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“We are excited to be participating in the SITC 2021 pre-conference workshop, and look forward to Dr. Reardon’s presentation: “INO-5401 and INO-9012 Delivered Intramuscularly (IM) with Electroporation (EP) in Combination with Cemiplimab (REGN2810) in Newly Diagnosed Glioblastoma."
Ino is analyzing data for OS30. Dr. Jeffrey Skolnik said “we still have yet to have reached median overall survival in our MGMT - methylated patients. That's a good thing that we haven't met that median yet. Pending those data, we'll really make decisions as to where we can bring this opportunity forward but in general, we're very encouraged by what certainly the key opinion leaders and the scientists and clinicians are telling us in this space.”
Patients can apply for Compassionate Use with FDA anytime now. There is a good market for it worldwide.
We are excited to be participating in the SITC 2021 pre-conference workshop, and look forward to Dr. Reardon’s presentation: “INO-5401 and INO-9012 Delivered Intramuscularly (IM) with Electroporation (EP) in Combination with Cemiplimab (REGN2810) in Newly Diagnosed Glioblastoma."
— INOVIO Pharmaceuticals (@InovioPharma) November 10, 2021
5:15 p.m 11/10 INO-5401 and INO-9012 Delivered Intramuscularly (IM) with Electroporation (EP) in Combination with Cemiplimab (REGN2810) in Newly Diagnosed Glioblastoma
David A. Reardon, MD – Dana-Farber Cancer Institute
5:25 p.m. Panel Discussion
Moderator: Giovanni Melillo, MD – AstraZeneca
Panelists: Jonathan Cheng, MD – Bristol Myers Squibb
Sandra Demaria, MD – Weill Cornell Medicine
Lawrence G. Lum, MD, DSc – University of Virginia
David A. Reardon, MD – Dana-Farber Cancer Institute
Session III: Novel Combinations
4:45–6:00 p.m. EST
Wednesday, Nov. 10, 2021*
2–6 p.m. EST
Independence Ballroom (Marriott Marquis)
Learning Objectives
At the conclusion of this activity, participants should be able to:
Outline the role of immune cells other than T cells in anti-cancer immunity
Summarize the state of CAR T application in solid tumors and future directions for this field
Discuss the rational combination of immunotherapies with other anti-cancer modalities to improve patient outcomes
The Evolution of Immunotherapy: An Exploration of Immunity Beyond T cells, CAR T in Solid Tumors and Novel Combinations is supported in part by grants from Bristol Myers Squibb and Genentech, Inc.
https://www.sitcancer.org/2021/program/pre-conference-programs/industryprogram
“We're very pleased, as you say it, being able to present our data later this week at the pre -conference symposium at the SITC meeting, where Dave Reardon will be presenting the OS24 data, again, with some updated immunology and some tissue-based data which we're particularly excited. I think utilizing those data, along with what we've known before -- again, we previously demonstrated median overall survival in our MGMT-unmethylated population that's been higher than what we would've expected with respect to historical controls, and we still have yet to have reached median overall survival in our MGMT - methylated patients. That's a good thing that we haven't met that median yet. Pending those data, we'll really make decisions as to where we can bring this opportunity forward but in general, we're very encouraged by what certainly the key opinion leaders and the scientists and clinicians are telling us in this space. We're very encouraged by the fact that again, we have the opportunity to present at a peer-reviewed scientific meeting. And so I look forward to next opportunities specifically for 5401 in the GBM” Dr. Jeffrey Skolnik
Moderna and NIH can't agree on who invented the lifesaving Covid-19 vaccine, and their feud is now public — report
Max Gelman
Editor
Moderna’s ongoing feud with the NIH over Covid-19 vaccine patents has spilled into the open.
In a new report from the New York Times published Tuesday afternoon, Moderna is asserting that three NIH scientists were not involved in inventing the key component in the biotech’s vaccine, to the surprise of the institute. The claim comes from a July filing with the US Patent and Trademark Office, which the NYT posted in full along with its report.
Within the filing, Moderna said it had “reached the good-faith determination” that three NIH scientists — John Mascola, Barney Graham and Kizzmekia Corbett — “did not co-invent” the sequence that prompts the body’s immune response to the coronavirus spike protein. The NIH, meanwhile, says the trio worked with Moderna at the outset of the pandemic to design the component in question.
In response to an Endpoints News request for comment, a Moderna spokesperson said the company has “all along” recognized the role the NIH played in developing the Covid-19 shot. But the spokesperson insisted only Moderna scientists invented mRNA-1273 — the codename for the company’s vaccine.
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The spokesperson also claimed that Moderna wasn’t not allowed to “choose” who to list on the patent application, per US law. It’s not clear to which law or laws Moderna is referring to.
“Following those rules, as we must, Moderna is required to only list Moderna scientists as the inventors for the patent claims to mRNA-1273,” the spokesperson wrote in an email. “Moderna’s conclusion is driven by nothing other than our obligation to comply with U.S. patent law.”
Endpoints has also reached out to the NIH and will update this story accordingly.
The patent has not yet been issued, and the NIH is reportedly insisting the three scientists be included on the application.
At the center of the debate is whether Moderna’s Covid-19 vaccine originally sprung from a collaboration between the biotech and the institute, as the pair had been researching other coronaviruses for four years when SARS-CoV-2 first emerged. The NIH called the shot the “NIH-Moderna vaccine” in press releases last year at the Phase III readout, though Moderna CEO Stéphane Bancel pushed back on that description in an interview with MIT Technology Review.
Should the PTO issue Moderna a patent based on the current application, the government would have to go to court to obtain a license. It’s not clear when the PTO is expected to make its decision.
Moderna’s back-and-forth with the NIH has been ongoing for over a year now. The NYT reports that the agency would not need Moderna’s permission to license the vaccine technology to other companies, countries or organizations if the scientists are named on the patent. Such a move could, theoretically, help boost vaccine supply.
The biotech has said previously it won’t enforce its patents during the pandemic, but the NIH backing would provide the authority of the US government rather than just a public company statement. The NIH could also benefit financially from its researchers being listed, though it’s not clear how much, the NYT’s report says.
Tuesday’s report comes as President Joe Biden’s administration has been ramping up pressure and criticism on Moderna for primarily selling vaccines to wealthier countries, despite pulling in billions of dollars in profits, and resisting calls to share its vaccine IP. Last week, Public Citizen also called on Moderna to “clarify” the NIH’s role in inventing the vaccine tech in a letter to agency director Francis Collins.
In the new book A Shot to Save the World out last month detailing the inventions of the mRNA Covid-19 vaccines, Wall Street Journal reporter Gregory Zuckerman wrote the three NIH scientists in question designed a sequence for a vaccine and sent it to Moderna. The biotech then used it to confirm their own designs and produce that vaccine.
Zuckerman wrote:
On Thursday, January 23, Wang packed his material in a container, trying hard to ensure it didn’t leak, and shipped it all to Kizzmekia Corbett, the government scientist who was doing similar work with other’s in Graham’s lab. Corbett, Graham and John Mascola chose an ideal spike-protein design and sent it to Moderna. The company’s scientists, relying on McLellan and Wang’s earlier work, had built their own spike-protein design. It matched the one from the government scientists, confirming they made the right choice. Moderna took their chosen sequence, employed some sophisticated computer software, and built an mRNA molecule capable of producing the stabilized spike protein. This would become Moderna’s vaccine antigen.
JK “ I would just say the devices are really important and obviously the partial hold was just in the U.S. so we really didn't have a material impact in opening countries and sites outside the U.S. As we've shown, 6 other country openings for our trial in last several weeks. But it really -- the clinical hold lift and authorization for Phase 3 in the U.S., it provides us additional validation, and it shows that we have met all of the concerns of the U.S. FDA satisfactorily. That being said, we're really pleased that -- to say that the dosing for INNOVATE Phase 3 trial has already begun and it's underway. And interim efficacy -- it's a case-driven study so magic number is around 150 lab-confirmed cases and of course, interim will be at the 50% of those cases.
So faster re-enroll and the percent of attack rate in those countries or those regions will really impact when exactly where we will meet that 50% efficacy -- these are all blinded until we hit about 75 cases. So that's why we left that as a broadly first half 2022. So that's what we're looking for. And it's always been the same design from when we started the INNOVATE Phase 3 trial. So our team is working really hard to open these sites, get approvals in the country's open sites, and in all subjects. Separately, the Solidarity trial is operating independently, and we're really grateful that the WHO has selected, or their independent panel has selected INO-4800 as one of 2 initial vaccines.
And I think there's 2 more being added in the future, but out of 20 or so candidates of second wave COVID-19 vaccines out there, so we're highly grateful for that selection. Obviously, we think we are the leader of the second wave of COVID-19 vaccines, and we have the opportunity to demonstrate our efficacy and safety. I have no qualms about our safety, but we still have to get to that efficacy data. And we have two shots on the goal with our INNOVATE Phase 3 trial that we're conducting with our partner vaccine, as well as WHO's Solidarity trials. We couldn't be any happier. We're excited in our opportunities here and our team is working really hard to achieve that.
What the clinical [Indiscernible] and actual Phase 3 authorization to proceed from the FDA means is we can now add the U.S. participants into this global trial. And we look forward to adding U.S. participants based on feasibility and availability of those participants.
We have received DOD funding on some of our device, 3PSP development, but IP belongs to Inovio, so we don't believe there is any overlap, but that's the thing that we -- as we work with various governments, including the U.S. government, we want to be very careful with.
I think India being a pioneering regulatory -- its regulatory agency having the experience, having the know-how to measure, and test, and grant approval, emergency approval for the Zydus's DNA vaccine. I think it's a tremendous advantage for us to have INO-4800 INNOVATE trial conducting in India. And as Anza mentioned, there are many other reasons. They have a huge population with a need for additional safe and effective vaccine. The difference between Zydus's DNA and Inovio 's is delivery. We use in vivo electroporation Selectra system that we feel has been demonstrated to optimize the delivery of DNA plasmids. We've tested this in tens of thousands of administrations. We've done a lot of clinical and preclinical studies around that. So we think our intradermal delivery of INO-4800 would give us a huge potential differentiating factor to Zydus 's DNA.
But it's also perhaps more advantageous to be the second in their regulatory process through India. They have -- India sites have a familiarity of working with DNA vaccines and I think there are other many advantages for India. So we -- we're very, very fortunate to have authorization in India, and we look forward to really having participants and data come out of India, as well as other parts of the world, in Mexico, Colombia, U.S., as well as Brazil, and other places. But I think India -- the reason why we highlighted India by Anza is their experience with the previous DNA vaccine.
Our RRP immunotherapy currently is undergoing Phase 1/2 trial. Enrollment is continuing and we hope to have both immune responses and early clinical benefit data, potentially in the first half of 2022.
there is two countries that overlaps that within the INNOVATE and Solidarity, and those are Colombia and Philippines. But the actual sites do not overlap. I think there's some synergies in that but we don't expect there to be any conflict.
our team is focused on enrolling INNOVATE as rapidly as possible and also providing the support to WHO for their Solidarity but they're driving that trial and I'm sure the efficiency and productivity is very good with the WHO. We look forward to having both sets of data as soon as they become available.
The other analysis that really helps us is the Zydus 's DNA vaccine. They were able to demonstrate efficacy with their three-dose DNA regimen, not using the same delivery system that Inovio is. With Selecta, we think that's -- and they were able to achieve their efficacy during the spike of the Delta variant in India.
So we're very optimistic that INO-4800 would fare well around the globe, especially in the countries that we have selected. In terms of where, we have selected these countries and we're recruiting these sites within those countries to maximize our likelihood of increasing the probability of getting to our endpoint as soon as possible. We have a very sophisticated information hub. It allows us to make those decisions pretty much in real time.
We have been working to scale up our plasmid -manufacturing capacities, working with various global collaborators like Thermo Fisher and others that we have in our consortium. And of course in the device side, our 3 PSP commercial device is getting prepped and ready to be scaled up. These work are getting done in parallel. These are intensive efforts to do that. Our current plan is to -- assuming we have the interim efficacy in the first half of '22, we plan to utilize that data along with the safety -- to safety data to that point to pursue emergency-use approvals in various countries where the mechanisms are available.
And of course, we would probably look to the countries that we're upgrading our Phase 3 trials in first. We also plan to pursue the emergency-use license through the WHO. And with the full efficacy data, as well as the full safety follow-up data, we plan to utilize the data in 2023, potentially for full licensures in these countries, as well as potentially PLA in the U.S. and EMEA through Europe. We have a pretty ambitious global plan. We're looking emergency approvals first in '22 and then full licensures in 2023.
Anza Mammen
in terms of the timing of getting the interim results, that's largely going to be dictated by the force of infection, as well as the rate in which each of these trials will enroll.
Jeffrey Skolnik
“ we've completed follow-up of our subjects in our REVEAL 1, the first of 2 Phase 3 pivotal studies evaluating VGX-3100 for the treatment of cervical high-grade squamous intra ephitelial lesions caused by HPV -16 and/or HPV -18, for safety and durability, a virological clearance for 18 months following the last administration. We expect to report our findings from REVEAL 1 later this year. In addition, we're continuing our partnership with Qiagen to co-develop a diagnostic tool to guide the clinical decision-making for the use of VGX-3100 in cervical HSIL.
And we look forward to sharing an update on our progress in the coming months. I'll reveal 2 studies is on track to complete enrollment of approximately 198 adult women with histologically confirmed cervical HCL before the year-end. Regarding our immuno -oncology efforts, Inovio and our partners continue to evaluate findings from our Phase 1-2 novel combination study of the DNA medicines INO -5401 and INO -9012, in combination with the PD-1 checkpoint inhibitor cemiplimab, which is being jointly developed by Regeneron and Sanofi in treating newly diagnosed glioblastoma or GBM.
And we look forward to sharing 2-year overall survival data, including correlative immunology and tissue data at a pre -conference workshop of the Society for Immunotherapy of Cancer, or SITC, the 36th Annual Meeting and pre -conference programs later this week, where Dr. David Reardon will be presenting and discussing the studies' latest findings. These will include overall survival at 24 months in both our MGMT promoter methylated and unmethylated subject cohorts, as well as correlative immunology and tissue data.”
We're very pleased, as you say it, being able to present our data later this week at the pre -conference symposium at the SITC meeting, where Dave Reardon will be presenting the OS24 data, again, with some updated immunology and some tissue-based data which we're particularly excited. I think utilizing those data, along with what we've known before -- again, we previously demonstrated median overall survival in our MGMT-unmethylated population that's been higher than what we would've expected with respect to historical controls, and we still have yet to have reached median overall survival in our MGMT - methylated patients. That's a good thing that we haven't met that median yet. Pending those data, we'll really make decisions as to where we can bring this opportunity forward but in general, we're very encouraged by what certainly the key opinion leaders and the scientists and clinicians are telling us in this space. We're very encouraged by the fact that again, we have the opportunity to present at a peer-reviewed scientific meeting. And so I look forward to next opportunities specifically for 5401 in the GBM
By a: “ Most interesting info from earning call:
Dosing 4800 phase 3 and Dr Kim confirmed that WHO trial may expand to next generation Covid vaccine. If I recall correctly, FDA allows to bridge the next version of vaccine to the phase 3 trial of current vaccine, so WHO can do the same or even more flexible to speed up the the next generation vaccine.
An awesome scenario for INO would be getting EUA for 4802 in Q1 2022. It is possible by starting phase 1/2 of 4802 later this month or early next month.
1. Do phase 1 of 4802 in Columbia and Philippine later this month or next month. INO completed pre-clinical trial and published the result. INO may be waiting funding to next phase, but it may be smarter to fund itself to speed up the process. The cost of doing phase 1 in Columbia or Philippine is not expensive.
2. In the mean time, INO 4800 phase 3 trials continues
3. Early phase 3 4800 and phase 1 4802 readouts in Jan
4. From the early results of both 4800 and 4802, WHO would fund and start an express 4802 phase 3 trial (skip phase 2, and smaller scale phase 3?), and allows to use phase 3 data of 4800 to partially support 4802.
5. From Jan to Mar, expect to receive EUA from China and some countries participated in the trials.
6. In a wonderful scenario, China and some countries may grant EUA for INO 4802 in Feb to Apr.
INO 4802 would be the first pan covid vaccine to receive EUA.
Certainly, PFE, MRNA, NVAX has been actively developing pan covid vaccine. mRNA has more advantage in speed, but due to the nature of their vaccines, their scientists may still not be able to resolve increasing side effects with boosters in short time. It may take even more time for NVAX to have pan covid vaccine.
The big advantage of INO is to give booster without concerning increasing side effects as it was confirmed from phase 1,2, booster trials while MRNA, PFE vaccines recorded increasing side effects after second doses from their trials.
Imagine 4802 get EUA and the newer Covid variants beat current vaccine badly. INO 4802 would be the game changer and take most of entire Covid market. As Dr Kim had mentioned last call, mRNA had good time, but INO DNA time will come. I think INO 4802 will not play as an support role of providing booster, but as central role of main vaccine against new Covid variants. With increasing covid cases in EU, Asia, and lack of vaccine in other parts of the world, new variants will come just a matter of time, and how dangerous they are.”
By StockHound “ 1. We beat earnings estimates, great, but we still took a loss of -.29 however was less that last earnings and expected.
2. Our burn rate was around $60M, which was as expected.
3. We still have $394 in cash, cash equivalents and short term investments
4. Even more countries are expected to join the P3 INNOVATE trial. This in itself is a mystery, why didn't INO provide clear P3 protocols, more specifically around number of participants. Their P3 trial seems likes its an open book, allowing more countries to come and participate at will. I feel, since the WHO solidarity trial is running parallel with INNOVATE and both have the same design and endpoints, it really doesn't matter who finishes first, the data will likely be the same. Inovio is using their INNOVAITE trial to lock down countries for future EUA, advanced orders and eventually full licensing. They can slow step their part of the P3 focusing on their future market while Solidarity powers through with their few select sites. this way, they get the data at rapid speed and a wide range of potential clients.
5. Stright from the man himself, Kim confirmed P3 dosing for INNOVATE has started.
6. Africa to soon follow in P3 INNOVATE
7. LOL, 99% of the P1 participant pool for 4800 opted for the booster dose. If this doesn't tell you something, you need to open your eyes.
8. VGX-3100 with Quigan biomarker data due by EOY
9. INO-5401 data due end of THIS WEEK, they seem very excited for the data
10. Everyone one of the analysts congratulated Kim on his recent successes and FDA hold lift, upgrades to follow?
11. Oppenhimer analyst Hartaj Singh asked what Inovio's plans are to launch INO-4802 as a booster after INO-4800 has launched. This is a forward thinking statement, showing his strong confidence that INO-4800 will go to market. Sounds like a done deal.
12. Columbia outreached to Inovio, not the other way around. These countries see the true data and is now approaching INO to be included in P3, this connects back to my #4.
13. Regarding the IP for the Cellectra 3PSP device, Kim says there is no overlap with the US government as they had previously help fund the development and scale up. He did say "I don't believe there is" which is a weak statement. Will need to keep a closer eye on this.
14. Kim said it's a board range when saying the data is due in the 1st half of 2022 because of the Interim data endpoints. The data could be sooner based on if the endpoints are met sooner.
15. Kim said INO is the LEADER of the 2nd generation vaccines
16. Getting India on board in P3 was very significant as they have already reviewed and developed an approval process for another DNA vaccine. It will be quicker to get approval there than anywhere else at the point.
17. They are still preparing to scale up 3PSP production once advanced orders are made
18. Kim's closing words were that they feel INO is in a transitional period going to a commercialization in the next several quarters. In my words, 6-9 months we'll be on the market. Anything can happen in the interim, funding, orders, data, etc. “
Cellectra 5PSP and 2000 Manufacturer: Inovio San Diego Facility. INO-4800 Vaccine Manufacturer: Kaneka Eurogentec SA ( Belgium ????), Thermo Fisher Scientific ( USA ????), Richte-Helm BioLogics ( Germany ????), Ology Biosciences ( USA ????), Advanccine( China ????), Inovio+ Colombia ???? in the future, likely the largest in the world SII (Serum Institute in India ????). It's being manufactured.
WHO must have reviewed all the trial data available to-date incl. pre-clinical, p1, p2, NHP, booster etc from Inovio and satisfied with it before selecting them for such an expansive and costly global trial that would cost
Over
$1B
WHO picked INO-4800 as 1 of 2 vaccines (out of 20 candidates) to fund.
Population
China ???? 1,439,323,776
India ???? 1,398,161,295
Brazil ???? 214,582,079
Mexico ???? 130,745,431
Philippines ???? 111,532,078
Colombia ???? 51,608,609
Mali ???? 21,027,779
Thailand ???? 70,035,975
The @US_FDA has lifted its partial clinical hold following review of additional non-clinical, clinical, and device information provided by INOVIO for our #COVID19 vaccine candidate, INO-4800.
[From what should have taken 30 days, now a year later they have finally realised they need Inovio …. At least the FDA have lined their pockets from the big pharma… blood on their hands.
Finally! Hopefully INO one day can tell how bad big pharma suppressed them and the involvement of the Govt. Sad having witnessed this manipulation. Finally, the U.S. back, why now? Because INO is sponsored by the "WHO Trials" and gigantic "advaccine-Inovate trials".
The FDA want to save some face after multiple countries around the world already approved for phase 3. Inovio will end Covid-19.
MRNA is just a stop gap. DNA is the future!
The @US_FDA has lifted its partial clinical hold following review of additional non-clinical, clinical, and device information provided by INOVIO for our #COVID19 vaccine candidate, INO-4800. Read more: https://t.co/1bAjEA6HMT pic.twitter.com/8sOoKnjezp
— INOVIO Pharmaceuticals (@InovioPharma) November 9, 2021
11/9 The FDA has lifted the partial clinical hold following the FDA's review of additional non-clinical, clinical, and device information provided by INOVIO.
Dr. J. Joseph Kim, INOVIO's President and CEO, said, "I want to recognize and express my appreciation to my INOVIO colleagues for their hard work throughout this process. We are pleased to have the opportunity for U.S. clinical trial participants to potentially contribute to the enrollment in our INNOVATE Phase 3 segment. Today's U.S. announcement builds on our intensive global efforts in India ????, Brazil ????, Philippines ????, Mexico ????, Colombia ????, and Thailand ???? where we have received authorizations to date."[ China ????, Mali ???? from SVT, upcoming South Africa ????]
INOVIO is partnering with Advaccine Biopharmaceuticals Suzhou Co., Ltd. to conduct the INNOVATE Phase 3 segment in multiple countries in the Americas, Asia, and Africa.
We are pleased to share that the Thai Food and Drug Administration has authorized the start of the INNOVATE Phase 3 segment for #COVID19 vaccine candidate, INO-4800, adding Thailand to the growing list of countries who have authorized INOVIO’s efficacy evaluation of INO-4800.
We are pleased to share that the Thai Food and Drug Administration has authorized the start of the INNOVATE Phase 3 segment for #COVID19 vaccine candidate, INO-4800, adding Thailand to the growing list of countries who have authorized INOVIO’s efficacy evaluation of INO-4800. pic.twitter.com/gs7gFuCG98
— INOVIO Pharmaceuticals (@InovioPharma) November 8, 2021
11/4 CEPI announced the first funding awards under its $200m programme to advance the development of vaccines that provide broad protection against SARS-CoV-2 variant. CEPI will support researchers at two institutions, MigVax Ltd, Israel, and the University of Saskatchewan’s (USask) Vaccine and Infectious Disease Organization (VIDO), Canada
The awards announced today have been issued in response to a CEPI Call for Proposals issued in March 2021, and additional awards are expected to be announced shortly. The programme forms part of CEPI’s next 5-year plan, published in March, which aims to reduce or even eliminate the future risk of pandemics and epidemics.
Both projects aim to establish preclinical proof of concept for ‘variant-proof’ vaccines that protect against new COVID-19 variants of concern. The vaccine platforms may also be applicable for developing vaccines which are protective against a broad range of betacoronaviruses
https://cepi.net/news_cepi/cepi-announces-first-funding-awards-in-quest-to-develop-variant-proof-covid-19-vaccines/
“The countries do not have to start at the same time. Different countries will have different start dates based on conditions on the ground.” 10/20/21
https://registry.healthresearch.ph/index.php/registry?view=research&layout=details&cid=3894&fbclid=IwAR30EEccm--YIE-RdM_plUoZe678mCpf4i-E67JM41NT22GbSi5dB0MQ_L8
https://clinicaltrials.gov/ct2/history/NCT04642638?A=8&B=9&C=merged#StudyPageTop
http://www.chictr.org.cn/hvshowproject.aspx?id=96875
Population
China ???? 1,439,323,776
India ???? 1,398,161,295
Brazil ???? 214,582,079
Mexico ???? 130,745,431
Philippines ???? 111,532,078
Colombia ???? 51,608,609
Mali ???? 21,027,779
4800 P3: Brazil ????, Philippines ????, Colombia ???? Finished recruiting, first doses administered to all participants at 3, 7, 5 sites, respectively. Status: [Active, not recruiting]. Mexico ???? ’s 3 sites are recruiting. India ???? sites will be added. 11/2
INNOVATE covering Brazil ????, Philippines ????, Colombia ???? , Mexico ????, India ????, …, South Africa ???? are equally funded by
Sponsors and Collaborators
Inovio Pharmaceuticals
Advaccine (Suzhou) Biopharmaceuticals Co., Ltd.
SVT covering Colombia ????, Philippines ????, Mali ????, more countries to be added late 2021, early 2022 are fully funded by the WHO, started 10/29/21.
“Our earnings call is scheduled for November 9th. The SOLIDARITY Trial Vaccines is run by the WHO and is completely separate from INNOVATE trials. The two trials will not be merged as the sponsors are different.
??? WHO? ?? ?? Solidarity trial vaccines? ?? ?? ????. Solidarity ???? ?? ?? WHO?? ?????. ? ?? ??? ?? ???? INNOVATE ???? ??? ????. ? ?? ??? ? ?? 3? ?? ??? ???? ?? ?? ????.
We are now participating in the Solidarity trial vaccines run by the WHO. Solidarity clinical trial costs are covered by WHO. This is different from the INNOVATE clinical trial that we run ourselves. Through this, we expect faster phase 3 test results.
“????? ??? IPO? ?? ?? ????? ??? ?? ??? ?? ? ????.
??? ?? ??? Advaccine? ?? ?? ?? ??? ?? ??? ?? ????? ????.
Ad Vaccine wants to do an IPO at the end of the year, but it may be delayed until early next year.
And it is difficult for us to share information arbitrarily because Advaccine is conducting clinical trials in China.” 10/27/21
BioNTech shares nosedive on news of whistleblower report & Covid pills 11/6/21
Shares of German biotech company BioNTech, which co-developed a Covid-19 vaccine with US company Pfizer, took a dramatic 20% plunge on Friday in the wake of a damning whistleblower report.
The price of BioNTech shares traded on the NASDAQ exchange briefly fell by around $60, and stood at around $216 at the time of writing.
Some analysts tied the dramatic fall – which amounted to more than 20% – to the publication of an explosive report on the trials of the Pfizer-BioNTech Covid vaccine. Published in the British Medical Journal (BMJ) on Tuesday, the report cites a former contractor and claims to expose a staggering level of incompetence in management, the handling of data, and patient safety during the testing process.
The whistleblower, identified as Brook Jackson, claimed that the company hired poorly-trained vaccinators, that it was slow to investigate the adverse effects, and even falsified data on the trials. She also provided the BMJ with dozens of internal documents to substantiate her claims.
Another possible reason for the surprise stock plunge is said to be Pfizer’s announcement of the results for its Covid vaccine. On Friday, it cited trial data showing that its “game-changer” pill, Paxlovid, reduces Covid-19 hospitalizations by 89%.
The news came on the heels of Merck & Co, another US pharma company, announcing that clinical trials show that its own vaccine reduces the risk of hospitalization and death in patients with mild to moderate Covid-19 by 50%. Merck’s drug has since been approved for treatment of Covid-19 patients in the UK.
There has been media speculation that the emergence of Covid-19 drugs might have made investors believe that demand for vaccines would decline. Another vaccine developer, Moderna, took a $55 drop on Friday, and briefly stood at $229 before slightly recovering. Novavax shares fell as well.
https://www.rt.com/business/539511-biontech-shares-plunge-pfizer/
4800 P3: Brazil ????, Philippines ????, Colombia ???? Finished recruiting, first doses administered to all participants at 3, 7, 5 sites, respectively. Status: [Active, not recruiting]. Mexico ???? ’s 3 sites are recruiting. India ???? sites will be added. 11/2
Population
China ???? 1,439,323,776
India ???? 1,398,161,295
Brazil ???? 214,582,079
Philippines ???? 214,582,079
Mexico ???? 130,745,431
Colombia ???? 51,608,609
Mali ???? 21,027,779
Mexico
SMIQ, S. de R. L. de C.V.
[Recruiting]
Querétaro, Mexico, 76070
Contact:Principal Investigator: Roselia Ramirez
Mexico, Jalisco
BRCR Global Mexico
Guadalajara, Jalisco, Mexico, 44600 BRCR Global Mexico
[Recruiting]
Guadalajara, Jalisco, Mexico, 44600
Contact:Principal Investigator: Isabel Montserrat Alvarado
Mexico, Querétaro
Unidad de Medicina Especializada SMA
[Recruiting]
San Juan del Río, Querétaro, Mexico, 76800
Contact:Principal Investigator: Carlos Alberto García
https://clinicaltrials.gov/ct2/history/NCT04642638?A=9&B=10&C=merged#StudyPageTop
“Regeneron mentioned that on their ESMO update yesterday, they're Head of Translational Medicine, Oncology that they're running a program with you in GBM. Could you just give us an update on that 5401?
JK
Regeneron has been a fantastic partner in this trial, in this program. GBM, as you know, is the deadliest cancer out there and this has always been a high-risk, high-benefit, aiming for the fences, so to speak. And all along the way, our treatment of newly diagnosed GBM patients with INO-5401 along with 9012 which is our IL-12 plasmid -- deliver IL-12, along with Regeneron's PD-1 inhibitor, we've shown very encouraging better than standard of care survival at PFS6, overall survival at 12 months, 18 months. And certainly, as we stated, 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.”
Jeffries on 11/18, Piper on 11/22 coincide with SNO conference 11/18-11/21 where Ino will present GBM 5401 OS24, correlation of protection, tissue data.
This is a great opportunity for JK to shine a spotlight on 5401, it’s roadmap, and share further collaboration with REGN.
INOVIO will participate in the following virtual investor conferences:
Stifel 2021 Virtual Healthcare Conference
Monday, November 15, 2021
10:40 AM ET
Fireside Chat
Jefferies London Healthcare Conference
Thursday, November 18, 2021
3:00 AM ET
Fireside Chat
Piper Sandler 33rd Annual Virtual Healthcare Conference
Monday, November 22, 2021
10:00 AM ET
Fireside Chat
The virtual presentations will be available through the INOVIO Investor Relations Events page. All presentation times are subject to change.
INOVIO will participate in the following virtual investor conferences:
— INOVIO Pharmaceuticals (@InovioPharma) November 4, 2021
Stifel 2021 Virtual Healthcare Conference
Monday, November 15, 2021
10:40 AM ET
Fireside Chat
Jefferies London Healthcare Conference
Thursday, November 18, 2021
3:00 AM ET
Fireside Chat
26th Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO)
Boston, November 18 - 21, 2021
Ino to Present GBM INO-5401 24-month overall survival and immunology data including correlative immunology and tissue data, as well as total study drug exposure and concomitant medication use
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
Pre-clinical follow-up study boosting with original formulation and next generation INO-4802 SARS-CoV-2 vaccine candidate
By Sreetama Dutt M.Sc.Nov 3 2021Reviewed by Benedette Cuffari, M.Sc.
The rollout of different vaccines to reduce the risk of transmission and disease severity among patients with the coronavirus disease 2019 (COVID-19) has been historic. However, with every passing day over the past year after vaccine distribution began, there have been reports of reduced antibody titers among both convalescent and vaccinated individuals with multiple reports of breakthrough infections.
This indicates that the current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants have changed drastically from the original Wuhan-based strain, as they are often associated with enhanced transmissibility and the potential to evade immune responses.
Background
Some of the notable SARS-CoV-2 variants of concern (VOC) include the Alpha (B.1.1.7), Beta (B.1.351), and Gamma (P.1) strains, as well as the currently predominant Delta (B.1.617.2) strain. An important question going forward is whether this immunity can be boosted by next-generation vaccines that target emerging variants while simultaneously maintaining long-term protection against existing strains.
Recent studies show that vaccine effectiveness of either the BNT162b2 or ChAdOx1 nCoV-19 vaccines is notably lower against the Delta (B.1.617.2) variant as compared to the Alpha (B.1.1.7) variant. The combination of viral escape mechanisms and waning immunity suggests that heterologous prime-boost strategies may be needed to provide sufficient coverage against novel variants.
Owing to the capacity of synthetic deoxyribonucleic acid (DNA) vaccines to initiate sufficient humoral and cell-based responses, along with added benefits of shortened clinical development, easy scale-up and manufacturing processes, and long-term temperature stability, researchers have studied such synthetic DNA vaccines and their effects in inducing longer, favorable immune responses in animal models, particularly primates.
In one recent study published on the preprint server bioRxiv*, researchers describe the antibody-inducing effects of DNA-based synthetic vaccines INO-4800 and INO-4802 and their benefits in prime-and-boost regimens against SARS-CoV-2 in non-human primates.
About the study
Previously, the researchers of the current study already had a reference of a synthetic DNA vaccine encoding the wild-type (Wuhan-Hu-1) spike protein. This vaccine, which was named INO-4800, has been shown to induce antigen-specific T-cell responses and functional antibodies that neutralize SARS-CoV-2 in preclinical studies.
In a non-human primate (NHP) challenge model, INO-4800 vaccination was associated with reduced viral loads and protection against respiratory tract disease. Phase I and II clinical trials of INO-4800 demonstrated favorable safety and tolerability profiles and immunogenicity.
In an effort to devise an even more effective vaccine, the researchers have designed INO-4802, which is a next-generation DNA vaccine expressing a pan-spike immunogen that has been shown to raise immunity across SARS-CoV-2 VOCs in animal models.
In this study, researchers investigated the durability and memory recall of antigen-specific SARS CoV-2 responses in a cohort of NHPs that were initially primed with the first-generation SARS-CoV-2 vaccine INO-4800.
Rhesus macaques were primed over one year prior with the first-generation INO-4800 vaccine. They were boosted with either INO-4800 or INO-4802 in homologous or heterologous prime-boost regimens.
Both boosting schedules led to an expansion of antibody responses that were characterized by improved neutralizing and angiotensin-converting enzyme 2 (ACE2) blocking activity across wild-type SARS-CoV-2, as well as multiple VOCs. However, the most notable observation was that the heterologous booster doses of the next-generation INO-4802 were able to induce even higher cell-mediated and humoral immune responses as compared to homologous booster with INO-4800.
Implications
The current study addresses two major concerns over vaccine rollouts globally, including the global shortage of vaccines and the ability of VOCs to escape immune responses from the available set of messenger ribonucleic acid (mRNA)- and vector-based vaccines.
Synthetic DNA-based vaccines are easier to manufacture, scale-up, and store. Additionally, heterologous boosters with these vaccines can also combat the most concerning VOCs like the Delta VOC.
These data illustrate the durability of immunity following vaccination with INO-4800 and support the use of either INO-4800 or INO-4802 in prime-boost regimens. Since NHPs have responded well to these trials, the findings of the current study support the transition to human trials with these vaccines in the near future.
https://www.news-medical.net/news/20211103/Pre-clinical-follow-up-study-boosting-with-original-formulation-and-next-generation-INO-4802-SARS-CoV-2-vaccine-candidate.aspx
11/2 4800 P3 almost finished recruiting in Brazil ????, Mexico ????, Philippines ????, Republic of Colombia
[Active, not recruiting]. We move stealthily and lightning fast.
Only 3 sites in Mexico ???? remain.
Mexico
SMIQ, S. de R. L. de C.V.
[Recruiting]
Querétaro, Mexico, 76070
Contact:Principal Investigator: Roselia Ramirez
Mexico, Jalisco
BRCR Global Mexico
Guadalajara, Jalisco, Mexico, 44600 BRCR Global Mexico
[Recruiting]
Guadalajara, Jalisco, Mexico, 44600
Contact:Principal Investigator: Isabel Montserrat Alvarado
Mexico, Querétaro
Unidad de Medicina Especializada SMA
[Recruiting]
https://clinicaltrials.gov/ct2/history/NCT04642638?A=9&B=10&C=merged#StudyPageTop
PLYMOUTH MEETING, Pa., Nov. 3, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to help protect people from infectious diseases, and help treat cancer, and HPV-associated diseases, today announced that it has received authorization from India's Central Drugs Standard Control Organization (CDSCO)'s Drug Controller General of India (DCGI) to proceed with the Phase 3 segment of INOVIO's global Phase 2/3 trial, INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy), in India for INO-4800, its DNA vaccine candidate for COVID-19. INOVIO is partnering with Advaccine Biopharmaceuticals Suzhou Co., Ltd. (Advaccine) to conduct the INNOVATE Phase 3 segment in multiple countries in Latin America, Asia, and Africa. Regulatory authorization in India follows authorizations from health authorities in Brazil, Philippines, Mexico and Colombia.
The global Phase 3 segment of INNOVATE will evaluate the efficacy of INO-4800 in a two-dose regimen (2.0 mg per dose), administered one month apart, in a 2-to-1 randomization in men and non-pregnant women 18 years of age and older. The primary endpoint of this case-driven Phase 3 trial is virologically confirmed symptomatic COVID-19.
"As COVID-19 continues to threaten the health and safety of the global population, and many areas of the world are still awaiting sufficient access to safe and effective vaccines, INOVIO is pleased to receive regulatory authorization to proceed with our efficacy Phase 3 trial in India," said Dr. J. Joseph Kim, President and CEO of INOVIO. "INOVIO remains steadfast in its mission to fight COVID-19 through the development of INO-4800, which is designed to serve the needs of those in India and beyond, as both a primary series and a booster vaccine."
INNOVATE's Phase 3 segment builds upon the Phase 2 segment, which was conducted in the U.S. and funded by the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, in coordination with the Office of the Assistant Secretary of Defense for Health Affairs and the Defense Health Agency. Interim Phase 2 data from the ongoing study was disclosed in a pre-print in MedRxiv in May 2021 and showed INO-4800 to be well-tolerated and immunogenic in adults 18 and older. In another previously disclosed study using clinical samples, INO-4800 was also found to provide broad cross-reactive immune responses, including neutralizing antibodies and notable T cell responses, against variants of concern (alpha, beta, gamma and, in subsequent research, delta) – factors which could be critical in containing COVID-19 as it shifts from pandemic to endemic spread.
This news builds on INOVIO's previously announced authorization to proceed in China with two Advaccine-sponsored clinical trials investigating the safety, tolerability, and immunogenicity of heterologous boost combinations with INO-4800, as well as recent positive homologous boosting data for INO-4800, which was found to produce robust immune responses and was well-tolerated as both a two-dose series and as a homologous booster dose in all adults, including participants 65 years of age and older. Of note, a durable antibody response was observed six months following the second dose, and a homologous booster dose administered 6 to 10.5 months following the second dose also significantly increased antibody and T cell responses. INO-4800 was well-tolerated, with no treatment-related serious adverse events reported. Most adverse events were mild in severity and did not increase in frequency with age and subsequent dosing.
Clinical Trial 'Solidarity of Vaccines' began in Tunja and Duitama, Columbia
Medigen and Inovio are the two new biologicals against COVID-19 that will be applied to volunteers from these municipalities in Boyacá.
Tunja, November 2, 2021. (UACP). Tunja and Duitama were selected from eleven municipalities in the country and will be the cities that will start the study, taking into account the significant progress in the National Vaccination Plan, their epidemiological situation, their population and the logistics conditions for the study.
The World Health Organization, WHO and the Ministry of Health and Social Protection seek to find an effective treatment against COVID-19, through two new vaccines that will be applied to the largest number of volunteers in these two cities, thus betting on development of science in the department.
According to Luis Alexander Moscoso Osorio, Vice Minister of Health, this is an important study that takes into account two new vaccines that, in clinical trials and studies, have shown good efficacy.
"Now we are going to carry out phase three of the study, which allows us to study the prolongation and efficacy of vaccines over time. These are important studies, not only for Boyacá but for the country and the world, they will allow us to provide a greater supply of vaccines and thus achieve the long-awaited herd immunity, ”said the Vice Minister.
In turn, he indicated that conducting this trial in the department will provide tools for vaccines, the availability of biologicals, as well as the training of researchers and the vocation of collective help.
"This study began a few days ago in the two cities and in each of them there are already volunteers to carry out this trial, however, I invite people who have not yet been vaccinated to participate and contribute to the scientific development of the region" , Moscoso pointed out.
For his part, Jairo Mauricio Santoyo Gutiérrez, Secretary of Health of Boyacá, said that these new biologics are called Medigen, which is a recombinant protein Inovio DNA platform vaccine against COVID-19.
“The WHO has been clear that despite the fact that there are already vaccines available, it must bet on the development of new biologics to determine at some point which will be the most effective in the search to preserve the life of Boyacá and the community. in general ”, Santoyo Gutiérrez pointed out.
He added that once these vaccines are applied, it will be carried out by the research group, which in the case of Boyacá is the Clinical Research Center of the Colombia de Sanitas University Clinic, permanent monitoring of volunteers, in person and by telephone, at the 14 days after the administration of the first dose, 14 days after the second dose and between six to 12 months later, taking into account that these vaccines are of two doses, with an interval of 28 days.
"Today this study reaches Colombia and especially Boyacá with two cities, we are the only department that managed to include two cities to apply these doses and evaluate the effectiveness of two vaccines to have them on the market very soon and thus find more options and reach more population vaccinated against COVID-19 ”, assured the head of the department's Health portfolio.
https://www-boyaca-gov-co.translate.goog/inicio-ensayo-clinico-solidaridad-de-vacunas-en-tunja-y-duitama/?_x_tr_sl=auto&_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=nui
Vaccine prioritization for WHO Phase IIb/III clinical trial showed why 4800 was selected among 20 candidates.
Purpose of the document
The proposed attributes and criteria provide considerations for the evaluation and prioritization of COVID-19 candidate vaccines to be considered for further development by WHO. The target audience includes vaccine scientists, product developers, manufacturers, regulators and funding agencies.
The attribute and criteria below lay out some of the considerations that structure WHO’s case-by-case assessments of COVID-19 vaccines in the future, with emphasis on prioritization for Phase IIb/III evaluation.
Criteria that are considered of major importance in ranking the vaccines are reported in bold in the table. WHO will also provide a scoring guide to promote consistency and predictability of evaluation.
Safety profile 25 points
MINIMALLY ACCEPTABLE PROFILE
Adverse event profile supports advancement to phase IIb/III
Data from animal and human studies support no apparent risk of enhanced disease in vaccinees
CRITERIA
Lack of significant disease enhancement risk supported by clinical and/or preclinical data from relevant/suitable animal model(s), and of unexpected serious findings (e.g. unexpected AE) that could require more investigations
Availability and rigor of safety follow-up , e.g. diary card etc
Safety database size adequate to support phase IIb/III 1
Type of population included, e.g Elderly, pregnant women and subjects with chronic conditions
Developmental and reproductive studies
Potential for efficacy 25 points
MINIMALLY ACCEPTABLE PROFILE
Evidence that the selected dose induces adequate immune responses in humans that might confer protection
CRITERIA
Magnitude of the immune response in humans (at selected dose) as compared with putative protective levels, supported by challenge studies showing vaccine protection from disease (e.g., pneumonitis) in characterized animal model or by other data (including any surrogate marker derived from clinical trial or natural history of disease data). Immune responses measured are ideally pertinent to the mechanism of protection of the candidate vaccine, e.g. titre of neutralizing antibodies and CMI responses for vaccines intended to induce one.
Quality of immune response assays for key immunogenicity read-outs2
Quality of data supporting putative protective levels3
Sufficient evidence supporting dose selection including dosing/response in the elderly Rapidity/level of immune response after the first vaccine dose
Durability of the immune response
2 E.g., for vaccines inducing humoral immunity (even if they also induce cellular immunity): Use of international standards in human studies where feasible, Neutralizing titers evaluate both IC50 and IC80, and Sensitivity of any pseudovirion neut assays is understood relative to WT virus; and for vaccines inducing cellular immunity: Sufficient assay qualification to interpret results.
3 E.g., for animal models, rigor of experiments and degree to which the model used has been characterized, and for human data, degree of confidence in surrogate markers
Vaccine stability 10 points
MINIMALLY ACCEPTABLE PROFILE
Stability data are sufficient to assure delivery of dose to be tested
CRITERIA
The vaccine has adequate stability4 Quality of stability studies
Vaccine implementation 15 points
MINIMALLY ACCEPTABLE PROFILE
Manageable regimen considering resource settings
CRITERIA
Any special requirements for immunization can be addressed
Maximum parenteral dose volume: 1 mL
Regimen: Single dose preferred
Acceptability of route of administration,
Dose volume (0.5 ml is preferred for parenteral) Special requirements that might interfere with implementation is not preferred
Moved regimen here from under “efficacy”, because it is critical for implementation.
Vaccine availability 25 points
MINIMALLY ACCEPTABLE PROFILE
Demonstrated capability to rapidly scale-up production to allow inclusion in the trial and for broader use5
CRITERIA
number of regimens of adequate quality available for Phase IIb/III clinical trial
Forecast of phased production capacity including buffer and delivery device capacity
https://www.who.int/docs/default-source/coronaviruse/criteria-17-may.pdf?sfvrsn=8a1eb5c7_1&download=true
WHO’s STV protocol design
https://cdn.who.int/media/docs/default-source/blue-print/who-covid-2019_solidarityvaccinetrial_14-june-2021_clean_for-registry.pdf?sfvrsn=77b2110a_11
ISRCTN15779782
https://doi.org/10.1186/ISRCTN15779782
Solidarity trial of candidate vaccines against COVID-19
https://www.isrctn.com/ISRCTN15779782
MedImmune Ltd., the global biologics research and development arm of AstraZeneca (NYSE: AZN), is terminating a cancer therapy partnership it has with Inovio Pharmaceuticals. 11/2
The partnership, formed in 2015, gave MedImmune of Gaithersburg, Maryland, exclusive rights to Inovio's experimental DNA-based cancer vaccine, known as INO-3112, for cancers caused by human papillomavirus (HPV) types 16 and 18.
MedImmune renamed the new drug candidate as MED10457 after acquiring its exclusive rights. The company has been studying the effectiveness of MED10457 as a combination therapy with AstraZeneca’s checkpoint inhibitor durvalumab, an immunotherapy for cancer.
Inovio disclosed MedImmune's decision to terminate the agreement in a document the Plymouth Meeting-based company filed last week with the Securities and Exchange Commission.
Since that notice was filed on Oct. 29, the company's stock is up about 2% at $7.29 per share.
Inovio (NASDAQ: INO) will reacquire the rights to INO-3112 and will no longer be entitled to receive potential future milestone payments or royalties from MedImmune. Inovio said it will also cease any development activities for which it would be entitled to seek reimbursement from MedImmune. The two companies will continue to have rights to jointly publish work relating to the product candidate.
MedImmune, according to Inovio's SEC filing, is conducting a phase 2 clinical trial of MED10457 in patients with head and neck squamous cell carcinomas. MedImmune has completed the final data cutoff for the trial and plans to complete the clinical study report by the end of 2022. Inovio expects that MedImmune will continue to sponsor this study until study termination. MedImmune will also continue providing financial support for an externally sponsored research study of MED10457 with the University of Texas MD Anderson Cancer Center until study completion.
Inovio stated it is "no longer substantially dependent" on the collaboration agreement. The company stated during the six months ended June 30, 2021, and the years of 2020 and 2019, it recognized a total of $33,000, $171,000 and $2 million, respectively, in revenue from MedImmune under the collaboration agreement.
"We remain focused on the development of our HPV vaccines, including our lead therapeutic asset VGX-3100," said Jeff Richardson, Inovio's vice president for communications. "Inovio will receive INO-3112 back, and we plan to develop it further on our own or with another partner."
The original partnership carried a potential value of up to $700 million for Inovio, contingent upon the partnership yielding approved cancer therapies.
In 2019, AstraZeneca and MedImmune announced they were discontinuing a significant portion of what was then their four-year-old research partnership with Inovio covering multiple product candidates.
At the time, MedImmune decided to move forward only with the development of MED10457.
Inovio also continues to work on a variety of vaccines include a potential Covid-19 vaccine and another targeting Lassa fever
https://www.bizjournals.com/philadelphia/news/2021/11/02/inovio-plymouth-meeting-astrazeneca-medimmune.html
RBC noted “a pattern of pressure” on Inovio’s pipeline, and the end of the MedImmune deal is another stressor. But the biotech’s COVID-19 vaccine INO-4800 is slowly making headway, even as it's fallen behind the first-to-market winners. The vaccine was recently selected to be part of a large phase 3 clinical trial conducted by the World Health Organization.
The goal of the trial is to develop the next generation of shots that can be needle-free. Inovio’s vaccine is given through a device called Cellectra that administers an electrical pulse to the skin to open up the pores for delivery of the medicine.
AZN is wielding the ax to a bloated pipeline and Inovio has found itself the latest victim. MedImmune, an AstraZeneca unit, has terminated a collaboration agreement with Inovio for the cancer immunotherapy MEDI0457, which was being developed to target cancers caused by certain types of the human papillomavirus.
The deal, originally signed in 2015, was worth $27.5 million upfront with $700 million in biobucks down the line. Inovio has managed to pick up a couple million dollars through the partnership, but the remaining funds are now off the table.
MedImmune will continue to fund a handful of phase 2 trials still underway as they wrap up. One trial in head and neck cancer recently completed a final data cutoff with a readout expected by year-end 2022, Inovio said. A second externally sponsored trial with MD Andersen will also continue until completion.
Inovio will regain the rights to MEDI0457, which was known as INO-3112 back at the Pennsylvania biotech’s headquarters. But the therapy’s future is still unclear. Inovio will cease any development activities that would have required reimbursement from MedImmune while they consider the next steps.
The news was revealed in an 8-K (PDF) from Inovio issued after-market on Friday, a key biotech method of tying to partly bury bad news. Inovio said the collaboration has so far garnered about $2 million and change from MedImmune. RBC Capital Markets had expected Inovio to collect about $210 million in milestones and double-digit royalties on $300 million in peak sales, according to a Monday note.
Inovio’s therapy has fallen victim to AstraZeneca’s “usual pipeline pruning,” according to RBC—but the cut is “still a disappointment.” This is not the first time the U.K. pharma has axed a collaboration with Inovio. The companies previously cut ties over two preclinical DNA-based oncology vaccine programs in 2019.
The 2015 partnership was also trimmed back in 2019 down to the one vaccine, MEDI0457.
Inovio's shares were mostly holding steady as the markets opened Monday, down just over 1% to $7.05.
https://www.fiercebiotech.com/biotech/inovio-falls-victim-to-astrazeneca-s-usual-pipeline-pruning-as-human-papillomavirus-cancer
Inovio announces preprint publication of NHP study on immunity after INO-4800 10:18 INO Inovio said via Twitter, "Today we announced the preprint publication in @biorxivpreprint of our NHP study illustrating the durability of immunity following vaccination with INO-4800 and the use of either INO-4800 or INO-4802 in prime-boost regimens. #COVID19" According to the abstract, "The enhanced transmissibility and immune evasion associated with emerging SARS-CoV-2 variants demands the development of next-generation vaccines capable of inducing superior protection amid a shifting pandemic landscape. Since a portion of the global population harbors some level of immunity from vaccines based on the original Wuhan-Hu-1 SARS-CoV-2 sequence or natural infection, an important question going forward is whether this immunity can be boosted by next-generation vaccines that target emerging variants while simultaneously maintaining long-term protection against existing strains. Here, we evaluated the immunogenicity of INO-4800, our synthetic DNA vaccine candidate for COVID-19 currently in clinical evaluation, and INO-4802, a next-generation DNA vaccine designed to broadly target emerging SARS-CoV-2 variants, as booster vaccines in nonhuman primates. Rhesus macaques primed over one year prior with the first-generation INO-4800 vaccine were boosted with either INO-4800 or INO-4802 in homologous or heterologous prime-boost regimens. Both boosting schedules led to an expansion of antibody responses which were characterized by improved neutralizing and ACE2 blocking activity across wild-type SARS-CoV-2 as well as multiple variants of concern. These data illustrate the durability of immunity following vaccination with INO-4800 and additionally support the use of either INO-4800 or INO-4802 in prime-boost regimens."
Read more at:
https://thefly.com/n.php?id=3398375
No adverse events recorded in 687 participants of WHO Solidarity Vaccine Trial piloted in Metro Manila hospitals [First P3 4800, Medigen doses. SVT started on time in Philippines ???? 10/29/21. WHO has immense reach and power. They move very fast.]
No adverse effects have been observed in the participants of the World Health Organization’s (WHO) Solidarity Vaccines Trial (SVT) that was piloted in three hospitals in Metro Manila, the Department of Science and Technology (DOST) said Sunday, Oct. 31.
DOST Secretary Fortunato “Boy” T. de la Peña said a total of 687 individuals have received their first dose of coronavirus disease (COVID-19) vaccines as they volunteered to be part of the Solidarity Trials for Vaccines organized by the WHO.
https://mb.com.ph/2021/10/31/no-adverse-events-recorded-in-687-participants-of-who-solidarity-vaccine-trial-piloted-in-metro-manila-hospitals/
Today we announced the preprint publication in @biorxivpreprint of our NHP study illustrating the durability of immunity following vaccination with INO-4800 and the use of either INO-4800 or INO-4802 in prime-boost regimens. #COVID19 Link:
https://www.biorxiv.org/content/10.1101/2021.10.27.466163v1
Today we announced the preprint publication in @biorxivpreprint of our NHP study illustrating the durability of immunity following vaccination with INO-4800 and the use of either INO-4800 or INO-4802 in prime-boost regimens. #COVID19 Link: https://t.co/8rfob36kHY
— INOVIO Pharmaceuticals (@InovioPharma) November 1, 2021
TBA in coming weeks: Report complete REVEAL 1 data (ITT, mITT, per protocol)
Report on pre-treatment biomarker with QIAGEN
Present GBM INO-5401 24-month overall survival and immunology data
Fully enroll Phase 1 Ebola study with INO-4201 as a booster to Ervebo®
INO-4201 as Booster in Healthy VSV-ZEBOV Vaccinees (Boost-EBOV)
https://clinicaltrials.gov/ct2/show/NCT04906629?term=Inovio&draw=4&rank=49
Drum roll for …4802 P1/2 start and external fundings…. Kick-started by:
10/29 Prime-boost vaccination regimens with INO-4800 and INO-4802 augment and broaden immune responses against SARS-CoV-2 in nonhuman primates
The studies described in this manuscript were funded by a grant from the Coalition for Epidemic Preparedness Innovations (CEPI).
https://www.biorxiv.org/content/10.1101/2021.10.27.466163v1
10/29 Prime-boost vaccination regimens with INO-4800 and INO-4802 augment and broaden immune responses against SARS-CoV-2 in nonhuman primates
https://www.biorxiv.org/content/10.1101/2021.10.27.466163v1
We recently described the design, immunogenicity, and efficacy of INO-4802, a synthetic DNA 203 vaccine expressing a pan-Spike immunogen aimed at inducing broad immunity across SARS-204 CoV-2 VOCs [17]. In a hamster challenge model, INO-4802 conferred protection following 205 intranasal challenge with either the Wuhan-Hu-1, B.1.1.7, B.1.351, P.1, or B.1.617.2 (Delta) 206 SARS-CoV-2 variants. Additionally, INO-4802 showed promise as a heterologous booster vaccine 207 by enhancing humoral responses against VOCs in hamsters previously immunized with INO-4800. 208 Here, we addressed the immunogenicity of INO-4800 and INO-4802 as booster regimens in rhesus209 macaques previously immunized with INO-4800 using clinically relevant dosing parameters. 210 Rhesus macaques receiving booster immunizations of either INO-4800 or INO-4802 showed a 211 robust induction of humoral responses, supporting the use of either vaccine in a prime/boost 212 regimen. Importantly, boosting of INO-4800-primed animals with INO-4800 or INO-4802 213 resulted in neutralizing antibody responses that were magnitudes greater compared to pre-boost 214 levels. Both treatment groups induced humoral responses capable of neutralizing wild-type and 215 several VOC pseudoviruses, suggesting broad protection among SARS-CoV-2 variants.216 Pseudovirus neutralizing activity against the Beta and Gamma variants trended higher in animals 217 boosted with the heterologous INO-4802 vaccine compared to those receiving INO-4800,
indicating potential for an enhanced level of protection against some emerging SARS-CoV-2 219 variants following boosting with the next-generation pan-SARS-CoV-2 vaccine.220 221 Neutralizing antibody responses correlated with inhibition of ACE2 binding activity, further 222 supporting the functional antibody responses following either a homologous or heterologous boost223 with synthetic DNA vaccine constructs. Levels of antibodies binding variant Spike proteins were 224 also increased following the boost immunization in both treatment groups. Together, these data 225 point to broad functional humoral responses following a boost with both the original INO-4800 226 and INO-4802 pan-SARS-CoV-2 DNA vaccines. The rapid boost in neutralizing antibody 227 responses can likely be attributed to the maintenance of a memory B cell pool following the 228 priming immunization.
Neutralizing antibody responses are predictive of immune protection against symptomatic SARS-236 CoV-2 infection [47], and as such, neutralizing antibodies are an important readout in the 237 evaluation of SARS-CoV-2 vaccines [48-50]. Owing to the critical role of T follicular helper (Tfh) 238 cells in providing help to maturing B cells in germinal centers, Tfh responses serve as a239 mechanistic indicator of neutralizing antibody responses in infection and vaccination, including 240 for EUA SARS-CoV-2 vaccines [25-27, 51-53]. We observed a positive correlation between the 12 frequency of circulating Tfh cells and functional antibody responses, further affirming the 242 immunogenicity of SARS-CoV-2 DNA vaccine boosters in animals with existing vaccine-induced 243 immunity.244 245 Overall, the development of safe and effective booster vaccines will be critical in maintaining 246 control of SARS-CoV-2 in the long term. Ideal treatment regimens should seek to expand immune 247 coverage to emerging variants while maintaining immune responses to existing SARS-CoV-2 248 variants. Current focus has shifted to evaluating the cross-immunogenicity of booster vaccines 249 against wild-type SARS-CoV-2 antigens and other VOCs and re-designing vaccines to investigate 250 this important question. In this study, we report that the next-generation pan-SARS-CoV-2 vaccine 251 INO-4802 boosts immune responses in animals primed with the wild-type-matched SARS-CoV-2 252 DNA vaccine INO-4800. These data support the immunogenicity and boosting capability of INO-253 4800 and INO-4802 in nonhuman primate, which may have broader application in the clinical 254 setting. 255 256 Acknowledgements257 The studies described in this manuscript were funded by a grant from the Coalition for Epidemic 258 Preparedness Innovations (CEPI).
The first DNA HPV vaccine officially launched Phase III clinical trials in China
October 30, 2021 01:02 HKT
Today, according to a report by Dongfang Gaosheng, the VGX-3100 project of its subsidiary Dongfang Lue has been approved by the Genetics Office, and the combination of VGX-3100 and the device CELLECTRATM 5PSP in the treatment of HPV-16/18-related cervical high-grade squamous intraepithelial lesions has been officially launched in China (HSIL) Phase III clinical study.
VGX-3100 is a DNA immunotherapy developed by Inovio. It is the world's first therapeutic vaccine for human papillomavirus (HPV)-related precancerous lesions. This DNA vaccine is developed by Inovio's SynCon platform, which uses specially designed computer algorithms to identify and optimize the DNA sequence of the target antigen (virus or tumor), and then generate an optimized DNA plasmid. Then the optimized DNA plasmid is directly delivered to the cells of muscle or skin through its proprietary smart device CELLECTRA. The CELLECTRA device uses a short electrical pulse to reversibly open small holes in the cell membrane, allowing plasmids to enter . Once in the cell, the DNA plasmid can induce the cell to naturally produce the target antigen, and the antigen can trigger the required T cell and antibody-mediated immune response, so that the body can obtain specific immune protection.
Once VGX-3100 is approved for marketing, it will be the world's first non-surgical treatment developed for the treatment of HPV-related precancerous lesions (cervical precancerous lesions, anal precancerous lesions, vulvar precancerous lesions, etc.), and also the world's first DNA drugs. Globally, these three indications currently have no treatment other than surgery, and drug treatment is temporarily blank.
In January 2018, Oriental Strategy and Inovio reached a cooperation, which has the exclusive development, production and commercialization rights of VGX-3100 in Greater China (Mainland China, Hong Kong, Macau, Taiwan). The indications include cervical, vulvar and anal precancerous Treatment and prevention of precancerous lesions caused by HPV infection.
VGX-3100 is currently undergoing two international multi-center pivotal phase III clinical trials, including REVEAL 1 and REVEA L2. On March 1 this year, INOVIO announced that the REVEAL 1 study has reached the primary and secondary clinical endpoints. This study is the first DNA therapy to achieve clinical endpoints.
The REVEAL 1 study enrolled 201 patients with HPV-16/18-related high-grade cervical squamous intraepithelial lesions. The results of the study showed that among the 193 patients with evaluable efficacy, 23.7% (31/131) of the patients in the treatment group reached the common primary endpoint of achieving HSIL lesion histological outcome and HPV16/18 virus clearance, while the placebo group was 11.3% (7/62), a statistically significant difference (p=0.022; 95%CI: 0.4, 22.5). The study also reached all secondary endpoints.
The safety of VGX-3100 is consistent with the results of early clinical trials. There are no treatment-related adverse events. Most of the adverse reactions are mild to moderate, and patients can alleviate spontaneously.
Inovio will continue to follow up REVEAL1 subjects for safety and durable response rates for 18 months after the last dose. At the same time, the REVEAL2 study has also started enrolling subjects.
https://inf-news.translate.goog/science/7efffc00133461570d149c793b68bb15.html?_x_tr_sl=auto&_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=nui
A randomized, open-label and positive-control phase I/II clinical trial to explore the safety and immunogenicity of the COVID-19 DNA injected as boost dose to subjects already immunized with COVID-19 inactivated vaccines
Study execute time: 11/30/21 To 7/31/22
Primary objectives: 1.To evaluate the humoral immunogenicity in healthy subjects over 18 years old after boosted with the COVID-19 DNA vaccine or inactivated vaccine. 2.To evaluate the safety of the healthy subjects over 18 years old after boosted with the COVID-19 DNA vaccine or inactivated vaccine. Secondary objective: To evaluate the cellular immunogenicity in healthy subjects over 18 years old after boosted with the COVID-19 DNA vaccine or inactivated vaccine. Exploratory objective: 1.To evaluate the immunogenicity persistence in healthy subjects over 18 years old after boosted with the COVID-19 DNA vaccine or inactivated vaccine. 2.To evaluate the neutralizing response against COVID-19 variants in healthy subjects over 18 years old after boosted with the COVID-19 DNA vaccine or inactivated vaccine.
ChiCTR2100049744 Scientific Title:
A phase I/II clinical trial investigating heterologous prime-boost COVID-19 vaccination in healthy volunteers aged over 18 years old
Applicant's institution:
Advaccine Biopharmaceuticals Suzhou. Pty. Ltd
Primary sponsor:
Sichuan Provincial Center for Disease Control and Prevention
Institution
hospital:
Neijiang City Center for Disease Control and Prevention
Study design: Parallel
4. The subjects in Groups B1, B3, B5 and C1 have received two doses of the COVID-19 inactivated vaccine within 3 months (+15 days) before participating in the screening of this study.
5. The subjects in Groups B2, B4, B6 and C2 have received two doses of the COVID-19 inactivated vaccine within 6 months (+15 days) before participating in the screening of this study.
Measure time point of outcome:3, 14, 30 days after the third dose => Very short trial
http://www.chictr.org.cn/hvshowproject.aspx?id=96875
ACT-Accelerator Strategic Plan & Budget October 2021 to September 2022
Enhancing equity in access to COVID-19 tools
28 October 2021
Major Vx milestones over the next 12 months
• By April 2022: Generate clinical evidence for expanded and optimized use of available vaccines, including for 3rd dose strategies, with a focus on LMIC use, and consistent with the Charter for Equitable Access to COVID-19 Tools
• Invest in next generation vaccines with optimized profiles, including those with potential to mitigate impact of future variants of concern. First interim efficacy results from second generation portfolio expected by Q1 2022
• Dec 2021: Allocate all available doses including the 1.4 billion doses currently forecasted to be available to the AMC92 by the end of 2021 per the September COVAX Facility supply forecast15
• Focus on supporting low-income countries, which are currently receiving fewer than one in seven of non-COVAX supplied doses – and 27 of the AMC91 have no non-COVAX supply
• Provide additional COVAX delivery funding as part of a coordinated COVAX effort to continue to support countries to scale-up delivery and mitigate key risks to routine immunisation and other essential health services, with a focus on countries without sufficient other sources of external financing
Vaccines priorities and associated activities
1. Continue to build a robust foundation for countries’ vaccination coverage ambitions, by pooling demand, supply & resources, complemented by other procurement mechanisms
• Implement an updated country participation model, with a focus on AMC countries while offering SFPs the opportunity to procure future doses and participate beyond procurement
• Continue to support countries in achieving their vaccination coverage targets, through Advance Purchase Agreement doses and dose donations (alongside other sources of supply)
• Aspire to provide AMC countries at least 600 million doses, in addition to already secured supply
• Sustain a robust and diverse portfolio, able to absorb shocks and respond to preferences
2. Support a portfolio and pipeline of effective, affordable and scalable vaccines in
the context of variants, boosters, sustained transmission and emerging platform preferences, ensuring sustained and early access to new vaccines, shaping the market for the long term
• Support investments in the development of improved product characteristics preferred by AMC92 and support tech transfer and manufacturing scale-up via maintenance of a supply marketplace and, if capacity and resources are available, the establishment of sustainable manufacturing capacity in regions lacking significant capacity, with support to overcome IP barriers where needed
• Continue engagement with countries and manufacturers on market-shaping to support the development of a healthy market and affordably priced vaccines
• Tackle evidence generation more systematically when there are meaningful differences between HICs and L(M)ICs and when interventions could prevent and control disease, and to manage future risk of additional variants
https://www.who.int/docs/default-source/coronaviruse/act-accelerator-strategic-plan.pdf?sfvrsn=70e4d906_5&download=true
The WHO‘s SVT and 193 state members legitimize DNA+EP, C2K platform in defiance of FDA who is influenced by BPs. Ditto INNOVATE P3 trial in Brazil ????, Columbia, Mexico ????, Philippines ????. C2K, 5PSP have obtained CEMark in EU. Ditto Mali ???? who hosts SVT, China ????, South Korea ????.
Solidarity Trial Picks Two COVID-19 Vaccine Candidates
October 27, 2021 • 5:40 am CDT
The WHO and the Ministries of Health of Colombia, Mali, and the Philippines announced on October 26, 2021, the launch of the co-sponsored Solidarity Trial Vaccines in over 40 trial sites.
This international, randomized clinical trial platform is designed to rapidly evaluate the efficacy and safety of promising COVID-19 vaccine candidates selected by an independent vaccine prioritization advisory group composed of leading scientists and experts.
To date, the independent vaccine prioritization advisory group has reviewed the evidence of around 20 candidate vaccines.
Following the recommendation of the working group, two candidate vaccines are now included in the Solidarity Trial Vaccines, that are as follows:
A protein subunit vaccine from Medigen (MVC-COV1901) located in Taiwan, and
A DNA vaccine encoding the spike protein from Inovio (INO-4800) located in Pennsylvania.
Two additional vaccines are expected to enter the Solidarity Trial Vaccines once further evidence and documentation has been reviewed and accepted as satisfactory by the independent vaccine prioritization advisory group.
It is expected that other candidate vaccines currently under consideration by the vaccine prioritization advisory group may be added to the trial in late 2021 and during 2022.
The Solidarity Trial Vaccines have the additional potential to uncover second-generation vaccines with greater efficacy, conferring greater protection against variants of concern, offering a longer duration of protection, and/or using needle-free routes of administration.
https://www.google.com/amp/s/www.precisionvaccinations.com/2021/10/27/solidarity-trial-picks-two-covid-19-vaccine-candidates%3famp
Ahead of the #G20RomeSummit, we're calling on @g20org leaders to:
1) Fund our $3.5bn plan to #EndPandemics
2) Strengthen global leadership to better
prepare and respond to future outbreaks
3) Include R&D and access in new governance
and financing systems
Ahead of the #G20RomeSummit, we're calling on @g20org leaders to:
— CEPI (@CEPIvaccines) October 28, 2021
1) Fund our $3.5bn plan to #EndPandemics
2) Strengthen global leadership to better
prepare and respond to future outbreaks
3) Include R&D and access in new governance
and financing systems pic.twitter.com/IrqbtNKFwT
PLYMOUTH MEETING, Pa., Oct. 27, 2021 /PRNewswire/ -- INOVIO (NASDAQ: INO) announced today that third quarter 2021 financial results will be released after the market close on November 9, 2021. Following the release, INOVIO will host a live conference call and webcast at 4:30 p.m. ET to discuss financial results and provide a general business update regarding its DNA Medicines Platform, including the company's global Phase 3 efficacy trial (INNOVATE) involving its COVID-19 vaccine candidate, INO-4800.
https://ir.inovio.com/news-releases/news-releases-details/2021/INOVIO-to-Report-Third-Quarter-2021-Financial-Results-on-November-9-2021/default.aspx
“Our earnings call is scheduled for November 9th. The SOLIDARITY Trial Vaccines is run by the WHO and is completely separate from INNOVATE trials. The two trials will not be merged as the sponsors are different.”
We are now participating in the Solidarity trial vaccines run by the WHO. Solidarity clinical trial costs are covered by WHO. This is different from the INNOVATE clinical trial that we run ourselves. Through this, we expect faster phase 3 test results.
Ad Vaccine wants to do an IPO at the end of the year, but it may be delayed until early next year.
And it is difficult for us to share information arbitrarily because Advaccine is conducting clinical trials in China.” 10/27/21
“During a press briefing on Wednesday, a reporter asked if after the WHO clinical trials on Medigen are completed, would the vaccine receive an emergency use listing (EUL). Health Minister and CECC head Chen Shih-chung (???) responded by saying that first of all, the fact that Medigen was among only two vaccines chosen out of a field of 20, demonstrates that it is an "excellent vaccine and a vaccine with potential for development."
Secondly, Chen said that the WHO will be sponsoring the Phase III trials, covering all the expenses incurred by the research in the three countries participating. Third, the CECC head said that if the results for Medigen are found to be favorable after the trials are completed, "the probability that it becomes a WHO-approved vaccine is very high."
You can be an idiot and believe this same Scenario does not apply to Inovio or just patiently wait for the press release. Doesn’t change the fact that the trial is fully funded.”
In 2015-2017, Trial cost per person for Respiratory Min=$39,062 Max=$59,814 Median=$53,590
Fast forward to 2021, 2022, with inflation the min cost could be $50K/person. Let’s use a conservative min cost $39K back in 2015-2017.
$39K times 40K ppl in Columbia alone = $1.56B.
adding more ppl from Philippines ????, Mali.
adding even more countries to be included late 2021 to early 2022 from Argentina, Peru ????, Brazil ????, Mexico ????, Thailand, Rwanda, Tunisia, Vietnam ????, …
Total cost = 120K ppl * $39K = $4.68B
WHO said they would fully fund SVT.
someone can’t do math still? Back to primary ??
Estimated clinical trial cost per patient by therapeutic area in 2015-2017* (in U.S. dollars)
https://www.statista.com/statistics/1197095/clinical-trial-cost-per-patient-by-therapy-area/
10/26 Massive update to INNOVATE 4800 P3 trial: Official sites in Columbia, Brazil, Mexico, Philippines
Brazil
IBPCLIN - Instituto Brasil de Pesquisa Clínica AS
Rio De Janeiro, Brazil, 20241-180
Brazil, Rio De Janeiro
Lobus Centro de Pesquisa Clinica LTDA
Volta Redonda, Rio De Janeiro, Brazil, 27253-003
Brazil, São Paulo
CEPES Centro de Pesquisa Multidisciplinar - Faculdade de Medicina do ABC (FMABC)
Santo André, São Paulo, Brazil, 09060-870
Colombia, Atlántico
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla, Atlántico, Colombia, 800001
Clinica de la Costa LTDA
Barranquilla, Atlántico, Colombia, 80002
Corazon IPS S.A.S
Barranquilla, Atlántico, Colombia, 80020
Ips Centro Cientifico Asistencial Sas
Barranquilla, Atlántico, Colombia, 80020
Colombia, Bogotá, D. C.
Bluecare Salud S A S Sede Centro Medico Integral Chico Medplus CRI
Bogotá, Bogotá, D. C., Colombia, 110121
Mexico
SMIQ, S. de R. L. de C.V.
Querétaro, Mexico, 76070
Mexico, Jalisco
BRCR Global Mexico
Guadalajara, Jalisco, Mexico, 44600
Mexico, Querétaro
Unidad de Medicina Especializada SMA
San Juan del Río, Querétaro, Mexico, 76800
Philippines, Iloilo
West Visayas State University Medical Center
Iloilo City, Iloilo, Philippines, 5000
Philippines, Manila
Mary Johnston Hospital
Tondò, Manila, Philippines, 1013
Philippines, Metro Manila
Philippine General Hospital
Ermita, Metro Manila, Philippines, 1000
Las Pinas Doctors Hospital
Las Piñas, Metro Manila, Philippines
Asian Hospital & Medical Center
Muntinlupa, Metro Manila, Philippines, 1780
Lung Center of the Philippines, clinical research Facility building
Quezon City, Metro Manila, Philippines, 1104
Philippines, Negros Occidental
Riverside Medical Center Inc.
Bacolod City, Negros Occidental, Philippines, 6100
Enrollment: 7517 [Anticipated]
Secondary IDs: INNOVATE [Inovio INO-4800 Vaccine Trial for Efficacy]
WHO UTN: U1111-1266-9952 [World Health Organization (WHO)]
https://clinicaltrials.gov/ct2/history/NCT04642638?A=8&B=9&C=merged#StudyPageTop
Taipei, Oct. 26 (CNA) A COVID-19 vaccine developed by Taiwan's Medigen Vaccine Biologics Corp. has been chosen to take part in an international clinical trial platform co-launched by the World Health Organization (WHO), according to a statement released by the organization Tuesday.
The Medigen COVID-19 vaccine, a protein subunit vaccine, the rollout of which started in Taiwan on Aug. 23, was chosen along with a DNA vaccine encoding the spike protein developed by American company Inovio Pharmaceuticals, for the Solidarity Trial Vaccines platform, the WHO said.
[40K participants in Columbia, $800M, fully funded by W.H.O. More participants, another $800M funded by W.H.O. from Philippines ????, Mali ????. Total: $1.6B. This is as good as $1.6B Novavax received from OWS in 2020.]
The platform is "designed to rapidly evaluate the efficacy and safety of promising new candidate vaccines selected by an independent vaccine prioritization advisory group composed of leading scientists and experts," the WHO said.
The two were chosen after an advisory group reviewed around 20 candidate vaccines, and two additional vaccines are expected to be chosen for the clinical trials co-sponsored by the WHO and the health ministries of Colombia, Mali and the Philippines, according to the WHO.
More could be added to the platform by the advisory group in late 2021 and during 2022, the WHO added.
Responding to the WHO statement, Medigen spokesman Leo Lee (???) said the company is pleased about the news, and will continue with ongoing clinical trials, so its products can be approved internationally.
The inclusion of the Medigen and Inovio vaccines in the WHO project was first announced in September by the Colombian National Food and Drug Surveillance Institute.
At the time, the institute said 40,000 volunteers aged 16 and older in Colombia who live and or work in places with a high risk of coronavirus infection, such as healthcare and front-line workers were to be recruited for the trial, which would last about 15 months.
In Taiwan, 615,696 people have been fully inoculated with two doses of the Medigen vaccine as of Tuesday, including President Tsai Ing-wen (???) and Vice President Lai Ching-te (???), shortly after it received an emergency use authorization from the Taiwan Food and Drug Administration on July 19, even though the company at that time had yet to conduct Phase 3 trials.
Among the 22,783,694 doses of COVID-19 vaccines administered since the rollout began on March 22, 1,369,639 doses, or about 6 percent, are the Medigen vaccine, according to data released by the Centers for Disease Control Tuesday.
On Oct. 20, Medigen said it was accelerating its Phase 3 clinical trial in Paraguay and expected results by the end of this year.
Earlier this month, New Zealand and Palau both announced plans to allow entry of fully vaccinated visitors to their countries, and the Medigen vaccine is on the list of vaccines the two countries recognize.
https://focustaiwan.tw/sci-tech/202110260025