Welcome to Medivir Q1 report. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answer session, participants are able to ask questions by dialing star five on their telephone keypad. I will hand the conference over to the speakers. CEO Jens Lindberg, please go ahead.
Thank you, welcome everyone to the Medivir quarter one webcast. let's move forward. I will be taking most of the presentation, but in the room with me, as we move into the question and answer sessions, is our CFO, Magnus Christensen, and I'm also joined by our, recently joined CMO, Pia Baumann, and our CSO, Fredrik Öberg. With that, let's move into the events of quarter one. Important information, as always, you'll find the presentation on our website, you can have a look at the information there. quarter one has been a very good quarter, from a Medivir perspective, both with regards to our main in-house project, fostrox, and our, pipeline projects.
If we look at the fostrox development, as a first go, we've seen that development pick up speed quite nicely in the first quarter. We were able to establish the recommended phase II dose for the first combination arm, which was for fostrox and LENVIMA, where we were able to dose up to 30 mg. In addition, we were able to sort of very quickly turn that around as we moved into phase II-a, the expansion phase, and had the first patient dosed very quickly upon initiation. Encouraging, we'll go into some of the little bit more details today than we've had at previous calls. Our longest-running patient still on treatment is now sort of longer than 8 months without disease progression. Again, as I said, a bit more details in a little bit.
We're seeing very rapid recruitment in the expansion phase for the fostrox plus LENVIMA arm. We now have 5 patients already dosed, and we have an additional 6 patients in screening after 6 weeks after initiation. Moving along very nicely, strong interest from clinicians and patients. In addition, we recently presented new data showing synergistic efficacy of fostrox in a triple combination with PD-1 and TKI or kinase inhibitor in tumor models which our CSO Fredrik Öberg presented at the AACR conference. We'll come back to that data, the importance of that data in a little bit as well. If we leave fostrox for a couple of minutes, when we look at the other portfolio, encouraging process across those projects as well.
We, IGM Biosciences, who has licensed the birinapant molecule, they recently announced that they have completed the 4th dose escalation cohort in the combination study of birinapant with their DR5 agonist IGM-8444. Encouraging, no DLTs observed to date. They have also started, they've dosed up sort of further in the birinapant molecule, so they are now enrolling in cohort number 5. I mentioned that we presented data at AACR. Similarly, our partner, Tango Therapeutics, who previously licensed our preclinical USP1 program, they presented data at the AACR conference as well, showing both single-agent activity as well as sort of synergy with PARP inhibitor for the molecule now named TNG348. They reiterated their intention to file for an IND in mid 2023.
They're moving into the clinic in 2023. Finally, our partner, Infex Therapeutics, they received the FDA QIDP designation for the MET-X program in early January. Nice movement across the entire portfolio in quarter one. If we dive into the pipeline overview. As we always do, our focus is on fostrox, hence we will spend most of our time today going through that program and digging into a bit more detail, and we will touch a little bit on the pipeline overview as well, or the other projects as well. If we move into our main project, fostrox, as we have outlined before, this is the program as we are running it currently.
On the left-hand side of the slide, so there's the phase I data where we showed sort of benefit as a monotherapy, but then we quickly moved into combination, as we believe that fostrox will bring the greatest clinical benefit in combination with other compounds or other mechanisms of action. This is where we now are. As mentioned, we communicated in Q1 that we re-identified the recommended phase II dose for the first combination arm of fostrox plus LENVIMA. The other combination arm, fostrox plus pembrolizumab, is still in phase I-b, so we haven't sort of set the recommended phase II dose yet. That arm is still ongoing. As I mentioned, encouragingly, we dosed up to 30 milligrams in the fostrox combination with lenvatinib without DLTs.
We have now sort of rapidly moved into the phase II-a expansion phase. If we go into that part, let's focus a bit more on the lenvatinib arm, considering that has sort of come the furthest along in development. On the left-hand side, and let's look at a bit more detail. On the left-hand side, as I mentioned, we've had a rapid inclusion in the first six weeks of that sort of phase II-a study. We've dosed five patients already. We have six patients in screening. As a reference, we had four patients in screening on Monday. Two more patients have entered screening during the week. Again, strong interest in this arm from clinicians and from patients.
I will touch a little bit on that, why we are seeing that interest, because there's a natural. There are a couple of sort of natural reasons why that arm is moving along with such speed. We wanted to take a little bit of take an opportunity to give a bit more details on what we are seeing sort of from the fostrox lenvatinib sort of dose cohort to dose cohorts and 2 patients, just to sort of give a little bit of a sample. Patient number 1 is a female Caucasian patient, relatively sort of young, 56 years of age, and has a viral-driven, sort of hepatitis C-driven, liver cancer. She came, she entered fostrox plus lenvatinib in the first dose cohort of 20 mg.
She had previously progressed on first-line treatment of TECENTRIQ plus Avastin. She progressed after 5 months. She's still on treatment after sort of a little over 8 months without disease progression. Encouraging ability to both stay on drug and also to stay on drug without sort of disease progression in a quite long time. We'll make a bit of comparison on that sort of on the next slide. Clearly sort of 1 patient only on this one, but encouragingly that they've been able to sort of stay without progression sort of longer than the first-line treatment. The second patient is a little bit the opposite from a demographics perspective.
A male patient, Asian descent, older, 71 years of age. Also sort of despite being Asian, a non-viral driven HCC, where most of the patients from the Asian population are viral driven. This is a non-viral driven HCC. He progressed on first-line TECENTRIQ Avastin as well. That's pretty much what we see. Most of the patients going into the fostrox lenvatinib arm, they come in after having progressed on TECENTRIQ plus Avastin. He progressed quickly after 1 and a half months, started on lenvatinib sort of for the first week, because that's what they do. They start sort of 1 week ahead of fostrox. The patient incurred side effects on lenvatinib after sort of 2 or 3 days. They sort of stopped the lenvatinib treatment.
The center decided to keep the patient on or keep the patients to initiate fostrox anyway. This patient has not counted toward the dose cohorts, but has stayed on fostrox monotherapy. It's a bit of an outlier, but it's interesting to follow to see because this patient is only getting fostrox from a treatment perspective. Again, he is sort of now six months into treatment without disease progression. He came in on the fostrox dose cohort of 30 milligrams. Again, sort of encouraging to see individual patients sort of staying on treatment for such a long period of time. Clearly, sort of it goes without saying that not all patients will have the same sort of benefit. Have we seen patients sort of progressing earlier? Yes, of course, we have.
I think it's an interesting perspective because as we, if we dive into what has been shown in this sort of second-line advanced HCC patient population before, and across the studies, regardless of whether you look at PD-1s or kinase inhibitors, the response rates and more importantly, the progression-free survival time is quite short. It's a very difficult population with regard to treatment. There's also a good chunk of patients that are not able to move into second-line. When they move into second-line, they're able to sustain treatment and benefit for six months and longer. Clearly, that's highly encouraging.
This is sort of the fact that sort of the response rates and the PFS, sort of timelines are quite short signals a very high unmet medical need. If we then start to look ahead, because now we're recruiting into phase II-a with speed, and our aim is sort of clearly to progress beyond phase II-a. As we've communicated before, sort of we are looking to select the best combination arm as we move into phase II-b. In trying to visualize this a bit, so we will be That are clearly looking at the data coming out of phase I-b, phase II-a, selecting the best combination arm.
When we say best, which I've put in quotation marks here, that's because there are a few different factors influencing that selection. On the one hand, safety and tolerability, of course. Also then clinical benefit for each combination arm. Those, that goes without saying. I think that an important element as well is that strategic fit in the treatment algorithm today, but more importantly, perhaps tomorrow. What will the second line treatment population treatment algorithm look like as we gaze into the future? This is sort of schematically trying to show then the that sort of treatment algorithm, where sort of HCC patients as they are diagnosed, they will be diagnosed at different stages of the disease.
Here we talk about the advanced stage or stage C, which I've highlighted with sort of the colors here. We are currently evaluating that sort of second-line patient population. What we are seeing, as I mentioned before, is that a majority of the patients in first line, they will receive the combination TECENTRIQ plus Avastin guidelines recommended. We see in our study that that's what they are getting. Sort of I actually believe that all of the patients on the, so far on the fostrox and LENVIMA arms are coming from TECENTRIQ plus Avastin. Importantly, what we are seeing as well is that what are clinicians then doing today in that second-line patient population. Today in clinical standard, LENVIMA is the preferred option.
That makes a combination with Fostrox plus LENVIMA probably the most relevant one strategically as we look to sort of further develop Fostrox in that second-line population. The fact that Fostrox plus LENVIMA arm is recruiting with such speed is quite encouraging as there are a number of factors or multiple factors favoring then the Fostrox LENVIMA arm as the best arm for second-line. I alluded to it previously, but the ability to sort of dose up Fostrox to 30 milligrams in combination with LENVIMA. LENVIMA can pose its challenges from a side effect perspective so that we're able to dose up to 30 is a very encouraging sign without DLTs.
As I highlighted before with a couple of sort of patient examples, it is encouraging with patients staying on treatments for such a long time in this very difficult to treat population. As I mentioned, the combination of fostrox plus LENVIMA being aligned with treatment guidelines moving forward. We feel that the steer from clinicians and KOLs are quite strong on this, that they see TECENTRIQ plus Avastin as the first-line option, LENVIMA as a second-line option today. Also in sort of that sort of short to medium term, i.e., that's what we could be aiming for to fit in, hence fostrox plus LENVIMA makes the most sense from a phase II-b perspective. Encouraging that that arm is recruiting the fastest. It's the other arm, the other combination arm. If I...
Sorry, I'll back up. The other arm of fostrox plus pembro, as I said, is still ongoing from a phase I-b perspective. It's still recruiting. There is still interest in that arm. But I think it's fair to say that considering LENVIMA is seen more as the preferred second line option is one of the reasons why that specific arm is also recruiting faster, i.e. the fostrox plus LENVIMA arm. One other element that is sort of a new development that could be interesting in the longer term and also speaks in favor of LENVIMA plus fostrox is recent data at AACR, where Roche presented results for TECENTRIQ plus Avastin as adjuvant therapy, i.e. after surgery.
On the left-hand side, and I know that the slide is relatively small, but sort of positive results with regards to sort of relapse-free survival for TECENTRIQ plus Avastin versus sort of watch and wait. I.e. the patients are benefiting from being treated with that combination for up to 12 months after surgery. The other part that is quite interesting is on the slide on the right or the picture on the right, and that is that they can see, and they've been able to see that patients coming out of surgery, there is 1 chunk of patients who will progress relatively quick, i.e. they will progress within the first year. They will progress while on adjuvant treatment with TECENTRIQ plus Avastin.
If you are progressing on Tecentriq plus Avastin, and you move into a more advanced stage, then TECENTRIQ plus Avastin will not be a logical sort of treatment to use in that setting. That will then for some patients, and it remains to be seen how many, that will move up Lenvima to a more of a logic first-line option, hence a combination of Fostrox plus Lenvima could also then potentially sort of, or have potential for earlier line, use as this sort of shift starts to happen. Again, this is sort of recently presented data, so it will take some time before it is approved, but it's something to keep an eye on.
As I mentioned, it could provide another rationale as to why fostrox plus LENVIMA at this stage is the more attractive arm to move forward with. With that said, as we move forward and we select the best combination arm for second line, there is a second arm which we are not selecting. Does that mean that that arm is not relevant? That is not the case. Instead, there could be addition sort of other opportunities for combination for that arm. Basically what we see is that we're seeing a very clear trend toward triple combinations.
This is where sort of this arm could play in, 'cause any dose that we set with pembrolizumab could inform combo dose potentially with other PD-1s or PD-L1s. As you, as I mentioned before, in the treatment sort of algorithm, a majority of patients are getting TECENTRIQ plus Avastin combo in first-line. We know that. The other part that we know is that many other combos or combinations of PD-1 and TKIs have tried to beat TECENTRIQ plus Avastin or show better efficacy, and they haven't succeeded. Many have tried, no one has succeeded. The conclusion we draw from that and the feedback we get from KOLs is that if you wanna, if you wanna reach, if you wanna sort of achieve something different, you need to do something different.
You need a different mode of action or additional modes of action to improve that benefit in first line. Since we know that combining chemotherapy, sort of with the PD-1 or the other mechanism could make a lot of sense, and that could open up an opportunity to move into a triple combination opportunity. This was sort of evidenced by the data that we also recently or Fredrik, our CSO, recently presented at the AACR conference. Basically, we showed two things. On the left-hand side, we showed that sort of fostrox has the ability to induce expression of PD-L1, LAG-3, and CD8, i.e., we're able to increase the immune-mediated antitumor activity.
With which then sort of leads to a situation where fostrox is able to basically help the PD-1 or PD-L1 do a better job as it has a positive effect on the tumor microenvironment. On the right-hand side, we can see that that is also sort of playing through. On this one, we tested fostrox with anti-PD-1 and LENVIMA combination. We can see on the graph here that sort of when you add fostrox to that PD-1 LENVIMA combination, you see a synergistic efficacy and a clearly sort of improved benefit in that patient population. Encouraging to see how, what fostrox brings to the table from a triple combination perspective, and something that we will, we are and we need to sort of consider as we move forward.
We believe, as we've said before, we know that Fostrox is unique, and we know it's a sort of first in class potential treatment for primary liver cancer. It is different from the other treatments on the market, where most of them are in the either the PD-1 bucket or kinase inhibitor bucket. Being unique in an area of significant unmet need means that we do believe that it has significant commercial potential. Being unique, that it also selectively targets cancer in the liver, so it's the only liver-directed one and therefore also bypasses resistance mechanisms. Perhaps most importantly, it has very strong potential for attractive combinations across lines of treatment, whether it be double combination or triple combination.
Again, as mentioned previously, very encouraging to see what we are seeing with the fostrox LENVIMA combination so far in that second-line treatment. As we move forward, sort of as Pia has come on board as our CMO, we've also taken a step to establish a more of a formal scientific council that will support shaping our future development as we move towards phase II-b and onwards, and we look towards different alternative combinations. It's important that we do that not in isolation, but that we do that with the expertise that is available. We are super happy that these five physicians, or three of them, Dr. Greten, Dr. Evans, and Dr. Heo, are involved in our current study, and they are joined by Dr. Finn from the U.S. and Dr. Vogel from Germany as our five-person strong scientific council.
We will sort of start to engage with them formally now and onwards to shape our future development. With that, I'll stop with fostrox and a few words on the clinical portfolio and partnerships before we also sort of handle the financial elements, of course. The only slide I have on the additional sort of the other project is on the TNG348, which is now the molecule name or the candidate name for the USP, the selected USP1 candidate drug from Tango Therapeutics. On the right-hand side, this is sort of part of the new data, and then there's much more than that on the poster, and which you can find on the Tango Therapeutics website.
Basically, they show that the TNG348 molecule synergizes nicely in vivo with PARP inhibitor, which we knew. They've also been able to show that it can overcome PARP inhibitor resistance. That opens up a nice sort of commercial opportunity in a relatively sort of big population across multiple tumor types. Very encouraging data. Tango also reiterated that sort of they are moving with as much speed as they can, and they plan to file for an IND mid-2023. Not far away now. And with that, we move into the financial highlights. Magnus?
Thank you, Jens. If we can move to slide number 23, where you can see the financial summary for quarter one this year, which I will briefly comment on. All numbers are in million SEK. From a financial viewpoint, Q1 was a pretty straightforward quarter this year in line with our current plan. The turnover was 0.4 million SEK, which relates entirely to royalty income that we received for Xeljanz. It's on principle the same level as last year. Other external expenses amount to -13 in Q1, it's significantly lower compared to last year. It relates foremost to lower clinical costs. As last year, we had higher clinical costs for the combination study, which was more or less in startup process.
The personnel costs are in line with last year and according to our plan. The operating loss for Q1 is almost minus SEK 20 and lower compared to last year, and as I mentioned, foremost due to the lower clinical costs that we have. The cash flow from the operating activities in Q1 amounts to minus SEK 16, which is in line with our current plan, and it's much lower than last quarter last year. To sum up, the cash position in the end of Q1 is around SEK 101 million. According to the current plans and with our current assumption, the cash run rate is into Q2 next year. With this, I will hand back over to Jens again.
Thank you. We will wrap things up by moving back to the highlight slide. I think that sort of overall, as I've hopefully been able to convey, we feel very happy about sort of the progress in the first quarter. Clearly, our main focus is on fostrox, our lead program, and being able to set the recommended dose, and to for 30 mg with LENVIMA, and then to turn that around and quickly start to recruit patients into the study is very encouraging. All the feedback that we're getting from the clinicians and KOLs are very positive with regards to attractiveness of the study.
Sort of there is a need to recruit for this patient population, and this specific combination fits very nicely with sort of the how they are approaching patients and how they are treating patients. That's very encouraging. As exemplified by a couple of patients here today, very encouraging to see that sort of with patients being able to sort of stay on drug, without progressing. As I mentioned, the longest-running patients that are still on treatment for now over eight months. It's worth saying, of course, that on one hand, not everyone will sort of respond or have benefit like this. This is a very difficult population.
It's also fair to say that we haven't shown the only two patients where we are seeing a ability to stay on treatment. We just want to give a little bit of a flavor of what we see, and we're looking forward to sharing much more detailed data going forward. As I mentioned, also excited about the additional data we showed at AACR with that potential opportunity for triple combinations in the future. I think the big take-home message from this is that it builds on what we've shown before.
Fostrox seems to provide a very strong benefit when combined with other drugs or other mechanisms of action, be it sort of PD-1s in the non-clinical models, be it with TKIs in non-clinical models, or in this case, a triple combination. It seems to find a nice position as a, as a very strong combination partner. That's what we believe. As I mentioned, encouraging process across our outlicense projects with the TNG348 molecule presenting new data and moving towards IND mid-2023. More to come in the year. With that, we'll stop there, and we will pause for questions.
If you wish to ask a question, please dial star five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial star five again on your telephone keypad. The next question comes from Clas Pelin from Erik Penser Bank. Please go ahead.
Thank you so much, and thanks for taking my questions. I just have a question about, I mean, giving your current financial position and the market environment currently, and the great opportunity it seems to be with the LENVIMA combo, are you still committed to start a second track with Keytruda that when the dose escalation part is finalized?
I think it's something we need to continue. We are watching it as we move forward, and considering that the steer we are getting towards the phase, sort of the second line where the LENVIMA combination seems to be strategically most sound, it would seem quite natural to sort of maybe take a decision to move forward with that. Also, as I mentioned, the other arm is important for future decision purposes. There is that element as well. I think we're sort of there's logic to just focusing at this stage for second line on the lenvatinib arm. As the other arm does have value as well for future, I think it's a question we are pondering and working through and that we.
Of course, we need to make a decision sort of upon that sort of recommended phase II dose timing of the pembro arm.
Okay, great. Then I have a question about the triple combination study that you presented at AACR. And this is a little bit of curiosity, and I think I understand, but you used a colorectal cancer model to evaluate Fostrox in this triple combination. Why did you do that?
Okay. Thank you for the question. There one obvious reason which is of course that liver metastasis from colorectal cancer is very, very common and a very problematic part of colorectal cancer treatment. The fact is that what we've seen at diagnosis in HCC patients is that the level of DNA damage at baseline is very, very low. It's below 1 per cell. There's not much of DNA damage response going on in HCC patients normally. However, in syngeneic mouse models, there's a lot of DNA damage going on, which means that they don't really reflect the biology of HCC patients. However, the this colorectal cancer cell line does.
In terms of the mechanism action of fostrox, i.e., inducing DNA damage and creating a cell death and an immune response, it's more relevant. That is the reason why in this study we chose the colorectal cancer cell line.
Okay. Great. Thank you so much. That was all for me.
The next question comes from Hans Engblom from EVM. Please go ahead.
Hello, guys, and welcome, Pia.
Thank you.
A few fact questions. In terms of the phase II-a in LENVIMA, how many patients are you planning to recruit?
I mean, what we've said is that sort of we will recruit in the phase II-a up to 30 patients in total, meaning then if you split across the two arms, then 15 is sort of the logic sort of next number. The first aim is to recruit sort of 15 patients in that arm. As per the question, as sort of Clas was alluding to earlier, as we look at the data, then we need to make a decision on sort of how do we then progress from there.
Sort of the initial sort of start is 15 patients in the phase II-a for the lenvatinib arm, meaning that we have four sort of in this first step, we have four slots remaining open to reach that 15 number.
Okay, that's great. In the fostrox pembro arm, what dose are you at the moment?
I think what we've said is that we haven't communicated dose on that arm and we didn't do it on lenvatinib arm either. We're kind of staying with the same approach from a communication that we will communicate the dose when we have it set. Rather than sort of saying where we are and where we're moving, 'cause that might just generate sort of uncertainty, then we will communicate that when we have finalized it. It's sort of keeping in line with previous kind of stringency and communication. Hope that's okay.
I guess there is no idea to ask you when you planning to start the phase II-b, but how long time would from start until last until sort of reporting are you thinking that that will take?
When you say from start to reporting, what do you mean sort of for phase II-a or?
For phase II-b, phase II-b.
Oh, you mean sort of from initiation of phase II-b to close of phase II-b?
Yeah. Yeah. Yeah.
I think that's a pretty much an impossible question to answer because it will depend on study size and so forth. I mean, we need to get a bit more detail from the two way study in order to then line on a design, but more importantly on a study size. That will then drive sort of how quickly it will take. I think that I could speculate wildly, but that would be difficult.
Okay. Okay. Okay. Let me go over to what you didn't mention during the presentation. First of all, the Xclair with the Chinese company, SYB. Is anything happening there, or are they looking for market approval, or?
Thank you, Hans, for the question. If there was like a slow process in the development of that. To be honest, they have not really carried forward from that. It's, we don't have any information. We're not running the program. We don't have any more information at this moment.
Okay.
I can't give you a clear answer on that. Sorry.
Yeah. Yeah. In the interim report, in respect of USP7 and MET-X, there is a slight difference in the wording, in respect of your profit or income sharing. Is that due to that there is a difference or is it just formulation, so to say?
The agreement for USP7 and Intas being revenue share agreements.
I think for USP7, it's always been a revenue share agreement.
Yeah.
And, and-
Yeah, sure. No, but.
Yeah
it was just a different wording in the two. I just wondered whether there is sort of apart from your share, which could be different, of course.
Yeah.
Is there something else that is different in the agreement, too?
No, they... No. Apart from the share, they are relatively sort of straightforward revenue share agreements. I think I mentioned that for last time for the Intas part then sort of there are no milestone related elements, et cetera. When Intas, when they out license or sell the molecule, which they will do because they are not looking to commercialize at one point in time, then we will sort of re-receive a share of that sort of revenue and any sort of future revenue sort of coming from that deal as well. They are, they are quite similar.
Okay.
We will need to look at the wording in the report. Thank you.
Okay. The last question then, in respect of Intas, I sort of went a bit deep into it, in sometimes in February and saw that Pfizer, which has some of the rights for something called ATM-AVI, which was in phase C, which is sort of could be seen as a competitor to MET-X. Have you any information what has happened with that trial, or is that too far away from you?
To be honest, I haven't followed that project, so, I couldn't say what has happened.
Yeah.
I think not something stellar or really game changing because then we would have known.
Okay. Sort of what's your feeling in terms of the Intas? Are they, are they in licensing discussions or is it too early for that?
Now we can only speculate. I mean, what they have communicated is that they are, they're aiming to move into clinic this year, looking at what they have done with other compounds, and I think I saw there was news around the remetinostat compound not long ago where they had sort of clinical data. My, my guess is that they will move into clinic, they will show benefit in the clinic because that's a good, I mean, that's a good value evolution for them rather than-
Yeah
... licensing this early. That would be my guess, considering that the, I mean, the likelihood of the clinic replicating pre-clinic in this area is quite high. It makes sense for them to run the clinical element before moving into discussions. Now I am speculating.
Yeah. Yeah. Sure. Sure. Anyhow, it seems very exciting, the molecule as such and its application.
Yeah, yeah. I think the other element to keep in mind here is that the value of Medivir will increase drastically the day, the U.S. or any other governing bodies put into place a financial construct that is more encouraging, i.e., if they implement these types of Netflix models, et cetera, then it will create sort of a value inflection for Medivir. I think that if I were them, I would keep it, develop it, and wait for that to happen because I think. Again, now I'm speculating a bit, but in the phase of the COVID experience, I think that has triggered further commitment from authorities to find solutions for situations like this.
Yep. Oh, very interesting. Thank you very much.
Thank you.
The next question comes from Joe Pantginis from H.C. Wainwright. Please go ahead.
Hey, everybody. Thanks for taking the call. A couple questions. First, I think today's call was definitely an improvement, especially with regard to the profile of fostrox. I think it's great to see, you know, not only the data in hand, but what's happening with the landscape and how the drug profile is evolving. With that said, couple questions. First, it's pretty intriguing with regard to the purported impact on immune cells, and just curious, you know, with regard to the phase II-a, and looking forward, what level of translational data might you be looking at, you know, from patients in the clinic?
The translational data that we're generating currently, will be from biopsies from these patients that are in the current study. Looking at the tumor microenvironment and looking at the tumor cells. That type of data we'll be generating, and we will put into the picture for the decision making.
Got it. Will you be doing that for future studies, including the phase II-a or II-b?
For the phase II-a, clearly, yes. For the phase II-b, yes, maybe, a slightly smaller scope and more focused depending on what we learn from phase I-b and II-a.
Sure. The focus will certainly be on the clinical efficacy. Then I think you shared a lot of important commentary today with regard to the evolution of the landscape. With that said, you know, it seems to have an important niche being laid out for fostrox. Is there any potential enrollment competition with other drugs? Because obviously you delineated, you know, you're going into later stage patients where the options are now limited, if not, you know, zero. Just curious about, you know, any enrollment competition that might impact looking to get additional patients in the studies, 'cause obviously you said they have interest from patients and docs.
No, I think, I think from a competition perspective, with regards to the fostrox and lenvatinib arm, we're not sort of sensing any... I would... No, maybe I'm being a bit strong now, looking at the air, any competition at all. I mean, the competition, if any, we're actually seeing between the two arms in the sense that it is more logical to move to LENVIMA after TECENTRIQ Avastin and then adding something on, onto LENVIMA, i.e. in this case, fostrox. There seems to be a stronger tendency towards that than moving to a pembro or a PD-1 solution after TECENTRIQ Avastin. So there is maybe a little bit of that competition going on, which is why that arm has recruited faster. It is also why, I mean, sort of we are including second and third line patients.
Clearly, a majority of the patients are second line. If we're seeing third line, we are seeing that in the pembro arm. I think that's the dynamics we are seeing. From other studies perspective, I know that the IMbrave150, is it 250? I mean, I think there's an IMbrave150 study which is looking at sort of continuing TECENTRIQ after progression on TECENTRIQ plus Avastin, is still recruiting, I believe. But I can't say that we've heard any real sort of communication or information indicating that as a competition from a recruitment perspective .
No, I think it's very, very important also to remember that fostrox is targeting the whole liver. If that is your question a little bit, TAI is something that we use for specific tumors in the liver, and they are combining it. I think almost everyone is combining with TAI. That is not competing with the patient population we have in our trials. We haven't seen any new suggestion of a mechanism of action in that kind of combination right now.
Great. Interesting feedback. I appreciate it. Lastly, I guess sort of internal logistics type of a question here. First, you know, where do you stand and with regard to your comfort levels around manufacturing needs for Fostrox for all the clinical expansion that's upcoming? The second part of that question is sort of where does Medivir stand today with regard to the right sizing of the company with regard to, you know, any personnel expansion, you know, this year or next year as everything else expands?
I'm looking at Magnus to see now whether he wants to take part of the question. I think from a, from a, from a manufacturing perspective, I'm not sure if we have communicated that we are working with Lonza, but that we're more than happy to say that we are working with Lonza, and we're quite happy with that sort of, with that, collaboration. On the manufacturing side, the CROs we're working with or contract development, them working well, and we are well prepared from a, from a sizing up perspective. That's not going to be a challenge whatsoever. That we feel quite comfortable about.
With regards to the sizing of the company, clearly sort of we feel quite comfortable where we are at the moment with the size of the company, but that will, of course, change as we move into 2B and onwards. I think that we need to make a decision on what that to be and also potential additional opportunities with fostrox towards potentially Triple, et cetera. We kinda need to align on and nail down those decisions before we look at sort of potent what will that sort of sizing up look like. At the moment, we are comfortable where we are, and we're not looking at any major changes in 2023 in the short term.
Great. Appreciate all the color. Thank you.
There are no more questions at this time, so I hand the conference back to the speakers for any closing comments.
Well, thank you everyone for calling in, and engaging, asking questions. I will just sort of take the couple of seconds to reiterate what we've said, I think, a couple of times. We are very happy with the progress in Q1, on primarily our main project fostrox, but also what we're seeing on the others. Looking forward to the rest of 2023, which we believe will be quite an eventful year for the company. With that, thank you everyone, and have a good rest of the day.