Dave Hering: Yes. On the first piece, right, I mean we continue to see viral evolution. That’s I guess one of the most critical components of the Invivyd strategy, right, which is we expect the virus to continue to evolve, which is why we see serial innovation as the answer, continuing to update antibodies, etcetera. As it relates to EG.5, we are looking to pull in and get in vitro data on it. But based on what we have seen so far, our belief is that it wouldn’t cause a significant activity reduction to VYD222. And so we will take a look at that now that it’s the predominant variant and do some additional confirmatory test, etcetera. I do think we have seen a progression from the summer into now, which is, like I have said, not unexpected.
We continue to do a variety of surveillance and predictive modeling on our side and look at mutation specifically, so even before they become specifically designated variants. And so that’s how we continue to look at what do we see coming, which ones would we like to start to test against, how we start to bring in assays against those and prepare for different eventualities. So, that’s really, like I have said, embedded into how Invivyd is structured in our strategy and looking to assess and then respond to the different variants as they emerge.
Patrick Trucchio: Great. And then just a clarification question. Is the expectation to have primary endpoint data from both Cohorts A and B at the end of 2023? And can you talk to us about the potential for government contracts for VYD222, or would this be primarily be commercialized through sort of traditional channels and methods? And then just lastly, can you talk about advantages of VYD222 compared to some of these other antibodies in development for COVID-19? And what are some of the advantages perhaps of the dosing schedule or others that you can point to relative to those approaches? Thank you very much.
Dave Hering: I can take government contracts. You want to take first the preliminary data we are expecting from the primary endpoint at around the end of the year?
Pete Schmidt: Yes, that’s a good question. So, our understanding and plan is actually that we don’t need the serum neutralizing titer data from Cohort B. There, that group just serves to increase the safety database, the exposure needed for an EUA. So, the preliminary data you will see will just be from the immune compromised cohort, which is Cohort A.
Dave Hering: Yes. And then related to your question about government contracts, based on the current environment and transition, we are not anticipating government contracts as the primary source for really putting much in terms of our commercial readiness related to government contracts. We are preparing for a traditional market, your activities related to reimbursement in payers and market access, etcetera. And so that’s really the focus of the team now as we are preparing for a potential launch and being ready for that in a traditional market. That said, a variety of the different acts that Congress took during the pandemic do provide different reimbursements and things of coverage for Medicare, etcetera. And so we continue to look at all of those.
So, even without government contracts, as we saw during the pandemic, there still is a variety of support that has been put in place for COVID-related products. As it relates to advantages of VYD222, one of the things that we have been saying for quite a while is 222 is a reengineered version of our original antibody ADG20. And we did this through an affinity maturation process and did it looking at the BA1, BA2 backbone of Omicron. And so with a set of slight changes, a, amino acids, we were able to reestablish binding where ADG20 has lost. ADG20 came from a SARS-CoV-1 survivor. And so we continue to see that 222 has broad neutralizing activity and is one that we really see as an antibody that, to-date, has not occurred in a natural setting.