Thanks for that introduction, Matt. Today I'm excited to announce our plans to build a leading anti-FcRn franchise consisting of batoclimab and another asset of ours under development, IMVT-1402. I'll be making some forward-looking statements, and I direct investors to this slide filed with our 8-K today and posted on our website. Everything at Immunovant starts with our vision to enable normal lives for people with autoimmune diseases. We want to bring therapies to market that improve substantially on the standard of care and provide differentiated benefits versus other therapies in development. With that in mind, I'm excited to unveil for the first time today IMVT-1402. As I think you'll come to see as we progress through the presentation, IMVT-1402 is a truly exciting new product that we believe will dramatically expand Immunovant's clinical and commercial opportunity, and together with batoclimab, enable us to deliver a leading FcRn franchise.
IMVT-1402 is a fully human monoclonal antibody that inhibits FcRn and is the product of a long-standing effort to bring another novel, potentially best-in-class anti-FcRn antibody forward to complement batoclimab. With the addition of IMVT-1402, our anti-FcRn franchise has even greater potential to address unmet need for people with autoimmune diseases. To bring everyone up to speed on our progress with IMVT-1402, our team has conducted the key development work needed to introduce this next generation anti-FcRn today. As I'll show in a few minutes, animal studies have demonstrated that IMVT-1402 may have deep, potentially best-in-class IgG lowering similar to batoclimab and with minimal impact on albumin and LDL. We believe that IMVT-1402 development can be accelerated by leveraging data from across the FcRn class. Data from our ongoing studies with batoclimab also represents an acceleration opportunity as these data provide proprietary insight into patient responses.
In addition, we intend to rapidly advance IMVT-1402 into the clinic with the goal of initiating a phase I study early in 2023, assuming FDA clears our IND. Based on this timeline, we expect data from this study in mid-2023. Finally, IMVT-1402's composition of matter patent, if issued as anticipated, is expected to have a patent term that extends to at least 2042. Before sharing more information about IMVT-1402 with you, I want to first take a step back and emphasize the opportunity we see for the anti-FcRn class. This mechanism has broad therapeutic and commercial potential, with 19 indications currently being pursued across the class. To date, we have announced development programs for batoclimab in five of these indications, which are listed in blue on this slide.
As you know, batoclimab, our lead asset, has been observed to deliver deep IgG reduction via a simple subcutaneous formulation. With so much opportunity across these indications, we've naturally been focused on continuous innovation. In fact, we've been able to take advantage of our knowledge and capabilities gained while working on batoclimab to develop IMVT-1402. I would like to share what makes the anti-FcRn class so attractive for continuous innovation and for a franchise approach. First, IgG is a well-established biomarker with more than 10 late stage trials showing a correlation between IgG lowering and clinical response. We believe this increases the ability to apply learning across development programs for key decisions like indication, selection, and study design. Second, across indications, there is a lot of clinical heterogeneity. This means that different patients likely require different degrees of IgG suppression in order to achieve maximum clinical benefit.
This is a central point to our strategy, as we believe many patients may require especially deep IgG suppression, potentially as high as 80% to achieve a maximum clinical benefit. In some cases, the need for this deep IgG suppression is for a relatively short period of time, during 12 weeks of induction therapy or during 4 weeks of rescue therapy. In other cases, we believe the need for deep IgG suppression will be longer than 12 weeks. Finally, because IgG reduction is a well-established biomarker for efficacy in autoantibody conditions, we believe we can leverage not only published data from other anti-FcRn programs, but also proprietary patient-level data from batoclimab's development programs to accelerate the development of IMVT-1402, potentially going from phase I directly into pivotal trials. I'll now share some of our initial insights on IMVT-1402. We are developing IMVT-1402 with three key product attributes in mind.
Our first aim is to match the deep IgG reduction with batoclimab can achieve and which we believe may offer an efficacy advantage in multiple indications. We also intend to match batoclimab's simple and convenient route of administration. Our team has completed CMC and formulation work to enable simple subcutaneous delivery that can be administered in seconds. Finally, we aim to deliver a profile with minimal or no changes in albumin and LDL. Animal studies with IMVT-1402 predict this potential profile in people. You may be wondering why we decided to introduce IMVT-1402 today. We recently received these data from our first IMVT-1402 study in monkeys and find them to be promising. With these validated data in hand, IMVT-1402 is now an important component of our franchise strategy alongside batoclimab.
Based on studies across the class, cynomolgus monkeys have been observed to be a reliable pharmacodynamic proxy for anti-FcRn mediated impact on IgG and albumin. While this monkey study used intravenous infusions, we have preliminary data from other ongoing studies with IMVT-1402 that indicate we have similar pharmacodynamics in cynomolgus monkeys, whether IV or subQ. This is also what we observed with batoclimab. Let's look first at the blue line on this slide. The blue line is a positive control and represents batoclimab administered at a very high dose. 50 mg/ kg Q-week in the monkey is roughly 5x the 680 mg Q-week dose in humans. Batoclimab is much more than maxed out at this dose. The purple line in this figure is a mid-range dose of IMVT-1402. Next, let's look at the gray line.
This is IMVT-1402. Given at the same very high 50 mg/ kg dose as batoclimab in blue. We expect the potency of IMVT-1402 to be about the same or perhaps slightly higher than batoclimab on a milligram per milligram basis. The gray line shows nearly identical IgG lowering compared to the blue line, suggesting that batoclimab and IMVT-1402 are the same or similar at the highest dose with regard to IgG lowering. Remember that we have observed batoclimab as capable of IgG reduction up to 80% in humans, and since we already know how well it behaves in humans, what we were really looking for here was whether IMVT-1402 would have a similar effect on IgG lowering. When we studied that question, we found the remarkable overlap between batoclimab and IMVT-1402 that you see in this slide.
Again, these compounds were studied head to head in the same study and at the same dose. This result really gives us confidence that IMVT-1402 can achieve similarly high IgG reductions in humans in our planned phase I study. Taken together, these data give us confidence that we'll be able to develop IMVT-1402 doses that should roughly match the 340 mg and 680 mg doses of batoclimab in terms of IgG lowering in people. This slide shows data from the same monkey study. The figures show similar changes in albumin, total cholesterol, and LDL for IMVT-1402 compared to placebo.
I'll walk you through the graphs in more detail, but if you consider the results from the last slide, that IMVT-1402 appears to lower IgG to the same extent as batoclimab, and then combine it with what you see here, that IMVT-1402 has an effect similar to placebo on albumin, cholesterol, and LDL in this study, you can understand why we're so excited to be unveiling IMVT-1402 today as part of our franchise strategy. Starting on the left-hand side, this is the most important graph because we believe albumin reductions are the driver of the analyte abnormalities we've observed in LDL in the past. Looking first at the purple line, which is the intermediate dose of IMVT-1402, that looks pretty similar to placebo during the dosing period.
The gray line shows the super therapeutic dose of IMVT-1402, and it was basically the same as placebo, which is the green line over the dosing period with regard to albumin. Staying with the gray line, if you look at the period of time just after the fourth dose around day 28, the gray line is actually numerically higher than the placebo in green. Remember, 50 mg/ kg is a super therapeutic dose around 5x the 680 dose in humans. So even at this very high dose, which we used intentionally to try to surface any issues, you'll see IMVT-1402 and placebo looks similar with regard to albumin. This is quite different than the blue line, which is the super therapeutic dose of batoclimab. Now to the middle and right side.
For both cholesterol and LDL, the intermediate dose of IMVT-1402 in purple was essentially the same as or sometimes lower than placebo. The high dose of IMVT-1402 in gray was also about the same as placebo throughout the dosing period. Taken together, these data may predict that we'll observe no or minimal albumin or LDL changes in humans with doses of IMVT-1402 that are similar to 340 and 680 of batoclimab in terms of IgG lowering. Overall, we believe this is a significant finding. It indicates that IMVT-1402 may combine two key features not yet found together in other anti-FcRns. This next slide shows a ribbon representation of the X-ray crystallographic structure of batoclimab and IMVT-1402 binding to the FcRn.
This is the result of actual co-crystal structure work that was done and is not just an illustration. Albumin structure and binding to the FcRn is also shown. Focusing on IMVT-1402 on the right, you can see how IMVT-1402 was intentionally selected to not interfere with the albumin binding site. The binding of IMVT-1402 to FcRn looks different than the binding of batoclimab to FcRn. This X-ray crystallographic structure gives us additional confidence in the monkey data that I just presented. Moving now to review our completed and ongoing development work for IMVT-1402 . This work includes the near term completion of the 6-week non-clinical study, which will support our planned IND filing in early 2023, and the GMP manufacturing run of high concentration drug product earlier this year.
Finally, and importantly, the expected phase 1 development costs for IMVT-1402, including CMC costs, are included in the cash guidance that we've shared to date. Our cash runway remains as previously disclosed, with runway expected to last into calendar year 2025. Given the product profiles and development timelines of both batoclimab and IMVT-1402, I'll now share some of our strategic thinking on how we'll pursue this franchise opportunity. As I mentioned, the anti-FcRn class is unique in terms of indication breadth and strength of IgG as a biomarker. Given this, we believe we have a tremendous opportunity for our franchise with the addition of IMVT-1402. Batoclimab already comes with a high degree of dosing flexibility and has been observed to deliver among the deepest IgG reductions observed in the anti-FcRn class via a simple subcutaneous injection over a matter of seconds.
This dosing flexibility enables two attractive dosing strategies, namely induction and maintenance and fixed duration dosing. Given the inherent heterogeneity of many autoimmune diseases, we believe there are other patients that could benefit from sustained maximal IgG reduction delivered chronically via simple subcutaneous injection with minimal impact to albumin and LDL. We believe this group represents a large opportunity to expand our reach in autoimmune diseases utilizing IMVT-1402. Building on the general dosing strategy on the last slide to get specific, we believe batoclimab is well suited for indications that benefit from tailored dosing. This includes induction and maintenance therapy in myasthenia gravis and CIDP. For these indications, we believe patients need deep IgG reduction early on to gain control of symptoms and more moderate IgG suppression chronically to manage symptoms.
We also believe batoclimab is well suited for fixed duration therapy, as in thyroid eye disease, where we anticipate 6 months of therapy will be the norm. Where do we expect deeper IgG reductions to be needed chronically? In many indications in rheumatology and also for indications in hematology. We expect some of these indications will need an induction period longer than 12 weeks, and in other cases, we expect chronic deep IgG reductions to be required for maximum benefit. With this anti-FcRn franchise strategy, we expect to benefit from synergies that result from developing multiple assets within the class. Graves' disease is an example we've been thinking a lot about. The expected development timelines for batoclimab and IMVT-1402 in Graves' disease dovetail nicely. Because we expect to have phase I data for IMVT-1402 in a similar timeframe that we plan to have initial Graves' phase II data for batoclimab.
The expected phase II data with batoclimab will provide us with proprietary insights regarding FcRn development in Graves', and the planned phase I study of IMVT-1402 should provide data required for dose translation from batoclimab to IMVT-1402. This is one concrete example of how applying batoclimab learnings to IMVT-1402 development may enable us to accelerate the development of IMVT-1402 from phase I directly to pivotal studies. This slide shows why we find the potential of our anti-FcRn franchise so compelling in the context of the growing anti-FcRn market. The first column of this table outlines key product candidate and program features for this emerging class. The X's indicate how this might play out. Recognizing it is early days for IMVT-1402, the product candidate features shown in the last column represent our expectation based on animal studies.
The first few rows of this table outline how batoclimab and IMVT-1402 may differentiate from efgartigimod on both IgG reduction and route of administration. Importantly, the dashed box highlights how these product differences may potentially translate to differentiated dosing schedules. The deep IgG reduction and subcutaneous dosing in seconds enables multiple dosing strategies that we believe are currently unique to our franchise and enable tailoring to address the heterogeneity inherent in many autoimmune diseases. Should our preclinical results for IMVT-1402 be confirmed with our phase I study planned for 2023, we believe the addition of IMVT-1402 may fundamentally shift the competitive landscape in favor of an optimized two-asset franchise approach to maximize the potential benefits across many indications. To sum up some broad takeaways, I'll reiterate that batoclimab development continues full speed ahead.
We have announced pivotal programs for MG, CIDP, and TED, indications where induction, maintenance, or fixed duration dosing leverage batoclimab's unique profile intended to deliver differentiated benefits to patients. As part of this development, and with the addition of IMVT-1402, we have the potential to benefit from additional synergies. In particular, we believe batoclimab may allow for potentially accelerated development of IMVT-1402 by generating data on optimal dose and dose frequency, as well as subgroup identification in broader market indications. For example, in rheumatology. The combination of batoclimab and IMVT-1402 also sets up the opportunity for future commercial benefits. Assuming regulatory approval and success of our batoclimab program, we believe its earlier launch may enable a range of commercial advantages for the franchise. This slide lays out upcoming expected catalysts. Together, batoclimab and IMVT-1402 could deliver both short-term and longer-term value.
As seen on this slide, development milestones for IMVT-1402 fit in nicely with the rich flow of data expected for batoclimab. Given our confidence in the mechanism, planning for IMVT-1402 pivotal trials will be done in parallel with its phase I, so we can move rapidly from top-line results to regulatory interactions to start of a pivotal trial. In closing, I want to reiterate the main points from today's call. First, we're excited about batoclimab's potential in MG, CIDP, and TED, and those programs are moving ahead as planned. As previously disclosed, we will also continue with our planned phase II study of batoclimab in Graves' disease, and we expect to engage with the FDA on warm autoimmune hemolytic anemia by the end of 2022. Second, we believe IMVT-1402 could bring together a constellation of features not yet seen with any other anti-FcRn.
Finally, as I described a few minutes ago, we believe the anti-FcRn market lends itself well to a franchise approach with a strong biomarker that can improve both the efficiency and effectiveness of developing batoclimab and IMVT-1402 together. We believe that being in position to potentially offer two distinct FcRn molecules affords us unique development and commercial opportunities and will help Immunovant truly maximize the opportunity ahead of us in this important drug class. Thanks for your time, and I look forward to addressing any questions.