The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Patrick Trucchio - H.C. Wainwright & Co., LLC - Analyst
: Yeah, terrific. And then maybe you can talk about the domains on HBV that have T cells targeting. And is there -- are there any potential for possible
off targeting with this approach?
Question: Patrick Trucchio - H.C. Wainwright & Co., LLC - Analyst
: Got it. And then maybe if we just maybe take a step back and just talk about which patients that you think therapeutic vaccines would be most
likely to demonstrate an efficacy signal. Are we thinking about e-antigen-negative or positive surface antigen above or below certain thresholds
and NUC experienced, NUC nanve, a lot of these variables that we've been talking today?
Question: Patrick Trucchio - H.C. Wainwright & Co., LLC - Analyst
: Yeah. So then why was immune complex or IC31 chosen as the adjuvant? What's unique or helpful about TLR9 adjuvant or some other TLR?
Question: Patrick Trucchio - H.C. Wainwright & Co., LLC - Analyst
: Can you remind us how the vaccine is being delivered and which tissues are being delivered to?
Question: Patrick Trucchio - H.C. Wainwright & Co., LLC - Analyst
: And then as we look at the data that has been generated so far, we have a readout from the Phase 1b trial for safety in immunogenicity including
transaminase levels, interferon gamma, ELISpot of cultured PBMCs, and quantitative hepatitis B surface antigen. What were the key learnings from
that trial that gave you confidence moving ahead to Phase 2?
Question: Patrick Trucchio - H.C. Wainwright & Co., LLC - Analyst
: Yeah, that makes sense. And then maybe we'll talk a bit about the Phase II trial just starting with the design and status of the Phase II program. And
maybe you could also elaborate on the baseline characteristics that are expected of the patients who are enrolled in this program and why those
were chosen?
Question: Patrick Trucchio - H.C. Wainwright & Co., LLC - Analyst
: So it's a 1-log reduction or clearance. Are you expecting to see clearance? And what proportion of patients might that be possible?
Question: Patrick Trucchio - H.C. Wainwright & Co., LLC - Analyst
: And I think you said that on average, the patients enrolled have a surface antigen of 200 IU. What was the range or --
Question: Patrick Trucchio - H.C. Wainwright & Co., LLC - Analyst
: Got it. Okay. And just in terms of the, I guess, the significance of having patients in that range, the idea would then be, first, you have some of these
novel antivirals to get the patients into that range. These are patients who are already within that range. I guess, how should we expect the treatment
to be -- the HepTcell to be sequenced? Presumably you'd have the antiviral first and then you follow with the HepTcell, but how are you thinking
about? Are there specific antivirals out there that you think are better suited for this approach?
Question: Patrick Trucchio - H.C. Wainwright & Co., LLC - Analyst
: I guess from a safety and tolerability perspective, what have you seen in the data so far, and what are you looking for here in the in the Phase 2
readout? And what would we want to avoid?
Question: Patrick Trucchio - H.C. Wainwright & Co., LLC - Analyst
: Right. That's interesting. And I guess, as we're thinking about this next Phase 2 readout, and we're looking at some of the other therapeutic vaccines
and immunostimulatory mechanism in development, how should we think about a 1-log reduction or clearance rate potentially of surface antigen
relative to these other approaches? What would be considered a differentiated outcome?
Question: Patrick Trucchio - H.C. Wainwright & Co., LLC - Analyst
: Got it. And then just in terms of potential partnering for the program, I think you mentioned that currently in discussions. How are those discussions
going, and when might we learn more about next steps for the program and possible to move into Phase 3?
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