3/15/22 JK “We have CELLECTRA 2000 that we are using for our clinical trials. We have extensive inventory to execute all of our trials, including COVID-19. We have CELLECTRA 5PSP that is currently being used in REVEAL1 and REVEAL2.
We have also used them in some of our Vulvar trial as well in P2. And we have plenty of inventory. We are actually gearing up commercial inventory, studying that as we prepare to wrap up REVEAL2 and potentially have the package in preparation for our feature commercialization.
And, of course, we are gearing up our CELLECTRA 3PSP both for regulatory approvals, but also for our potential emergency use. Once our INNOVATE and SOLIDARITY trials, once we can demonstrate efficacy and safety, of course, our endgame is to apply for emergency approval and then the full approval.
So, we have been solving the scaling up of device manufacturing. It’s one of those platform things. It does slow us down of our clinical device from going from P1, P2, P3 for COVID vaccine. But we have solved for these issues. And the beauty of this platform is that once you solve for them, you don’t have to deal with the same issues again. So, our inventories are very strong.“
("anti-vector responses" from multiple mRNA jabs)-“Our strategy of heterologous boost is there's a lot of science supporting that when you mix and match various vaccines, some of these parts are better than just homologous boosting or just sticking with Pfizer or Moderna or J&J. And some of the vaccines cannot be boosted because of the – like the viral vectors, adenovirus vector vaccines are going to have a trouble boosting because of the anti-vector responses you generate. Because of the formulations, some people may start to have more severe reactions to additional shots of boosters and such.
This is where I think DNA vaccines like INO-4800 will come to play an important role in this ever-boosting environment of COVID pandemic and subsequently endemic. Our vaccines have been shown to be able to be readministered without any anti-vector responses.”
”We have four separate Phase III trials going for our lead products, INO-4800 And VGX-3100, two Phase IIIs each. We have about 350 people.
In 2022, you could see Inovio bringing a third Phase III program. We're currently finishing a Phase I/II trial for our orphan drug indication against recurrent respiratory papillomatosis in INO-3107. We received the orphan designation in 2020. We look forward to having that data in 2022 from this Phase I/II trial, safety, immunogenicity and efficacy, and we're looking to push that into a Phase III trial before the year-end this year. So, we really have a lot going on. So, I think 2022 will be a very eventful year for Inovio.”
