December 11, 2020
Estimated Enrollment :
542 participants
Brief Summary:
The purpose of this Phase 2a, randomized, blinded, placebo-controlled, multi-center study is to evaluate the safety, tolerability and immunogenicity of INO-4700 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA™ 2000 device in healthy adult volunteers for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection. This study is divided into 2 parts: Part 1- dose finding stage and Part 2- dose expansion stage.
Locations
Jordan
Pharmaceutical Research Center / Jordan University of Science and Technology
Irbid, Jordan, 22110
Lebanon
American University of Beirut Medical Center
Beirut, Lebanon
Hammoud Hospital University Medical Center
Saida, Lebanon
Sponsors and Collaborators
Inovio Pharmaceuticals
Coalition for Epidemic Preparedness Innovations (CEPI)
Investigators
Study Director: Mammen P. Mammen, Jr., MD, FACP, FIDSA Inovio Pharmaceuticals
Identifier: NCT04093076
Official Title:
Dose-Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Combination With Electroporation in Healthy Volunteers in Ghana
Estimated Study Start Date :
December 7, 2020
Estimated Enrollment :
220 participants
Brief Summary:
This P1 is a randomized, blinded, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA™ 2000 device in healthy volunteers in Ghana.
Locations
Ghana
Noguchi Memorial Institute for Medical Research, University of Ghana
Legon, Accra, Ghana
Contact: Dr. Susan Adu-Amankwah +233 24 473 4811 SAdu-Amankwah@noguchi.ug.edu.gh
Contact: Dr. Kwadwo A. Koram +233 302 501178 KKoram@noguchi.ug.edu.gh
Sponsors and Collaborators
Inovio Pharmaceuticals
Coalition for Epidemic Preparedness Innovations (CEPI)
Investigators
Study Director: Mammen Mammen, MD, FACP, FIDSA Inovio Pharmaceuticals
4 Confs: KB-at-12/2/20 HEALTH-INNOVATION-DAY-2020 8:45AM-9:45AM
Managing Supply and Pharma Distribution
The panel will discuss the lessons learned to date on supplies and pharma access/shortages, distribution, emergency approval process, safety surveillance and collaboration within and outside the government during the pandemic. In additional one of the pharma firms will discuss their vaccine and its clinical approval pathway.
Dr. James Peake, Former Secretary of Veteran Affairs and US Army Surgeon General, Senior Vice President, CGI Federal, Moderator
Kate Broderick, PhD, Senior Vice President, R&D, INOVIO
Dr. Lee E. Payne, Major General (Retired), DoD COVID-19 Task Force, Department of Defense
Elissa Prichep, Lead on COVID-19 Vaccines, World Economic Forum
Jennifer Zacher, Deputy Chief Consultant - Formulary Management, VA Pharmacy Benefits Management Services, Department of Veterans Affairs
https://www.actiac.org/events/health-innovation-day-2020
Dec 9th - Empower the Immune System to Treat Glioblastoma: DNA as Medicine, PANEL DISCUSSION: An Overview of Emerging Therapeutic Targets
Jeffrey Skolnik Vice President, Inovio Pharmaceuticals
https://glioblastoma-drugdevelopment.com/about/agenda/
Dec. 10th -11th Bing Wan, Ph. D. Professor and Scientific Board Member, Fudan University Basic Medical College Co-Founder of Advaccine (Suzhou) Biopharmaceutics, Co LTD. (INO chinese partner ) Rapid development of a DNA vaccine against COVID-19
cnaf.org.cn/en/speakers/
Pharmaceuticals, Inc. Pharmacovigilance and Risk Management Strategies Conference
Jan 26, 2021 9:45 AM – Jan 28, 2021 5:00 PM ET
Mammen (Anza) P. Mammen, MD, FACP
SVP, Clinical Development, COVID-19
INOVIO Pharmaceuticals, Inc., United States
Dr. Mammen served as the Chief of the Pandemic Warning Team for the U.S. Department of Defense (DoD) at Fort Detrick, MD, where his interagency team monitored for early indicators of global pandemics. He managed vaccine programs for the U.S. Army Medical Research and Materiel Command, served as Chief, Department of Virology at the Armed Forces Research Institute of Medical Sciences (AFRIMS), and served as an infectious disease officer at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, MD. Dr. Mammen retired from the U.S. Army with a rank of Colonel and was awarded the Legion of Merit medal for exceptional service. Most recently, Dr. Mammen led clinical development at Vical Inc., a San Diego-based DNA vaccine developer.
https://www.diaglobal.org/en/conference-listing/meetings/2021/01/pharmacovigilance-and-risk-management-strategies-conference-21002/speakers#showcontent
Hadassah research head raises questions about mRNA vaccine safety
By MAAYAN JAFFE-HOFFMAN DECEMBER 1, 2020 20:33
Prof. Yossi Karko explains Israel’s vaccine candidate, questions efficacy of Russia’s Sputnik V
Prof. Yossi Karko, director of the clinical research unit at Hadassah-University Medical Center, has warned that the data published by Moderna and Pfizer about their coronavirus vaccine candidates is limited.
Both companies have applied for Emergency Use Authorization (EUA) from the Food and Drug Administration for their vaccines but Karko, who has been overseeing the clinical trial of Israel’s vaccine at Hadassah, said that “while they seem to be very efficient vaccines, we have to remember that this data has shortcomings.”
First, he told The Jerusalem Post, the data only tracks volunteers for one month following vaccination. While he said that “it really protects subjects quite well now,” questions remain about what happens next month and the month after.
“We do expect that the vaccine will protect us for a longer period of time, but this data is not available,” he said.
Second, Karko noted that the safety data is “very short” – only spanning the period of about two months from inoculation.
“The FDA has a mechanism of approving drugs and vaccines for emergency cases. What this means, is that the FDA has initial safety data. But if this was a usual situation, the researchers would have followed the volunteers for at least two years before the vaccine was approved,” he said.
“We need to know these reservations,” Karko said. “These things are new. There are concerns and we have to be very careful.”
He emphasized that he is not saying the vaccines are “not excellent or terrific,” but just that “we should be aware of the limitations of the data.”
Pfizer’s and Moderna’s vaccine candidates are both messenger RNA (mRNA) vaccines. If approved, these will be the first-ever vaccines of this type brought to market for human recipients.
These vaccines use a sequence of genetic RNA material produced in a lab that, when injected, enters the cells and sparks production of the viral components that subsequently train the immune system to fight the virus.
Michal Linial, a professor of biological chemistry at the Hebrew University of Jerusalem, told the Post she believes there is no cause for concern.
Linial explained that “mRNA is a very fragile molecule, meaning it can be destroyed very easily... If you put mRNA on the table, for example, in a minute there will not be any mRNA left over. This, as opposed to DNA, which is as stable as you get.”
She said that this fragility is true of the mRNA of any living thing, whether it belongs to a virus, bacteria, plant, animal or human.
She said the worry should not be that the mRNA won’t get into the cells and will stay outside, floating in the body and causing some kind of reaction. Rather, the concern should be that if it doesn’t enter the cells, it will disintegrate and will not be effective.
She said that while Moderna and Pfizer base their vaccine candidates on new technologies, they are asking our bodies to do something they do every day: protein synthesis, the process in which cells make proteins.
IN CONTRAST to the mRNA vaccines, Karko said that Israel’s Brilife, which was designed by the Israel Institute for Biological Research, is a vector-based vaccine. The vaccine takes the virus vesicular stomatitis virus (VSV) and genetically engineers it so that it will express the spike protein of the novel coronavirus on its envelope.
Once injected, it does not cause a disease by itself: VSV does not infect humans. Instead, the body recognizes the spike protein that is expressed on the envelope and begins to develop an immunological response.
“It’s like getting a virus like coronavirus without getting the disease,” he said. “Then, if you happen to be exposed to the real coronavirus, the immunological response that was triggered by the vaccine will prevent infection.”
Phase I of the IIBR study was completed last week and Phase II is expected to launch in the next two weeks.
“Up to now, there are no safety concerns,” Karko said. “We are very happy with the results.”
The Phase I study included 80 volunteers: 40 inoculated at Hadassah and 40 at Sheba Medical Center.
The Phase II trial will include 960 participants and take place at nine medical centers across the country: Hadassah, Sheba Medical Center at Tel HaShomer, Barzilai Medical Center, HaEmek Medical Center, Tel Aviv Sourasky Medical Center, Samson Assuta Ashdod University Hospital, Rambam Medical Center, Shamir Medical Center and Meir Medical Center in Kfar Saba.
The Phase I study included healthy volunteers between ages 18-55. The Phase II study will include volunteers between ages 18-85, including those with some chronic diseases. The medical centers are actively recruiting for this study now.
ON MONDAY, IIBR head Prof. Shmuel Shapira charged that development of the country’s vaccine candidate could have been further along, but it was delayed due to “over-regulation” by the Health Ministry. Karko said that “Israel’s regulatory bodies were never asked to evaluate a vaccine” and “under the circumstances, they stood up to the challenge.”
When asked why the institute would not aim for FDA or even European Medicines Agency approval, Karko said that “IIBR does not have presumptions to produce a vaccine that is going to be commercialized. The objective is to produce an efficient and safe vaccine to serve the citizens of Israel.”
He said that while there is excitement over the possibility that Pfizer or Moderna vaccines could arrive in the country by the end of this month, he does not believe Israel will receive enough doses for mass vaccination before the end of next year, making it even more necessary for the country to develop its own vaccine.
Moreover, Karko added that he believes coronavirus will mutate and will be with the world for more than a year and because of this, “it seems to me we will need to vaccinate more than once. Under these circumstances, having our own ability to produce a vaccine is important.”
And what about Russia’s Sputnik V vaccine, which Hadassah is vying to manufacture in Israel?
“It is a well-developed vaccine,” he said. But he admitted that the clinical process of evaluating the efficacy of the vaccine could be “deficient.”
“Until I see a publication with scientific data that has undergone peer review, I cannot really comment,” Karko added.
https://news.google.com/articles/CAIiEIvM4K0s2_Ia1fgB6lwv74gqGAgEKg8IACoHCAowr9eeCTDYlm4woYuuBg?hl=en-US&gl=US&ceid=US%3Aen
GAVI:How small clinical trial sample sizes can offer important findings
Scientists have been racing to develop COVID-19 vaccines that could reach millions, yet many of the studies have surprisingly small sample sizes drawn from the clinical trials. Does that matter?
1 December 2020
https://www.gavi.org/vaccineswork/how-small-clinical-trial-sample-sizes-can-offer-important-findings
Before a vaccine or drug is made available to the public it normally needs to undergo clinical trials, some of which involve tens of thousands of people. But, as we have seen with interim results for some COVID-19 vaccines, often only a small proportion, or sample, of these people actually end up exposed to the virus.
Moderna recently reported that its vaccine candidate had an efficacy of 94.5% after phase 3 trials involving 30,000 volunteers began in July – yet only 95 people in the trial have so far actually contracted COVID-19, and only five of them had been vaccinated. Based on these results, the company has said it will have 20 million doses by the end of the year.
The Pfizer/BioNTech vaccine trial that made it through phase 3 trials with an efficacy of 95%, had 170 cases of COVID-19 (it’s worth noting that sample size is different to trial size, which in this case is 43,000 participants). But though the sample sizes may seem tiny, many important drugs or vaccines have been found with similarly small sample sizes.
FROM HIV TO EBOLA
Trials with a very small sample size might not seem to have enough statistical “power” to be able to determine whether a drug or vaccine is effective at treating or preventing disease. Yet, for diseases that are either life-threatening (e.g. COVID-19) or rare (certain cancers), trying to test a vaccine in larger numbers of people than are needed to reach a decision on its efficacy could be challenging and even unethical. A key question on ethics is how efficacious the intervention will need to be to make using it worthwhile. COVID-19 vaccine trials were actually geared towards detecting a lower level of efficacy because that would justify their use.
In 2015, when scientists were trying to find a vaccine to stop the Ebola outbreak in West Africa from spreading, the vaccine was declared 100% efficacious after 16 cases of disease in a ring vaccination trial. Back in 1994, the drug zidovudine, used to stop mother-to-child transmission of HIV, was scaled-up based on a trial which was stopped early after 53 cases of disease.
A key factor is that sample size is only meaningful in the context of the efficacy of the intervention. The more efficacious the intervention, the smaller the number of clinical outcomes needed to demonstrate its efficacy. If all of the negative outcomes are in the control group, the value of the intervention becomes clear very quickly.
To put this simplistically, think of a randomised controlled trial comparing jumping out of an airplane from a high altitude with or without a parachute. If the parachute works really well, it won’t take many trial participants’ landings before convincing people the parachute is the way to go.
SO WHY ARE SMALL SAMPLE SIZES ACCEPTED AS BEING VALID?
A group of statisticians writing about small samples sizes in the journal Clinical Investigation in 2012, said “If one starts from the premise that there is considerable uncertainty regarding this unknown quantity, then data from even small numbers of patients in a well-designed clinical trial will make steps towards reducing that uncertainty.”
In other words, a small sample size in clinical trials doesn’t necessarily reduce the importance of the findings.
Researchers have cautioned, however, that some COVID-19 vaccine trials with very small sample sizes – such as Russia’s Sputnik V vaccine which has 20 people with COVID-19 – may be too small.
Small sample sizes in clinical trials: a statistician’s perspective
Lucinda Billingham*1,2, Kinga Malottki1 & Neil Steven2,3
https://www.openaccessjournals.com/articles/small-sample-sizes-in-clinical-trials-a-statisticians-perspective.pdf
Finally, some good news
After nearly two months of the U.S. Food and Drug Administration's (FDA) partial clinical hold, the agency has finally given its green light for the phase 2 portion of Inovio's coronavirus vaccine candidate's (INO-4800) study. The company still has to satisfy the FDA's questions regarding its vaccine injector is safe for use in the phase 3 portion. The exact details of why the clinical trial was halted are unknown.
Luckily, Inovio is no longer alone in funding its stalled vaccine's development. The U.S. Department of Defense (DOD) announced it would be fully funding both parts of INO-4800's phase 2/3 investigation. That should give the company some credibility to pave the way for government orders and help ease its expenditures. Year to date, Inovio has spent over $67 million in research and development expenses.
Before investors rejoice, there are still many unresolved issues. As of Nov. 24, INO-4800's phase 1 data has yet to receive validation from a peer-reviewed scientific journal. We still do not know how many participants who took INO-4800 developed neutralizing antibodies against SARS-CoV-2, a critical metric for all coronavirus drugmakers in their clinical studies.
Another pressing matter is the lack of orders for INO-4800. Even before multiple coronavirus vaccine candidates demonstrated efficacy in late-stage trials, governments worldwide booked more than 5.7 billion pre-orders of them. For example, CureVac (NASDAQ:CVAC), convinced the European Union to order 405 million doses of its experimental vaccine based on just interim phase 1 data. This makes Inovio's lack of pre-emptive orders all the more puzzling.
An unexpected hand
Lately, however, fortune has been kind to the company and its immunotherapy pipeline. Inovio's immunotherapies use biological agents to elicit the body's own immune system to fight against cancer growth.
Inovio recently announced results from an open-label, phase 1/2 clinical trial involving three immunotherapies plus standard of care (SOC) drugs to treat glioblastoma. Glioblastoma is the deadliest form of brain cancer, with abysmal survival rates. The three experimental therapies are INO-5401, INO-9012, and Libtayo.
In the study, patients who received the triple-combination and SOC immunotherapy in the unmethylated cohort survived for a median of 17.4 months. Methylation refers to a chemical change in the tumor cells' DNA repair protein; patients who are unmethylated are more difficult to treat with chemotherapy. This compares well to historical median survival data for unmethylated and methylated patients who received SOC alone, which stands between 15 and 16 months.
That is undoubtedly promising. Take the case of Novocure (NASDAQ:NVCR), which engineered a device called Optune that applies a gentle electric field to the tumor site in patients with glioblastoma. In 2015, the device quickly advanced to approval for this indication after improving the survival rate of patients who also took SOC by a median of 4.5 months, compared to patients who only received SOC (19.6 months versus 15.2 months) in phase 3 studies. Novocure is now a $12 billion market cap company due to the commercialization of Optune alone.
Inovio's second step to listing on KOSDAQ
Inovio Pharmaceuticals (hereinafter Inovio), a DNA vaccine developer, is attracting attention from domestic and overseas markets by advancing research on the Corona 19 vaccine. Inovio, as a listed company on the NASDAQ, has announced plans for secondary listing on the KOSDAQ since last year. It is promoting entry into the KOSDAQ through the technology special case system and is currently coordinating the schedule with the Korean Exchange. It is continuing its listing process by opening a Seoul office and hiring management.
According to the industry on the 23rd, Inovio is preparing a request for preliminary examination for listing on the KOSDAQ. Inovio passed the technical evaluation by obtaining AA and A grades from two specialized evaluation agencies in February. In order for a foreign company to use the technology exception system, it must obtain A grade or higher from two evaluation agencies.
Since the technology evaluation is effective for 6 months, a preliminary listing review must be requested by August. However, Inovio and its representative organizer, Samsung Securities, are not in a hurry to meet the timing. It looks like they are making every effort to prepare for the completion of the listing, leaving the possibility of receiving a technical evaluation again.
Inovio is currently headquartered in Seoul, a wholly owned subsidiary, Inovio Asia, LLC. This month, CEO Kim Gene Joonsung joined Inovio Asia. He has a long relationship with the company and has the experience of leading the IPO of a domestic company, so he is evaluated as the right person to complete Inovio's listing on the KOSDAQ.
Mr. Kim earned an MBA from the University of Pennsylvania's Wharton School and served as Chief Financial Officer (CFO) at Inovio's U.S. subsidiary, VGX Pharmaceuticals. He is a person who contributed to the foundation of Inovio. Inovio's predecessor was Viral Genomics (VGX), and in 2009 it merged Inovio Biomedical and changed its name. At that time, CEO Kim led the merger.
Afterward, he moved to Wemade and served as CFO for 8 years. CEO Kim also won Wemade's IPO. Just before joining Inovio Asia, he worked as Vice President and CFO at Africa TV for three years.
As of the 23rd, Inovio's market capitalization on NASDAQ was close to 5 trillion won ($4.14 billion. The expectation for the development of the Corona 19 DNA vaccine is reflected in the corporate value. The pipeline is INO-4800, which is currently undergoing phase 1 clinical trials in Korea and the United States.
Inovio's main pipeline is a DNA vaccine related to human papillomavirus (HPV). Currently, research on cervical cancer treatment (VGX-3100) is leading the way. It is in the phase 3 clinical phase and clinical data is expected to be available by the end of the year.
The founder of Inovio is the CEO of Korean-American Joseph Kim. They have a relationship with a spin-open company in Korea. It is the second largest shareholder with a 4.97% stake in Jinwon Life Sciences through its subsidiary, VGX Pharmaceuticals. It also holds a 13.24% stake in Plumline Life Sciences, a KONEX listed company. Inovio, in March, directly invested 2.2 billion won in Plumline Life Sciences and secured a 6.76% stake.
http://m.thebell.co.kr/m/newsview.asp?svccode=00&newskey=202007231417003040105731
I-am-getting-my-first INO-4800-inoculation for-Phase-2/3 in-Kansas/City on-December-14th
Scott2 hours ago
@Lance For what it is worth, I am getting my first INO-4800 inoculation for Phase 2/3 in Kansas City on December 14th.
Don't care if folks believe me or not.
JayCeeNIO2 hours ago
@Scott .......... I am getting my first INO-4800 inoculation for Phase 2/3 in Kansas City on December 14th also :D
This dovetails with P2 trial fully recruiting 400 ppl by 12/15. Expect a PR on 12/15 about 400 ppl getting first shots.
12/1/20-Ino-officially-starts-INO-4800-P2-recruiting-today.Call-Acurian-Health:888-351-9685.One-central-number-for-all-16-sites. They will assign you to a site near you. Recruiting will finish 12/15/20. All 400 participants will have already had first dose by then.
Expect a PR to this effect on 12/15 - another catalyst.
Screener.acurianhealth.com
I urge you to call the above number immediately to participate.
Four-reasons why we need multiple-vaccines for Covid-19
Charlie Weller
CEPI Head of Vaccines Programme
20 November 2020
Having a range of Covid-19 vaccines available for people to use around the world will be essential to bringing the pandemic under control. Here’s why.
The preliminary data shared by Pfizer-BioNTech and Sputnik V last week, and Moderna this week, showing their vaccines to be more than 90% effective, has given us all hope that an end to Covid-19 may be in sight.
So why is it important to keep working on and investing in the hundreds of Covid-19 vaccines still in development?
1. We need a range of vaccines that can work for a range of people
We need Covid-19 vaccines to work for a diverse range of people – including healthcare workers, older people, and those with underlying health conditions. At this stage, we don’t have the complete efficacy data for the vaccines emerging from phase III clinical trials, including how effective they are for people of all ages, from different ethnic backgrounds, with different immune systems, and in different countries. We also don’t know how long immunity might last for, or whether the vaccines stop transmission of the disease.
With these unanswered questions, we can’t rely on one or two vaccines to help us gain control of the pandemic.
And it might be that one vaccine is not as effective for everyone. We often need multiple vaccines for a disease, to be able to protect different groups. For example this year in the UK we’re using four different flu vaccines – the decision for which one is given is based on a person’s risk group and how their immune system might respond. The vaccine given to a teenager with a robust immune system is not the same as the vaccine given to someone over the age of 65.
If we have a varied Covid-19 vaccine portfolio, we can be confident to find the right vaccine for every person.
2. We need to produce billions of vaccine doses to protect those most at risk
To bring the pandemic under control we will need to produce and roll out vaccines at a scale and speed never seen before. To meet the aim of vaccinating high-risk populations around the world by the end of 2021 (opens in a new tab), we need at least 2 billion vaccine doses.
Moderna, for example, hopes to produce 500 million doses of their vaccine next year. But with each person requiring two doses to be vaccinated, it’s a long way off the full number required.
We have also never licensed or scaled-up an RNA vaccine before – the technology that the Moderna and Pfizer-BioNTech vaccines use – so there may be unforeseen manufacturing issues.
By developing and investing in multiple vaccine candidates we stand a much better chance of having the volume of doses we need to get the virus under control.
3. We need vaccines that can reach everyone, everywhere
We will need to get Covid-19 vaccines to everyone who needs them, wherever they are in the world – from people living in metropolitan areas in the UK, to rural populations in the far reaches of Africa and Asia (opens in a new tab).
Both the Pfizer-BioNTech and Moderna vaccines have extreme refrigeration requirements for transportation and long-term storage, with the Pfizer vaccine needing storage at -70C, and Moderna -20C, to ensure they stay viable. This will prove difficult in many locations, and no vaccine requiring such cold storage has ever been rolled out to so many countries all at once. Comparatively, most childhood vaccines require storage at between 2 to 8C – similar to a domestic fridge.
Dosing also creates an additional challenge. Both Moderna and Pfizer-BioNTech’s vaccines require two doses, spaced a few weeks apart. Developing an effective single-dose vaccine will be critical to protect people for whom getting two doses might be difficult, such as those without access to regular healthcare or refugees.
These technical considerations mean it is crucial we continue to develop and invest in multiple vaccine candidates, which may be able to offer high levels of efficacy without the need for such cold storage and multiple doses.
4. We need vaccines that are available to all countries and supported through COVAX
To overcome the pandemic, people all around the world must have access to vaccines, treatments and tests. However, many of the vaccines being developed are being bought up by countries making deals directly with pharmaceutical companies for their populations.
More than half of all advanced Covid-19 vaccine orders have been from high-income countries (opens in a new tab), with the US accounting for more than one sixth. And the UK has already secured 300 million vaccine doses – five times the size of its population. Pfizer-BioNTech have already promised all doses from their first round of production to a small number of countries.
The COVID-19 Vaccine Global Access Facility (COVAX) (opens in a new tab) is a multilateral effort to make sure that poorer countries are not frozen out of vaccine access. It works by supporting the research, development and manufacturing of a wide range of Covid-19 vaccines, and negotiating their pricing. All participating countries, regardless of income levels, will have equal access to these vaccines once they are developed. Moderna, and many of the vaccines yet to report their phase III data, are part of COVAX.
We need to see countries, like the UK, with vaccine doses secured in bilateral deals, committing to donate excess doses to COVAX, so that they too can be fairly distributed.
https://wellcome.org/news/four-reasons-why-we-need-multiple-vaccines-covid-19
Advaccine-Bio-founder-Dr. Bin-Wang-to-present-Ino-4800-P1,2 at-8th-China/Nucleic-Acids-Forum Dec-10
which coincides with Jeffrey Skolnik, VP Inovio-Pharmaceuticals, 2nd Annual Glioblastoma Drug Development Summit 12/9-10, 3:05P ET Dec 9 presentation. Beijing is 13 hrs ahead of ET
Together with P1PR to be published online in NEJM, P3 3PSP hold lifted resulting in DoD actual dollar amount announcement for P2, 3, CEPI’s P2/3 funding for manufacturing scale-up, Serum Institute in India manufacturing deal which has been in the work for months, these are great ST catalysts.
Presentation Title
Rapid development of a DNA vaccine against COVID-19
Summary
SARS-CoV-2, belongs to beta-coronavirus family, causing severe pneumonia and death in human namely COVID-19 has rapidly emerged as a global public health crisis. Stop the pandemic, the need to develop a safe and effective COVID-19 vaccine must be quick and easy to be manufacturing. DNA vaccine is the technology suitable for such purpose. Aiming to this goad, a task force team between China and USA was formed in January 2020, and rapid development of a DNA-based vaccine targeting the full-length of Spike protein of SARS-CoV-2 was produced. The engineered DNA vaccine induces robust expression of the Spike protein in vitro. Following immunization of mice and guinea pigs with the DNA vaccine, animals were induced antigen-specific T cell responses, functional antibodies which block and neutralize the SARS-CoV-2 infections. These vaccinated animals were well protected after SARS-CoV-2 challenges. These preclinical studies on both sides had led to Phase I and II clinical trials in both US and China. Currently, volunteers received the DNA vaccine were well tolerance and safe. This DNA vaccine is likely to be as a potential COVID-19 vaccine candidate to encounter the COVID-19 outbreak.
Bio:
Professor and Scientific Board Member, Fudan University Basic Medical College
Co-Founder of Advaccine (Suzhou) Biopharmaceutics, Co LTD.
The roughly $908 billion proposal includes $16B vaccine dev, $288 billion in small business aid such as Paycheck Protection Program loans, $160 billion in state and local government relief and $180 billion to fund a $300 per week supplemental unemployment benefit through March, according to a draft framework. It would put $16 billion into vaccine development, distribution, testing and contact tracing, funnel $82 billion into education, put $45 billion into transportation and allocate funds for rental assistance, child care and broadband.
https://www.cnbc.com/2020/12/01/coronavirus-stimulus-update-senators-to-unveil-relief-bill.html?__source=iosappshare%7Ccom.apple.UIKit.activity.Message
Lawmakers unveil bipartisan $900 billion coronavirus stimulus package as stalemate drags on
PUBLISHED TUE, DEC 1 20209:12 AM ESTUPDATED 10 MIN AGO
Jacob Pramuk
@JACOBPRAMUK
A group of bipartisan lawmakers offered a new $908 billion stimulus plan in an effort to break the legislative stalemate as the coronavirus surges throughout the country.
Jeffrey Skolnik,VP-Inovio-Pharmaceuticals,2nd Annual Glioblastoma-Drug-Development-Summit-12/9-10
Dr. Skolnik oversees all of Inovio’s cancer immunotherapy programs, as well as those for several infectious diseases. Dr. Skolnik was previously at Tetralogic Pharmaceuticals, where he was Vice President of Clinical Research and later Chief Medical Officer, and oversaw all clinical programs in oncology, infectious diseases and dermatology. He was also a Medical Affairs lead in oncology at GSK and held several positions at AstraZeneca including Senior Director for both early and late stage compounds. Dr. Skolnik is also a practicing pediatric Hematologist-Oncologist, and has published several papers regarding pediatric oncology trial design.
Day One
Wednesday, December 09, 2020
6:05 pm | PANEL DISCUSSION: An Overview of Emerging Therapeutic Targets
• Examine the current treatment options and emerging targeted therapies
• If targeted therapies show limited efficacy as single agents, can the combination of several targeted
therapies be of benefit to GBM patients?
• Additional research is urgently required to identify therapeutic targets in GBM: How can the industry
design novel therapeutic strategies for the treatment of GBM?
3:05 pm | Empower the Immune System to Treat Glioblastoma: DNA as Medicine
• Explore DNA medicines that have the potential to create robust, antigen-specific T cell responses
• Evaluate Inovio’s DNA medicine, INO-5401 has promising, early data in GBM showing early efficacy, and immunogenicity
• Discuss Inovio’s DNA medicine, its technology, and other promising approaches to GBM therapy will be discussed
Day Two
Thursday, December 10, 2020
5:35 pm | PANEL DISCUSSION: Lessons Learned from Failed and Discontinued Clinical Trials for the Treatment of Glioblastoma
• Debate the common challenges with moving GBM clinical trials forward
• What can we learn from the plethora of failed phase 2 trials?
• With a high failure rate of phase 3 glioblastoma trials, panellists examine the need for greater reliability
of earlier studies
David Reardon
Clinical Director, Center for NeuroOncology
Dana-Farber Cancer Institute
Day One
Wednesday, December 09, 2020
11:40 am | An Exclusive Update on Neoantigen Vaccination for Glioblastoma
• Describe rationale for targeting neoantigens for anti-tumor vaccination
• Summarize therapeutic development of neoantigen vaccination for
oncology to date
• Overview results of neoantigen vaccination application for glioblastoma
• Enhance next steps to optimize neoantigen vaccination for glioblastoma
Day Two
Thursday, December 10, 2020
5:35 pm | PANEL DISCUSSION: Lessons Learned from Failed and Discontinued Clinical Trials for the Treatment of Glioblastoma
https://glioblastoma-drugdevelopment.com/about/speakers/
Count on the Advancement of DNA Medicine with Inovio Stock
INO stock could have a breakout moment anytime as next-gen science moves forward
By Louis Navellier and the InvestorPlace Research Staff, Editor, Growth Investor Nov 30, 2020, 3:41 pm EST
Too often, traders tend to pigeonhole certain stocks. For example, some folks might think of Inovio Pharmaceuticals (NASDAQ:INO) as a Covid-19 vaccine company and INO stock as nothing more than a novel coronavirus stock.
Don’t get me wrong. Inovio absolutely is part of the nationwide and global battle against the coronavirus. But there’s no need to pigeonhole INO as just a coronavirus stock.
The company works diligently to develop DNA medicines to treat a range of infectious diseases and cancers. There’s positive news about Inovio’s development of its Covid-19 vaccine candidate, INO-4800, but there’s also good news in other departments.
Therefore, it’s worth investigating both Inovio’s Covid-19 vaccine efforts as well as the company’s progress in other areas. That way, you can get a complete picture of this fascinating biotech company with breakout potential.
INO Stock at a Glance
If the market is telling us anything about INO stock, it’s that the shares are underappreciated and undervalued. You might even say that INO is one of the biotech sector’s most compelling bargains at the moment.
INO stock achieved its 52-week high of $31.71 on June 29, but somehow the market decided that this wasn’t the right price for the stock. As a result, a gradual sell-off commenced.
At the close of Nov. 24, INO stock settled slightly above $10 per share. Sometimes people say that they like to buy low and sell high. When the time comes to buy a stake in a promising company at a low price, however, those same traders tend to chicken out.
If you hesitate, you might miss out on a rare opportunity with INO stock. Even if you’re only thinking relatively short-term (i.e., as a swing trader), there’s potential here. INO has a tendency to spike quickly from time to time, just like it did in mid-September. This could easily happen again if there’s good news.
Not Just Covid-19
I’m going to take a different approach from many commentators and veer away from the topic of Covid-19 vaccine candidates. Let’s not discount the significance of the other conditions that Inovio is working to address.
One example is INO-3107, Inovio’s DNA medicine candidate designed to treat Recurrent Respiratory Papillomatosis (RRP). Inovio just dosed its first subject with INO-3107 in a Phase 1/2 clinical trial for this condition.
RRP is a very unfortunate and rare ailment. Caused by certain types of human papillomavirus (HPV), RRP is incurable and causes non-cancerous tumor growths that lead to life-threatening airway obstructions.
Usually, surgery is used to treat RRP. Furthermore, sometimes patients need multiple surgeries, which can severely impact their quality of life. The U.S. Food and Drug Administration (FDA) already granted INO-3107 Orphan Drug Designation, so it’s great to hear that there’s progress in developing this less invasive treatment.
Advancing Other DNA Medicines
For Inovio, INO-3107 isn’t the only DNA-based medicine that’s showing progress. It’s well documented that the FDA cleared the Covid-19 vaccine candidate, INO-4800, to proceed with Phase 2 clinical trials.
Yet, let’s also acknowledge the progress in other areas. Encouragingly, Inovio recently announced that its DNA medicines INO-5401 and INO-9012, in combination with PD-1 Inhibitor Libtayo (cemiplimab), are under review in the treatment of newly diagnosed glioblastoma multiforme.
This condition is a type of cancer that starts in the brain. Under certain conditions, the described combination of INO-5401 and INO-9012 appears to demonstrate a well-tolerated safety profile.
Dr. David Reardon, Clinical Director of the Center for Neuro-Oncology at the Dana-Farber Cancer Institute, clearly sees the potential of Inovio’s work in this area:
“We look forward to continuing to review these data, with an eye towards those patients who are most likely to benefit from this innovative approach and to see whether, over time, there is an extension of survival in these very hard-to-treat patients.”
The Takeaway
Yes, it is possible to take a bullish stance on INO stock because of INO-4800. Inovio’s Covid-19 vaccine candidate does hold great promise.
However, there’s more to Inovio than INO-4800. Just as Inovio isn’t just a horse in the vaccine horse race, INO stock isn’t just a coronavirus stock. That’s why I’ve given it an “A” rating in my Portfolio Grader.
SD-Optimal-Research,LLC-said-INO-will-green-light-start-11/30-COB-or-tomorrow. Recruiting-end-12/15/20
They can start pre-screening today. If qualified, they will call back tomorrow after Ino green-lights. The participant will come in for a blood draw and COVID-19 viral test. The sample will be sent to a PCR lab. After result comes back negative, they will schedule the participant to come in to get first shot. This site will recruit 40 ppl. Recruiting will end 12/15/20 which synchronizes with China P2 trial. This means all participants will have first shot by 12/15/20. Then the study will be updated with “Active, not Recruiting”.
https://clinicaltrials.gov/ct2/show/NCT04642638#contacts
San Diego, California, United States, 92108
Contact: Prinicipal Investigator Patrick Yassini pyassini@optimalsites.net
5920 Friars Rd UNIT 200, San Diego, CA 92108
Located in: PARK PLACE PLAZA
Open · Closes 5PM
(619) 291-2845
Official-INO-4800-P2-start-in-China-Recruiting-11/27-12/15, 640 ppl, 18-85 yrs old
Registration number:
ChiCTR2000040146
Date of Last Refreshed on:
2020-11-22
Date of Registration:
2020-11-22
Registration Status:
Prospective registration
Public title:
A Phase II, Randomized, Double-blinded, Placebo-controlled, Dose-finding Clinical Study to Evaluate the Safety and Immunogenicity of Different Doses of INO-4800 Administered Intradermally Followed by Electroporation in Healthy Adult and Elderly Volunteers
Objectives of Study:
Primary objectives: ? To evaluate the safety and tolerability of INO-4800 at different dose levels in healthy subjects (= 18 and < 60 years old as well as = 60 and = 85 years old); ? To evaluate the humoral immune response of INO-4800 at different doses in healthy subjects (= 18 and < 60 years old as well as = 60 and = 85 years old). Secondary objective: ? To evaluate the duration of humoral response of INO-4800 at different doses in healthy subjects at different ages ((= 18 and < 60 years old as well as = 60 and = 85 years old). Exploratory objective: ? To evaluate the cellular immune response of INO-4800 at different doses in healthy subjects ((= 18 and < 60 years old as well as = 60 and = 85 years old).
Study execute time:
From 2020-11-27 To 2020-12-15
Recruiting time:
From 2020-11-27 To 2020-12-15
Group:2
Sample size:640
Country: China
Province:Jiangsu
Hospital: Danyang City Center for Disease Control and Prevention
http://www.chictr.org.cn/showprojen.aspx?proj=64452
mRNA-P1PR-took-4-mos 7/14-11/12. Ino-submitted 7/31, should-be-published-12/2-NEJM
Moderna Announces Publication in The New England Journal of Medicine of Interim Results From Phase 1 Study of Its mRNA Vaccine Against COVID-19 (mRNA-1273)
July 14, 2020 at 5:14 PM EDT
https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-publication-new-england-journal-medicine
An mRNA Vaccine against SARS-CoV-2 — Preliminary Report
List of authors.
Lisa A. Jackson, M.D., M.P.H., Evan J. Anderson, M.D., Nadine G. Rouphael, M.D., Paul C. Roberts, Ph.D., et al., for the mRNA-1273 Study Group*
November 12, 2020
N Engl J Med 2020; 383:1920-1931
https://www.nejm.org/doi/full/10.1056/nejmoa2022483
P1PR will likely be published online in NEJM Wed, 12/2/20. Now that P2-starts, the reviewers have no reason not to accept and publish.
P2 funding for 400 ppl, $50K/per, $20M must have been disbursed for P2 to start. Considered a material event, It’d show up immediately in 8-K and eventually in 10-K soon!!
P3:6187 ppl, $309.35M. Total $330M could be announced in whole (likely) or in part as P2/3 are combined in a single FDA ClinicalTrials ID. CEO Joseph Kim might have waited for P3 hold lifted after 3PSP questions are satisfactorily answered to announce $330M.
Inovio responds to questions about experimental Covid-19 vaccine, awaits ruling on late-stage trial
John George, Senior Reporter
Nov 2, 2020, 4:33pm EST
Inovio said Monday it has responded to the Food and Drug Administration's questions about its experimental Covid-19 vaccine and the vaccine's delivery device.
The federal agency now has 30 days to respond, from the date it received Inovio's answers, and let the Plymouth Meeting biotech company know whether it can begin late-stage testing of its INO-4800 vaccine candidate.
Inovio declined to say exactly when it submitted its response.
"We look forward to hearing back from the FDA in November and continue to prepare for a planned phase-II/III trial of INO-4800," Inovio said in a statement provided to the Philadelphia Business Journal. "As a reminder, the partial clinical hold by the FDA is not due to the occurrence of any adverse events related to Inovio’s ongoing expanded phase-I study of INO-4800, which has continued, and does not impact the advancement of Inovio's other product candidates in development.”
On Sept. 28, Inovio (NASDAQ: INO) disclosed its planned phase-II/III clinical trial for INO-4800 was going to be delayed because the FDA had raised additional questions about the experimental vaccine and Inovio's Cellectra 2000 device used to deliver the vaccine.
Inovio, one of more than 125 life sciences companies around the world working on a potential Covid-19 vaccine, had hoped to initiate the late-stage clinical trial by the end of September.
Big Pharma companies AstraZeneca, Pfizer and Johnson & Johnson, along with small biopharm companies Moderna and Novavax, have advanced vaccine candidates into late-stage clinical testing.
Both AstraZeneca (NYSE: AZN) and Johnson & Johnson (NYSE: JNJ) had to temporarily halt their late-stage studies because of unexplained illnesses of study participants. Regulators and independent committees overseeing the studies have since determined both trials can safely resume.
Inovio's INO-4800 vaccine candidate is a DNA-based vaccine the company developed in a partnership with the Wistar Institute in Philadelphia and others. The vaccine's proprietary Cellectra delivery device, developed by Inovio, delivers the vaccine into the patient’s skin using an electrical pulse in a process that takes only a few seconds.
The hand-held Cellectra device administers a brief electrical pulse to reversibly open small pores in skin-area cells. Once inside the cell, the vaccine's DNA plasmids instruct the cell to produce the targeted antigen against the virus.
https://www.google.com/amp/s/www.bizjournals.com/philadelphia/news/2020/11/02/inovio-covid-19-vaccine-candidate-fda-study-trial.amp.html
CEPI funded up to $56M to support Inovio’s pre-clinical and clinical advancement through Phase 2 of INO-4500, its Lassa fever vaccine, and INO-4700, its MERS vaccine. The shared goal of Inovio and CEPI is for the Lassa and MERS vaccines to be available as soon as possible for emergency use.
21 Oct 2020
Inovio Pharmaceuticals completes phase I trial for Lassa fever (Prevention) in USA (Intradermal) (NCT03805984)
December 7, 2020
NCT04093076
Drug: INO-4500
Device: CELLECTRA™ 2000
Drug: Placebo
Sponsor/Collaborators:
Inovio Pharmaceuticals
Coalition for Epidemic Preparedness Innovations (CEPI)
Number Enrolled: 220
Official Title:
Dose-Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Combination With Electroporation in Healthy Volunteers in Ghana
The Lassa virus causes a severe viral hemorrhagic fever that often presents itself alongside the Ebola virus. Those infected with Lassa virus experience respiratory distress, vomiting, facial swelling, chest pain, tremors, and brain inflammation. Lassa fever can be up to 20-50% fatal in humans, and causes permanent hearing loss in about one- third of those who survive.1 The number of Lassa virus infections per year in West Africa is estimated at 100,000 to 300,000, with approximately 5,000 deaths.2
The development of a vaccine to combat infectious diseases such as Lassa fever is necessary and is likely to have more success in the form of a DNA vaccine.
When modified DNA of a virus is used in a vaccine, the expression
of the target genes results in the subjects’ immune system responding in a protective manner against the virus. While progress has been made in the creation and manufacturing of a DNA vaccine for Lassa fever, routine usage has been historically hindered due to ineffective delivery models. Delivering the Lassa DNA vaccine intramuscularly, directly into the muscle, a current method of vaccine delivery, has the potential to protect those infected from death, but preliminary studies show that it does not prevent fevers and viremia, a condition that causes measurable levels of the virus in blood samples.
Geneva researchers Dr. Connie Schmaljohn, Senior Research Scientist and Dr. Kathleen Cashman, Co- Investigator at the U.S. Army Medical Research Institute of Infectious Diseases, in collaboration with Dr. Kate Broderick, Senior Director of Research and Development at Inovio Pharmaceuticals, are developing a way to improve DNA vaccine delivery for Lassa fever through the use of an intradermal electroporation (ID-EP) device.
The ID-EP device delivers an electric pulse to increase the uptake of the vaccine delivered under the skin, allowing for the vaccine to enter cells more effectively and resulting in an enhanced immune response. The use of the ID-EP device is painless for subjects as it only penetrates the surface of the skin and uses an extremely low level of voltage, making it especially appealing for use in pediatric and geriatric populations. Additionally, unlike other current delivery methods, the use of the ID-EP device increases efficacy of the vaccine by not only protecting those infected from death, but also by preventing viremia, meaning that the vaccine and dermal electroporation delivery will prevent secondary spread of the virus to close contacts.
The development of the ID-EP device in conjunction with a Lassa DNA vaccine has the potential to provide an effective response to Lassa virus as well as other biological health threats worldwide. With further developments, the hope is to apply similar methods in the delivery of vaccines for other infectious diseases, HIV, and cancer.
https://clinicaltrials.gov/ct2/show/NCT04093076?term=Inovio+and+Lassa&draw=2&rank=1
Advaccine-announced-the completion-of-more-than-200M-yuan-in-Series-B-financing. Investors in this round include new and existing shareholders such as Jenner LLP, Jingwei Venture Capital, Lianxin Capital, and Star Capital.
2020-09-30 08:39Investment community sybil
The investment community (ID: pedaly2012) reported on September 30 that Advaccine announced that it has completed more than 200 million yuan in Series B financing, which is another after the merger of Sauer Biotech in September this year. Milestone events. Round investors include medical Jenner (Jenner LLP), Matrix Partners , linking the new capital of old and new shareholders, capital and other stars.
Dr. Bin Wang, co-founder and chief scientist of Ai Diweixin, said: “As the third-generation nucleic acid vaccine, DNA vaccines have obtained a large number of positive human clinical data, both in terms of safety and effectiveness. Proof of concept, and because of its relatively simple production and storage conditions, it has the advantage of large-scale industrial application. Ai Di Weixin has the world-class DNA plasmid large-scale production technology. After the merger of S.A. Equipped with high-standard hardware facilities for the mass production of vaccines. We are very confident in the upcoming late-stage clinical trials of the new crown DNA vaccine, as well as Ai Di Weixin’s domestic and foreign partners. I believe that with Ai Di Weixin B With the completion of the round of financing, the clinical research and industrialization of DNA vaccines will be further accelerated and moved to a new level."
It is understood that Advaccine is a global clinical stage vaccine technology company driven by innovative technology. With an internationally leading technology platform for immune tolerance and immune activation, it focuses on the development and application of innovative vaccine technologies such as genetic engineering vaccines, DNA vaccines, and new vaccine adjuvants. It is also a leading company in the field of DNA vaccines in China.
Ai Diweixin's research varieties include novel coronavirus preventive vaccine (new coronavirus DNA vaccine), respiratory syncytial virus pneumonia preventive vaccine (recombinant protein RSV vaccine), recombinant protein hepatitis B therapeutic vaccine, etc., all have broad unsatisfactory Clinical and market demand. Ai Diweixin's new coronavirus DNA vaccine is a key vaccine technology research project for the national joint prevention and control of new coronary pneumonia. It has now entered the clinical stage in China, and clinical trials are being carried out simultaneously in the United States. The new respiratory syncytial virus (RSV) pneumonia vaccine developed by Ai Diweixin has been supported by the national "Twelfth Five-Year" major new drug creation project. Phase II clinical research is being initiated in Australia, and the development progress is leading the world.
https://translate.googleusercontent.com/translate_c?depth=1&hl=en&nv=1&pto=aue&rurl=translate.google.com&sl=auto&sp=nmt4&tl=en&u=https://m.pedaily.cn/news/460573&usg=ALkJrhhLD9dXI7XJUy1UctBwJImJlw5_pA
Translated from http://news.pedaily.cn/202009/460573.shtml
DNA Vaccine INO-4500 Delivery-for-Lassa-Virus P1 starts 12/7/20
Geneva researchers Dr. Connie Schmaljohn, Senior Research Scientist and Dr. Kathleen Cashman, Co- Investigator at the U.S. Army Medical Research Institute of Infectious Diseases, in collaboration with Dr. Kate Broderick, Senior Director of Research and Development at Inovio Pharmaceuticals, are developing a way to improve DNA vaccine delivery for Lassa fever through the use of an intradermal electroporation (ID-EP) device.
NCT04093076
Drug: INO-4500
Device: CELLECTRA™ 2000
Drug: Placebo
Sponsor/Collaborators:
Inovio Pharmaceuticals
Coalition for Epidemic Preparedness Innovations (CEPI)
Number Enrolled: 220
Official Title:
Dose-Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Combination With Electroporation in Healthy Volunteers in Ghana
Estimated Study Start Date :
December 7, 2020
Estimated Primary Completion Date :
July 2022
https://genevausa.org/wp-content/uploads/2018/08/DNA-Vaccine-Delivery-for-Lassa-Virus.pdf
Dose-ranging Study: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers in Ghana
https://clinicaltrials.gov/ct2/show/NCT04093076?term=Inovio+and+Lassa&draw=2&rank=1
Advaccine founder Bin Wang congrated inovio as FDA cleared path for phase 2 in U.S. Wang said that he was looking forward to working with the inovio team. As a partner n sponsor taking place in China with the phase 2. back in September 30th, Advaccine announced a 2 billions RmB funding by 4 different investment firms which they are Advaccine major shareholders.
Bin Wang also mentioned in an article that he now has all the top notch DNA standard to mass produce the very advance n effective vaccine.
$20M must be disbursed to start P2. Per SEC, that’s a material event. It’s illegal for Ino not to file 8-K immediately.
If you think P3 will be lifted this Dec - I think Ben spoke to you about this timeline, right?, then CEPI would announce funding. DoD may too.
BARDA, OWS (co-chaired by HHS, DoD, General Pena), CEPI pre-announced fundings to many candidates even before they start P2 or 3. Why would DoD behave any differently?
It’d-cost-less-than-$6 (Analysts said about others; DNA vaccine is even cheaper to make) to manufacture a dose of 4800 Avg Depending on packaging, 6-pack, 10-pack, ... TMO provides end-to-end plasmid, vaccine manufacturing via fill and finish in 100M’s doses. Thus, TMO cost is lower than most. Of course, TMO will Mark up.
Serum Institute in India can make 4800 even cheaper. They have been in discussion with Ino per court docket. Perhaps, a PR will be forthcoming this Dec.
China, India, S. Korea account for 1/3 of world population (8B). With 2 doses each person. Let’s say only 50% takes vaccine.
That would be 2.67B*$20=$53.4B annually as ppl need annual booster shot like flu shot.
I have not taken into account other low, mid income countries yet.
Would you’d rather take US population? Wake up!
At-min, Ino-will-PR $20M 400-ppl, $50K/person P2-DoD-funding-as-P2-starts-Mon-11/30. The fund must have been already disbursed before P2 can start. Thus, 8-K will be filed same day as PR. So, this is imminent. 10-K will mention that as well.
NEJM normally publishes online Wed or Thursday.
Other COVID-19 peer review took 4 mos (long pole) from manuscript submitted to acceptance, online publishing. Non-CV publications may take 4-4.5 mos.
Thus 4800 P1PR will definitely be accepted and published online Dec 2020.
I pick 12/2 which is more than 4 months from July end manuscript submission.
JK reiterated that it is not contingent on FDA lifting hold.
“ The publication through a peer review process of our Phase 1 data is not tied to the FDA approval of Phase 2/3. So these are two independent events.”
Ino-4800 P2: US-measures-B-KillerT-cell-response. China-measures-same-and-B-cell-durability-640-ppl
Humoral immunity is named so because it involves substances found in the humors, or body fluids. It contrasts with cell-mediated immunity. Humoral immunity can also be referred to as antibody-mediated immunity.
B cells are responsible for humoral immunity. Helper T cells aid the development of B cells into plasma cells. It is plasma cells that produce and secrete immunoglobulins iG, or antibodies.
Humoral immunity secretes antibodies to fight against antigens, whereas cell-mediated immunity secretes cytokines and no antibodies to attack the pathogens. The Humoral immunity is rapid or quick in their action against antigens, while the Cell-mediated immunity (by Killer T cells) show delay though permanent action against any pathogens.
https://clinicaltrials.gov/ct2/show/NCT04642638?term=Ino-4800&draw=2&rank=3
Primary Outcome Measures :
Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-?) Enzyme-linked Immunospot (ELISpot) Assay [ Time Frame: Baseline up to Day 393 ]
Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay [ Time Frame: Baseline up to Day 393 ]
Phase 3: Percentage of Participants With Virologically-confirmed COVID-19 Disease [ Time Frame: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393) ]
Primary objectives: ? To evaluate the safety and tolerability of INO-4800 at different dose levels in healthy subjects (≥ 18 and < 60 years old as well as ≥ 60 and ≤ 85 years old); ? To evaluate the humoral immune response of INO-4800 at different doses in healthy subjects (≥ 18 and < 60 years old as well as ≥ 60 and ≤ 85 years old). Secondary objective: ? To evaluate the duration of humoral response of INO-4800 at different doses in healthy subjects at different ages ((≥ 18 and < 60 years old as well as ≥ 60 and ≤ 85 years old). Exploratory objective: ? To evaluate the cellular immune response of INO-4800 at different doses in healthy subjects ((≥ 18 and < 60 years old as well as ≥ 60 and ≤ 85 years old).
http://www.chictr.org.cn/showprojen.aspx?proj=64452
P1PR-will-likely-be-published-online-in-NEJM-Wed-12/2-submitted-at-July-end,4-months-ago. Now-that-P2-starts,reviewers-have-no-reason-not-to/accept and publish.
P2 funding for 400 ppl, $50K/per, $20M must have been disbursed for P2 to start. It’d show up in 10-K or 8-K for sure.
P3:6187 ppl, $309.35M
Total $330M could be announced in whole (likely) or in part as P2/3 are combined in a single FDA ClinicalTrials ID.
JK might have waited for P3 hold lifted after 3PSP questions are satisfactorily answered (heard from others that IR expected Dec 2020? Do you agree?) to announce $330M from DoD.
JK said it wouldn’t be right to announce a dollar amount if hold was not completely lifted, being tactful to the Grantors. The money was already budgeted there to take.
CEPI funding could be contingent on P3 hold lifted as well. CEPI has funded Ino thru and thru. There is no reason to stop now that P2 starts and P3 hold will be lifted this Dec.
Official-INO-4800-P2-start-in-China-Recruiting-11/27-12/15, 640 ppl, 18-85 yrs old
Registration number:
ChiCTR2000040146
Date of Last Refreshed on:
2020-11-22
Date of Registration:
2020-11-22
Registration Status:
Prospective registration
Public title:
A Phase II, Randomized, Double-blinded, Placebo-controlled, Dose-finding Clinical Study to Evaluate the Safety and Immunogenicity of Different Doses of INO-4800 Administered Intradermally Followed by Electroporation in Healthy Adult and Elderly Volunteers
English Acronym:
Scientific title:
COVID-19 DNA vaccine phase II clinical trial
The registration number of the Partner Registry or other register:
Applicant:
Xuefen Huai
Study leader:
Fengcai Zhu
Applicant telephone:
18351991682
Study leader's telephone:
13951994867
Applicant Fax:
Study leader's fax:
Applicant E-mail:
xuefenhuai@advaccine.com
Study leader's E-mail:
jszfc@vip.sina.com
Applicant website(voluntary supply):
Study leader's website(voluntary supply):
Applicant address:
Room 308, Building B1, No.218 Xinghu Street, Suzhou Industrial Park, China
Study leader's address:
Room 330, Building A, No.172 Jiangsu Road, Nanjing
Applicant postcode:
215000
Study leader's postcode:
Applicant's institution:
Advaccine (Suzhou) Biopharmaceutical.,Ltd.
Approved by ethic committee:
Yes
Approved No. of ethic committee:
JSJK2020-A063-02
Approved file of Ethical Committee:
????View
Name of the ethic committee:
Ethics Committee of Jiangsu Provincial Center for Disease Control and Prevention
Date of approved by ethic committee:
2020-11-06
Contact Name of the ethic committee:
Huiyuan Cai
Contact Address of the ethic committee:
No.172 Jiangsu Road, Nanjing
Contact phone of the ethic committee:
Contact email of the ethic committee:
Primary sponsor:
Jiangsu Provincial Center for Disease Control and Prevention
Primary sponsor's address:
No.172 Jiangsu Road, Nanjing
Secondary sponsor:
Country:
China
Province:
Jiangsu
City:
Institution
hospital:
Advaccine (Suzhou) Biopharmaceutical, Ltd.
Address:
Room 308, Building B1, No.218 Xinghu Street, Suzhou Industrial Park, China
Source(s) of funding:
Sponosor
Target disease:
COVID-19
Target disease code:
Study type:
Prevention
Study phase:
2
Objectives of Study:
Primary objectives: ? To evaluate the safety and tolerability of INO-4800 at different dose levels in healthy subjects (≥ 18 and < 60 years old as well as ≥ 60 and ≤ 85 years old); ? To evaluate the humoral immune response of INO-4800 at different doses in healthy subjects (≥ 18 and < 60 years old as well as ≥ 60 and ≤ 85 years old). Secondary objective: ? To evaluate the duration of humoral response of INO-4800 at different doses in healthy subjects at different ages ((≥ 18 and < 60 years old as well as ≥ 60 and ≤ 85 years old). Exploratory objective: ? To evaluate the cellular immune response of INO-4800 at different doses in healthy subjects ((≥ 18 and < 60 years old as well as ≥ 60 and ≤ 85 years old).
Description for medicine or protocol of treatment in detail:
Study design:
Parallel
Inclusion criteria
1. Age ≥ 18 years old and < 60 years old, male or female (for adult subjects only); 2. Age ≥ 60 years old and ≤ 85 years old, male or female (for elderly subjects only); 3. Body mass index (BMI) of 18-35 kg/m2 (inclusive); 4. Axillary temperature < 37.3 ? on the day of vaccination; 5. Subjects are considered by the investigator as healthy subjects eligible for immunization with this product based on inquiry of medical history and inspection of the physical examination results; 6. Subjects volunteer to participate in this clinical trial, and are able to correctly understand and sign the written Informed Consent Form (ICF); 7. Subjects can cooperate with the investigator, observe the requirements of the protocol, and complete the examinations according to relevant procedures in the protocol; agree to abide by the mode of life stipulated in the protocol (restrictions on overseas trips, business trips or travel) during the study period.
Study execute time:
From 2020-11-27 To 2020-12-15
Recruiting time:
From 2020-11-27 To 2020-12-15
Group:2
Sample size:640
Country: China
Province:Jiangsu
Hospital: Danyang City Center for Disease Control and Prevention
http://www.chictr.org.cn/showprojen.aspx?proj=64452
The AstraZeneca Covid Vaccine Data Isn't Up to Snuff
There's been even more good news this week, this time from the Oxford-AstraZeneca trials. But a closer look reveals some very shaky science.
https://www.google.com/amp/s/www.wired.com/story/the-astrazeneca-covid-vaccine-data-isnt-up-to-snuff/amp