Vir Biotech at TD Cowen’s Summit: Strategic Focus on HDV and Oncology

On Tuesday, 27 May 2025, Vir Biotechnology Inc. (NASDAQ:VIR) shared its strategic vision at TD Cowen’s 6th Annual Oncology Innovation Summit. The company emphasized its commitment to advancing its hepatitis delta virus (HDV) and oncology programs, while also addressing challenges and opportunities in these areas. CEO Marianne DeBacker highlighted the company’s robust cash position, providing a financial cushion to support its ambitious goals.

Key Takeaways

• Vir Biotech has approximately $1 billion in cash, securing operations until mid-2027.
• Strategic focus on hepatitis delta infections and metastatic solid tumors.
• Introduction of PRO X10 dual masking technology to improve T cell engager safety and efficacy.
• Ongoing clinical trials for PSMA-targeted TCE (VIR-5500) and HER2-targeted TCE (VER-5818).
• Plans for further data releases as clinical programs progress.

Financial Results

• Vir Biotech reported a strong cash position of approximately $1 billion.
• This financial reserve is expected to sustain the company’s operations and strategic initiatives through mid-2027, allowing for continued investment in key programs.

Operational Updates

• The company is sharpening its focus on hepatitis delta infections and metastatic solid tumors, areas with significant unmet medical needs.
• Vir’s PRO X10 dual masking technology is designed to enhance the safety and efficacy of T cell engagers, with seven preclinical programs currently underway.
• In the HDV program, the first patient has been dosed in the ECLIPSE 1 trial, with enrollment completion targeted by year-end.
• The EGFR-targeted TCE program (VIR-5525) is expected to achieve its first patient in by the first half of the year.

Future Outlook

• Vir plans to release more data on efficacy, safety, dose response, and dosing frequency as clinical trials mature.
• The ECLIPSE 1 trial is expected to reach its primary completion date in December 2026, with ECLIPSE 2 potentially providing data in a similar timeframe.
• The ECLIPSE 3 trial will offer a head-to-head comparison with velvetride.

Q&A Highlights

• The PSMA-targeted TCE (VIR-5500) demonstrated a 58% PSA50 response rate in early dose escalation trials.
• The HER2-targeted TCE (VER-5818) showed a 33% confirmed response rate in HER2-positive colorectal cancer patients.
• Masking technology preclinical assays indicated no T cell activation up to 1 micromolar, with clinical data showing a 25% rate of Grade 1-2 CRS without prophylactic steroids.
• Vir is exploring a Q3 week dosing schedule for its TCEs.

Readers interested in more detailed information are encouraged to refer to the full conference call transcript below.

Full transcript - TD Cowen’s 6th Annual Oncology Innovation Summit:

Phil Nadeau, Biotech Analyst, TD Cowen: Good afternoon, and welcome once again to TD Cowen’s sixth annual oncology innovation summit insights for ASCO and EHA. I’m Phil Nadeau, one of the biotech analysts here at Cowen, and it’s my pleasure to moderate a fireside chat with Veer Biotechnology. We have with us today Marianne DeBacker, the CEO, and Mika Derink, the executive vice president of therapeutic oncology. With that, Marianne, thought I’d hand it to you for a brief overview. What’s the state of Veer today?

Biggest strengths, biggest challenges, and what do you think VEER needs to achieve to drive performance over the next year or two?

Marianne DeBacker, CEO, Veer Biotechnology: Hey. Great. Thank you, Phil. Really excited to to be here. And it’s also a really important time for our company.

As you know, we have sharp our strategic focus. So we are really focused now on two core areas where we believe, you know, the unmet need for patients is truly high, and we can also create a significant difference. So one is hepatitis delta infections, which is a disease where patients who already are infected with hepatitis B progress really fast to liver cirrhosis or hepatocellular carcinoma. And we have a treatment, in our ECLIPSE program, which is in registrational trials, that can really, you know, significantly impact that disease. There’s no proof treatments in The US for hepatitis delta infection.

The other one is addressing the unmet need in metastatic solid tumors, where we believe that our masked T cell engager platform is creating very exciting data. We have shown proof of concept already in two clinical studies targeting validated oncology targets, one being HER two and the other one being PSMA. And we’re due to start a third program targeting eGFR. Your question on our strengths, yeah, definitely our pipeline, also our platform. So we have this differentiated PRO X10 dual masking technology that really allows a T cell engager to be masked in circulation and only be activated in the tumor microenvironment.

And that creates for much more advanced safety profile, allows you to achieve a much better therapeutic index. And again, we have shown proof of concept of this already in two clinical programs. We are progressing a third one to the clinic, this quarter, and we have also started seven preclinical programs really taking advantage of that platform. And then we have a very experienced leadership team, because one of the people we brought in through, the deal with Sanofi on the T cell engagers. And underpinning all that, maybe also important to note that we have a very strong financial position.

So we have approximately $1,000,000,000 in cash, providing runway into mid-twenty twenty seven, and that obviously gives us the resources to advance all our key programs through a number of value inflection points.

Phil Nadeau, Biotech Analyst, TD Cowen: To dive into the TCE platform in a bit more detail, can you remind us of the terms of the deal that brought those those compounds into beer?

Marianne DeBacker, CEO, Veer Biotechnology: Sure. Yes. So we acquired the worldwide rights to the Pro X10 masking platform in oncology and infectious disease that was last year in September. We struck this deal with Sanofi, which really has three components. One is the platform.

And as I mentioned, we have acquired the rights in oncology and infectious disease. Sanofi retained the rights in other areas, for example, INI. We also brought in three clinical stage T cell engagers and today are masked T cell engagers, as I mentioned. And in addition, we have brought in a group of about 50 Sanofi former Amunix employees who have very deep expertise in the platform, in the assets, in the manufacturing. And as mentioned, Mika is, is one of those employees we brought in.

As it relates to the deal terms, so, the deal closed in September. We paid about 100,000,000, upfront, to Sanofi. There is also, as we have shared, a $75,000,000 escrowed payment. It’s a milestone for when we progress our EGFR program to first in human dosing. And then, of course, the deal also includes other milestones, and, tiered royalties on worldwide sales.

Phil Nadeau, Biotech Analyst, TD Cowen: And you you noted that the, TCs are masked. Can you discuss the structure of the masking?

Marianne DeBacker, CEO, Veer Biotechnology: Yeah. Mika, you wanna take it?

Mika Derink, Executive Vice President of Therapeutic Oncology, Veer Biotechnology: Sure. Yeah. So, these are this is a universal T cell engager platform. At the core of the of the the the molecule, there’s a a bispecific, which is the T cell engager itself. It’s sort of like a bite where one binds to the tumor antigen and the other binds to T cells, the anti c d three component.

And surrounding the T cell engager are these long protein polypeptide masks, which are the Extend Pro Extend masks. These have been developed over over a decade to perfection in order to not have any secondary structure so they don’t fold. They’re hydrophilic. And so they basically wrap around the T cell engager and prevent any protein protein interaction with the T cell engager. This this physicochemical structure of just in that hydrophilic nature really prevents it from binding into any hydrophobic grooves, which makes it ideal for a universal platform because you could just basically attach it to any protein and T cell engager and just swap in and out, your tumor antigen of choice.

At the base of these Xtend masks are these protein, these protease cleavable linkers. These are linkers that have also been designed to be cleaved by multiple different types of proteases, three different classes of proteases. And, again, it’s the same protease linkers that we use across all of our platforms, all of our Pro XPEN platforms. And so there’s this nice clinical validation that occurs with this universality that you learn from, for example, from our HER two program that that can apply to the PSMA program and and now to the EGFR, and then as Mary Anne has said, seven other potential molecules coming into the clinic. And the way that these things work is is basically in circulation, these the masks stay intact.

Protease inhibitors is the most abundant protein in plasma. But once it gets into the pro to the tumor microenvironment, they’re cleaved by the tumor activated proteases, and then you have a very potent bite that’s able to T cell engage T cells to synapse with tumor cells to cause that potent cytotoxic killing.

Phil Nadeau, Biotech Analyst, TD Cowen: Earlier this year, data released for the PSMA targeted TCE as well as for the HER two. Maybe we’ll talk through those two data sets now. Can you remind us of the design of the trial for VIR five thousand five hundred, the PSMA targeted TCE, and the top line efficacy data that were disclosed?

Mika Derink, Executive Vice President of Therapeutic Oncology, Veer Biotechnology: Yeah. So there are four parts to the study. The first part is dose escalation as monotherapy. The second part is expansion cohorts looking in different set lines of of prostate cancer as a monotherapy. The second part is in combination with standard of care agents, and then the fourth part is is expansion cohorts with the combination.

What we’ve reported most recently in January is the early portion of our dose escalation. We’re currently still in dose escalation in part one, and and that’s currently where we are today.

Phil Nadeau, Biotech Analyst, TD Cowen: And you go through the the highlights of the the efficacy data, what were the PSA fifty, PSA ninety rates, and whether in Vera’s opinion, there was a dose response. So

Mika Derink, Executive Vice President of Therapeutic Oncology, Veer Biotechnology: the PSA response rates, we were very excited to see at this very relatively low dose, a fifty eight percent PSA fifty out of twelve patients, and then we had an eight percent PSA ninety. This was we saw responses across multiple dose levels. But, you know, we have not used any prophylactic steroids and which is which is certain certainly required for other T cell engagers. We’re the only T cell engager program that doesn’t require this. And despite that, we’re seeing with a really nice safety profile, we’re seeing this really encouraging data.

Now in terms of dose response, you know, our numbers per cohort are, like, three or four patients per cohort. It’s really hard. We’re still at the early early parts of the dose escalation. Certainly at the very lowest doses, we didn’t see as much activity. But then as we’re getting up to the, higher doses, we’re beginning to see some responses.

We are very encouraged the the on the prospect of dose dose escalation. We’ve seen a dose response within the HER two program. We have a patient also who interpatient dose escalated from what we would consider an unappropriate dose level at sixty micrograms per kg in the HER two program, who then dose escalated into the efficacious dose range and showed a nice dose response where he, had a nice, confirmed partial response, continues on study for for now with the duration of response of of eighteen months. So nice proof of concept of a dose response there, and we hope to see the same. And then with other competitor programs, we do see a dose response.

So Janix did report, a dose response early on, but we did, they did see a higher dose response at higher doses. And so we’re we’re encouraged. We’re still early. You know, we’ve got a a huge therapeutic index, and, and we’re encouraged to see that the efficacy of the higher doses.

Marianne DeBacker, CEO, Veer Biotechnology: Yeah. I would just add, Phil, that, I mean, these were all heavily pretreated patients, right, patients who had exhausted all prior lines of therapy. And to see that above a hundred, twenty micrograms per kg, really all patients so showed some level of PSA decline was really, you know, remarkable to see.

Phil Nadeau, Biotech Analyst, TD Cowen: On the therapeutic index and prospects for, higher efficacy at higher doses, Some of Vir’s potential competitors note that there was data disclosed in the 5,500 patent filings that suggest the mass TCE as an activity at, call it, 5.6 to 47 nanomolars based on preclinical assays. And so those competitors argue that since VERE is already achieving more than 10 molar met nanomolar plasma concentrations at current doses, any additional dose escalation would yield levels at which the masked TCE will have activity even in the even in the circulation. What data do you have that refutes this this interpretation? How how are those potential competitors misinterpreting the preclinical findings in in the patent?

Mika Derink, Executive Vice President of Therapeutic Oncology, Veer Biotechnology: Yeah. Thanks thanks for the opportunity to address this question. We’ve we’ve heard this before. So base the preclinical data and I do think it is a bit of a misinterpretation. The the preclinical data that I believe they are referring to is is the in vitro cytotoxicity assays where we do believe there are some artificialities with that assay and that it underestimates the actual dose required to see cytotoxic activity.

And if you if you actually look at competitor mass T cell engagers, they similarly using a a similar in vitro cytotoxicity assay, they similarly are exposures where you would you would potentially predict there might be some cytotoxic activity. Where I think is probably the more relevant in vitro data is is the T cell activation assay that we use preclinically. And there, you can you you can go up to a a level of one micromolar and see no evidence of T cell activation with a masked molecule, where, of course, you do with the fully unmasked molecule. And we are definitely not achieving any exposures. You know, we’re logs below one micromolar exposure, so we don’t believe that that assay, the cytotoxicity assay, really is is a good way to assess this.

And the last thing is is, you know, the proof is in the pudding. I mean, we’ve got great PK. We don’t show any evidence of cleavage. There’s a very low level as you might expect with natural metabolism, and we start seeing really minimal CRS. We’re seeing a 25 grade one two CRS.

We, again, are the only ones that don’t require prophylactic steroids or any prophylactic anti I l six. And so that really tells you that we do have this pretty good therapeutic index. We’re continuing to dose escalate. We’re pretty excited about this the potential for the really extended therapeutic index and that I would say those pre preclinical data is really not not really informative.

Phil Nadeau, Biotech Analyst, TD Cowen: And how does the preclinical assay you just referenced differ from the one in the the patent filings? Are are they basic?

Mika Derink, Executive Vice President of Therapeutic Oncology, Veer Biotechnology: Yeah. It’s the same. We’re we’re basically the same. So you do you do get single digit, double digit nanomolar e c fifties for the cytotoxicity assay. And I didn’t wanna get into technical details around around it, but but but needless to say, in the assay itself, bathe the the tumor cells and your human lymphocyte cells, your T cells, over three days and and basically look at increasing concentration of your drug.

Over those three days, as you get tumor lysis, you get activated proteases, and those activated proteases then cleave off the mask. So you get an artificial system which then underestimates your EC fifties. If you look at T cell activation, though, in vitro, same sort of format, you incubate tumor cells with lymphocytes, increasing amount of drugs, and you look for evidence of T cell activation. With a fully masked drug, you see no evidence of T cell activation up to one micromolar. So I think that there’s there’s an inherent flaw with the cytotoxicity assay saying exposure to exposure, is gonna be the same in patients.

And then the other thing I didn’t even go into is, you know, patients, it’s a dynamic exposure. And so it’s not like you’re gonna get those exposures for three days at that high level.

Phil Nadeau, Biotech Analyst, TD Cowen: Got it. When could we see data from 5,500 next? Kinda what does Veera wanna see before releasing the data? And then following that data release, what would be the next steps for the program?

Marianne DeBacker, CEO, Veer Biotechnology: Yeah, Phil. So our phase one study is well on track. So as Mika mentioned, we’re in the midst of dose escalation. We’re also exploring different dosing frequency, as you know, every week, every three weeks. I mean, the half life of the drug being eight to ten days allows us to explore dose less frequent dosing, which is going to be really important if we go into earlier lines of therapy.

We have a waiting list for patients. We are executing as expeditiously as we possibly can. The team is working very, very hard, and we plan for success. So we last presented data in January. We will be sharing more data as soon as, you know, we have efficacy, safety, dose response, frequency of dosing, all those insights.

And as soon as we have that meaningful data set in hand, we will be sharing it with the public either through a major medical conference, participation or through a focused investor event as we have done a couple of months ago.

Phil Nadeau, Biotech Analyst, TD Cowen: Sorry. Go ahead, Mika. Just to add,

Mika Derink, Executive Vice President of Therapeutic Oncology, Veer Biotechnology: you know, and I didn’t mention this in the trial design. You know, we’re looking at a q three week dosing schedule. We hadn’t presented that in January. We we will you know, we’re dose escalating currently in this q three week. We’re very encouraged.

We are already doing q three week in the HER two program, and we’re seeing efficacy and safety in that program. So we do think that that’s gonna read through well nicely. Our half life is eight to ten days, so that q three week is, I think, a big important differentiator for us.

Phil Nadeau, Biotech Analyst, TD Cowen: Moving to the HER two program, VER fifty eight eighteen, can you briefly, describe the efficacy data that were presented from that program in January?

Mika Derink, Executive Vice President of Therapeutic Oncology, Veer Biotechnology: Yeah. So in in that study, we looked at HER two positive from IHC two plus and above in in a similar format with four part study. Our combination is with pembrolizumab. We what we shared with you is dose escalation data at the monotherapy. We look at both the q week, and then we opened up subsequently a q three week dosing level.

In the HER two positive patients who were dosed above what we think is a minimal efficacious dose, which is four hundred micrograms per kg, we did see about fifty percent of those patients have some form of tumor shrinkage. In the colorectal, the HER two positive colorectal subset, we were very encouraged to see a thirty three percent confirmed response rate in that setting. That included that patient that I talked about earlier, which is a patient who started at 60, went up to six hundred micrograms per kg, had was on study for over two and a half years, very well tolerated, confirmed his response when he got up to the that six hundred microgram per kg dose level and has a duration of response of of over eighteen months. So really nice in a very heavily pretreated patient population. Similarly, the safety profile was very, very impressive in in that we are seeing very low levels of of CRS.

We don’t mandate prophylactic steroids, and we’re we’re still evaluating and continuing to dose escalate. We’ve opened up the combination with the pembrolizumab combination, and that’s currently dose escalating as well.

Phil Nadeau, Biotech Analyst, TD Cowen: What did you see in HER two positive breast cancer, and when do you think you’d be in a position to make a go, no go decision on further development there?

Marianne DeBacker, CEO, Veer Biotechnology: No. Go ahead.

Mika Derink, Executive Vice President of Therapeutic Oncology, Veer Biotechnology: So the the HER two positive breast cancer, we did enroll both IHC two plus and above as well as IHC three plus. We did see that one very impressive response in a patient with very extensive chest wall involvement had multiple prior lines of treatment, including in HER two, who had a really dramatic response. But other than her, we haven’t actually had a lot of HER two positive breast cancer patients at the upper cohorts. I think one of the challenges of this study is is that we enrolled sort of a very heterogeneous patient population across 10 or so different indications. So really hard to make an assessment in in in breast.

You know, we had this one collection of the colorectal cancer patients, and that was because of that early responder that we saw that that pay that the investigators put these patients on. But other than that, we only really have a handful of patients in in any given one indication who are bona fide HER two positive. Having said that, you know, we did see a ctDNA response in a HER two low patient. And so, you know, I think if we once we are able to do a concentrated effort in a homogeneous indication at a at a at a homogeneous dose level, the recommended phase two dose level, I think that’s when we’re gonna really be able to assess fully the activity.

Phil Nadeau, Biotech Analyst, TD Cowen: When could we see additional data from fifty eight eighteen, and and what would be the next steps, for the program generally?

Marianne DeBacker, CEO, Veer Biotechnology: Yeah. Phil, a little bit similarly. Right? We are waiting for the data really to mature. So, Mika talked about the the results we saw in that of metastatic colorectal cancer patients.

Importantly, those were also microsatellite stable patients where you typically don’t see immunotherapies to be working. So we really want to investigate that further. We obviously want to see more mature data across a more homogeneous set of types of tumors. The way that the study was set up, as Mika explained, is a basket style study. So you don’t sort of know which kind of patients you’re going to get in.

But as the trial matures, you’re getting more meaningful data across certain tumor types, and that’s why we got this very interesting insights into CRC. We wanna see some early data on the combination approach with pembro as well. And we’re also exploring, again, both weekly and q three weekly dosing. So as soon as that, you know, package all comes together again, we will be sharing it with the public.

Phil Nadeau, Biotech Analyst, TD Cowen: You you referenced BIR fifty five twenty five in your your opening comments. Can you give us a brief status update on on that, EGFR CD three TC?

Mika Derink, Executive Vice President of Therapeutic Oncology, Veer Biotechnology: So we’re really excited that, you know, again, with it has the same platform. Platform. We do think that the clinical validation that we’ve seen together with the first two programs will read through through the EGFR program. It has really a pretty exciting preclinical data set. And so we anticipate FBI in the first half of this year, but we’re very encouraged about seeing seeing the data come out of that program.

Phil Nadeau, Biotech Analyst, TD Cowen: I know that today we’re we’re focused on oncology, but, Erin, as you mentioned, in HDV, you have a pivotal program ongoing. Could you give us a brief update on the status of the HDV program? When can we see initial initial initial results from those pivotal trials?

Marianne DeBacker, CEO, Veer Biotechnology: Sure. Yes. We’re actually making excellent progress in our hepatitis delta program. We announced in the first quarter that we have dosed the first patient in the ECLIPSE one trials, and we are targeting completion of enrollment by the end of this year. We also have, shared that the primary completion date is December 2026.

So that gives you a little bit of insight as to when the top line data might become available. Our ECLIPSE two trial is, one with a shorter twenty four week endpoint, so we could potentially see data in a very similar time frame. And it’s the combination of ECLIPSE one and ECLIPSE two that forms the package, for both the FDA and the EMA for registration of our regimen. We’re also in full preparation for starting ECLIPSE two, for starting ECLIPSE three. ECLIPSE three is a study that we are doing, comparing head to head with velvetride in, countries where velvetride is available, mostly Europe.

And that is gonna be important for, you know, pricing and reimbursement again in in in Europe, for example. Maybe just also to mention that, you know, this is a program that addresses a very high unmet need. We have breakthrough designation, fast track designation, prime designation, orphan drug designation. So, our teams are working very collaboratively with the agencies, to bring this regimen to patients as quickly as we can.

Phil Nadeau, Biotech Analyst, TD Cowen: Great. With that, I think we are out of time. Thank you for a very, efficient summary of all that’s going on with Veer, and and best of luck with the second half of the year.

Marianne DeBacker, CEO, Veer Biotechnology: Thank you so much, Phil.

Mika Derink, Executive Vice President of Therapeutic Oncology, Veer Biotechnology: Appreciate it. Thank you.

Phil Nadeau, Biotech Analyst, TD Cowen: Thank you.

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