Welcome to the Invivyd conference call. At this time, all participants are in a listen-only mode. After the speakers prepare remarks, there will be a question-and-answer session. Please be advised that today's conference call is being recorded. I would now like to hand the conference over to Scott Young, Senior Vice President of Investor Relations and Corporate Communications. Please go ahead.
Thank you, Operator. A short while ago, we announced the FDA's emergency use authorization of PEMGARDA, formerly known as VYD-222. The associated press release and the slides that are being used on today's webcast can be found on the Investor section of the Invivyd website under the Press Release and Events and Presentation sections, respectively. For those who are viewing the webcast, the slides can also be found in the upper right-hand corner of the webcast player. The PEMGARDA fact sheets and letter of authorization can be found on PEMGARDA.com. Today's discussion will be led by Dave Hering, Invivyd's Chief Executive Officer, and he's joined by Jeremy Gowler, Chief Operating and Commercial Officer. Additionally, Bill Duke, Chief Financial Officer, and Robbie Allen, Chief Scientific Officer, are also available for Q&A.
During today's discussion, we will be making forward-looking statements concerning, among other things, the emergency use authorization and our commercial plans for PEMGARDA, the future of the COVID-19 landscape, our ongoing research and development efforts, regulatory matters, our business strategies and objectives, our financial position and future prospects, and other statements that are not historical fact. These forward-looking statements are covered within the meaning of the Private Securities Litigation Reform Act and are subject to various risks, assumptions, and uncertainties that may change over time and cause our actual results to differ materially from those expressed or implied today. These forward-looking statements speak only as of the date of this call, and Invivyd assumes no duty to update such statements. Additional information on the risk factors that could affect Invivyd's business can be found in our filings made with the U.S.
Securities and Exchange Commission, including our most recent Form 10-K, which is also available on our website. I will now turn the call over to Dave.
Thanks, Scott, and thank you all for joining the call. It is a pleasure to be speaking with you today to discuss an exciting momentous accomplishment for Invivyd and an important step forward for certain populations vulnerable to COVID-19 disease. Despite the rapid initial progress made with COVID-19 vaccines and antivirals, SARS-CoV-2 continues to play too large a role in daily human life, and major portions of our population who are immunocompromised remain at very high risk of adverse outcomes following symptomatic COVID-19 disease. Turning to slide 4, immunologic protection from respiratory viruses follows a gradient such that, in general, higher levels of antiviral neutralizing antibody titer confer higher degrees of protection.
COVID-19 vaccines are well-established as providing protection from the most severe outcomes from a subsequent bout of COVID-19 for the general population, but many immunocompromised populations cannot achieve sufficient protection from vaccination and remain at risk for severe outcomes. Engineered recombinant monoclonal antibody therapeutics targeting the SARS-CoV-2 spike protein have been shown as protective in randomized clinical trials, not just of severe outcomes such as hospitalization and death, but also can be highly protective of symptomatic disease. Accordingly, our strategy is to develop monoclonal antibodies that provide high protective titers and consequently higher protection against symptomatic COVID-19. Most of us now have existing baseline immunity as a result of exposure to COVID-19 and/or utilization of vaccines, but nonetheless, Invivyd has been devoted developing product candidates that strengthen immunity against COVID-19 for vulnerable populations.
Today's announcement of the FDA's emergency use authorization, or EUA, of PEMGARDA for the pre-exposure prophylaxis or prevention of COVID-19 in certain adults and adolescents with moderate to severe immune compromise who are unlikely to mount an adequate immune response to COVID-19 vaccination, as further described in the PEMGARDA fact sheet, is a critical step in our fight against this ubiquitous disease and an important milestone for populations most vulnerable to adverse outcomes who have been without a mAb for pre-exposure prophylaxis or PrEP for more than a year. As highlighted on slide five, our journey to reach this point has been remarkable.
In less than a year, we initiated a phase I clinical trial, gained alignment with the FDA on an immunobridging design for our phase III pivotal clinical trial, CANOPY, initiated, fully enrolled, and announced positive initial results from CANOPY, submitted a request for emergency use authorization to the FDA, and now today we are here to discuss that EUA, provide an update on the CANOPY clinical trial data, and discuss the commercial launch of PEMGARDA. While it mirrors the plans we articulated last year, upon reflection, it is a truly impressive set of accomplishments which, by typical industry standards, were achieved at light speed, and none of them could have happened without our platform approach in the mAb, as well as the tenacity, dedication, and passion of our superb team.
I would like to thank each and every Invivyd team member for their impressive execution and helping to position us for continued success as we begin an exciting new chapter for Invivyd. While obtaining the EUA was a true team effort, I would be remiss if I did not extend special thanks to our medical, clinical, and regulatory affairs teams who worked tirelessly over the past year to ensure that PEMGARDA would become commercially available to appropriate patients as quickly as possible. Thank you. Further, the U.S. Food and Drug Administration has worked tirelessly with Invivyd to chart a pathway for the rapid development of important new medicines. Their intellectual leadership throughout the COVID-19 pandemic and now in the endemic, long-term fight against COVID-19 has been and will be critical to the well-being of many Americans, and we are grateful for their work.
Moving to slide 6, PEMGARDA is an exciting new emergency use authorized product for the prevention of COVID-19 in appropriate individuals. Even as we were awaiting the EUA from the FDA, some people questioned the need for a preventive monoclonal antibody for COVID-19 and if the FDA would grant an EUA since COVID vaccines are now readily available to people in the U.S. The unfortunate reality is that for many immunocompromised individuals, COVID vaccines may only provide limited or insufficient benefit because they rely on the patient's immune system to generate protection. For vulnerable individuals like the immunocompromised, COVID-19 remains a very real and potentially life-threatening disease. Furthermore, it's clear that, similar to flu and RSV, COVID-19 is likely to be with us for generations to come.
For the immunocompromised, this means that the risk of becoming seriously ill or hospitalized remains as real today as it was in early 2020. So it's not surprising that, unlike vaccines which have seen consumer demand waning, immunocompromised individuals, as well as the professionals who care for them, have been calling for new protective antibodies. In recent months, we have had multiple immunocompromised individuals reach out to us and share their feelings of being forgotten, left behind, and isolated as the rest of the world eagerly moves on from COVID. We hope PEMGARDA may address an urgent need for the most vulnerable of the immunocompromised.
Turning to slide 7, Jeremy will provide more specifics on the market opportunity, but as we have previously discussed, based on our market research, there are more than 9 million immunocompromised people in the United States, and we are initially focused on approximately 485,000 moderately to severely immunocompromised individuals who are the most vulnerable and at greatest risk of serious illness from COVID-19. These include individuals undergoing stem cell transplants, solid organ transplants, and cancer treatments, which can weaken a person's immune system, making them more susceptible to the potentially devastating consequences from the disease. This population is largely familiar with and commonly undergoes intravenous infusions as a part of their treatment regimens. Very briefly, it is worth recalling that Evusheld, a mAb combination for the prevention of COVID-19 in certain patients, was a critical option for COVID-19 PrEP for more than a year.
Unfortunately for those patients, Evusheld lost antiviral activity due to viral evolution. However, it is notable that Evusheld utilization grew through to the end of its availability, a testament to the growing awareness of and interest in enhanced protection for vulnerable populations. As in other areas of COVID-19, the government-based contracting paradigm that was in place for Evusheld will now convert to a more traditional commercial pharmaceutical marketplace with PEMGARDA. However, we believe that there may be substantial demand in vulnerable populations to activate in the coming quarters and years. Moving on to the CANOPY data, I'd like to walk you through an update of the CANOPY clinical trial, including key elements that supported the emergency use authorization of what we believe is an urgently needed investigational product.
Recall, zooming out, what CANOPY and PEMGARDA reflect is the result of a highly novel development and regulatory pathway that is designed to prioritize speed and flexibility. Overall, I think you will appreciate that in order to provide such rapid delivery of a novel medicine, we and the FDA aligned on pursuing conservative immunobridging benchmarks to support the development and authorization of the first PrEP mAb to leverage this type of novel approach. This conservatism dictated our use of a high dose of VYD-222 in CANOPY, in fact, the highest dose contemplated in our first in-human study.
This dose of VYD-222, combined with the PK profile of the drug and further combined with the antiviral potency of VYD-222, has two broad effects: high drug mass, 4.5 grams, and, given current circulating viruses, very high titers across the dosing interval, including titers well above those contemplated in prior published estimates of clinical protection. In a few slides, we will walk you through the details. The ongoing phase III CANOPY trial utilizes an innovative immunobridging approach, and on slides 10 and 11, we describe the trial design and the demographics of the participants in the two cohorts A and B. In cohort A, we enrolled approximately 300 individuals who are significantly immune compromised and representative of the groups at highest risk for severe COVID-19 disease that we plan to focus on at launch.
Given these subjects' risk factors, all participants in cohort A received VYD-222 with no placebo arm, and the co-primary endpoints are safety and tolerability and serum neutralizing titers at Day 28 against relevant SARS-CoV-2 variants. These titers are calculated from pharmacokinetic concentration of VYD-222 from the immunocompromised participants and the IC50 value for VYD-222 against relevant SARS-CoV-2 variants. Different from cohort A, cohort B is a randomized, placebo-controlled cohort where we enrolled approximately 450 individuals who are at risk for exposure to SARS-CoV-2, which is essentially anyone who has regular unmasked interactions with others in an indoor setting. Participants in cohort B were all comers versus significantly immunocompromised and randomized 2-to-1 to receive VYD-222 or placebo, and the primary endpoint is safety and tolerability.
Moving to slide 12, the safety profile of VYD-222 is based on exposure of 623 participants who received at least one 4,500-milligram IV dose of VYD-222 across both cohorts, including adults with complex underlying medical conditions. The interim safety data we presented today included 296 people in cohort A who received a second dose of VYD-222 three months after the initial dose. In cohort B, 450 participants received a second dose of VYD-222 or placebo three months after the initial dose. Cumulative safety with the first two doses of VYD-222 is assessed only in cohort A because unblinded safety data in cohort B were not available after Day 28.
Other than systemic infusion-related reactions and hypersensitivity reactions, including 4 cases of anaphylaxis, which I will discuss in a moment, the most common treatment emergent adverse events in cohort A across both the first and second dose cumulatively, irrespective of causality, observed with VYD-222 in participants who have moderate to severe immune compromise in CANOPY were upper respiratory tract infection, infusion site infiltration, viral infection, influenza-like illness, fatigue, headache, nausea, and local infusion site reactions. Moving to slide 13, we provide a summary of the anaphylaxis and systemic infusion-related reaction and hypersensitivity reactions observed in CANOPY. In cohort A, the reactions were generally mild, 17 of 27, or moderate, 8 of 27. Two anaphylaxis reactions were life-threatening. The PEMGARDA fact sheet includes the boxed warning for anaphylaxis, which was observed in 4 out of 623, or 0.6%, of participants in CANOPY, all in the immunocompromised cohort.
Two of these four adverse reactions were life-threatening, as mentioned. Two were initially classified as mild or moderate hypersensitivity adverse reactions, but during the review of the EUA application, the FDA reclassified these as anaphylaxis. In cohort B, there were no observations of anaphylaxis in the VYD-222 arm as of Day 28, but unblinded safety data in cohort B were not available yet after Day 28. During the CANOPY trial, the infusion time was increased from 30 minutes to 60 minutes with the aim of potentially reducing the frequency of systemic infusion-related and hypersensitivity reactions. However, increasing the infusion time is not anticipated to impact the incidence of anaphylaxis. While the administration guidelines were changed for CANOPY, there were only a small number of patients who received VYD-222 with the revised guidelines, so there is not yet enough data to determine the potential impact of the change.
We plan to continue to explore how all these factors combine to potentially reduce infusion-related reactions. It is important to note that PEMGARDA will be administered in the hospital or infusion center setting where these institutions are accustomed to administering IV drugs with similar safety profiles. Now, moving to slide 14 to generate data for the immunobridging endpoint, CANOPY utilizes pharmacokinetic serum concentrations or PK data collected from patients. Using this PK data and potency values from relevant variants allowed us to calculate serum neutralizing titers. Those titers were then compared to titer values from our previous prevention study, EVADE. As a reminder, EVADE was a phase II/III randomized, double-blind, placebo-controlled clinical trial of adintrevimab, ADG20, the parent mAb for VYD-222, in which titers were correlated with observed clinical efficacy in prevention of symptomatic COVID-19.
The immunobridging target for cohort A came from the day 90 titer value of 3514 from EVADE. This conservative benchmark was chosen in order to utilize the rapid bridging approach while minimizing the residual clinical uncertainty associated with a bridging approach. This day 90 value was extrapolated back to Day 28 and created a reference or target titer of 8,944. To establish immunobridging, a ratio of 0.80, similar to a test for non-inferiority, of the actual day 28 calculated titers to the benchmark was needed. As you can see from the graph on the left from the Schmidt paper et al. in Science Translational Medicine, scientific literature suggests that people may receive meaningful clinical protection with much lower titer levels. On slide 15, we present the interim immunobridging results from the immunocompromised cohort A.
The day 28 calculated serum virus neutralizing titer for VYD-222 against JN.1 was 7,365, with a 90% confidence interval of 7,148-7,589. The ratio between the day 28 titer for VYD-222 against JN.1 of 7,365 and the day 28 adintrevimab reference titer of 8,944 was 0.82, with a 90% confidence interval of 0.80-0.85, showing that immunobridging was established in the CANOPY clinical trial. The day 90 calculated serum virus neutralizing titer for VYD-222 against JN.1 prior to redosing was 3,199, with a 90% confidence interval of 2,995-3,418. The titers against JN.1 are projected to stay above the reference titer from EVADE of 3,514 for approximately 77 days, median, following a single dose of VYD-222.
Furthermore, the range of titers achieved against JN.1 for three months following administration of VYD-222 were consistent with the tighter levels associated with efficacy of other SARS-CoV-2 targeting mAbs in prior clinical trials. We believe prescribers and patients will see tremendous value in a mAb that offers the potential to provide meaningful protection from developing symptomatic COVID-19, especially in light of data from a recent CDC study, which found that COVID vaccines' effectiveness among all adults aged greater than 18 years was 54% protection against symptomatic disease at a median of 52 days post-vaccination. At the recent ACIP meeting, they recommended an additional booster for individuals 65 and older, and at that meeting, they referenced data showing that moderately to severe immunocompromised individuals who receive boosters every six months still face a significantly elevated absolute risk of severe COVID-19 compared to the general population.
In summary, we are tremendously pleased and excited that we will be able to offer PEMGARDA to certain moderate to severely immunocompromised people in the very near future. Moving to slide 16, this brings me to the overall drivers of our future success and the elements of our platform. At Invivyd, we have assembled an extraordinary team with some of the most talented and experienced individuals working in industry, and this is especially true for our commercial and medical affairs teams, two areas that will be instrumental to our launch. Jeremy will share details on the former, and with respect to the latter, I will say that they have been busy building out an impressive group of medical science liaisons who will be available to provide critical medical information to prescribers and payers.
They are also actively working on a slate of scientific abstracts and manuscripts to present key PEMGARDA data this year. While the spotlight is appropriately now squarely focused on the PEMGARDA launch, we firmly believe the virus will continue to evolve, and that at some point in the future, it will change significantly enough that a new antibody will be needed. Invivyd is uniquely positioned to keep pace with that expected evolution. We have now demonstrated the speed of our platform approach, an approach we intend to refine and make faster and more efficient as we move forward. PEMGARDA is the first of what we expect will be many monoclonal antibodies that will come from Invivyd as we continue to advance our platform approach with the strategy of continuously having products with activity against SARS-CoV-2 and meeting the ongoing unmet need.
While we believe we can generate exciting sales of PEMGARDA with our initial targeting strategy, we believe we will just be scratching the surface of where we anticipate taking our COVID franchise in the years to come as we seek to expand our reach and make monoclonal antibodies for pre-exposure prophylaxis of COVID-19 available to more and more people with moderate to severe immune compromise. Which leads me to the third reason for my excitement about the future: our platform approach and pipeline. Even today, as we prepare for the launch of PEMGARDA, our team is busy running our innovation engine, INVYMAB, at full throttle.
Our platform approach leverages state-of-the-art viral surveillance, advanced AI predictive modeling tools, and the extensive knowledge and experience of our discovery scientists to anticipate how the virus will evolve so we can aim to keep pace with it by potentially developing and advancing new antibodies that can be rapidly deployed once needed. We will be discussing our pipeline programs in more detail over the coming months, but what I will say today is that we believe PEMGARDA represents an important achievement not just for Invivyd but for science and medicine. Monoclonal antibodies have long played a vital role in the treatment of diseases across many therapeutic areas. However, the use of monoclonal antibodies to prevent disease is still a concept in its nasency, and that is a true competitive advantage for Invivyd.
We are building a biotech company that's designed to last and which aims to challenge and change the current COVID-19 prevention paradigm. Just as flu and COVID-19 vaccines now utilize immunobridging approaches to bring new versions to market without massive resource-intensive phase 3 trials, we have now demonstrated there is a similar opportunity for COVID-19 PrEP mAbs. As leaders in this new space, we have an opportunity to leverage our learnings to advance future programs more quickly and efficiently and advance science for the most vulnerable among us. Finally, before I turn it over to Jeremy, I would end by emphasizing how excited we are about the opportunity ahead of us. While we will continue to evaluate our needs and opportunities on an ongoing basis, from a balance sheet perspective, we feel we are well-positioned for launch.
We ended 2023 well-capitalized with estimated cash and cash equivalents of $200.6 million, and in February, sold shares totaling $40.5 million under our ATM facility, further strengthening our balance sheet ahead of the PEMGARDA launch. Based on current operating plans and excluding anticipated cash collections from PEMGARDA sales, Invivyd expects its existing total cash and cash equivalents will enable the company to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2024. Now, over to Jeremy.
Thanks, Dave. It's such a pleasure to join today's call to discuss the launch of PEMGARDA, share details of key aspects of the launch, and introduce some of the initial launch metrics that we will be discussing in quarters ahead to provide visibility into our progress and the uptake of PEMGARDA. Moving to slide 18, before I discuss some of the key elements of our launch plans, I would like to reiterate a few of the important points that Dave just made. We are in a unique position with an important investigational product that we believe has a compelling profile. We're entering into an established and yet open market that has been without a monoclonal antibody product for pre-exposure prophylaxis of COVID-19 since Evusheld was withdrawn more than a year ago.
Starting with Dave and his invaluable experience launching Pfizer's mRNA vaccine, we have an experienced commercial team that is excited, confident, and ready to embark on what we believe could be one of the most exciting launches of our careers. With respect to our launch activities, in short, our commercial team is ready. We began preparing for possible EUA product launch throughout the past year while the development was ongoing, and today, we are rapidly gearing up for the full launch of PEMGARDA. I'll briefly walk through the key elements which center around product availability, the rapid buildup of our field organization, and pricing and reimbursement. As we've discussed in the past, our manufacturing team has been busy preparing for the EUA for many months.
We manufactured initial supply of PEMGARDA at risk, and we expect product will be available for purchase through the major distributors such as Cardinal Health and McKesson imminently. In the meantime, we have been building our commercial team and preparing to hit the ground running. The vast majority of the estimated 485,000 highest-risk moderately to severe immunocompromised people we are targeting receive care in about 1,150 cancer or transplant or infusion centers located across the country, and we believe we can effectively call on all of them with a focused, concentrated field team of 20-25 contracted key account managers or KAMs. We are utilizing IQVIA as our commercial partner for the launch as they have extensive experience selling innovative new products within an institutional call point, which requires a very specific skill set.
Their selling strengths are further supported by the vast resources and access to strategic intelligence which would not be available to us independently at this time. We are currently in the process of preparing for our KAMs to enter the field so they can initiate commercial sales activities with their target institutions with the goal of having PEMGARDA added to institutional formularies in the coming weeks. Each hospital center has a unique process for evaluating new products for inclusion on their formularies. In general, the timeline can vary from a few days to weeks or months. However, the centers we are focusing on are very familiar with seeing innovative new medicines come through their P&T committees, and we believe many will work quickly to add PEMGARDA.
Regarding pricing, we have not yet indicated what the wholesale acquisition cost will be, but we plan to announce the price of PEMGARDA in the coming weeks. For now, what I will share is that we conducted extensive market research across physicians and payer groups, and the price of PEMGARDA will be based on the substantial part of the value that the unique product provides to patients, payers, and the healthcare system as a whole. For context, a recent study found that the cost of COVID-related hospitalization in the U.S. is approximately $64,000, and that doesn't begin to account for the emotional and physical toll that COVID can have on individuals receiving care for an organ transplant or while undergoing cancer treatment. Furthermore, while the consequences of the acute disease are well-known, there is mounting evidence pointing to the very real and lingering risks presented by long COVID.
The NIH recently announced that they are investing an additional $550 million over the next four years into the RECOVER initiative, a nationwide research program to fully understand, diagnose, and treat long COVID. While new therapies for the treatment of COVID-19 are critically important, none would bring the benefit of preventing symptomatic COVID-19 in the first place. Turning to slide 19, as for the reimbursement for PEMGARDA, our target populations are estimated to be roughly split 50/50 between CMS's Medicare and Medicaid and commercial payers. PEMGARDA is a physician-administered buy-and-bill product that falls under Medicare Part B. CMS confirmed in Physician Fee Schedule Final Rule that all COVID-19 monoclonal antibody products for pre-exposure prophylaxis of COVID-19 and their administration are covered. We expect PEMGARDA will receive a product-specific reimbursement code in the coming weeks.
Regarding commercial payers, we have a national account management team which has been actively engaged in discussions with most major plans, and while payers all have different processes and timelines, we believe that they will make coverage decisions or implement policies for PEMGARDA within the coming weeks and months following supply availability. Shifting to slide 20, obviously, product sales are the most important metric of any launch, but as with any new product, we expect it will take a few quarters before adoption starts to ramp, recognizing that we plan to share additional launch metrics that can help serve as surrogate markers for the success of launch during the early stages.
Specifically, in the coming quarters, we plan to provide updates on patient lives covered via CMS and commercial payers, our progress reaching and calling on our targeted institutions, the number of targeted accounts that have ordered products, and the number of targeted accounts placing reorders. As the launch advances, we anticipate that we'll revise these metrics with the goal of providing additional visibility into our progress and performance. Thank you. Operator, please open the call for questions.
Certainly. Ladies and gentlemen, if you do have a question at this time, please press star 11 on your telephone. If your question has been answered and you'd like to remove yourself from the queue, simply press star 11 again. One moment for our first question. Our first question comes from the line of Michael Yee from Jefferies. Your question, please.
Hi. Good afternoon. Congrats on the approval, and thanks for taking our questions. This is Joanna W ang for Mike. Our question will be, have you identified a bolus of patients that you anticipate being able to move onto the treatment rather quickly and then slowly ramping as you roll out the launch into other key accounts? And secondly, I know you haven't disclosed the pricing, but should we anticipate it being the ballpark of similar antibodies before? Just any helpful thinking there. Thank you.
Yeah. I can talk a little bit to the first one, and Jeremy, you can further add. So we have been looking in this space for quite some time and been talking to different patient advocacy groups. As I mentioned during the upfront part of this call, it is very notable where the moderately to severe immune compromised patients reside. And as Jeremy mentioned, we've really looked at the different transplant centers and cancer treatment centers where these folks are. And then combining that with the patient advocacy groups who continue to reach out and ask for us, we do feel we have a very defined target base for our outreach and a set of patients who have been waiting for a very long time with no product on the market having utilized Evusheld previously. And so we're very confident that they are ready.
And now, as Jeremy mentioned, we've been focused on the market access side of this. The transition from government purchase into the more traditional market involves reimbursement and access and the like, which we have teams already deployed and working on. Jeremy, anything else you have on the targeting side?
No, I think it's about right there.
Okay. On the pricing side, yeah, there's more to come on that soon. We've talked a little bit about this in the past. Some of the monoclonal antibodies previously for prevention were priced in a range of, I don't know, $1,700-$2,500, something like that. We had seen that the pricing would move up from that particular point based on a few factors. One, that was done under the government purchase pricing. Two, as Jeremy said, we've really looked at this from a health economic perspective and what the product could provide, and of course, factoring in the higher dose and COGS associated with it. So more to come, but certainly, a lot of research has gone into the pricing, and we're just at the sort of final refinement stages of that.
Very helpful. Thank you so much, and congrats again.
Thank you.
Thank you. One moment for our next question. Our next question comes from the line of Maxwell Skor from Morgan Stanley. Your question, please.
Great. Thank you. And congratulations on this milestone. So I have two questions. First question, what are your expectations around patients, specifically immunocompromised, receiving a second dose, let's say, over a year span? Do you expect them to get one dose, two doses, three doses? And my second question would be, could you elaborate on the anaphylaxis risk and whether you think a lower dose would reduce a patient's relative risk? Thank you.
Yeah. So on the first question, as is in the fact sheet, dosing can occur every three months, and so that's one of the components there. I think this will always be a decision between patients and providers as they look at their own individual risk. And certainly, what we've seen is when you provide a second dose, you can, again, elevate the titer values that you would expect similar to when we start from baseline and go from the first dose. We're still working through and seeing how that redosing interval will work in practice and how that will be utilized. And that's one of the things that we'll continue to refine as we see the data and look at our own forecasts. As it relates to the question about anaphylaxis and dosing, so what we've seen is anaphylaxis in less than 1% of the participants in the trial.
They were all observed in cohort A. It's an area that we want to continue to better understand and see what additional data we could provide. You mentioned lower dosing, and that's certainly something that we could look at down the road. There's always an offset between those two components. We picked this higher dose, as I mentioned, the highest dose from the first-in-human, really to provide the high titers that we had seen associated with high efficacy in scientific literature and really at direction and coordination with the FDA. So this is one of those elements that we'll continue to work on. As we've stated, we have this platform capability, and we're looking to do this repeatedly. And so we continue to look to explore the relationship between titer levels, efficacy, baseline titers, calculated titers, all of that ensues.
More to come as we look at this and the scientific relationships between all of those variables, but certainly something that we continue to work on.
Great. Congratulations again. Thank you.
Thank you.
Thank you. One moment for our next question. Our next question comes to the line of Patrick Trucchio from H.C. Wainwright. Your question, please.
Hi, team. Congratulations. This is amazing news. And I got a couple of questions to get a little bit more color on the future plan. Do you plan to actually submit a full BLA for PEMGARDA, and do you think that future products that might address other viruses, other variants, will follow this accelerated path, or do you think they will require a different, more traditional BLA path through approval? And then I have a follow-up question.
Sure. The first two, we can handle. So as it relates to the future plans for a BLA, what I can tell you is CANOPY was designed for immunobridging and was stipulated with the agency, the FDA, that it would be used to support a potential EUA, which is what we've done. Additional studies, efficacy studies, would be required for a BLA, so that is something that we would continue to have conversations with them. In the meantime, what we've stated is our strategy is this serial monotherapy approach and to be able to do that rapidly to keep pace with viral evolution. And so we're really focused in that regard as to how we can refine the process we just went through at what could be described as light speed and do it repeatedly again and again.
And so with that, we do see Immunobridging and EUAs as a possible path going forward. It's certainly a path that remains open. As we stated, there have been no products on the market until today to really go after this significant unmet medical need of moderate to severe immunocompromised patients. And so that is an approach that we continue to look at while we have engaged with regulatory authorities on what could be an approach for licensing a sort of possible platform or looking to mirror what occurs more readily currently in vaccines, sort of an annual approval and then an SBLA follow-up.
Great. That's really helpful. And regarding addressing new variants, new COVID variants, or even other types of diseases, so going forward, this is seen as a platform that addresses viral evolution. Right now, PEMGARDA addresses all the variants. I think you've mentioned that before, but could you just say well, could you just talk about how it performs with the latest variants? Thank you.
Yeah. So JN.1 is still by far the most prevalent variant that's circulating here in the U.S. I'll let Robbie, our Chief Scientific Officer, talk a little bit more about how we do surveillance and how we're looking and approaching and seeing what's coming next. That is one of the areas that we feel particularly differentiated in, in our capabilities. There's a lot of work that's been going on in order to continue to drive that forward. And that predictive modeling and looking at what variants we see coming influences the pipeline and the different mAbs that we continue to look at from a development standpoint. But Robbie, anything more you'd like to say on the current state of variants?
Well, I think we spend a lot of time looking at wastewater data and looking at clinical data to see two things. One, which variants are actually coming into existence, say, in the wastewater? And two, which variants are becoming more prevalent in the clinic? Those two considerations have led us to a program that is very well refined in its ability to both identify risk in the wastewater and also attach risk to anything that we see in the clinic. With that in mind, we've been able to hold the activity of VYD-222 or PEMGARDA at a level which we are very comfortable with at this point with all of the existing variants.
Thanks, Robbie.
Thank you.
Thank you. This does conclude the question-and-answer session of today's program. I'd like to hand the program back to Dave Hering for any further remarks.
Yeah. Thank you all for joining the call today. In closing, I would just come back to where I began. We could not be more excited about the opportunity ahead of us, the opportunity to build a brand, to establish Invivyd as a leader in this space, to deliver real value to our shareholders, and to improve the lives of the immunocompromised. Thank you so much.
Thank you, ladies and gentlemen, for your participation at today's conference. This does conclude the program. You may now disconnect.