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STOCKHOLM, Oct 6 (Reuters) - Sweden and Denmark said on Wednesday they are pausing the use of Moderna's (MRNA.O) COVID-19 vaccine for younger age groups after reports of possible rare cardiovascular side effects.
The Swedish health agency said it would pause using the shot for people born in 1991 and later as data pointed to an increase of myocarditis and pericarditis among youths and young adults that had been vaccinated. Those conditions involve an inflammation of the heart or its lining.
"The connection is especially clear when it comes to Moderna's vaccine Spikevax, especially after the second dose," the health agency said.
Shares of Moderna fell 4.9%, or $16.08, to $316.11 in afternoon trading.
https://www.reuters.com/business/healthcare-pharmaceuticals/sweden-pauses-use-moderna-covid-vaccine-cites-rare-side-effects-2021-10-06/
Version 2: Design, immunogenicity and efficacy of a Pan-SARS-CoV-2 synthetic DNA vaccine
https://www.biorxiv.org/content/10.1101/2021.05.11.443592v2
History
August 4, 2021.
ARTICLE VERSIONS
Version 1 (May 11, 2021 - 15:28).
You are viewing Version 2, the most recent version of this article.
In addition to the use of INO-4802 as a prime vaccine, we assessed employing it in a heterologous boost regimen (Fig. 5a). INO-4802 boosting effect was measured approximately 8 months after priming with pWT vaccine in the Syrian Golden hamster model. Delaying the INO-4802 boost by approximately 8 months provide time for the maturation of the immune response the first round of vaccination and potentially antigenic imprinting to WT spike antigen. However, initial humoral immunogenicity readout suggests strong boost of binding antibody titers across the panel of WT and VOC antigens. The increase in binding titers against all the VOCs tested was greater than same dose boost of pWT.
Further studies are ongoing and planned to fully investigate INO-4802 as a boost to first generation vaccine responses generated by INO-4800 and other platform technologies.
We have reported on the design and testing of a pan-SARS-CoV-2 vaccine, INO-4802. High levels of cross-reactive neutralizing activity against multiple VOCs was demonstrated by pseudotyped virus neutralization, and superior protection against B.1.351 challenge was observed compared to a strain-matched vaccine (Fig. 4e). Additionally, INO-4802 has shown utility in both prime and heterologous boost immunization scenarios. Vaccination with INO-4802 led to cross-reactive T cell immune responses as well as circulating populations of Tfh cells correlative of both memory and neutralizing antibody responses. In summary, INO-4802 represents a potentially useful pan-SARS-CoV-2 vaccine approach against multiple variants of concern and the data presented in this report supports its further development.
Abstract
Here we have employed SynCon® design technology to construct a DNA vaccine expressing a pan-Spike immunogen (INO-4802) to induce broad immunity across SARS-CoV-2 variants of concern (VOC). Compared to WT and VOC-matched vaccines which showed reduced cross-neutralizing activity, INO-4802 induced potent neutralizing antibodies and T cell responses against WT as well as B.1.1.7, P.1, and B.1.351 VOCs in a murine model. In addition, a hamster challenge model demonstrated that INO-4802 conferred superior protection following intranasal B.1.351 challenge. Protection against weight loss associated with WT, B.1.1.7, P.1 and B.1.617.2 challenge was also demonstrated. Vaccinated hamsters showed enhanced humoral responses against VOC in a heterologous WT vaccine prime and INO-4802 boost setting. These results demonstrate the potential of the pan-SARS-CoV-2 vaccine, INO-4802 to induce cross-reactive immune responses against emerging VOC as either a standalone vaccine, or as a potential boost for individuals previously immunized with WT-matched vaccines.
10/6 KB interview: San Diego pharmaceutical company beginning third phase of trials for new COVID-19 vaccine
INOVIO says their vaccine can survive for at least one year at room temperature and for at least one month at 98.6 degrees Fahrenheit.
San Diego pharmaceutical company beginning third phase of trials for new COVID-19 vaccine
Updated: 10:38 AM PDT October 6, 2021
SAN DIEGO — A local pharmaceutical company that has been working on a COVID-19 vaccine will soon start its third phase of trials.
News 8’s Neda Iranpour went to their lab in February last year and we just returned back to their lab now 1.5 years later to find out where their vaccine stands. We learned INOVIO could hold the key to a vaccine for third world countries and possibly provide a booster shot for all.
INOVIO Pharmaceuticals has had a very busy year and a half. As soon as China released the sequence for COVID-19, INOVIO was one of the first labs to work on a vaccine.
In fact, within 3 hours researchers in Sorrento Valley had a vaccine to test. Researchers explained to News 8 they have an algorithm they designed, and they put the DNA sequence into the algorithm to create their vaccine.
A lot has happened around the world since then. While other big-name pharmaceuticals got approval to administer vaccines, INOVIO’s was going through clinical trials. Now they’ve been accepted into a phase 3 efficacy trial.
“We’re going into our phase 3 trial with a huge amount of confidence,” said Dr. Kate Broderick, the Senior Vice President of research and development at INOVIO. She says they’ve been approved to test the vaccine on people in Mexico, Brazil, and the Philippines.
“I think the whole world is so thankful for the huge advances by what we call the Wave 1 vaccines, however, a kind of sobering thought is only two percent of the population in lower-income countries have the vaccine,” Dr. Broderick said.
INOVIO's is the type of vaccine that does not need to be stored in a freezer. In fact, a refrigerator or room temperature would work for storage. Unlike the Pfizer and Moderna shots which require freezing.
Dr. Broderick explains, “RNA is actually an unstable molecule that’s why you’ve heard it has to be kept in freezer… DNA is different, you can keep it outside at room temperature.” She says INOVIO’s vaccine can survive for at least one year at room temperature and for at least one month at 98.6 degrees Fahrenheit.
How does it work? It gives the body a copy of the virus’s genetic material to build T-cells and the antibody response to COVID-19, “I think of it as like giving the body an FBI picture. So if you see this, make sure you respond to it.”
Dr. Broderick says their shot could also work as a booster, “it’d be really beneficial if we could do a mix and match scenario.”
That’s because with all the variants, she doesn’t believe this virus is going anywhere for a while, “I completely understand people are over this but unfortunately this is not the case. We’re going to keep giving people booster shots. I know it’s frustrating, gosh it’s just another thing to be concerned about but it’s the right thing to do.”
They’re aiming to complete the efficacy trial by early next year, then they’d need each country to approve their vaccine.
So far, Dr. Broderick says they haven’t had any major issues with side effects, just some redness of the skin. She added they don’t administer this vaccine into the muscle.
https://www.cbs8.com/article/news/health/coronavirus/vaccine/inovio-covid-19-vaccine/509-8162681e-4d86-4b07-a16e-d0261bfbf532
10/5 AZN seeks EUA for AZD7442 dMAb®-cloned by Ino
Under DARPA’s two-year grant, INOVIO and Wistar teams will construct COVID-19 dMAb candidates designed to mirror AstraZeneca’s traditional recombinant monoclonal antibody candidates now being tested in clinical trials to treat COVID-19, such as AZD7442.
https://www.genengnews.com/covid-19-candidates/inovio-pharmaceuticals-and-astrazeneca-dmabs/
AstraZeneca seeks emergency approval for COVID-19 antibodies isolated at VUMC
Oct. 5, 2021, 12:13 PM
by Bill Snyder
The global biopharmaceutical company AstraZeneca said Oct. 5 it has requested emergency use authorization (EUA) from the U.S. Food and Drug Administration for a long-acting antibody combination originally developed at Vanderbilt University Medical Center to protect against COVID-19.
If the EUA is granted, the combination of long-acting monoclonal antibodies, called AZD7442, would be the first to be given to prevent symptoms of COVID-19 and serious illness in people who are infected by the COVID-19 virus, SARS-CoV-2
The EUA application is based on results of a phase 3 clinical trial, which showed that AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% compared to placebo. Importantly, the trial included immunocompromised and chronically ill adults in whom vaccination against SARS-CoV-2 may not provide sufficient protection against COVID-19.
“This single-shot prevention is likely to be a game changer for at-risk patients,” James Crowe Jr., MD, director of the Vanderbilt Vaccine Center who led the research effort, said when the clinical trial results were released in August.
“The near-term availability of AZD7442 comes at an opportune time,” added Robert Carnahan, PhD, associate director of the Vanderbilt Vaccine Center. “It is clear that we need additional solutions beyond vaccines to protect those most vulnerable members of our society, such as the immunocompromised.”
Delivered by intramuscular injection, the two-antibody treatment was well tolerated with only minor side effects and could afford up to 12 months of protection from COVID-19, company officials said. Preliminary laboratory findings also suggest that AZD7442 can neutralize recent emergent variants of the virus, including the delta variant, they said.
The original antibodies that were the basis for the engineered long-acting antibodies that make up AZD7442 were isolated last year at VUMC. Crowe and his colleagues have developed ultra-fast methods for discovering highly potent antiviral human monoclonal antibodies and validating their ability to protect small animals and non-human primates.
Six of the antibodies were licensed to AstraZeneca in June for advancement into clinical development. In October the company announced it was advancing into phase 3 clinical trials an investigational therapy consisting of two long-acting antibodies discovered at VUMC and optimized by AstraZeneca.
Crowe is the Ann Scott Carell Professor and professor of Pediatrics and Pathology, Microbiology & Immunology at VUMC. Carnahan is associate professor of Pediatrics and Radiology and Radiological Sciences.
The VUMC research was supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, the Defense Advanced Research Projects Agency of the U.S. Department of Defense, the Dolly Parton COVID-19 Research Fund at Vanderbilt, and Merck KGaA, Darmstadt, Germany.
https://news.vumc.org/2021/10/05/astrazeneca-seeks-emergency-approval-for-covid-19-antibodies-isolated-at-vumc/
10/5 As part of our $3.5bn plan to end the COVID-19 pandemic and prepare for future infectious disease outbreaks, CEPI is leading on this concerted R&D push to:
1) Develop a better understanding of the performance of existing COVID-19 vaccines, for example through gathering data looking at the potential to ‘mix and match’ doses of vaccines with the University of Oxford, and funding studies to assess the immune response generated by vaccines in specific populations, like immunocompromised patients (with Oslo University Hospital and partners). This additional data will allow us to ‘get smart’ and use our tools for maximum impact.
2) Enhance the next generation of COVID-19 vaccines targeted to protect against newly emerging variants of concern, as well as those with specific design features like vaccines as nasal sprays, or vaccines that don’t require complex cold-chains. CEPI has already funded the development of next-generation vaccine candidates with SK bioscience, VBI Vaccines, University of Hong Kong, Zerun Biotech, and Gritstone Bio, and has run a call to advance broadly protective vaccines against new emerging SARS-CoV-2 variants.
As new candidate vaccines progress, it is imperative that Governments, vaccine developers, and manufacturers commit to making their approved vaccines available as comparator vaccines to allow for these potentially life-saving clinical trials to continue.
3) Increase the number of vaccines available so that we can increase global supply and, ultimately, protect vulnerable populations through COVAX.
https://cepi.net/news_cepi/further-vaccine-rd-is-critical-to-end-the-devastating-covid-19-pandemic/
Sponsored by WHO! High-end will conduct a 15-month clinical trial in Colombia
Time: 2021-10-04 Source: Member Contribution
Foreign media reported that Taiwan’s domestically produced high-end vaccine has officially become a candidate vaccine and is sponsored by the World Health Organization. A 15-month clinical trial will be conducted in Colombia.
Foreign media reported that the Colombian National Food and Drug Administration reported that it approved the "Vaccine Solidarity Trial" for the new crown vaccine candidate. The study is an international randomized trial sponsored by the WHO to collect the effectiveness and safety of the candidate vaccine. information.
Invima pointed out that Colombia will conduct two vaccine trials, one is the MVC-COV190115 protein subunit vaccine developed by a Taiwanese high-end company, and the other is the INO-4800 vaccine developed by Inovio Pharmaceuticals of the United States, using DNA technology. .
The experiment will recruit people over 16 years old, living in epidemic-stricken areas or exposed to high-risk work environments as subjects, including medical personnel, epidemic-related front-line personnel, and sex workers. It is expected to recruit 40,000 volunteers and the experiment will take a long time. Up to 15 months.
Colombia has emerged from the world’s 20 candidate countries and has become one of the six American countries participating in the clinical trial. The Liberty Times pointed out that other vaccine candidates will continue to join the research program, and it is expected that the number of subjects worldwide will reach 12 ten thousand.
https://m-yszvv-com.translate.goog/pinglun/117937.html?_x_tr_sch=http&_x_tr_sl=auto&_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=nui
Philippines will be using the same global clinical trial protocol proposed across all participating countries and there will be no separate country-specific protocol that will be followed.
In the Phase 3 segment, approximately 6714 seronegative and 402 seropositive subjects 18 years of age and older will be randomized at a 2:1 ratio to receive either active investigational product (INO-4800, 2.0 mg) or placebo (SSC-0001). Approximately half of seronegative subjects and approximately half of seropositive subjects will be 18-50 years of age, and the other half will be ≥51 years of age as is operationally feasible. Also, approximately 711 subjects will be ≥65 years of age, if operationally feasible. The recruitment target for the Philippines is approximately 587 subjects (randomized). Phase 3 total study duration is 13 months; it can be up to 14 months if the subject uses the full screening period (of 30 days + 56 weeks for treatment and follow up).
COUNTRIES OF RECRUITMENT
Brazil
Colombia
Mexico
Philippines
Rwanda
Thailand
Tunisia
Vietnam
The primary objective of this study is to evaluate the efficacy of INO-4800 in the prevention of COVID-19 disease in subjects who are SARS-CoV-2 negative at baseline. The secondary objectives of this study are to 1) evaluate the safety and tolerability of INO-4800; 2) evaluate efficacy of INO-4800 in the prevention of COVID-19 disease according to degrees of severity in subjects who are SARS-CoV-2 seronegative at baseline; 3) evaluate the cellular and humoral immune response to INO-4800; 4) evaluate the efficacy of INO-4800 in the prevention of COVID-19 disease in subjects who are SARS-CoV-2 seropositive at baseline.
FDA APPROVAL DATE
2021-09-07
https://registry.healthresearch.ph/index.php/registry?view=research&layout=details&cid=3894&fbclid=IwAR30EEccm--YIE-RdM_plUoZe678mCpf4i-E67JM41NT22GbSi5dB0MQ_L8
”INNOVATE is not the same as the WHO’s Solidarity vaccine trial.
We have UPM-PGH site in Manila. You can check with the investigator- Dr. Villalobos around November once they start the study.”
UPM-PGH site: University of the Philippines Manila - Philippine General Hospital
https://www.herdin.ph/index.php/registry?view=research&layout=details&cid=3973
Solidarity Trial Vaccines
REGISTRY ID
PHRR210930-003973
Start: 9/30/21. Duration: 18 mos
FDA CLINICAL TRIAL REFERENCE (CTR) NUMBER
2021-CT0627
SCIENTIFIC TITLE
SOLIDARITY TRIAL VACCINES: An international randomised trial of candidate vaccines against COVID-19
DATE OF FIRST ENROLMENT
2021-09-30
The trial will recruit volunteers 16 years of age and older who reside in locations with high and forecasted incidence based on surveillance data and epidemiologic modelling, or whose circumstances put them at appreciable risk of exposure to SARS-CoV-2 and COVID-19. This trial is endpoint driven, as the main analysis for each vaccine arm versus the concurrent shared placebo/control arm is triggered by occurrence of a total of 150 cases of COVID-19 across these two arms, at which point the results will be reported but blinded follow-up will continue.
Funding: The WHO, DOST, DOH
10/1 REVEAL 2 Major Progress
https://clinicaltrials.gov/ct2/history/NCT03721978?A=31&B=32&C=merged#StudyPageTop
Western Connecticut => Nuvance Health Network
[Recruiting]
Danbury, Connecticut, United States, 06810
Contact:Contact: Primary Study Coordinator Margaret Mukwaya 203-794-5610 margaret.mukwaya@nuvancehealth.org
Contact:Principal Investigator: Dr. Chuang
Precision Clinical Research, LLC
[Completed]
Sunrise, Florida, United States, 33351
Boston Medical Center
[ Not yet => Recruiting]
Boston, Massachusetts, United States, 02118
New Jersey Medical School
[Recruiting]
Newark, New Jersey, United States, 07103
Contact:Contact: Primary Study Coordinator Yanille Taveras 973-972-6262 taveraya@njms.rutgers.edu
Contact:Principal Investigator: Dr. Einstein
Columbia University Medical Center
[Not yet recruiting]
New York, New York, United States, 10032
Contact:Contact: Primary Study Coordinator Reena Vattakalam 212-342-6895 rmv2110@cumc.columbia.edu
Contact:Principal Investigator: Dr. Tergas => Hou
Unified Women's Clinical Research - Greensboro
[ Active, not recruiting => Completed]
Greensboro, North Carolina, United States, 27408
Argentina
Hospital Italiano de Buenos Aires
[ Not yet => Recruiting]
Ciudad Autonoma de Buenos Aires, Argentina, C1181ACH
DIM Clinica Privada
[ Not yet => Recruiting]
Ramos Mejía, Argentina, B1704ETD
Brazil, Bahia
Associação Obras Sociais Irmã Dulce Hospital Santo Antônio
[Recruiting]
Salvador, Bahia, Brazil, 40420-000
Brazil, Goiás
Hospital das Clinicas de Goiânia
[Recruiting]
Goiânia, Goiás, Brazil, 74605-050
Brazil, Paraná
Hospital Erasto Gaertner
[Recruiting]
Curitiba, Paraná, Brazil, 80530-010
Finland: Newly added
Northern Savo Hospital District Muncipal Federation
[Not yet recruiting]
Kuopio, Finland, FI-70210
Contact:Contact: Study Coordinator Jatta Salomaa +358447176780 jatta.salomaa@kuh.fi
Contact:Principal Investigator: Dr Marjo Tuppuranien
Finland, Uusimaa
HUS Naistentaudit ja synnytykset
[Recruiting]
Helsinki, Uusimaa, Finland, FI-00290
Contact:Contact: Study Coordinator Ka
Poland
Centrum Medyczne Angelius Provita
[Not yet recruiting]
Slaskie, Poland, 40-611
Contact:Contact: Study Coordinator Ewa Gwiazda +48515924387 e.gwiazda@angelius.org
Contact:Principal Investigator: Dr Mariusz Kiecka
Poland, Lubelskie
Niepubliczny Zaklad Opieki Zdrowotnej Profimed
[Not yet recruiting]
Lublin, Lubelskie, Poland, 20-880
Contact:Contact: Study Coordinator Monika Ochal +48663586227 monika.ochal@profimed.lublin.pl
Contact:Principal Investigator: Dr Andrzej Nowakowski
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
[Not yet recruiting]
Lublin, Lubelskie, Poland, 20-880
Contact:Contact: Study Coordinator Bartlomiej Bar
University of Cape Town
[ Not yet => Recruiting]
Cape Town, Western Cape, South Africa, 7925
Spain
Hospital General Universitario Gregorio Maranon
[ Not yet => Recruiting
9/30 Slide 8: Lassa Fever, Middle East Respiratory Syndrome (MERS), and Ebola booster (first officialLy mentioned) programs progressed to Phase 1/2 trials
• Our experiences with infectious diseases, including coronaviruses, have supported faster development of INO-4800 as well as our second-generation, pan-COVID vaccine candidate, INO-4802
INO-4201 as Booster in Healthy VSV-ZEBOV Vaccinees (Boost-EBOV)
https://clinicaltrials.gov/ct2/show/NCT04906629?term=Inovio&draw=4&rank=49
9/27 Update: VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions. Added new site:
United States, Massachusetts
Boston Medical Center
[Recruiting]
Boston, Massachusetts, United States, 02118
Contact:Contact: Irene Pokuaa 617-414-5149 Irene.pokuaa@bmc.org
Contact:Principal Investigator: Elizabeth Stier, MD
https://clinicaltrials.gov/ct2/history/NCT03603808?A=11&B=12&C=merged#StudyPageTop
9/30 Important Update: Heterologous Prime-Boost Trials
• Received regulatory allowance in China to conduct two clinical
trials investigating heterologous boosting with INO-4800
o Heterologousprime-boostsequentialimmunizationsusingINO-4800
and CoronaVac®
o Completed cross prime-boost pre-clinical animal tests; prime-boost
strategy stimulated high-level of humoral and cellular response
• Thermo Fisher, a member of INOVIO's global manufacturing consortium, opened a new cGMP plasmid DNA manufacturing facility in Carlsbad, California in July 2021 with INOVIO as its first client
INNOVATE Global Phase 3 Trial
• INOVIO with Advaccine jointly conducting a global Phase 3 trial for INO- 4800
• Healthy men and non-pregnant women 18 years and older (2.0 mg dose)
• Focus on countries currently underserved by vaccines, primarily in
Latin America, Asia and Africa
• Recently received regulatory approval to proceed from Brazil, Philippines, Mexico, and more
9/30/21 Key Findings for INO-4802 include:
• Cross-reactive immune responses demonstrated against current and emerging viral variants*
• Induced potent neutralizing antibodies, T cell responses, and protection in a pre-clinical model against the original wildtype strain as well as against the alpha, beta, gamma, and delta variants
• Can potentially provide boosting capabilities in addition to an initial vaccination regimen with INO-4800 and/or other first-generation vaccines, including both adenovirus and mRNA-based platforms
INO-4800
? 1H22: Report interim efficacy data from Phase 3 INNOVATE trial
VGX-3100
? 4Q21: Report complete REVEAL 1 data (ITT, mITT, per protocol)
? 4Q21: Report on pre-treatment biomarker with QIAGEN
INO-5401
? 4Q21: Present 24-month overall survival and immunology data
Platform Development
? 3Q21: Initiate Phase 2 MERS study with INO-4700 funded by CEPI
? 4Q21: Fully enroll Phase 1B field study for Lassa with INO-4500 funded by CEPI
“At best the Merk pill is in competition with Regenron’s monoclonal antibody treatment, not vaccines. At worst, it’s a glorified $700 pill competing with Ivermectin ?? de-??-er. ?? Seriously. This is an AFTER the fact treatment for those who get mild covid. It is NOT a preventative vaccine that keeps you from getting covid. It doesn’t produce antibodies or killer T-cells. It doesn’t stop the spread of the virus or keeps it from mutating. I am literally shaking my head at those that sold today on this “news”. Y’all got manipulated out of your shares for nothing. Good going. ????? Meanwhile your shares got scooped up by the big institutions. And smart investors who know manipulation when they see it. So congrats on picking up more shares. Nothing has changed. INO is rolling out phase 3 trials in multiple countries. Deals will be announced. I’d bet good money. Anyway… I know what I own. Enjoy the ride back up. We good” By Greenmeenie.
Even with the news of a potentially effective new treatment for COVID-19, experts stressed the importance of vaccines for controlling the pandemic, given that they help prevent transmission and also reduce the severity of illness in those who do get infected.
“We love having more treatments available, but prevention is the first goal,” Schaffner said. “Vaccination continues to be the foundation of how we can get ahead of COVID.”
Still, effective therapies will be critical given that billions of people around the world remain unvaccinated.
Earlier study results showed the drug did not benefit patients who were already hospitalized with severe disease.
https://apnews.com/article/merck-says-experimental-covid-pill-cuts-worst-effects-a9a2245fdcee324f6bbd776a0fffcc60
JK at Cantor 9/30/21
So, the total case for the primary endpoint is the lab confirmed COVID-19 case, symptomatic COVID-19 case. It's about 149, it's exactly 149 total cases, is the primary. So, our first analysis is going to be 50% of that. So 75 people will be when the first analysis will be made. So, with the variance, delta being predominant, most experts are saying, anywhere between 60% to 80% of efficacy is fantastic, even approved vaccines, likely will not be reaching 90 as they've demonstrated against the original one.
So, I'm very heartened by Zydus this interim data with their 66% efficacy. I think we will be very happy, if we can match that and or even best that level with INO-4800,
our secondaries are also looking at the moderate to severe including the cases of hospitalization. So most vaccines, regardless of what their symptomatic COVID case efficacy have been, have had greater than 90% efficacy against moderate to severe COVID cases. And really the name of the game is look you may get infected after vaccination, but if you're not sick, if you're not dramatically sick or you have to go to the hospital or you have to miss work and that's really the end game for the vaccines. And we'll be measuring that and we would love to be at the level of other previously approved vaccines in the 90 plus percent efficacy level.
Charles Duncan
And then there is durability of course or an ability to protect against subsequent infections.
Zydus achieved 66% efficacy against the delta predominantly delta strain. In India, where we're Delta variant actually originated initially, now deltas are everywhere in the world, they were able to achieve 66% efficacy. It's a three dose regimen of DNA vaccines delivered with jet injection and already that are CELLECTRA delivery provides a superior delivery of our DNA vaccine.
So, there are three those regimen is not as immunogenic as our two those regimens deliver with CELLECTRA system. But I think the success of Zydus in DNA vaccine although kudos to them, provides a great proof-of-concept for our INO-4800 deliver with a better delivery system, better immune responses against the delta, I'm very optimistic that we will be able to achieve the efficacy levels that is at least as good as Zydus. And I'm very hopeful that we will achieve efficacy that are better than Zydus has.
we have launched our global Phase 3 trials, we announced the recent authorization by Brazil, Mexico and Philippines, just to start off the trial, but we expect additional countries to be added in this global INNOVATE Phase 3 efficacy trials. So looking forward into early part of 2022, first half, we are hopeful that we'll hit the interim efficacy milestone, that's a 50% of case driven cases of COVID-19. Our Phase 3 is designed much similar to all the other approved vaccines, let say, double-blinded placebo controlled two to one randomized case driven, COVID-19 case driven efficacy trial.
Our first interim is that 50% of the cases, and we're hopeful that we can reach that in the first quarter. And with that data, we plan to go to seek emergency approval in those countries that have those pathways and have the urgent need for the vaccines at that time.
we will be talking about emergency approved COVID-19 vaccine, INO-4800, achieving the efficacy endpoint earlier in the year in '22. Looking forward to the BLA in May present for 4800, really celebrating the first approved vaccine for Inovio, but also one of the earliest ones for DNA that's seen.
We're also I would be excited to talk about the efficacy readout from our second Phase 3 trial REVEAL 2 from our VGX-3100, meeting our endpoint of our REVEAL 2 which we were looking forward to fully enrolling that study by the end of this year and having the full follow-up data from REVEAL 1 by the end of this year.
So, you talked about a expansive pipeline, but, most part of our two Phase 3 programs, which are at the cusp of commercialization of 4800 and VGX-3100, and that's what I would be -- these would be what, I would be most proud of at our next conference in a year.
https://seekingalpha.com/article/4457900-inovio-pharmaceuticals-inc-ino-ceo-joseph-kim-presents-cantor-2021-global-healthcare?source=copyToPasteboard
9/30 Beijing Olympics Bans International Spectators, Requires 21-Day Quarantine for Unvaccinated Athletes
The Winter Games are scheduled to kick off in Beijing on Feb. 4, 2022
Additionally, the IOC states that all participants, including athletes competing in the Games, who are not fully vaccinated will be required to quarantine for 21 days upon arrival in Beijing. Those who are fully vaccinated will enter a "closed-loop management system" after arriving — limiting travel to only Games-related venues.
Last week, the U.S. Olympic and Paralympic Committee (USOPC) announced in a statement that the COVID vaccine will be mandated for all Team USA athletes hoping to compete in the Beijing Games, starting on Nov. 1.
1,053 Turkish health workers volunteered to participate in the study and the frequency of getting sick and the antibody levels created by the vaccine were investigated in the study group after the vaccination.
"In those with only two doses of CoronaVac, the levels of antibody protection decreased to 56% after the third month following the second vaccine. This data has proven that applying a 3rd dose of the vaccine is a sound decision," the statement read.
The study also showed a difference in efficacy between continuing with a third dose of CoronaVac or switching to BioNTech for the final dose, although both provided protection.
"Regardless of the preference of the third-dose vaccine, all individuals receiving three doses of vaccine achieved protective antibody levels. The BioNTech vaccine applied as the third dose of vaccination showed significant superiority in protection (both in terms of antibody levels and disease status) compared to the third dose of CoronaVac vaccine."
It also touched upon the subject of a further fourth booster shot.
[No wonder Advaccine, and Sinovac rush to start heterologous booster trial using 4800.
China: 2 4800+Sinovac; 2 Sinovac+4800
https://www.chictr.org.cn/hvshowproject.aspx?ID=96769]
"Those who received the third dose of BioNTech had antibody levels above the maximum measurable titer in 95% of the participants. As such, it can be considered that it is still early to apply the 4th dose of BioNTech vaccine after two doses of CoronaVac and one additional dose of BioNTech."
"The question of when the possible 2nd dose of BioNTech vaccine (4th dose in total) should be administered, can be answered when the results are obtained at the 3rd and 6th months after the 3rd dose administration."
The statement also noted: "None of the 44 employees who got sick in the period after the 3rd vaccine were hospitalized, and they had the disease on an outpatient basis."
https://www.dailysabah.com/turkey/turkish-university-reveals-findings-of-3-dose-efficacy-of-sinovac/news/amp
PLYMOUTH MEETING, Pa., Sept. 29, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, will present three posters at IDWeek 2021, taking place virtually from September 29th - October 3rd.
Dr. Laurent M. Humeau, INOVIO's Chief Scientific Officer, said, "We are excited to participate in our first IDWeek with the presentation of three posters that confirm our approach of developing DNA vaccines to combat the ongoing COVID-19 pandemic. Our vaccine candidates' study results have demonstrated INOVIO's platform-wide safety and tolerability profile, as well as the ability to generate CD8 and CD4 T cells and neutralizing antibodies against SARS-CoV-2 and variants of concern. We look forward to sharing our work with infectious disease experts around the world and hope they find the results generated by DNA COVID-19 vaccines to be very impactful."
The following abstracts and presentations are currently available for meeting attendees viewing:
Abstract #571: Safety and Immunogenicity of INO-4800, a COVID-19 DNA Vaccine as a Primary Series and Booster
Abstract #578: INO-4800 DNA Vaccine Induces Neutralizing Antibodies and T cell Activity Against Global SARS-CoV-2 Variants
Abstract #579: Design and immunogenicity of a Pan-SARS-CoV-2 synthetic DNA vaccine
https://ir.inovio.com/news-releases/news-releases-details/2021/INOVIO-to-Present-Three-Posters-at-IDWeek-2021/default.aspx
9/29 Turkey's Manisa Celal Bayar University (MCBÜ) announced Wednesday findings from a study conducted on 1,053 healthcare professionals working at the university's Hafsa Sultan Hospital. The results revealed that those who received three doses of China's Sinovac COVID-19 vaccine achieved the level of protective antibodies.
According to the written statement from the university, MCBÜ's Scientific Research Projects Unit investigated the 6th-month follow-up results of the two-dose Sinovac SARS-CoV-2 inactivated vaccine – also known as CoronaVac – administered in Turkey and the efficacy results after a 3rd dose.
It stated that 1,053 health workers volunteered to participate in the study and the frequency of getting sick and the antibody levels created by the vaccine were investigated in the study group after the vaccination.
"In those with only two doses of CoronaVac, the levels of antibody protection decreased to 56% after the third month following the second vaccine. This data has proven that applying a 3rd dose of the vaccine is a sound decision," the statement read.
The study also showed a difference in efficacy between continuing with a third dose of CoronaVac or switching to BioNTech for the final dose, although both provided protection.
"Regardless of the preference of the third-dose vaccine, all individuals receiving three doses of vaccine achieved protective antibody levels. The BioNTech vaccine applied as the third dose of vaccination showed significant superiority in protection (both in terms of antibody levels and disease status) compared to the third dose of CoronaVac vaccine."
It also touched upon the subject of a further fourth booster shot.
"Those who received the third dose of BioNTech had antibody levels above the maximum measurable titer in 95% of the participants. As such, it can be considered that it is still early to apply the 4th dose of BioNTech vaccine after two doses of CoronaVac and one additional dose of BioNTech."
"The question of when the possible 2nd dose of BioNTech vaccine (4th dose in total) should be administered, can be answered when the results are obtained at the 3rd and 6th months after the 3rd dose administration."
The statement also noted: "None of the 44 employees who got sick in the period after the 3rd vaccine were hospitalized, and they had the disease on an outpatient basis."
https://news.google.com/articles/CBMiaGh0dHBzOi8vd3d3LmRhaWx5c2FiYWguY29tL3R1cmtleS90dXJraXNoLXVuaXZlcnNpdHktcmV2ZWFscy1maW5kaW5ncy1vZi0zLWRvc2UtZWZmaWNhY3ktb2Ytc2lub3ZhYy9uZXdz0gFsaHR0cHM6Ly93d3cuZGFpbHlzYWJhaC5jb20vdHVya2V5L3R1cmtpc2gtdW5pdmVyc2l0eS1yZXZlYWxzLWZpbmRpbmdzLW9mLTMtZG9zZS1lZmZpY2FjeS1vZi1zaW5vdmFjL25ld3MvYW1w?hl=en-US&gl=US&ceid=US%3Aen
9/29-10/3 INOVIO is proud to participate in @IDWeek2021 with the presentation of three posters about our approach of developing DNA vaccines to combat the ongoing #COVID19 pandemic. Register and see more at idweek.org!
INOVIO is proud to participate in @IDWeek2021 with the presentation of three posters about our approach of developing DNA vaccines to combat the ongoing #COVID19 pandemic. Register and see more at https://t.co/RvS6NlO9WM! pic.twitter.com/8ofLc3ONsZ
— INOVIO Pharmaceuticals (@InovioPharma) September 29, 2021
9/29 PH still awaiting WHO’s green light for solidarity vaccines trials
The World Health Organization’s (WHO) Solidarity Vaccines Trial (SVT) has yet to start in the country, the Department of Science and Technology (DOST) has disclosed.
DOST Undersecretary for Research and Development (R&D) Dr. Rowena Cristina L. Guevara, who heads the Task Group on Vaccine Evaluation and Selection (TG-VES), said there is no definite schedule yet as to when the SVT will be conducted in the country.
“To date, the study is still awaiting the go signal from WHO for the official start of the trial. Nonetheless, the Philippine team is continuously preparing all the identified sites and trial staff involved for the actual clinical trial proper,” she said in an interview with the Manila Bulletin.
She said around 15,000 eligible participants are targeted to participate in the SVT.
Guevara noted that recruitment will be conducted in 20 identified hospital and community-based sites across the National Capital Region (NCR).
“Moreover, the possibilities of expanding the trial sites on the different regions will be based on the WHO and DOH (Department of Health) Epidemiology Bureau’s monitoring and analyses of COVID-19 high attack rates.”
The DOST official said serving as lead investigators of the trial are Dr. Jodor A. Lim and Dr. Marissa M. Alejandria from the University of the Philippines Manila – Philippine General Hospital (PGH).
Guevara said the completion of the SVT will be dependent on the pace of recruitment in the country, adding that “the target is to complete recruitment within three months of the official global launch.”
After recruitment, follow-up of participants for six to 18 months will be done, she said.
“The complete clinical trials results are expected to be released once the follow-up of the participants has been completed. Follow-up may take six months up to 18 months. However, interim results on the safety and efficacy of candidate vaccines may be released by WHO at an earlier period based on the WHO Core Protocol,” she said.
DOH Secretary Francisco Duque III and WHO Chief Scientist Dr. Soumya Swaminathan had signed a letter of agreement for the conduct of SVT in the country.
The Philippines’ participation in the WHO SVT was approved by the Inter-Agency Task Force for the Management of Emerging Infectious Diseases (IATF-EID) through its Resolution No. 47.
The WHO’s SVT has a project duration of 18 months and is funded by the Philippine government through DOST and DOH.
https://mb.com.ph/2021/09/29/ph-still-awaiting-whos-green-light-for-solidarity-vaccines-trials/
Lancet: The WHO Solidarity Vaccines Trial9 (figure) aims to evaluate efficiently and rapidly (within 3–6 months of each vaccine's introduction into the study) the efficacy of multiple vaccines,10 helping to ensure that weakly effective vaccines are not deployed. The trial seeks to achieve rapid, reliable results by the simplicity of the trial design plus real-time checks on the quality of the limited amount of data sought, facilitating high recruitment rates. A major challenge with vaccine trials at fixed study sites is that unexpectedly low attack rates can delay progress. The WHO trial will mitigate this by geographical diversity, recruiting in many high-incidence countries through fixed and mobile (pop-up) research sites in localities where there are substantial COVID-19 attack rates at the time of enrolment.
The primary outcome is laboratory-confirmed symptoms >14 days after vaccination is completed. Analyses of each vaccine after about 40, 70, and 100 primary outcomes occur in the placebo group will report success if they show ≤10 versus 40, ≤30 versus 70, or ≤50 versus 100 outcomes. The third analysis is reported regardless of its findings. In all cases placebo-controlled follow-up continues until at least month 12 (or local deployment of an effective vaccine) to assess safety, disease severity, and duration of protection.
For a one-dose or two-dose vaccine that halves risk the main result on short-term efficacy should emerge within 3–6 months, unless definite results for a highly effective vaccine emerge in interim analyses. Placebo-controlled follow-up then continues until at least month 12, or until an effective vaccine is deployed locally. This approach increases the reliability of the evidence on younger and older adults, duration of protection, efficacy against severe disease, and any disease enhancement.
Funders, vaccine developers, researchers, and government institutions11 have signed an international statement of collaboration in vaccine research. Several of these developers and more than 250 research sites intend to join the WHO Solidarity Vaccines Trial in the hope of bringing forward the time when the world will move beyond the widespread disease, death, and disruption from the COVID-19 pandemic. The trial costs will be a fraction of the societal costs of COVID-19, and this global collaboration could rebut detrimental vaccine nihilism and vaccine nationalism.
We all participated in writing the protocol for the WHO Solidarity Vaccines Trial and declare no other competing interests. This Comment reflects the views of the authors and should not be construed to represent the views or policies of the US Food and Drug Administration.
https://www.thelancet.com/article/S0140-6736(20)31821-3/fulltext#fig1
9/28 Thermo Fisher to pump $82.5M into St. Louis biologics manufacturing site. Four months after Thermo Fisher Scientific announced a $600 million global push to upgrade and expand its bioprocessing operations, the company is unveiling a major piece of that plan.
Thermo Fisher will shell out $82.5 million to expand production capacity at its St. Louis biologic drug substance manufacturing site. The investment will more than double its overall production capacity while supporting both short-term COVID-19 demand and long-term efforts, the company said.
The Waltham, Massachusetts-based CDMO said the expansion in St. Louis will create 169 new jobs. The site, which currently employs 700 people, produces biologic compounds for the treatment of COVID-19, cancer and other diseases.
Two new manufacturing suites will be part of the 58,000-square-foot expansion. The site will house about $15 million in updated equipment that will expand manufacturing and production to support a 5,000-liter processing scale and 2,000-liter capacity, the company said. The current footprint of the plant is 360,000 square feet.
“This new expansion will enable further innovation in biologics manufacturing to address the continued growth in important therapies and medicines,” Michel Lagarde, Thermo Fisher's executive vice president, said in a statement.
Thermo Fisher got into the contract manufacturing business back in 2017 with a blockbuster $7.2 billion deal to buy Patheon, one of the largest contract manufacturers in the world at the time.
https://www.fiercepharma.com/manufacturing/thermo-fisher-to-pump-82-5m-into-st-louis-biologics-manufacturing-site
Intradermal-delivered DNA vaccine induces durable immunity mediating a reduction in viral load in a rhesus macaque SARS-CoV-2 challenge model
Author links open overlay panelAmiPatel1†Jewell N.Walters2†Emma L.Reuschel1†KatherineSchultheis2†ElizabethParzych1†Ebony N.Gary1†IgorMaricic2MansiPurwar1ZeenaEblimit2Susanne N.Walker1DianaGuimet2PratikBhojnagarwala1Opeyemi S.Adeniji1ArthurDoan2ZiyangXu1DustinElwood2Sophia M.Reeder1LaurentPessaint3Kevin Y.Kim1AnthonyCook3NeethuChokkalingam1BradFinneyfrock3EdgarTello-Ruiz1AlanDodson3JihaeChoi1AlisonGenerotti2JohnHarrison3Nicholas J.Tursi1Viviane M.Andrade2YayaDia1Faraz I.Zaidi1HanneAndersen3MohamedAbdel-Mohsen1Mark G.Lewis3KarMuthumani1J JosephKim2Daniel W.Kulp1Laurent M.Humeau2Stephanie J.Ramos2Trevor R.F.Smith2David B.Weiner1Kate E.Broderick2‡
1
Vaccine and Immunotherapy Center, The Wistar Institute, Philadelphia, PA, 19104, USA
2
Inovio Pharmaceuticals, Plymouth Meeting, PA, 19462, USA
3
Bioqual, Rockville, MD 20852
Received 25 November 2020, Revised 25 May 2021, Accepted 22 September 2021, Available online 28 September 2021.
Summary
Coronavirus disease 2019 (COVID-19), caused by the SARS-CoV-2 virus, has had a dramatic global impact on public health, social, and economic infrastructures. Here, we assess the immunogenicity and anamnestic protective efficacy in rhesus macaques of an intradermal (ID)-delivered SARS-CoV-2 spike DNA vaccine, INO-4800, currently being evaluated in clinical trials. Vaccination with INO-4800 induced T cell responses and induced spike antigen and RBD binding antibodies with ADCP and ADCD activity. Sera from the animals neutralized both the D614 and G614 SARS-CoV-2 pseudotype viruses. Several months after vaccination, animals were challenged with SARS-CoV-2 resulting in rapid recall of anti-SARS-CoV-2 spike protein T cell and neutralizing antibody responses. These responses were associated with lower viral loads in the lung. These studies support the immune impact of INO-4800 for inducing both humoral and cellular arms of the adaptive immune system which are likely important for providing durable protection against COVID-19 disease.
https://www.sciencedirect.com/science/article/pii/S2666379121002822
Oct 20, 16:00 WORLD VACCINE CONGRESS EUROPE 2021
BARCELONA, 19 - 21 OCTOBER 2021
[Virtual] Inovio’s DNA COVID vaccine update
Respiratory Diseases
Joseph Kim,Chief Executive Officer, Inovio Pharmaceuticals
https://www.terrapinn.com/conference/world-vaccine-congress-europe/agenda.stm?utm_source=pardot&utm_medium=email&utm_campaign=UK_10450_WVC+EU+2021_CONFPROM_Awareness_-4&utm_term=email
Turmoil at CBER: Peter Marks grabs control of FDA's Office of Vaccines ahead of 2 key career leader departures
FDA’s top vaccine official Peter Marks is pulling the plug on a months-long transition for two top career vaccine officials who abruptly called it quits in late August.
Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, her deputy director Phil Krause, announced their departures and then raised concerns with Covid-19 booster shots ahead of and during a recent Covid-19 booster vaccine advisory committee.
“It is important to allow both Marion and Phil to have time to transition before their departure after so many years with our Center,” Marks said in a memo to CBER staff on Monday morning. “Therefore, I want to let you know that beginning today, September 27, I will be assuming responsibilities as the Acting Office Director, and Marion will transition oversight and management of the activities of the office to me.”
The memo follows a hectic and at-times confusing few weeks where both Gruber, who said she was leaving in October, and Krause, who said he was leaving in November, announced their departures from FDA, then raised concerns with the booster shots in the Lancet, and questioned Pfizer’s data at the FDA’s vaccine advisory committee reviewing the boosters.
At the beginning of the Q&A session at the booster adcomm with Pfizer and the FDA, Gruber gave Krause the opportunity to question Pfizer on the statistical models used in a real-world study in Israel.
Krause claimed there was a discrepancy between the efficacy Pfizer reported using a specific model, which said efficacy after 8 months fell to 58% from 61%, but numbers calculated through a different mathematical process using cases per person-years resulted in 93% efficacy. These disparate figures, Krause said, came from the same number of cases in a study by California health care company Kaiser Permanente.
Two former FDA chief scientists — Jesse Goodman and Luciana Borio — raised concerns with the New York Times over Marks’s decision to name himself, with Goodman calling it, “extremely unusual and concerning.”
But other former senior officials have taken on additional roles as the FDA looks for a permanent replacement. Janet Woodcock was at one time head of both CDER and OND on an acting basis, before becoming acting commissioner, as the agency looked for a permanent OND leader.
BioCentury also reported Monday that two additional FDA vaccine reviewers quit their jobs as a result of Marks’s announcement. FDA media relations director Stephanie Caccomo did not respond to an Endpoints News request to verify those other two departures.
Paul Offit, a vaccine expert and member of the FDA adcomm that met to discuss the boosters, told Endpoints he thought Gruber and Krause are leaving because they didn’t like the way the booster process played out.
“They see their job as protecting the public from pharmaceutical companies’ products that may not have not been adequately tested and I think that’s what worries them about this,” Offit said.
Saad Omer, director of Yale’s institute for global health, added, “A lot of specialized expertise has been underutilized and that’s a problem.”
Sanofi calls it quits on mRNA Covid-19 shots, scrapping vaccine from $3.2B Translate Bio buyout 9/28/21
Sanofi is throwing in the towel on mRNA-based Covid-19 vaccines.
The French drugmaker will halt development on its unmodified mRNA Covid-19 shot despite what it said were positive Phase I/II results, a spokesperson told Endpoints News on Tuesday morning. Sanofi said the reason it’s stopping the Covid-19 mRNA program, developed in partnership with its new $3.2 billion acquisition Translate Bio, is because the market is too crowded.
“Our ambition is to make a significant and relevant contribution to the ongoing pandemic,” the spokesperson, Nicolas Kressmann, wrote to Endpoints in an email. “From a public health perspective, mRNA Covid vaccines are widely available today so it does not make sense for us to further advance our mRNA Covid vaccine into Phase III.”
The move represents a quick punt from Sanofi, coming a little over a year after CEO Paul Hudson shelled out $425 million upfront to partner with Translate Bio on mRNA vaccines. Hudson had seen enough positive results to approve the full $3.2 billion acquisition last month, but now Sanofi will set its sights on mRNA programs for flu and other areas rather than Covid-19.
When asked about other mRNA candidates in development, Kressmann pointed toward Sanofi’s June launch of a Phase I study for its mRNA flu shot. The company hopes to have six clinical mRNA-based candidates by 2025 across a wide range of indications including infectious disease, immunology and oncology, he said.
The Covid-19 program from Translate uses unmodified mRNA, which is different from the vaccines made by Pfizer/BioNTech and Moderna. Unmodified mRNA therapies are earlier iterations of mRNA technology that have generally seen more pronounced innate immune responses — and, consequently, side effects — in patients. Sanofi said the Phase I/II trial saw no safety concerns and had tolerability “comparable to that of other unmodified mRNA Covid-19 vaccines.”
Some mRNA companies, including BioNTech and Moderna, moved toward the modified version after a breakthrough by University of Pennsylvania scientists Katalin Karikó and Drew Weissman showed it to be safer. The pair modified one of the four nucleosides that make up RNA to help the therapies better evade the body’s natural defenses.
Moving forward, Kressmann said Sanofi will pursue both unmodified and modified mRNA-based treatments and vaccines, with a particular emphasis on “accelerating” the modified mRNA technology. In addition to the Phase I mRNA flu shot study, Sanofi is shooting to get a quadrivalent mRNA flu vaccine into the clinic in 2022.
“Based on the positive results that we have now, we are now accelerating our work to next-generation mRNA vaccines and aim to work on a less reactive and more stable technology, which is what makes sense now for public health,” he said.
Sanofi is still working on its recombinant-based Covid-19 vaccine with GlaxoSmithKline, currently in Phase III, and launched a study to evaluate the shot as a booster. The companies are trying to position the vaccine as a booster for any Covid-19 shot, regardless of platform, highlighting preclinical data that they said “strongly boosted” immune responses.
“The Cantor fireside chat change in date has to do with scheduling conflict. The analyst at Cantor and Dr. Kim had scheduling conflicts so we had to make adjustments” 9/28/21
Register for the Cantor Global Healthcare Conference
Inovio Pharmaceuticals, Inc.
Presenting at: 9/30/2021 12:40 PM (ET)
Why does the fireside chat move from 9/27 to 9/28, then 9/30?
Does Ino wait for WHO’s announcement of Solidarity Vaccine Trial before announcing 4800 P3 start, its trial protocol, and participating countries?
Will Brazil’s first 4800 P3 shot be administered on 9/30?
4802 status? dMAb collaboration with AZN status?
3rd GBM Drug Development Summit. Conference Day Two
Thursday, January 20, 2022
A Deep Dive into DNA Damage Repair for GBM
Jeffrey Skolnik
VP Clinical Development Inovio
8:40A EST
Inovio’s DNA Medicine for the Treatment of Glioblastoma:
• UsingnovelDNA-encodedmedicinestotreathumancancerssuchasGBM
• Generating robust, specific anti-tumor T cells against GBM antigens
• Combining DNA medicine with immune checkpoint inhibitors to build clinical responses
January 18 - 20, 2022 | Boston MA
www.glioblastoma-drugdevelopment.com
9/17/21 4700 542ppl P2 MERS Update: Two Kenya sites were added for DoD-funded Walter Reed Project (WRP). MERS has been funded together with Lassa fever by $56M CEPI. This is the first indication DoD would fund it too.
Kenya
Kenya Medical Research Institute (KEMRI)/Walter Reed Project (WRP)
[Not yet recruiting]
Kericho, Kenya, 20200
Ahero Clincal Trials Unit
[Not yet recruiting]
Kisumu, Kenya, 40100
clinicaltrials.gov/ct2/hist...
in addition to 2 sites in Jordan and 2 sites in Lebanon.
American University of Beirut Medical Center
[Recruiting]
Beirut, Lebanon
Hammoud Hospital University Medical Center
[Recruiting]
Jordan
Clinical Research Center, Irbid Specialty Hospital (CRC/ISH)
[Not yet recruiting]
Irbid, Jordan, 21110
Pharmaceutical Research Center / Jordan University of Science and Technology
[Recruiting]
https://clinicaltrials.gov/ct2/history/NCT04588428?A=12&B=13&C=merged#StudyPageTop
Mexico ???? ??, Brazil ??????, Philippines ???? ??, China ???? ??, Colombia ??????, Argentina ????, Peru ????, Thailand ????, Vietnam ????, Czech Republic ???? , Poland ???? , Rwanda ????, Tunisia ????
https://stocktwits.com/porfstock/message/380211605
https://www.world-today-news.com/invima-authorizes-clinical-trial-of-covid-vaccines-in-colombia-government-economy/
https://registry.healthresearch.ph/index.php/registry?view=research&layout=details&cid=3894&fbclid=IwAR30EEccm--YIE-RdM_plUoZe678mCpf4i-E67JM41NT22GbSi5dB0MQ_L8
China: 2 4800+Sinovac; 2 Sinovac+4800
https://www.chictr.org.cn/hvshowproject.aspx?ID=96769
Inovio announced that it has received authorization from COFEPRIS, the national health regulatory agency of Mexico, to conduct a clinical trial in that country as part of P3 segment of INOVIO's global P2/3 trial, INNOVATE, for its DNA vaccine candidate for COVID-19, INO-4800. INOVIO is working with its partner Advaccine Biopharmaceuticals Suzhou Co., Ltd. on the INNOVATE Phase 3 segment in multiple countries. INOVIO recently announced that it has received regulatory authorization to proceed with Phase 3 clinical trials in Brazil and the Philippines and is seeking authorization to conduct trials in additional countries.
https://ir.inovio.com/news-releases/news-releases-details/2021/INOVIO-Receives-Regulatory-Authorization-to-Conduct-Phase-3-Efficacy-Trial-of-its-COVID-19-DNA-Vaccine-Candidate-INO-4800-in-Mexico/default.aspx
the key number to remember is about 150 symptomatically confirmed COVID-19 disease. Our first interim look is at 50% of the cases, so about 75 cases. We have a second interim look at 75%; and then, of course, full data analysis at above 150 cases. So we expect the first interim readout to be in the first quarter, before the end of first quarter in 2022. And with the data, if we're successful, we plan to rapidly apply for emergency use authorization through the WHO pathway but also various countries where emergency uses would be still available.
And then, with full data set and safety follow-up, we are planning to apply for the BLA in the U.S. MAA in Europe, of course, as available in all different jurisdictions in 2023.
That's one of our biggest strength, having such a low frequency of AEs and severity of AEs. We look forward to demonstrating that having -- and also having that global database of safety and efficacy that allows under our current understanding for bridging additional vaccines to -- such as INO-4802 to bridge back to and leverage the efficacy and safety data from INO-4800. So, I think the name of the game is to bring these additional variant focused vaccines or even pan-variant vaccines out as rapidly as possible to combat the trajectory of this COVID-19 disease.
We can generate a vaccine sequence that's not like any of a naturally occurring sequence but it looks a lot like many of the variants of concern of today but also potential outbreaks in the future.
So we've designed it that way. We've built our SynCon proprietary system around it and we're testing 4802 against that. In preclinical animal studies, we've been able to show protective responses and actual protection against most of the available variance of concerned variants. And then, we're planning to start the first Phase 1/2 trial before the year-end. 9/21/21 JK@Oppenheimer
“we plan to present at a fourth quarter cancer conference, our results of OS24 but also median OS. And I don't want to take the punchline but we have been achieving better than standard of care in each of those characteristics and milestones. So we couldn't be any happier in the progress from this trial.
We also plan to bring out what our next steps might be around that time. So as I said, Regeneron has been a wonderful partner and we look forward to executing with them this trial and potentially additional ones to come.“ 9/21/21 JK @Oppehheimer
“looking at DNA vaccines where we did a study with Inovio and their DNA vaccine platform in GBM. So, these are all in the early stages, exploratory stages. We hope we will be able to present data at meetings like SITC, AACR as well as ESMO and ASCO. And all I can say there is kind of stay tuned.” 9/20/21 Israel Lowy, Senior Vice President, Transitional Sciences and Oncology, Regeneron.
9/7/21 Philippines awaits WHO go signal for solidarity vaccine trial
MANILA – The Philippines is ready and just waiting for the World Health Organization's (WHO) go signal for the conduct of solidarity vaccine trial, an official of the Department of Science and Technology (DOST) said Tuesday.
"The hospital sites, (vaccine) trial teams, and the supplies needed were already prepared. We are just waiting for the formal announcement of the WHO for the global and local launching of this study," said DOST Undersecretary Rowena Cristina Guevara in a public briefing.
Asked why the solidarity vaccine trial takes long to start, Guevara said this is a global study, and the Philippines is not the only country to participate.
"As such, the WHO ensures that every participating country is prepared for the launching of the solidarity vaccine trial," she said.
The WHO conducts a thorough negotiation and review of the vaccines that will be included in the study, Guevara added.
She also said the WHO had also to consider the new Covid-19 variants as well as update the clinical trial protocols and standard operating procedures.
Among the objectives of the solidarity vaccine trial, she said, is to determine the effectiveness of the vaccines against the variants of concern in the country. The study targets to include participants 16 years old and above.
Guevara said aside from the WHO solidarity vaccine trial, the country has been receiving applications for independent clinical trials.
There are applications that would like to include people aged 3 to 16, as well as people with human immunodeficiency virus (HIV), she added.
Results of clinical trials are important to be considered in the National Covid-19 Vaccination Program, to determine ways forward, she said.
"It is important to consider the genetic differences of various ethnicity, to see the effectiveness and safety of the vaccines. We could see and compare data from other countries. This would help in vaccine development, as well as on deciding which among the vaccines are best against the new variants," she said.
The DOST and the Department of Health have been coordinating with each other regarding the allotment of vaccine doses for clinical trials.
Local chief executives, on the other hand, are preparing the vaccine trial sites, according to Guevara. (PNA)
https://www.pna.gov.ph/articles/1152859
9/16/21 Two expert health leaders from Brazil, Columbia join CEPI Board
https://cepi.net/news_cepi/two-expert-health-leaders-join-cepi-board/
Brazil, Columbia started 4800 P3.
Together, Dr. Lima and Dr. Uribe will serve as the two Latin American representatives on the CEPI Board. Dr. Lima will serve as a Board voting member and will also sit on CEPI’s Audit and Risk Board Committee. Dr. Uribe takes over the World Bank’s seat on the CEPI Board, a non-voting institutional role previously held by former World Bank representative, Dr. Muhammad Ali Pate. They will both assume their roles at CEPI’s Board Meeting, taking place today and tomorrow (16th-17th September).
9/13/21 H.C. Wainwright 23rd Annual Global Investment Conference. JK said AZN-dMAb clone is in P1. 4800 P3 started in Brazil. Interim readout in 1Q22. If excellent, will apply for WHO’s EUL in 1Q22, and EUA in other countries.
9/13/21 H.C. Wainwright 23rd Annual Global Investment Conference. JK said AZN-dMAb clone is in P1. 4800 P3 started in Brazil. Interim readout in 1Q22. If excellent, will apply for WHO’s EUL in 1Q22, and EUA in other countries.
China: 2 4800 doses+Sinovac; 2 Sinovac doses+4800
https://www.chictr.org.cn/hvshowproject.aspx?ID=96769
9/13/21 From Inovio's answers and counterclaims in the GeneOne/Inovio Cellectra contract lawsuit:
"Currently, Inovio's Vaccine Candidate is in Phase III clinical testing in Argentina, Brazil, Colombia, the Czech Republic, Mexico, Peru, and the Philippines."
https://stocktwits.com/porfstock/message/380211605
9/14/21 Invima authorizes clinical trial of covid vaccines in Colombia: INO-4800 as part of Vaccine Solidarity Trial sponsored by WHO.
https://www.world-today-news.com/invima-authorizes-clinical-trial-of-covid-vaccines-in-colombia-government-economy/
Link to Philippines study
https://registry.healthresearch.ph/index.php/registry?view=research&layout=details&cid=3894&fbclid=IwAR30EEccm--YIE-RdM_plUoZe678mCpf4i-E67JM41NT22GbSi5dB0MQ_L8
4800 P3 COUNTRIES
Brazil ????, Colombia ????, Mexico ????, Philippines ????, Rwanda ????, Thailand ????, Tunisia ????, Vietnam ????
Two 4800 Heterologous Prime-Boost trials in China ????
“I think listing in Korea will probably be difficult this year. As noted before OS24 data with accompanying immune data will be announced at an upcoming oncology conference before the end of the year. Advaccine will drive the booster study in China.” 9/15/21
9/16/21 NEJM: Safety and Immunogenicity of an Anti–Zika Virus DNA Vaccine
List of authors.
Pablo Tebas, M.D., Christine C. Roberts, Ph.D., Kar Muthumani, Ph.D., Emma L. Reuschel, Ph.D., et al.
Supported by GeneOne Life Science and in part by a grant (AI069534) to the Clinical Trials Unit at the University of Pennsylvania from the National Institutes of Health. Inovio Pharmaceuticals (codeveloper of the vaccine) provided electroporation devices and supplies. Dr. Weiner is supported in part by a grant (R01-AI092843) from the Intramural Research Program of the National Institute of Allergy and Infectious Diseases and through the W.W. Smith Chair in Cancer Research.
BACKGROUND
Although Zika virus (ZIKV) infection is typically self-limiting, other associated complications such as congenital birth defects and the Guillain–Barré syndrome are well described. There are no approved vaccines against ZIKV infection.
METHODS
In this phase 1, open-label clinical trial, we evaluated the safety and immunogenicity of a synthetic, consensus DNA vaccine (GLS-5700) encoding the ZIKV premembrane and envelope proteins in two groups of 20 participants each. The participants received either 1 mg or 2 mg of vaccine intradermally, with each injection followed by electroporation (the use of a pulsed electric field to introduce the DNA sequence into cells) at baseline, 4 weeks, and 12 weeks.
RESULTS
The median age of the participants was 38 years, and 60% were women; 78% were White and 22% Black; in addition, 30% were Hispanic. At the interim analysis at 14 weeks (i.e., after the third dose of vaccine), no serious adverse events were reported. Local reactions at the vaccination site (e.g., injection-site pain, redness, swelling, and itching) occurred in approximately 50% of the participants. After the third dose of vaccine, binding antibodies (as measured on enzyme-linked immunosorbent assay) were detected in all the participants, with geometric mean titers of 1642 and 2871 in recipients of 1 mg and 2 mg of vaccine, respectively. Neutralizing antibodies developed in 62% of the samples on Vero-cell assay. On neuronal-cell assay, there was 90% inhibition of ZIKV infection in 70% of the serum samples and 50% inhibition in 95% of the samples. The intraperitoneal injection of postvaccination serum protected 103 of 112 IFNAR knockout mice (bred with deletion of genes encoding interferon-a and interferon-ß receptors) (92%) that were challenged with a lethal dose of ZIKV-PR209 strain; none of the mice receiving baseline serum survived the challenge. Survival was independent of the neutralization titer.
CONCLUSIONS
In this phase 1, open-label clinical trial, a DNA vaccine elicited anti-ZIKV immune responses. Further studies are needed to better evaluate the safety and efficacy of the vaccine. (Funded by GeneOne Life Science and others; ZIKA-001 ClinicalTrials.gov number, NCT02809443. opens in new tab.)
https://www.nejm.org/doi/full/10.1056/NEJMoa1708120?query=TOC&cid=NEJM%20eToc,%20September%2016,%202021%20DM295772_NEJM_Non_Subscriber&bid=616644539
9/13/21 From Inovio's answers and counterclaims in the GeneOne/Inovio Cellectra contract lawsuit:
"Currently, Inovio's Vaccine Candidate is in Phase III clinical testing in Argentina, Brazil, Colombia, the Czech Republic, Mexico Peru, and the Philippines."
https://stocktwits.com/porfstock/message/380211605
“Dr. Kim mentioned during his chat that we will be announcing our GBM data at an oncology conference later this year and we are on track to do so” 9/15/21
24-month OS data expected later this year, including correlative immunology and tissue data, as well as total study drug exposure and concomitant medication use.
26th Annual Meeting and Education Day of the Society for Neuro-Oncology
November 18 - 21, 2021
The General Abstract acceptance emails were sent on 8/6/21
Embargo Details:
The embargo for abstracts published in the 2021 abstract supplement to SNO official journal Neuro-Oncology will lift at 7:00 AM (EDT) on Thursday, November 11, 2021.
These abstracts will be made available at: https://academic.oup.com/neuro-oncology
General Abstract Deadline was Monday, May 24, 2021, 11:59pm EDT
Late Breaking Abstract Deadline: Friday, September 3, 2021, 11:59pm EST.
9/15 WHO-sponsored program to test efficacy of Medigen's, Inovio's vaccines: 40K ppl, 16 or above in Columbia, Argentina, Brazil, Chile, El Salvador, and Mexico
TAIPEI (Taiwan News) — Human trials for Taiwan’s homegrown COVID vaccine developed by Medigen Vaccine Biologics Corp. (MVC) will be conducted in Colombia, sponsored by the World Health Organization.
The food and drug regulator of Colombia said on Mon (Sept. 13) that Medigen and U.S.-based Inovio Pharmaceuticals have been granted permission to run clinical trials for their COVID vaccines in the country.
The trials are backed by the WHO, which selects vaccine candidates on a random basis. Colombia was chosen from a list of 20 countries, making it one of the six Latin American nations to have participated in trials for a COVID vaccine, along with Argentina, Brazil, Chile, El Salvador, and Mexico.
The 15-month trials for both candidates will involve 40,000 volunteers aged 16 and above who belong to high-risk groups.
They will include those dwelling in high-risk areas, medical and frontline workers, and unvaccinated employees who play a role in keeping society running, according to CNA.
Medigen is the first of the three Taiwanese COVID vaccine manufacturers to be rolled out and has seen over 710,000 doses administered nationwide. United Biomedical Inc. (UBI) failed to secure emergency use authorization, while Adimmune on Monday announced trial plans in Indonesia.
https://www.taiwannews.com.tw/en/news/4287586
“We do not have a transcript available for the Wainwright conference.
The countries can start independently. They do not have to wait until all target countries have approved the start of the trial.
The China booster trial consist of two trials – one where INO-4800 is a booster to Sinovac’s vaccine and another where Sinovac’s vaccine is a booster to INO-4800.” 9/14/21
9/14/21 Invima authorizes clinical trial of covid vaccines in Colombia: INO-4800 as part of “Vaccine Solidarity Trial – an international randomized trial of vaccine candidates against covid-19”; study sponsored by the World Health Organization-WHO.
National Institute for Food and Drug Surveillance (Invima), reported that it approved the clinical research protocol with drugs for the beginning of “Vaccine Solidarity Trial – an international randomized trial of vaccine candidates against covid-19”; study sponsored by the World Health Organization-WHO.
The authorization is given after jointly by the Clinical Research Group of the Directorate of Medicines and Biological Products and the Specialized Room for Medical Devices and In Vitro Diagnostic Reagents The Institute will evaluate the information provided for Colombia to join this clinical trial that aims to collect information regarding the efficacy and safety of various vaccines against covid-19, through the design of a highly innovative study.
Colombia was chosen among 20 candidate countries worldwide, and in the region it will be together with Argentina, Brazil, Chile, El Salvador and Mexico.
The trial is designed with the objective of coordinating a rapid, efficient and reliable evaluation of the candidate vaccines under development against SARS-CoV-2, in relation to their safety and efficacy and to identify those that will be appropriate to delay the progression of the illness.
Initially Colombia will participate with two types of vaccines: MVC-COV190115 developed by the company Medigen Vaccine Biologics Corp, a live attenuated virus vaccine; and INO-4800, developed by Inovio Pharmaceuticals, which uses a deoxyribonucleic acid (DNA) technology and also links the use of an electroporation device called CELLECTRA ™ 2000
It is expected that other types of vaccines will enter during their development with the participation of 120,000 volunteers worldwide and around 40,000 in Colombia, volunteers must be over 16 years of age who reside in places with a high incidence of the SARS-CoV-2 virus , or whose circumstances represent a significant risk of exposure, such as health workers, frontline workers, essential workers in areas that do not yet have access to vaccines, and will last approximately 15 months.
Initially The institution authorized to carry out this clinical trial is the Colsanitas SA Clinic, University Clinic Headquarters located in the city of Bogotá, with Dr. Julio Alberto Chacón Sarmiento as the main investigator of this trial.
However, institutions certified in Good Clinical Practices (GCP) or those that have the endorsement of a certified entity in accordance with the provisions of Resolution 730 of 2020 may participate in the clinical study.
This study is added to the 5 clinical trials of vaccines that are being carried out in Colombia.
https://www.world-today-news.com/invima-authorizes-clinical-trial-of-covid-vaccines-in-colombia-government-economy/
4800 P3 COUNTRIES OF RECRUITMENT:
Brazil ????, Colombia ????, Mexico ????, Philippines ????, Rwanda ????, Thailand ????, Tunisia ????, Vietnam ????
Two 4800 Heterologous Prime-Boost trials in China ???? : 2 doses of 4800 followed by either 0.5mL Sinovac’s CoronaVac or 2mg 4800
Danyang City Center for Disease Control and Prevention
Started 8/4/21
Link to China Study
https://www.chictr.org.cn/hvshowproject.aspx?ID=96769
Link to Philippines study
https://registry.healthresearch.ph/index.php/registry?view=research&layout=details&cid=3894&fbclid=IwAR30EEccm--YIE-RdM_plUoZe678mCpf4i-E67JM41NT22GbSi5dB0MQ_L8
In the Phase 3 segment, approximately 6714 seronegative and 402 seropositive subjects 18 years of age and older will be randomized at a 2:1 ratio to receive either active investigational product (INO-4800, 2.0 mg) or placebo (SSC-0001). Approximately half of seronegative subjects and approximately half of seropositive subjects will be 18-50 years of age, and the other half will be ≥51 years of age as is operationally feasible. Also, approximately 711 subjects will be ≥65 years of age, if operationally feasible. The recruitment target for the Philippines is approximately 587 subjects (randomized). Phase 3 total study duration is 13 months; it can be up to 14 months if the subject uses the full screening period (of 30 days + 56 weeks for treatment and follow up).
PRIMARY OUTCOMES
Incidence of virologically-confirmed COVID-19 disease starting 14 days after completion of the 2-dose regimen until 12 months post-dose 2 (End of Study (EOS)) in subjects who are SARS-CoV-2 seronegative at baseline