Ladies and gentlemen, thank you for standing by, and welcome to the Arvonis Fitzer Collaboration Conference Call. Please be advised that today's conference may be recorded. I would now like to hand the conference over to your host today, Randy Till, Vice President, Corporate Development at Arvanus. Please go ahead.
Thank you, operator. Good morning, everyone, and thank you for joining us to discuss our strategic collaboration with Pfizer focused on our ER targeting protact grader, ARV-four 71. Earlier today, we issued a press release announcing the collaboration. That press release as well as the presentation for today's call can be accessed in the Investors section of our Venice website and also on the Pfizer website. With me today are Venice President and Chief Executive Officer, John Houston Chief Financial Officer, Sean Cassidy and Chief Medical Officer, Ron Peck.
In addition, we're pleased to have our Pfizer colleagues, Angie Schmelz, Global President and General Manager of Pfizer Oncology and Chris Boshoff, Senior Vice President and Chief Development Officer, Oncology, Pfizer Global Product Development joining our call as well. Page 2 of our presentation is a reminder that today's discussion will contain forward looking statements that involve risks and uncertainties. These risks and uncertainties are outlined in the company's recent filings with the Securities and Exchange Commission, which we urge you to read. We undertake no obligation to update or revise any forward looking statements to reflect new information or future events, except as required by law. Our actual results may differ materially from what is discussed on today's call.
Pfizer's forward looking statements are included as well on Page 3. With that, I'll now turn the call over to Arvina's CEO, John Houston.
Thanks, Randy, and good morning, everyone, and thank you for joining us today. Together with Pfizer, we are thrilled to announce our global collaboration agreement to develop and commercialize ARV-four 71. This is a landmark event for both our VENICE and for patients with breast cancer in need of potential new therapies. And I'd like to turn your attention to Page 4 of the presentation. At Aventis, we have built our proprietary PROTAG discovery engine platform to design proteologists targeting chimeras or ProTac targeted protein degraders that are optimized to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease causing proteins.
We are pleased to have built the most advanced and successful discovery and development platform in protein degradation and have achieved a scale that is unmatched in the space. Our vision has been to build on our strengths of drug discovery and development to create a global fully integrated biopharmaceutical company that brings new medicines to patients with serious diseases. Our PROTAG discovery engine has allowed us to build a robust pipeline of protein degraders, targeting both well validated and previously undruggable proteins. We are proud that Pfizer is joining us in our plan to bring ARV-four 71 to patients with breast cancer. I'll now refer you to Page 5 to provide an overview of ARV-four 71 before discussing the rationale for the collaboration, which I'll do jointly with Chris and Andy.
ARV-four 71 is a protank that induces degradation of the estrogen receptor or ER, a well known driver of breast cancer. ARV-four 71 currently is being investigated in an ongoing Phase 2 clinical trial for the treatment of patients with locally advanced or metastatic ER positive HER2 negative breast cancer. Despite advancements in oncology in recent years, breast cancer remains a considerable unmet need. Breast cancer is the 2nd most prevalent cancer in women and 1 in 8 women will be diagnosed with breast cancer at some point in their lifetime. Each year, over 200,000 women in the U.
S. Are treated for breast cancer 1% of new breast cancers are diagnosed in men. 80% of all breast cancers express the estrogen receptor. The current backbone of treatment for patients with ER positive breast cancer is endocrine therapy, which directly or indirectly targets ER. While existing endocrine therapies benefit patients, they have significant limitations.
Despite these shortcomings, no new endocrine therapies have been approved since the ER targeting therapy fulvestrant was approved nearly 20 years ago. Recently, the combination of targeted therapies with existing endocrine treatments have become commonplace in the management of advanced ER positive breast cancer. Of note, CDK4six inhibitors such as Ibrance have been firmly established as a standard of care for the initial treatment of metastatic ER positive breast cancer. But even with these advances, breast cancer remains a major public health issue. Since the approval of fulvestrant, many companies have attempted to create a safe oral drug that degrades the estrogen receptor better than fulvestrant.
We believe we have treated ARB-four 71 to be exactly that therapy. Unlike fulvestrant, ARV-four 71 is delivered orally and preclinical studies demonstrate that ARV-four 71 is a much more potent and effective degrader of ER than pervesterin. We believe that 471 has the potential opportunity to become the future backbone of care in ER positive breast cancer from the adjuvant setting all the way through to late line metastatic breast cancer. Now with that opportunity as a backdrop, we realized that ARB-four 71 may benefit from a collaborator that shares our commitment to combating breast cancer and whose global commercial capabilities would provide the perfect complement to our leadership in developing targeted protein degraders. Our rationale for the collaboration we're announcing today is on Page 6.
We wanted a partner to accelerate and broaden both the development and commercialization of ARB-four 71. We wanted to partner with a breadth of expertise, demonstrated success and a global footprint alongside whom we could build and integrated Arvinus. And it was important to us that we retain ARV-four 71 in our pipeline, while sharing costs in this as we work with a strategic partner to bring its patients in need. In Pfizer, we have found a true strategic partner and have asked our colleagues from Pfizer Oncology to join our call today to talk about their experience in breast cancer and how we can work together to accelerate ARV-four 71 as a potential new therapy for patients with breast cancer. As we move to Slide 7, I'll turn the microphone over now to Chris Boshoff, Pfizer's Oncology Chief Development Officer.
Chris?
Thank you, John. Pfizer Oncology is thrilled with this collaboration with Avianus as we have been excited to see the early encouraging clinical data for ARB-four 71, a potential first in category therapy with potential to become an endocrine therapy of choice. We see a strong strategic fit for ARB-four 71 with Pfizer Oncology's portfolio and our overall vision to transform outcomes for people living with breast cancer. IRB-four 71 is a compelling example of external scientific innovation with the potential to deliver a breakthrough therapy to patients. From a clinical development perspective, Pfizer Oncology has a long track record and industry reputation for accelerating trials and innovative study designs without compromising quality of patient safety.
We plan to quickly and collaboratively bring that to the table through our partnership with ARB-four 71. We plan to leverage our strong research and development expertise as well as global regulatory footprint, which has allowed us to study our medicines in patients with breast cancer since the early 1990s. With our Venus, we plan to apply innovative approaches to global clinical trial execution, including digital solutions and virtual site engagement, allowing us to save time and drive efficiencies. We plan to also leverage our strategic partnerships with leading investigators, patient advocacy and cooperative groups around the world, supporting us to maintain an industry leading breast cancer development program. There are significant synergies in our own portfolio that can help maximize the combination potential of ARV-four 71 with Ibrance as the current market leading CDK4six inhibitor.
We will also explore additional novel combination partners, including with our next generation CDK program. I'll now turn the call over to my colleague, Andy Schwalch, the Global President for Pfizer Oncology.
Andy? Thanks, Chris and John. From a business perspective, Pfizer has long been a leader in delivering breast cancer innovation, as evidenced by our in line portfolio of 4 medicines, as well as our exciting breast cancer pipeline. As John noted, there is still a significant unmet need in hormone receptive positive metastatic breast cancer. Endocrine therapy, the current standard of care, has transformed the treatment paradigm, particularly over the past 5 plus years with the advent of combinations with CDK4six inhibitors like Ibrance.
Now we believe ARB-four 71 poised to be the next scientific advance in hormone therapy. Our partnership with Arvenus puts Pfizer in a good position to leverage our leadership position, capabilities and infrastructure with our extensive breast cancer portfolio. We believe ARV-four 71, both as monotherapy and in combination with Ibrance in the metastatic setting and potentially as monotherapy in early breast cancer could provide hope to many people. And in the future, potential additional combination regimens could be on the horizon, offering the possibility of even better outcomes. As Chris said, we're very impressed with the science here and excited for the potential of ARV-four 71 as the first protactigrator in hormone therapy of choice.
Are looking forward to combining our expertise with our patients to develop and commercialize 471 as a potential novel hormone therapy backbone for hormone receptor positive breast cancer. With that, I'll turn the call over to Sean Cassidy for a review of the details related to the transaction.
Sean? Thanks, Andy, and good morning, everyone. I'll begin on Page 8. As John touched on earlier in the call, this transaction is a worldwide co development and co commercialization partnership. This is a potentially multibillion dollar agreement under which Pfizer will pay our VINET 650,000,000 upfront and invest $350,000,000 in Arvina in the form of approximately 3,500,000 newly issued shares of Arvina's common stock priced at approximately $101 per share, which is a 30% premium to the 30 day VWAP on July 20, 2021.
The collaboration agreement and equity agreement are separate transactions. Our Vinnis and Pfizer will share equally development expenses, commercialization costs and profits worldwide. Our venous is also eligible to receive up to $400,000,000 in approval milestones and up to $1,000,000,000 in commercial milestones. In total, this means that our business is eligible for 2,400,000,000 in upfront equity investment and approval in commercial milestones. This is in addition to the worldwide profit share for ARV-four 71, which we believe is positioned to be a potentially best in class ER targeting therapy.
Looking at some of
the other terms on Page 9, this collaboration offers an opportunity for Arbenas to build our development and commercialization capabilities worldwide alongside Pfizer, 1 of the world's pharmaceutical powerhouses. Our venous will be the marketing authorization holder and will book sales in the United States, and Pfizer will be the marketing authorization holder and book sales outside of the United States. We will share leadership of and joint accountability for the clinical trial program with each of Pfizer and Arbenas leading multiple critical trials. From an overall financial perspective for Arvinnis, the partnership decreases our planned expenses for ARV-four 71 and results in pro form a cash, cash equivalents and marketable securities of $1,600,000,000 as of June 30, 2021. This includes both the upfront payment, the equity investment as well as the existing cash that we had as of June 30.
With that, we have the flexibility to invest in progressing our pipeline as rapidly as possible as well as continuing to invest in our industry leading ProTac discovery engine for our pipeline of the future, the platform that has produced 2 clinical programs that demonstrated efficacy signals in patients. Closing of the equity investment agreement is contingent upon completion of a review under antitrust laws, including the Hart Scott Rodino Antitrust Improvements Act of 1976 in the United States. The equity investment is expected to close by the end of August 2021. With that, I'll turn the call back over to John.
Thanks, Sean, and I'll pick up on Page 10. We've known that to maximize the potential impact to patients, ARV-four 71 would likely benefit from a partner like Pfizer with extensive experience and capabilities. Interim data from the ongoing Phase 1 dose escalation clinical trial of ERV-four 71 in patients with locally advanced or metastatic ER positive HER2 negative breast cancer show this potential to be a best in class ER targeted therapy. This study enrolled heavily pretreated patients with all patients having received prior treatment with CDK4six inhibitors. Despite this, the interim data from the Phase 1 study released in December 2020 demonstrated that ARV-four 71 had a deep ER degradation and a high clinical benefit rate, while exhibiting an excellent safety and tolerability profile.
We believe that these data position ARV-four 71 as a potentially best in class therapy in a large area of unmet need. The development path to achieve success in the ER targeting space is clearly defined, but also complex, requiring multiple pivotal trials in various settings of breast cancer. ARB-four 71 may show promise as both a monotherapy and in combination and even has the potential for use as an adjuvant therapy for patients with breast cancer. For a view of our upcoming milestones, I'll turn to Page 11. ARV-four 71 is currently in 3 ongoing clinical trials as a treatment for ER positive, HER2 negative metastatic breast cancer, including a Phase 1 monotherapy dose escalation study, a Phase 1b combination study with Ibrance and the VeriTAC Phase 2 monotherapy dose expansion study.
In partnership with Pfizer, we will jointly develop ARV-four 71 through a broad based clinical program designed to position 471 as a best in class endocrine background therapy across the breast cancer treatment paradigm from the adjuvant setting through to late line metastatic disease. We intend to initiate at least 2 additional trials of ARV-four 71 this year, including a combination trial with everolimus and a study in early breast cancer. This sets out for a data rich 2022 when we expect to share data from the VERITAC monotherapy Phase 2 study as well as data from the Phase 1b trial in combination with eyebrows. Also in 2022 with our partner, we intend to initiate Phase 3 studies across multiple lines of therapy in metastatic breast cancer, including combinations of Ibrance, followed by pivotal studies in the early breast cancer setting. We also plan to study ARB-four 71 in combination with other agents to identify other potential paths to patient benefit.
We believe that this robust clinical development program is warranted due to the potential for 471 to be a best in class ER targeting therapy. We look forward to advancing this promising therapy in conjunction with Pfizer. And as you can see on Page 12, we are delighted with our partnership with Pfizer for many reasons, not least of which is that it validates our confidence in ARV-four 71. It will also accelerate and broaden the development and potential commercialization of 471 and allow us to closely collaborate with Pfizer as we build our development and commercial capabilities. These capabilities will be critical for our entire pipeline, including ARB-one hundred and 10, which is currently in Phase 2 trial in men with metastatic prostate cancer.
Our entire disclosed pipeline is shown on Page 13 and as a result of over 8 years working on our PROTECT discovery engine includes both validated and previously undruggable targets in oncology, immuno oncology and neuroscience. We've always known that partnerships and collaborations could play a role in expediting the delivery of these important new medicines. Today's announcement of our first strategic collaboration with Pfizer on ARD-four 71 is an important step on our journey. Now I'll close by saying that our commitment to advancing protac degraders to patients has never been stronger, and we are grateful for the tireless dedication of our entire Arginis team. It is their vision and tenacity that has allowed us to innovate and pioneer this new class of medicines.
I'd also like to thank our partners at Pfizer for joining us on the call today and in their commitment to bring 471 to patients in need. We are looking forward to this new stage in ARV-four 70 one's development and we are excited to see the benefits that we can bring to patients together. Most importantly, I thank those patients who have volunteered to participate in our clinical trials. Without them, none of our progress would be possible. And with that, operator, we're ready to open the call for questions.
Thank you.
Thank you. Our first question comes from the line of Terence Flynn with Goldman Sachs. Your line is now open.
Great. Thanks for taking the questions and congrats on the collaboration here. John, just wanted to confirm that Pfizer has had access to data from the ongoing 471 Phase 1, 2 trials, including the high brands combo trial. And then would love perspective from the team on pursuing an accelerated approval pathway with the drug. I recognize you're going to start a broad Phase III program next year, But again, how are you guys thinking about a potential accelerated approval path on potentially a Phase II data?
Thank you.
Thanks. And for the second half of that question, I'll certainly be able to pass on to Ron Becker, our CMO. In terms of the process, yes, this has been a several months process that we initiated at the beginning of the year. Pfizer and other companies were part of that process, And it was clear that the data that we had from our mid December release was a significant amount of exciting data for people to pursue these types of partnerships. Pfizer have had access to other data since then as part of their diligence.
Clearly, that's been a thorough diligence, and that's got them excited with the idea of this partnership. Ron, do you want to talk about Phase III and the potential accelerated plans?
Yes, certainly. Parents, I think when you're referring to accelerated approval, I assume that you're referring to a single arm trial or response rate is the primary endpoint. And what I would say there is that while there isn't a precedent in this disease and it's also a setting where response rates are typically very low even with existing therapies like fulvestrant. Having said that, to think about moving this drug quickly through trials to reach approval, The situation in late line patients is that the endpoints occur very quickly. These studies typically are designed around progressing through survival and the follow-up is so short because outcomes are so poor.
And as a result, the trials can be done quickly. And so while it's not a single arm approach, it could be done through a Phase III. Having said all that, I would say that we are very actively with our new partners with Pfizer thinking about how can we advance this as quickly as possible. So we'll certainly be turning over all rocks and doing that.
Thank you. Our next question comes from the line of Ellie Merle with UBS. Your line is now open. Hey, guys. Congrats on the
deal and thanks so much for taking the question. Just in terms of moving into earlier line settings, can you elaborate a bit on sort of what drives your confidence maybe or maybe how you're thinking about the ability of 471 to show superiority versus say aromatase inhibitors and become a new endocrine backbone? I guess, how are you thinking about how much we know about how much more degradation leads to greater efficacy? And how to think about sort of the potential to display sort of some of those earlier endocrine backbone?
Thanks, Ellie. Thanks for the question. And again, I might, in a second, hand over to Chris and Ron for an answer to that. In terms of the competitive profile, as you know, from a mid December data, we believe that both the degradation and the safety and tolerability profile we had really got us excited about the fact that 471 could have a potential best in class profile. That belief has continued, and we believe those elements of significant degradation, good tolerability and safety will drive that best in class profile forward.
Ron and Chris,
do you want to say
anything about the second half of the question?
Sorry, Ron, do you want to start? Ron?
Yes. I mean, maybe I can just kick it off and only just to say that, this degradation is has been obviously validated within the form of fulvestrant that is being viewed by most experts in the field as most effective endocrine therapy today. But as John had pointed out early in the talk that there are a number of limitations, 1 of which, of course, is how it's administered. The other 1 is that it is more of an indirect degrader versus the PROTECT technology that really hijacks the ubiquitin protozem system. The other thing that I would say and then Chris can pick up from this is that the experience of fulvestrant has actually proven that magnitude of degradation actually translates into better outcome when they've studied higher doses, the current approved dose of 500, showing greater degradation than 250 and that 500 also translate into greater efficacy.
That really is a good point of evidence that more degradation matters and we've also shown that pre clinically.
Thanks, Mark. Just to add to that, thank you. As you know, there's been no new directly probably for the last 2 to 3 decades now. And if you can't ungared knee survival is approximately 10 to 12 months. And so significant unmet need, previous data that we released and durable stable disease and sponsors were observed in patients who were previously heavily pretreated including previous therapy with CDK and HVAC plus orbestinib.
And that really provided additional confidence to us that it had a significant potential in earlier
Thank you. Our next question comes from the line of Alethia Young with Cantor. Your line is now open.
Hey, guys. Thanks for taking my questions. And let me add my congrats on a very lucrative deal for both parties. My first 1 is just, obviously, I just want to talk a little bit about like how quickly and aggressively you can start potential adjuvant, neoadjuvant study and what that market potential you kind of think about could be ultimately since obviously the upfront was 6 $50,000,000 with a $350,000,000 investment, it must mean multi multi $1,000,000,000 opportunity. And then just kind of following on to that, just with the space where there's obviously I think assets best in class, but there's other assets roaming around.
Just talk a little bit about the potential for variable combination studies to truly, truly differentiate and kind of really push the strategy out kind of to make the incredibly broad, large market opportunity here?
Thanks for the question, Lucy. And yes, certainly, the whole attraction of finding a strategic partner such as Pfizer was the possibility to both accelerate the development of 471 and to have a more comprehensive approach to our trials with the aim of getting a drug to patients in a more assertive way. So we're excited about the fact that that's a real strong possibility, but we can start taking several new trials over the coming 1 or 2 years. So we believe this is going to be a very attractive way forward for 471. In terms of the commercial opportunity and how could we get to adjuvant setting, I don't think we're describing any kind of detail today around when we get to the adjuvant setting.
I don't know if Andy would want to say something about the commercial opportunity overall.
Sure. Happy to, John. Thanks. Look, the breast cancer category today is about $20,000,000,000 plus overall and is anticipated to grow to $40,000,000,000 plus over the next 5 to 7 years. Certainly, Ibrance in 2020 generated $5,400,000,000 in revenue.
And putting that in context, Ibrance is exclusively in the metastatic setting, and we think that there is this opportunity for these combination regimens, CDK inhibitor, Ibrance of course is about 80% of the CDK category, in combination with 471 could really be the forward kind of standard of care regimen for first line metastatic breast cancer. And in the early breast cancer setting, I think all the studies with the CDK inhibitors are looking at 1 to 2 years of therapy and then stopping. Of course, today's standard of care with aromatase inhibitors in the early setting can be up to 5 years of therapy. So I think there's great potential given the safety and efficacy profile of 471, obviously a lot to be proven out with additional studies to have to be a great advance, significant advance in the adjuvant setting. So we're super excited to move forward in partnership with Arbenas here.
Awesome. Thank you very much.
Thank you. Our next question comes from the line of Yigal Nochomovitz with Citigroup. Your line is now open.
Great. Thank you very much. And let me add my congratulations to both companies as well. Just want to circle back on a previous question quickly. Could you just provide a bit more color as to how much the global alliance was catalyzed by Pfizer's interest in the data emerging from the Phase Ib combo with Ibrance as opposed to only the Phase Ib monotherapy study?
Thank you. Thanks, Yigal. Clearly, we ran a process which was largely focused on our mid December data release. And then after that, there was a selection of companies that would move to different stages of diligence, Pfizer being 1. And at that point, there was access to some other data.
I can't answer for Pfizer at what point the excitement level picked up. We do know that there's been a number of companies, including Pfizer, that have been very interested in protein degraders for a number of years and have been tracking 471 for that length of time as well. I don't know if Chris or Andy want to say anything to this, but we're just excited about the fact that the data we saw certainly in mid December was pretty exciting for them.
Thanks, John. Perhaps I can just add that you're correct. We did look at early data in combination with palvo, povaciclib. Recognizing that these are early data, it did provide us with additional confidence that these 2 medicines could potentially be combined into future pivotal trials. So it did help us to make a decision.
Thank you.
Okay. Thank you very much. And just 1 housekeeping question. Does today's agreement contain any auction clauses that could expand the alliance to breast cancer degraders beyond 471 that may emerge from the earlier 2018 research collaboration and license agreement with Pfizer?
These are separate agreements. So the Discovery Alliance, which is going well, is a separate deal and separate contract from this 1.
Okay. Got it. Thanks for clarifying.
Thank you. Our next question comes from the line of Michael Schmidt with Guggenheim. Your line is now open.
Hey, guys. Thanks for taking my questions and congratulations to the deal as well, very impressive. Just perhaps another follow-up for the Pfizer team. I was just wondering the decision to license a partner on this ProTac Product Canada? Was it more driven was it exclusively driven by the Phase I data that has emerged so far?
Or how much of the decision was driven by the mechanistic rationale as being a protag perhaps in context of other oral steroid inhibitors that are being developed at the moment?
Chris, do you want to take that?
I will start and then hand it to Andy. This is, as I've stated, a truly first in category medicine. We are very interested in innovative medicines that could be potentially transformational and breakthrough medicines. And this clearly is the 1st in category medicine. The data we've seen, the clinical data also suggested to us that this could be a best in class ER degrader.
And then to your point, the preclinical data are very compelling. The preclinical data definitely provided significant additional evidence to execute this deal. Andy?
Just to add, clearly over the past 5 years, the standard of care in hormone receptor positive metastatic setting is endocrine therapy in combination with a CDK inhibitor. And we of course have lots of experience knowing that it's quite competitive, even amongst the CDKs out there. And the next big advance is to elevate the hormone backbone and both 471 is a PROTAC and we're aware of all have the potential to improve upon the current standard of care. We believe that based on our diligence that 471 is poised to be best in category. And of course, the combination of 471 with the CDK inhibitor like Ibrance today and potentially downstream in combination with other investigational CDKs in Pfizer's portfolio can truly be transformational.
So we have eyes wide open that there'll be many options out there, but we're excited for the regimens that are possible and the benefit to patients with breast cancer from this partnership.
Great. Thank you.
Thank you. Our next question comes from the line of Joon Lee with Truist Securities. Your line is now open.
Hi. Thanks for taking our questions and congrats on Zio as well. So I have 2 questions. 1 is, also on the Palbo-four 71 combination. What do you have in terms of preclinical data that this is going to be either synergistic, additive or incremental?
And also does this preclude combination with other CDK inhibitors such as ribociclib or is there any reason why 471 wouldn't work just as well with those CDK inhibitors? And the second question is, I think many investors were expecting this would happen at some point in the collaboration deal, but feel like it came a little bit earlier than expected ahead of some of the key internal data as well as some data from the competition as well, specifically from Sanofi. So what in particular, triggered this deal? Specifically, why now? Thank you.
Yes. Thanks for the question for both those questions. In relation to our preclinical data that we had with PABO and 471, we had really significant synergy data showing that we are seeing profound tumor reductions in our animal models. So that data goes very excited about the potential of FOSUM-one in combination with Pfauvo, and that's why we move forward with that as part of our plan. So there yes, there's a lot of preclinical validation for that synergistic effect.
In terms of by now, we've got a lot coming up. You named the fact that there's a lot of competition. This is space in terms of serves. We believe we have the potential of a best in class profile. And we know that to close the gap and to close the gap in such a way that in the adjuvant or first line setting, we get closer and closer.
We'd have to take on a much more comprehensive aggressive game plan. And there was a realization that we didn't want to wait to do that. We had sufficient exciting data for us to say, let's do it now and let's having that partner now. And we're just ecstatic that Pfizer is the partner that has joined with us to move this forward. Now this is the right time for us.
This will allow us to move forward with a very strong plan to get 471 into the right pivotal trials next year. So this is the right time for us, absolutely.
Our next question comes from the line of Monika Merchandani with Evercore. Your line is now open.
Great. Thanks for taking the questions. Congrats on the partnership here. Just wanted to dive a bit deeper into the palbo combination strategy as well. Can you talk a little about what you're hoping to see over time from the 471 Ibrance combo study to have confidence and superiority of that regimen versus CDK4six inhibitors in combo with aromatase inhibitors or fulvestrant?
Wondering since, as you mentioned, fulvestrant has superiority versus AI as monotherapy, but that difference seems to get diluted a bit in context of CDK4six inhibitors. And then for the upcoming data at SABOX, can you give us a sense for the scope of data to expect there in terms of patient numbers and end of levels? Thanks.
Yes. Good questions and thanks for that. And I will certainly be handing over to Ron to give a view. But the combo combo study we have right now is essentially a safety study. And as that progresses, we get more data, which we'll release next year and I'll position us to decide the next steps in terms of pivotal studies with combinations.
Ron, do you want to add to that and also talk about other combinations?
Yes. I think so I can say in terms of other combinations because I know that was a question earlier between Pfizer and ourselves as part of this partnership. We definitely have put a lot of thought into other combinations that will make sense and that we're anxious to start to investigate. And that includes also some of the Pfizer assets that make really good sense in breast cancer. I think the other question that I heard was with expectations around the abstract that was submitted for San Antonio.
And essentially, as we had communicated in the past, we would be looking to present the data when we completed the dose escalation portion with regard to enrollment. And so you can expect that we'll have more data that includes the continuation of the dose escalation from the point that we presented back in December. And that would also include an update on the data on ER degradation from paired biopsies and safety as well.
Thank you. Our next question comes from the line of Matthew Luchini with BMO Capital. Your line is now open.
Great. Good morning. Thanks for taking the questions and congrats on the deal. 2 from me. So first, recognizing that it's a fifty-fifty split, could you just talk a little bit about the decision making process around who will actually be doing what?
What I mean is, will each will all decisions related to development plan, commercial strategy be made at a sort of like steering committee level? Or does 1 company or the other going to kind of drive certain aspects of the collaboration? And then secondarily, just I just want to confirm, in terms of the actual deal making process here, were other companies that advanced into later stages of diligence also able to see post December 2020 update data? Or was it only Pfizer that had access to some of the early Apollo data? Thank you.
Yes. And I won't go into the details of how many companies go through this process. We're just ecstatic that Pfizer went to the stage it did and we're a partner. In terms of the how the whole plan of working together is going to operate, it's clear that this is fifty-fifty development in both in the U. S.
And ex U. S. And fifty-fifty in terms of commercialization. We yes, our VINIS will be building our capability to deliver on that 50 copilot status. We have been making sure that we will be able to build the development capabilities to run the trials and build the commercial capabilities to do similarly.
So in terms of governance, this will be joint governance. It's clear that the teams already have worked very well together with looking at the potential things that could be done. The governance is going to be very clear both in terms of developments, regulatory and commercial. So we're very happy with the process and it will be fifty-fifty all the way.
Great. Thank you.
Thank you. Our last question comes from the line of Mark Breidenbach with Oppenheimer. Your line is now open.
Hi, this is Jacqueline for Mark from Oppenheimer. Congratulations on the collaboration. I just had a few questions. Are you planning to present a PFS analysis along with response rate and disease control rate from the Phase I trial or 471 later this year?
For the VASHL abstract, it will be an end of Phase 1 release. So all the information we have at that time, we will be putting out at that time.
Okay, thanks. Another question I had was how much better clinical data versus upcoming oral SERDS will 471 will have to show to gain meaningful adoption?
Sales in development. We believe that our profile, if it holds all the way through, means that porcelain will have a meaningful opportunity in this market regardless of the timing. Obviously, with this partnership, we're going to be accelerating 4,701 as much as we can to close that gap. But the most important thing is the safety profile, tolerability profile of an oral targeted degrader. I think that's going to be a significantly competitive profile.
So yes, as data comes out from other companies, we'll be monitoring it, but we have great belief in the profile of our compound going forward.
Okay. And then last question would be, is the collaboration with fiber exclusive?
Sorry, I missed that last bit. Could you say it again?
Is the collaboration with Pfizer exclusive?
Yes, this is yes, absolutely. Yes, it's exclusive. This is Pfizer and us together and moving this compound forward as best we can all the way.
Okay. Thanks for taking my questions and congrats again on the deal.
Thank you very much.
Thank you.
Thank you. There are no further questions. I will now turn the call back to John Houston for closing remarks.
Yes. I just want to thank everybody for joining us this morning. It's really great questions. And hopefully, you picked up on the excitement the team here, both at Avinis and Pfizer have for this new collaboration. So thank you for your continued interest and support of Avinis, and have a great day.
Thank you.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.