Welcome to the Iovance Biotherapeutics special update conference call. My name is Michelle, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. During the question-and-answer session, if you have a question, please press Star one one on your touchtone phone. Please note that this conference is being recorded. I will now turn the call over to Sara Pellegrino, Senior Vice President, Investor Relations and Corporate Communications at Iovance. Sara, please begin.
Thank you, operator. Good morning, and thank you for joining our conference call to discuss recent corporate, clinical, and regulatory up. These updates were highlighted in a press release we issued earlier this morning, which can also be found on our corporate website at iovance.com. On today's call, Dr. Fred Vogt, our Interim President and Chief Executive Officer, will provide a brief introduction and summary about our acquisition of Proleukin, a recombinant human interleukin-2 product, as well as our phase 3 confirmatory study in frontline advanced melanoma. Dr. Friedrich Ingenhain, our Chief Medical Officer, will review the details for our frontline melanoma trial prior to highlighting new positive clinical data and our regulatory strategy in frontline advanced non-small cell lung cancer, or NSCLC. Dr. Jean-Marc Bellemin, our Chief Financial Officer, will also comment on our cash position and anticipated cash runway.
Following the prepared remarks, we will hold a question-and-answer session. Several additional members of our executive leadership team are available to participate. Dr. Igor Bilinsky, our Chief Operating Officer, Dr. Raj K. Puri, our Executive Vice President, Regulatory Strategy and Translational Medicine, and Jim Ziegler, our Executive Vice President, Commercial. Before we start, I would like to remind everyone that statements made during this conference call will include forward-looking statements regarding Iovance's goals, business focus, business plans, pre-commercial activities, clinical trials and results, regulatory interactions, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interactions, licenses and collaborations, cash position and expense guidance, and future updates. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings.
Our results may differ materially from those projected during today's call. We assume no obligation to publicly update any forward-looking statements. With that introduction, I will turn the call over to Fred.
Thank you, Sara, and good morning, everyone. We are pleased to hold this call to review a series of corporate, clinical, and regulatory updates that strengthen our mission to be the global leader in innovating, developing, and delivering TIL therapies for people with cancer. Today's call will highlight several key updates. First, we have entered into a definitive agreement to acquire worldwide rights to Proleukin, a human interleukin-2, or IL-2 product, for which we have a strong strategic fit and rationale. Next, we have alignment with the FDA on the phase 3 TILVANCE-301 confirmatory trial on frontline advanced melanoma. As a result, we can provide additional detail on the study design, which we think is very favorable.
As mentioned in the press release, we remain on track to complete our BLA submission and post anti-PD-1 advanced melanoma this quarter, and we expect TILVANCE-301 to be well underway at the time of potential approval. We also reported new positive clinical data as well as our regulatory strategy in frontline advanced non-small cell lung cancer, or NSCLC, and we look forward to discussing with FDA, along with potential registration trial design to take advantage of these results. Finally, the strength of our balance sheet, including proceeds from our ATM facility, we are well positioned to fund our operating plan into 2024. I'll begin today's discussion with the Proleukin transaction.
As we prepare for our first potential approval and commercial launch, as we advance our pipeline in the earlier treatment settings and larger clinical trials, we decided to enter into a strategic transaction with Clinigen to acquire worldwide rights to Proleukin, an IL-2 product used to promote T cell activity following TIL infusion. Benefits of this transaction are expected to include immediate and future revenue, security of the IL-2 supply chain and logistics surrounding TIL therapy administration, and lower cost of goods and clinical trial expenses for Proleukin use with TIL therapies. Terms of the agreement included upfront payment of GBP 166.7 million, GBP 41.7 million milestone payment upon first approval of lifileucel in advanced melanoma, and double-digit global sales royalties from Iovance to Clinigen.
As Jean-Marc will highlight in further detail, this transaction will be financed with sufficient cash and is expected to close in the 1st quarter of 2023, subject to required regulatory approvals and clearances and other customary closing conditions. Moving to our recent clinical and regulatory updates, I would also like to highlight our Phase 3 TILVANCE-301 confirmatory trial in frontline advanced melanoma. During the fourth quarter of 2022, we reached agreement with the FDA regarding the TILVANCE-301 trial design to support accelerated and full approvals of lifileucel in frontline advanced melanoma, as well as a full approval of lifileucel in post anti-PD-1 advanced melanoma. I will now ask Friedrich to further highlight details of the TILVANCE-301 trial design and our clinical and regulatory updates. Friedrich?
Thank you, Fred. We are pleased to have reached agreement and to be moving ahead with the FDA regarding the phase III TILVANCE-301 trial of lifileucel in combination with pembrolizumab in frontline advanced melanoma.
TILVANCE-301 will randomize 670 patients to investigate lifileucel in combination with pembrolizumab in the experimental arm in comparison with pembrolizumab monotherapy in the control arm. The FDA agreed to dual primary endpoints of subjective response rate or ORR to support accelerated approval and progression-free survival or PFS in TILVANCE-301 to support full approval of lifileucel in front-line advanced melanoma. TILVANCE-301 will also serve as a confirmatory trial to support full approval of lifileucel in post anti-PD-1 advanced melanoma. We are confident in achieving our target enrollment and potentially enabling regulatory submissions in multiple geographies by including an appropriate number of global sites, such as many large US and European cancer centers, as well as sites in numerous countries beyond the US and Europe, where we expect strong enrollment.
This trial is now starting up and is expected to be well underway at the time of potential BLA approval for lifileucel in post anti-PD-1 advanced melanoma. We expect to provide further details on trial design later in 2023. We are confident in this design based on the latest data from cohort 1A in the IOV-COM-202 trial of lifileucel in combination with pembrolizumab in front-line advanced melanoma, which remained consistent with previously reported robust ORR by RECIST 1.1 and durability of response. We look forward to sharing additional data from cohort 1A and moving forward with our front-line melanoma strategy this year. Today, we also shared top-line initial data in patients with non-small cell lung cancer who are now eased to anti-PD-1 therapy from cohort 3A of the IOV-COM-202 trial.
We observed a confirmed ORR by RECIST 1.1 of 47% or 8 of 17 patients in Cohort 3A patients treated with a combination of TIL therapy and pembrolizumab. Responses were observed regardless of PD-L1 status, and safety was consistent with other studies of Iovance TIL therapies in combination with pembrolizumab. Cohort 3A comprises three distinct clinical subsets of anti-PD-1 naive metastatic non-small cell lung cancer patients in the advanced setting. Treatment-naive, post-chemotherapy, and EGFR mutant after prior treatment with tyrosine kinase inhibitors or TKIs. The observed differences in ORR among patient subsets are informing the design of a subsequent potential registration study. For example, response rates were highest in treatment-naive patients for whom we observed an 80% ORR in four out of five patients, and in post-chemotherapy patients for whom we observed a 43% ORR in three out of seven patients.
In EGFR mutant patients after prior treatment with TKI, ORR was 20% or one out of five patients. Two patients in cohort three A achieved complete response and remain on study, which consists of one post-chemotherapy patient and one EGFR mutant post-TKI patient. Study enrollment in cohort 3-A remains ongoing, and we plan to present details and updated results at a medical meeting this year. Based on initial cohort 3-A positive results, particularly within the treatment-naive and post-chemotherapy subset, we plan to meet with FDA in 2023 to discuss data and a potential registration path for lifileucel in front-line advanced non-small cell lung cancer patients. The proposed design supporting this path will take advantage of the findings of cohort 3-A and explore TIL therapy combined with pembrolizumab administered after standard limited duration chemotherapy.
Our goal is to offer frontline advanced non-small cell lung cancer patients improved responses in PFS compared with single agent maintenance pembrolizumab. In summary, we are excited about the opportunities for TIL therapy as an earlier treatment in frontline advanced melanoma and non-small cell lung cancer. Now I will pass the call to Jean-Marc. Jean-Marc?
Thank you, Fred. I would like to provide additional details about our cash balance and runway. As Fred mentioned, we are financing the Proleukin acquisition with our existing cash. As of January 20, 2023, our unaudited cash position was approximately $477 million, which includes approximately $227 million in net proceeds from an at-the-market equity financing facility raised during the fourth quarter of 2022 and early 2023. We agreed to terms for a secured line of credit of up to $100 million from Cugene Capital. These proceeds are expected to fund the acquisition of Proleukin and our operating plan well into 2024, including manufacturing and launch readiness activities, launch execution, and pipeline advancement in our planned trials. I will hand the call back to the operator to kick off the Q&A session. Operator?
As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press Star one one again.
Please stand by while we compile the Q&A roster. The first question comes from Michael Yee with Jefferies. Your line is now open.
Hey, good morning. Thank you for the update. Two questions, although both related. Can you give us, maybe some color on what the gaining steps are still left for the melanoma filing and what supports the confidence to complete that filing in Q1? And whatever you can say on that would be helpful. Secondly, I guess, can you give some color, on the confirmatory, timeline for the melanoma study? And maybe just I know there's been discussion in the past with other companies about how much of that study actually needs to be completed, enrollment or substantially enrolled, et cetera. What have your conversations been with FDA around that as it relates to the filing and the actual PDUFA date?
Thank you.
Yeah, thanks, Mike. The BLA remains on track. We intend to file the BLA, complete the rolling BLA submission in Q1. The activities that are going on right now include validation activities, that we've discussed publicly previously, which are well underway. Not to, not to use the term that for the other part of this question, too much, they're underway right now and in good shape, and we think we're gonna be able to complete the BLA submission on time. I can't really give you any more details. Most of it is heavy CMC related work, it's going well. On the confirmatory timeline and the real well underway, as FDA says it, we received very positive feedback from FDA at the meeting where we described the study to them on our timings.
There was no discussion of any kind of percentage enrollment or anything like that. They thanked us and were happy with the timings of the study. We had this meeting with them last year, of course, and got a lot of feedback then, so they were comfortable with our timings, and we think that's gonna be supportive of our BLA approval.
Okay. Thank you.
Please stand by for our next question. Our next question comes from Tyler Van Buren with Cowen. Your line is now open.
Great. Thanks, guys. Appreciate the question and nice to see all the updates. Two questions. The first one is, can you give us a sense on the outlook for Proleukin sales moving forward? The second one is related to the non-small cell lung update from cohort 3A. Can you help us understand what duration of response looked like in the two subgroups that you're moving forward in, especially as we think about the prior update at SITC 2021?
Sure, Tyler. on Proleukin sales, we're not providing guidance right now on sales. What we, at some point, you know, in the future as a commercial company, we'll be able to do things like that. What we can say is that it will contribute significantly, we think, to the overall sales of the company once lifileucel is approved, because it is a supporting part of the regimen and, by capturing those sales that is, we think is gonna be a very significant addition to the potential sales potential of lifileucel in melanoma. On the durability of non-small cell lung, it's still early, but we are seeing durable responses.
We're very encouraged by this, and that's why we wanna go talk to the FDA, and we'll provide more details on that at a medical meeting. Frederick can talk a little bit more on that, as we go here, but you've seen the update. It's very encouraging in terms of response rate. Like I said, it is still early, but we're seeing durable responses and we're very positive. Operator, are there any additional questions?
Our next question comes from James Shin with Wells Fargo. Your line is now open. Our next question comes from James Shin with Wells Fargo. Your line is now open. Our next question comes from Mark Breidenbach with Oppenheimer & Co. Your line is now open.
Hey, good morning. Can you hear me all right?
Yeah.
Okay, great. Just a couple quick ones for me. First of all, thanks for this update. Can you maybe briefly comment on the amount of COGS savings associated with the Proleukin acquisition? You know, in terms of a rough percentage, that would be fantastic. The second question is just, are you planning to offer any updated guidance on the regulatory package cervical cancer in 2023, or is it gonna kind of focus on longer next year? Thank you.
Mark, just to be clear on your first question, you want some idea of the potential savings for clinical trial usage of Proleukin or?
COGS. With respect to lifileucel, how much will the acquisition of Proleukin impact COGS, for lifileucel?
lifileucel is a separate product, and while it could impact COGS in some way because we can use it during manufacturing as well. It's not, you know, it's sold separately as a separate, a separate transaction to the hospital. Don't think of like, as like a direct effect on COGS in that manner, although it can affect manufacturing and improve it. It certainly would improve COGS in that case. It's sold separately. What this gives us is it gives us control and security over the supply chain as well as revenue from the sales of Proleukin alongside of lifileucel, which we expect will act essentially like a relaunch of the Proleukin product.
When lifileucel hits the market, Proleukin sales should increase much more than they ever have in the past, and we'll be able to capture some of that revenue because of this transaction. Then on your question regarding regulatory updates on cervical, hopefully we can provide an update on that at some point this year. We did provide an update last year on that, we, when we noted that we had talked to FDA and we were expanding enrollment in the study and tended the study to be pivotal. Right now we're enrolling, and I don't have any updates for you today, but hopefully we can say more about that at some point this year.
Thanks so much.
Please stand by for our next question. Our next question comes from James Shin with Wells Fargo. Your line is now open.
Hey, guys. Good morning. Can you guys hear me?
Yeah. Sorry about that, James.
No, sorry. I think it's something on my end. just had a question. Will this Proleukin deal have any impact on the Iovance 3001 program? Given Proleukin only has, I think the label only has RCC and melanoma on its label, will Iovance need to gain approval in the lifileucel other indications?
No. No and no. We think we're gonna continue to develop our own IL-2 asset because it's differentiated from this. However, this gives us an approved asset already, which is, you know, it's part of the treatment regimen today. This is the product we've been using as part of our treatment regimen all along for our studies. You know, the new asset, the IOV-3001 asset, will eventually be in that category too, but it's obviously early in development. This, you know, is that, does that answer your question, James, or?
Yeah. Then for the new indications, I guess, like what's the plan for that part?
We're developing this as part of the treatment regimen for TIL therapy. The product's approved for melanoma and renal cell carcinoma in the United States and in certain number of other jurisdictions. Those are minor indications. Really what we're focused on is having Lifileucel approved, and the label for Lifileucel will have a treatment regimen that includes this product with it.
Oh, I see. Got you.
Yeah. It's not like a classic label expansion, although by acquiring the asset, it does give us some control over the label, so we can do some things with the label down the line.
Understood. Thank you so much.
Please stand by for our next question. Our next question comes from Peter Lawson with Barclays. Your line is now open.
Great. Thank you so much. Thanks for taking the questions. Just on the long data, I guess initially, if you could, if you had any sense how responses looked in the different PD-1 expression levels?
Yeah. As it's mentioned in the press release, Peter, we've seen responses in both PD-1 negative, PD-L1 negative, and PD-L1 positive are pretty evenly distributed. Frederick, do you wanna comment at all on this?
Yeah, I can. I mean, the data-wise, Fred, you're absolutely right. We see responses in both groups, and that's important to know, right? Because the combination here is with pembrolizumab, and there's no chemotherapy involved. I think that is interesting and important that we're seeing the responses, meaningful responses in PD-1 negative patients as well. That's the basis and the starting point for our thoughts around how to now follow that up with subsequent studies and the registrational strategy.
Gotcha. Those CRs, were those in PD-1 high patients?
Not necessarily.
Gotcha. Thank you. I wonder if you could just talk through any kind of prior revenues that were seen for IL-2, say in 2022 or 2021, just to give us a kind of a baseline.
I think it's been reported in Clinigen's financials. The product was primarily selling to TIL companies actually, although it sells small quantities around the world for the renal cell carcinoma. Jean-Marc, you know, do you wanna make any well, maybe I can just say, Peter, we can't provide guidance on this, but it was in the low double-digit million sales when they last were reporting their financials. They were acquired by a private equity firm. You know, some of that stuff is no longer publicly visible, but that's what they were doing back then.
Gotcha.
Would you still continue to sell it to other tool companies?
Sure, yeah. I mean, we're not... You know, we're, we'll continue to provide the asset to everybody. You know, we're not, we're not trying to restrict anything here. Our big thing here is we're trying to capture the, you know, the combined revenues of the two products, control over the products so that we can, you know, steer it where we think it should best be suited. It's, you know, it goes hand in hand with Lifileucel. Yeah, I think it's very important that we have ownership over it. You know, we can use it in the clinic. We can get a lot of savings by using it in the clinic, in our own trials, including in the TILVANCE-301 trial, for example. These can be quite significant to us.
Final question. Would you transfer manufacturing?
We can. Right now it's manufactured by a CMO, and you can do those sorts of things downstream, but our facilities are designed for cell therapies. We don't have protein production facilities at Iovance. That's not something that we, you know, is really on the radar for short term.
Perfect. Thank you so much.
Please stand by for our next question. Our next question comes from Benjamin Burnett with Stifel. Your line is now open.
Hey, thanks very much for holding the call and let us ask a question. I just wanted to follow up on that last, that last discussion. I guess did Clinigen have any agreements with other cell therapy companies? I guess if so, are these agreements carrying over to you?
Yes. Generally, Ben, that's the way a transaction like this goes. They can have supply agreements with various companies, and when they sell the asset, those transfer to the buyer. Yes, although there's, you know, a lot of them are small and we don't really share details of those things. They do exist.
Okay.
Yeah.
I guess mechanically, are there any like conflicts of interest, things need to be negotiated? Like if a potential competitor or cell therapy competitor, you know, in oncology is using IL-2, like how does that work?
Just like any, supply of drug for comparators or for use as a part of a treatment regimen or co-therapy, you know, we can supply that. You know, drug companies supply those things all the time, and that's what we would do too. We're not looking in any way to restrict supply of the product.
Okay, awesome. Thank you very much.
Please stand by for our next question. Our next question comes from Joe Catanzaro with Piper Sandler Companies. Your line is now open.
Great. Thanks for taking my questions and thanks for the update here. Maybe two quick ones from me. Given the activity you're observing in cohort 3A of IOV-COM-202 with the Pembro combination, I guess where is your thinking now for monotherapy activity or plan in a post-PD-1 non-small cell lung cancer setting? With regards to Proleukin, appreciate a lot of the potential benefits, but in terms of longer term downstream revenues, can you remind us what's sort of the current IP situation and the remaining period of exclusivity there is there? Thanks.
Sure. On the first question, yes, post PD-1 non-small cell lung remains very important to us. We've got multiple studies running in that line, including our LU 1202 study, which could potentially be supportive of registration. We've already put out the cohort 3B data, which shown a 21% response rate with some nice durable responses that we saw in those patients. You've seen all that data that's in our deck. That is very interesting to us and continues to be extremely high priority for us. We think this data in cohort 3A just adds to the overall equation and the proposition of TIL therapy in non-small cell lung.
It shows that TIL therapy works in another line in non-small cell lung in a promising manner that we think is worthy of, you know, significant investigation. It's really a vote of confidence in the fact that TIL therapies work in non-small cell lung. With respect to the IP position for Proleukin, it's an older product. It's been around for a long time. There's a, you know, the traditional IP mechanisms like patents are, you know, no longer really relevant to the Proleukin franchise. There's tremendous amount of know-how. There's just natural entry barriers to come in with that product today. You know, we don't worry too much around the moat around that product. We think it's pretty secure.
Okay. Got it. Thanks for taking my questions.
Please stand by for our next question. Our next question comes from Mara Goldstein with Mizuho Group. Your line is now open.
Hi, this is Sapir calling for Mara. Thank you for taking our questions. You mentioned earlier in the call that in with regard to the BLA submission that the company is in alignment with the FDA. I was wondering if you can add some specificity to that statement.
yeah
talking about.
Yeah, we're in alignment with the FDA on the confirmatory study, TILVANCE-301, that we announced today, including that very favorable trial design, ORR, which is an, you know, an interim endpoint, which dramatically improves our timeline for accelerated approval. You know, FDA recommended ORR and was highly supportive of this, of our dual endpoint strategy here. We think there's a tremendous amount of alignment here between us and FDA on this study, and that we think is quite positive for us.
Got it. Got it. Okay. I know we just talked about NSCLC for a bit earlier, but I'm just curious, so given the results that was just shared by the press release, is it reasonable to assume that the front line non-small cell lung cancer is now prioritized over the later-line treatment?
No, not necessarily. We've already got IOV-LUN-202, potentially registrational study running in late-line lung, and this is just adding another dimension. The way to think about it is just like with melanoma, we're attacking lung from two different angles. In fact, with lung we're attacking it from a third angle too, with the genetically modified TILs. We are not... this is not something that should make you think that somehow our late-line lung program is no longer a priority. It's extremely high priority. That's why we talk about it all the time. We have data out on that. We expect to have more data out on that in the future.
Got it. Got it. Thank you. If I may squeeze in one last question on cash. I'm just curious if there's any certain milestone that needs to be met in order to access the $100 million credit from Quogue Capital.
No.
Okay. Thank you.
Please stand by for our next question. Our next question comes from Ashika Gunawardana with Truist. Your line is now open.
Hey, guys. It's Ashika from Truist. Thanks for taking my questions. First off, can I just ask, the confirmatory study in melanoma, the 670 patient study, how long do you think it'll take to recruit that? Then I got a couple of follows for Frederick.
We think it'll recruit quite quickly. We're going to, maybe Frederick can add a little bit of color here after I go. We're gonna really extend the scope of this study very widely across the world, and we intend to have a lot of sites active. It's gonna be quite significant number of sites, you know, potentially into the triple digits. We are very interested in making sure enrollment's fast and taking advantage of the fact that we've got ORR as an endpoint here, which, you know, really speeds up our timeline for accelerated approval. Frederick, do you wanna add anything?
No, that's right. We're gonna go aggressively after this. Obviously, open an appropriate number of sites and geographies that we think make sense. As we shared, we can do this in geographies that go beyond U.S. and Europe, and that's important to keep in mind there as well. We're pretty confident that we can get this up and running pretty quickly.
Got it. Okay. If I have to just pivot to Non-Small Cell Lung Cancer in the data that you announced today, ORR is certainly really attractive. Frederick, I'm wondering, in this naive population, the PD-1 naive population, the chemo-experienced PD-1 naive population, what kind of durability would be attractive to you?
Fredrich, do you wanna answer that?
Yeah, I think-
Go ahead.
Yeah, I'm here. Can you guys hear me? Yes.
Yeah, I'm here.
I think there's benchmarks out there, right? I think, one of the things that we need to think about is what do you see with the standard of care. Keep in mind what we just, also disclosed is the approach here, in further developing this may not necessarily be an approach where we are going against benchmarks, existing benchmarks with, standard of care chemo plus Pembro, which now, as you know, is pretty widely used. Finding a way of actually adding on to that. It's not so much about beating benchmarks here, but it's about adding on to that.
Would that also mean that maybe looking at specific patient subpopulations, like maybe PD-L1 negative patients, might also be a viable path to market here?
Yes. That's, and that is very consistent with what we are seeing in the melanoma member, where we do not see any dependence on correlation with PD-L1 expression. That makes sense because we believe that cell therapy is differentiated from PD-1 check inhibitors in that regard.
Got it. This is very helpful. Thanks for answering my questions, guys.
Thanks.
Please stand by for our next question. Our next question comes from Kelsey Goodwin with Piper Sandler . Your line is now open.
Hey, good morning. Thank you for taking my question. Thanks for providing the updates today. Just a couple quick questions from me. I guess, first, how important is the core biopsy to your overall non-small cell lung cancer strategy? How should we think about lifileucel versus IOV-3001 and how they kind of fit into your non-small cell lung cancer strategy?
Last one, just kind of quickly on the modeling of Proleukin. I guess, can you provide any color or guidance on what the price per TIL administration has been historically or what or how we should kind of think about that going forward? Thank you.
Sure. All right. Core biopsy, we have a cohort in IOV-LUN-202 called cohort 3, which is exploring core biopsy, and we've been a leader in that space for a long time. It's a very interesting technology. It's early stage. We think it's very promising. We are very encouraged with that approach. It's not, no pun intended, it's not core to our non-small cell lung strategy. Our non-small cell NSCLC strategy right now is running quite well with excisional biopsies. If we can get core biopsies as to that, obviously we think that would be an additional, you know, expansion of the applicability of TIL therapy to some other hard to treat patients. lifileucel versus 4001 and LN-145 versus 4001.
You know, the way we think about those things is 4001 is a potentially a product with potentially increased potency and efficacy because of its incorporation of a PD-1 knockout. We're able to do these gene knockouts of checkpoint genes like PD-1 and CTLA-4 and TIGIT and others, we think this is a potentially very powerful strategy because it mimics a, you know, an antibody combination with the TIL potentially. Whereas lifileucel of course, carries its own efficacy too. TILs themselves are. You know, you can think of a TIL PD-1 knockout as like a single product that really embodies a combination product. We're very excited about that technology and the ability to boost responses with that. Finally, for the model for Proleukin, you know, Proleukin's current list price is around $5,000 a vial.
This is something you can find publicly. With TIL administration, we typically give about 16 vials. The actual, you know, the target is 18 vials, but most cases we give around 16 on average. You know, from that, I think you can understand exactly how much Proleukin might be sold with the TIL infusion.
Perfect. Okay, that's super helpful. Thank you so much.
At this time, I show no further questions. I would now like to turn the conference back to Fred for closing remarks.
Okay. Thank you again for joining the Iovance corporate regulatory and clinical update call today. Please feel free to reach out to our investor relations team with any follow-up questions. Thanks everyone.
This concludes today's conference call. Thank you for participating. You may now disconnect.