James Molloy: The final question would be on the triple combo. I know that you highlighted earlier how it’s somewhat out of your hands with a partner running the trial. Can you walk through expectations or the current expectations for sort of data €“ next data from this? I know 003 is clear, the focus here. But any thoughts on potentially a Phase 3 study in the triple combo at some point in the future?
Frank Bedu-Addo: Absolutely. I think with the triple combination, so the triple combination is not out of our hands. The NCI trial is essentially completed. Right now, what we’ve done is we have acquired PDS0301. So, really, it’s now in our control in terms of the partnership with Merck KGaA. They are providing us with the material, we’re designing the trial. However, to complete design of that trial and to have an efficient trial, we’re also looking at PDS0101 plus KEYTRUDA which is a commercial checkpoint inhibitor in this exact patient population we’re going to be treating, which is recurrent metastatic head and neck cancer. And, therefore, we anticipate that we should see this data sometime in Q3. That data, even though we’re looking at PDS0101 and KEYTRUDA without IL-12, we know that IL-12 is critical in these checkpoint inhibitor refractory patients.
So that data will not necessarily be essentially what we would anticipate seeing in the Phase 3 trial, but it will be very informative. If, for example, we already see an improvement in overall survival, even without IL-12 in that patient population. That information then allows us to more efficiently design the statistical portion of that Phase 3 clinical trial. So, those are the key pieces of information we’re looking for. We’re also, at the same time, doing the work needed to identify the correct commercial manufacturer for that product as we take it over. So, essentially, what we want to do as we go into our Phase 3 clinical trials is to make sure that it’s going to be pretty much very similar to what the commercial product is going to look like in terms of the manufacturing.
That mitigates your risk significantly. It speeds up going from your BLA to actually producing and selling your commercial product. So, those are some of the key things that we did for VERSATILE-003 and would like to take the same approach with the triple combination to make that process much more efficient once we start it from beginning to end. So, currently, we are prioritizing getting VERSATILE-003 up and running. But once that’s happened, our then primary goal is €“ primary focus would then be getting the triple combination also up and running. Our key here is commercialization of PDS0101 and commercialization of PDS0101 Plus PDS0301. So that’s really the approach we’re taking to make sure that we mitigate risk as much as possible and make sure that we can execute the most efficient trial possible.
Operator: . Our next question is coming from Robert LeBoyer from Noble Capital Markets.
Robert LeBoyer: Thank you for all the details you’ve given on the VERSATILE and the triple therapy trials. My question has to do with the MD Anderson and the Mayo Clinic data that’s been coming out and whether you have plans to include those in trials or any milestones going forward or things to look forward to from those indications.
Lauren Wood: As Frank mentioned, both the MD Anderson led IMMUNOCERV trial, as well as the Mayo Clinic trial are investigator-initiated studies. So, we don’t have control over the accrual rates or actually the publication or presentation of scientific data from those trials. However, we do know that there has been significant interest and enrollment and accrual to the Mayo IIT trial. Just reminding everyone that this is using and investigating PDS0101 alone or in combination with KEYTRUDA prior to definitive curative surgical resection in individuals who are presenting for initial treatment of HPV 16 oral pharyngeal cancer. Our hope is that we will be hearing from investigators and that they’ll be able to present some interim data, hopefully, this year regarding preliminary findings in this population.
It’s very important to us because this study is going to provide us insight into not only immunogenicity, tumor shrinkage prior to surgery, pathologic response in tissues, but also an important examination of the biomarker of circulating tumor HPV 16 DNA. The IMMUNOCERV data from MD Anderson was on the first nine subjects who had actually completed their day 170 evaluations. We know that there are additional patients from this study that have already undergone treatment, but we’re not at that time point to allow presentation of their data at the end of 2022. So, we look forward to additional data as that matures from that study as well.
Frank Bedu-Addo: Lauren, do you want to add a little bit of about the Mayo Clinic and how it could be translated into a potential randomized trial? I think that may also help.
