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The following are the officially announced INO-4800 Phase 3 clinical trial countries.
8/26/21 Brazil
9/22/21 Mexico
10/11/21 Columbia
10/20/21 China
10/29/21 Philippines
11/3/21 India
11/8/21 Thailand
11/9/21 USA
The following are additional countries that were mentioned in various global articles for countries that may potentially be added. There is potentially 20 countries plus or minus that may be participating.
Rwanda
Tunisia
Czech Republic
Peru
Argentina
El Salvador
Vietnam
Poland
Chile
Where was this information posted from regarding the trials?
Looks like Richter-Helm, one of INOVIO’s global manufacturing partners is tripling it’s manufacturing capacity.
https://www.calameo.com/read/006113385ca3f0870fdca
The Tsunami Wave is Forming.
I agree 100%. Advanced DNA medicines will be a disruptor to big pharmaceuticals sales model. They aren’t going to like it, but they can’t stop it.
Ridiculous comments. You’re in for a big surprise. Remember this post as I will remember yours.
Something to consider here is that when the CELLECTRA device goes out to China, Latin America, Western Europe or wherever, the doctors using the device will be asking,
“What is this new medical device, and what else can it be used for?”
The PR for this device will be all over the news in these countries.
This is going to be a great sales pitch opportunity for INOVIO’s pipeline in the works.
No doubt countries will be asking about INO-4802 as a booster, and about the HIV and cancer cures in the works.
Dr. Bin Wang with Advaccine and Dr. David B. Weiner with The Wistar Institute have known each other for over 26 years from the University of Pennsylvania, and have collaborated together and been friends all this time.
Dr. Wang has done a lot of work with DNA therapies.
Here is INOVIO Asia IR response to an email I sent at 10:30 PM last night. I received an answer by midnight. Now that’s fast. If you have questions, ask INOVIO Asia IR. They typically answer within the same day.
We believe there are certain advantages of pursuing an ex-US P3 strategy such as lower trial costs, faster enrollment rates (enrollment in the US will be very challenging given the wide availability of vaccines), etc. As you know we are working with overseas governments about starting the trials in the respective countries. As Dr. Kim had mentioned, we had also received CE Marking for Cellectra a while ago. Hence, we are able to begin trials in our target countries once the respective governments provide clearance. We consider FDA's decisions very important and we will continue to work with the FDA, but to reiterate, our ability to start the P3 trials overseas is not predicated on the FDA. I want to stress, though, that we will continue to seek FDA's guidance and maintain constant communication.
Thank you
Investor Relations
I was trying to find this rule to confirm but couldn’t. I guess we will know soon enough. Tomorrow possibly.
Miami? Calling Miami! Did today and the several days look like a daily dump? You better get used to it.
Miami? Miami? Calling Miami.
Here is a response to a recent question I submitted to INOVIO Asia IR. They are very quick to respond if you should have any questions.
investor.relations@inovioasia.com
Dear Mr. ———
Yes. We are definitely considering doing our trial in the heart of the storm – Africa, India, etc…
We will keep you informed.
Thank you as always
Investor Relations
No doubt China is a huge market potential. Just a little matter of time.
Dr. Kim,
So with our pan-COVID vaccine, INO-4802 the candidate, we just published great immune data in animal models in bioRxiv. Our plan is to advance this program into an accelerated Phase 1 plus 2 trial, whereby the end of this year or very early part of '22, we will have a full immune data set from this new candidate 4802 from several hundred volunteers from the globe. So we're moving both our lead product, INO-4800, through efficacy and our goal is to commercialize that in those countries initially, go attend WHO emergency use license, as well as getting the conditional or emergency approval in these various countries. And we also plan to bring it fully back to the U.S. for BLA application on approval.
Phase 3 going global soon.
EUL via the WHO to follow later this year or very early 2022.
Miami, are you taking notes?
Daily increases here soon. Lots of catalysts in the works.
INOVIO’s time has come.
Nice price action lately. Monday is a holiday. Jefferies meeting Tuesday. Next week is a short week. Somebody knows something big is coming. Tick, tick, tick, boom!
Sorry, keep bashing but you can’t stop the science.
DNA advanced medicines here soon.
The price is in reversal mode on the way up. Phase 3 here soon. Wait for it. Won’t be long now.
Look at the real world progress of the clinical trial patients for INO-5401 for glioblastoma brain cancer and VGX-3100 for cervical cancer.
The patients have shown real life cancer regression and some have shown complete regression of the cancer.
You can’t deny the real life results that INOVIO’s cancer cures are working.
Institutional ownership now 46%. It was 39% just 3 months ago.
Just think, all these different tutes have teams of investment researchers seeking to buy the best investments.
They know where to put their money. The first DNA advanced medicine is on it’s way.
INOVIO will make history with it’s first with more to follow.
Yes sir! It’s on it’s way. INOVIO has 3 new job openings for Clinical Device Training and Operations Associates Specialist.
The position requires 30% domestic and international travel and must be able to leave at a moment’s notice.
We’re going global!
Phase 3 news on the way. There’s no stopping it.
Dr.Kim 2 weeks ago today,
“We are 100% confident that we will be meeting the FDA questions with the CELLECTRA device prior to starting their Phase 3 trials. We have developed and are currently testing our commercial CELLECTRA 3PSP device.”
3 New job postings at INOVIO for Clinical Device Training positions.
Doubters get ready!
They are getting ready!
The NIH also have funded The Wistar Institute for melanoma research. Look it up.
The Wistar Institute and Other Top U.S. Cancer Centers Call for Urgent Action to Get Cancer-Preventing HPV Vaccination Back on Track.
https://wistar.org/news/press-releases/wistar-institute-and-other-top-us-cancer-centers-call-urgent-action-get-cancer
The DOD just paid $54.5M to INOVIO for the manufacturing scale up for the CELLECTRA 3PSP device. That means they reviewed and approved the device. That also means the FDA will release the hold. Phase 3 on the way.
https://govtribe.com/award/federal-contract-award/other-transaction-agreement-w911qy2090016
Check this out!
Kate on the San Diego news talking about their development of a universal Covid-19 vaccine.
https://www.10news.com/news/coronavirus/san-diegos-inovio-makes-progress-on-universal-covid-19-vaccine
Well, nice day today. Many more on the way. The tide is changing. Just sayin.
Remember this one? Sounds like INOVIO and CEPI are collaborating doesn’t it? Hmmm...more CEPI funding? Sounds like it to me.
Dr. Kim,
In parallel, we are advancing INO-4802, a more pan-varian or pan-covid vaccine which uses all of our gene engineering and gene optimization, using our SynCon approach, designed our INO-4802 with all the different gene sequences from thousands of different variants, and we can use artificial intelligence to predict and provide a sequence that looks a lot like every other sequence, but it’s not identical to one.
CEPI launches funding call to advance development of broadly protective coronavirus vaccines.
https://cepi.net/news_cepi/cepi-launches-funding-call-to-advance-development-of-broadly-protective-coronavirus-vaccines/
Well just look at that. Looks like investors liked the Bank of America investor meeting. Somebody knows something.
I’m glad I made you laugh.
Believe it or don’t. That’s your choice.
They will be fast tracking Phase 1/2 for INO-4802 in 2021. Get used to it.
This is CEPI’s $3.5B plan. I believe INO-4802 will be part of their plan as a pan-coronavirus vaccine.
https://endpandemics.cepi.net/
Should know something in about a couple weeks what’s going on with their global Phase 3 strategy.
My guess is CEPI via COVAX will be funding INOVIO and I believed that for a long time.
It seems that they are collaborating together based upon their posts and timing of their posts.
CEPI is already a partner for INO-4800 in their pipeline chart.
I guess you can’t post pictures here but I have a snapshot of a COVAX chart that includes 9 vaccine candidates. INOVIO, IVI, and Advaccine are all grouped together for INO-4800. There’s lots of news articles coming out of China about INO-4800 and VGX-3100.
Here’s what Dr. Kim stated about funding.
We should be able to articulate in full detail our Phase 3 strategy in the next few weeks as we execute these plans. We are working with our funders and our partners to bring this all together within the next few weeks.
More good news on the way.
The Phase 3 trials will be done in multiple countries, so it makes sense that we perform in those countries that are the most interested in acquiring our vaccine once our vaccine is approved. We have multiple ongoing and in parallel discussions for potentially, and advanced market contracts with these countries. Once these come to the fruition, we will be sharing with the investor community about this progress.