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
