Transcript fra Q4
For fimaVACC, we have data – Phase I interim data that suggests enhancement of several parameters of importance for vaccination, and I’ll come back to some more data around CD8 positive T cells, which is what we’ve seen in the preclinical setting. This is a technology where we can enhance that, and we now have some results to show to you about the CD8 results in – and also in man. In the fourth quarter, we also had a U.S. patent granted for this band-aid-like device for skin illumination and also potentially for injection, which is an important patent, where we’re going to widely distribute the fimaVACC technology to a larger population.
I’m not going to go through the preclinical data. You’ve probably seen that before if you follow this company for a while. Very strong CD8 positive responses. And then what we wanted to do is to take this into the clinic. And by doing healthy volunteers studies show that we can get these kind of T cell cellular immune responses enhanced of the fimaVACC also in man. The study consists of 3 different parts: tolerability, which has been completed; fimaVACC vaccination in dose finding, which has been completed; and then potentially, an optimization of the fimaVACC regimen, if needed.
Of today, we have more than 90 subjects treated in total in this study. Data generated, so far, suggests enhancement of antigen-specific T cell response at tolerable doses. We see earlier responses, and we see higher response rates. So more of these subjects have this cell – immune cells, and they come earlier after vaccination.
What we’ve done now is we’ve started to look into more – into depth what is this – what are these T cells. So we are doing this together with Professor van der Burg’s group in Leiden. They are doing the analysis for us. So we are sending the samples there. In this study, we set a high bar for induction of CD8 tests of T cells because we use a specific protein from HPV that is very, very difficult to induce CD8 T cells in man with. So by this, we set the bar very high. Data from the first 2 fimaVACC cohorts that we have analyzed or that this group in Leiden has analyzed suggests that the vaccination regimen provides a higher number of responders with CD8 T cells. So 5 out of 6 in both of those groups that, after completion of vaccination regimen, had CD8 T cells. While in the control, which are with the state-of-the-art adjuvant that is being used in clinical development today, 2 of 6 of the controls show the same kind of enhanced or engagement of CD8 T cells. Analyses of further cohorts with this will be completed with the aim to publication of these results.
I think I confirmed this question before, but just to make sure I remember why there. It’s about the fimaVACC. You have proved that there’s no safety issue with that if another company would like to use a product they have together with fimaVACC. They have been passed the Phase I, the safety phase. Then they, I guess, they could use fimaVACC together with their product in the Phase II or potentially also a Phase III study. They don’t need to do a Phase – combined Phase I study again?
Per Walday, PCI Biotech
It’s – they probably would need to do some kind of a dose-finding thing. Because if they have done already clinical studies with their product and they know something around the dose and this – they are then combining this product with another technology that had never been combined before but both of those have shown to be safe, this is normally peptide protein antigens. So they are quite harmless in themselves, most of them. And therefore, you can – you don’t need to do a proper Phase I study normally for this, but you would need to do some kind of run-in dose-finding to ensure that you have the right level of the components for the patient population. Is that a clear enough answer?