Iovance Biotherapeutics Inc

NASDAQ:IOVA

Earnings Call Transcript 2022-Q1

[Operator]

Welcome to the Iovance Biotherapeutics First Quarter 2022 Financial Results. My name is Andrew, 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. [Operator Instructions] Please note that this conference is being recorded.

Please note that this conference is being recorded. I will now turn the call over to Sara Pellegrino, Vice President, Investor and Public Relations at Iovance. Sara, you may begin.

[Sara Pellegrino, Vice President, Investor and Public Relations]

Thank you, operator. Good afternoon, and thank you for joining us. Speaking on today's call, we have Dr. Fred Vogt, our Interim President and Chief Executive Officer; Dr. Igor Bilinsky, our Chief Operating Officer; Jim Ziegler, our Senior Vice President, Commercial; Dr. Friedrich Finckenstein, our Chief Medical Officer; Dr. Madan Jagasia, our Senior Vice President, Medical Affairs; and Jean-Marc Bellemin, our Chief Financial Officer. Dr. Raj Puri, our Executive Vice President, Regulatory Strategy and Translational Medicine is also on the call to participate in the question-and-answer session.

This afternoon, we issued a press release that can be found on our website at iovance.com, which includes the financial results for the three months ended on March 31, 2022, as well as recent corporate updates. 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 regulatory plans and results, research and preclinical activities, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interaction, collaboration, 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 undertake no obligation to publicly update any forward-looking statements.

With that, I will turn the call over to Fred.

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

Thank you, Sara, and good afternoon, everyone. I am pleased to highlight our positive start to the year at Iovance during today's conference call. First and foremost, we are moving rapidly towards our first-ever BLA submission for our lead TIL therapy, lifileucel and metastatic melanoma. This is our top priority at Iovance. As we announced last month, we received positive feedback from the FDA regarding our potency assays and assay matrix for lifileucel. For next steps, we intend to hold a pre-BLA meeting in July 2022 and submit the BLA in August 2022.

In addition, we continue discussions with the FDA about our registrational strategies in cervical cancer and non-small cell lung cancer so that we may offer TIL therapy to patients with significant unmet need in these additional tumor types. As we prepare to launch lifileucel, we are also making progress in our commercial readiness and internal manufacturing capabilities at the Iovance Cell Therapy Center, or iCTC, in Philadelphia.

Our organization is growing to further our mission of innovating, developing and delivering TIL therapies. We now have nearly 400 employees at the Company who have on average within four years of cell therapy experience. The talent within our organization is a testament to the potential of our Iovance TIL therapy and our global leadership within the field. We're excited about the momentum for our growing TIL pipeline.

We continue to enroll patients across four Iovance-sponsored clinical trials and plan to initiate two additional trials this year. The FDA has allowed an IND to proceed for a clinical trial of our PD-1 inactivated, gene-edited TIL therapy, IOV-4001. We also plan to conduct a Phase III trial of TIL in combination with pembrolizumab in frontline melanoma, where clinical data demonstrated the potential to improve patient outcomes compared with pembrolizumab alone in patients who are naive to immune checkpoint inhibitors.

As we prepare to launch the first one-time cell therapy in solid tumors, we believe that our TIL platform, clinical data and people set a strong foundation to establish Iovance TIL therapy as the next class of paradigm-shifting therapies for people with cancer. Manufacturing and managing demand for new cell therapy is key to our success.

So I'll ask Igor to talk more about our progress in these areas.

[Dr. Igor Bilinsky, Chief Operating Officer]

Thank you, Fred. Across our manufacturing network, we continue to focus on patient needs and operational excellence, maintaining a TIL manufacturing success rate of more than 90% in more than 500 patients treated with Iovance TIL therapy. Today, I will summarize key activities of the Iovance Cell Therapy Center, or iCTC, which is our 136,000 square foot cell therapy manufacturing facility.

Recently, Iovance was honored by the International Society for Pharmaceutical Engineering with the 2022 Facility of the Year category award for iCTC, a remarkable reflection of what we have accomplished since the initial groundbreaking of this facility only three years ago. At iCTC, the main priority remains preparation for the BLA and commercial launch. We designed iCTC to have the capacity to provide commercial and clinical TIL supply for thousands of patients per year.

We expect iCTC to handle most of our commercial demand at launch with the added flexibility to use contract manufacturing to optimally manage capacity and address patient demand. We are performing numerous activities to support the BLA submission at iCTC in parallel with clinical manufacturing, which began at iCTC last year. In addition, we are on track in preparing the iCTC and our contract manufacturer facility for BLA, for FDA approval inspections, which we expect to occur as part of the BLA review process.

In addition to manufacturing, we have established a strong quality control, or QC Group, at iCTC. The QC team performs release testing of two products, which will include commercial release testing of lifileucel upon potential approval. In collaboration with our analytical development group, our QC team has been completing BLA-related activities needed for our two potency assays and assay matrix, including our new potency co-culture assay.

Turning to our Intellectual Property, or IP. We continue to build our robust and growing IP portfolio to support our proprietary manufacturing processes as well as our know-how surrounding TIL therapy. We currently own more than 40 granted or allowed U.S. and international patents. This IP covers TIL compositions and methods of treatment and manufacturing in a broad range of cancers, including Gen 2 patent rights that are expected to provide exclusivity into 2038.

I would now like to hand the call to Jim Ziegler to highlight our commercial launch preparations. Over to you, Jim.

[Jim Ziegler, Senior Vice President, Commercial]

Thank you, Igor. Our cross-functional team has built the foundation to scale rapidly and efficiently from BLA submission into launch and commercialization. We are partnering with the leading U.S. cancer centers to develop their TIL service line capabilities, and we aim to have at least 40 authorized treatment centers, or ATCs, for launch. The key onboarding and training activities are also aligned with the BLA-related milestones to ensure just-in-time training and readiness at our ATCs.

Our market access team continues to engage commercial, state and federal payers such as the Centers for Medicare and Medicaid Services, or CMS, to ensure patients have appropriate and timely access to lifileucel. CMS released the fiscal year 2023 in-patient prospective payment, or IPPS, and proposed rules as part of their annual process in April. In this draft rule, CMS proposes the continued policies that were finalized in the fiscal year 2022 rule making cycle, which expanded DRG 18 for CAR-Ts and other immunotherapies, including lifileucel.

This means hospitals will have more appropriate payment for Medicare beneficiaries upon lifileucel approval. In the rule, CMS also summarizes the new technology add-on payment, or NTAP applications, including lifileucel. With the anticipated BLA timelines, we plan to submit our NTAP application in the next fiscal cycle. We appreciate the positive steps CMS has taken to improving Medicare patient access to cell therapies, and we look forward to working with CMS and other key stakeholders to ensure access for the emerging class of cell therapies.

In addition to supporting access, we are also developing our proprietary IovanceCares program to assist health care providers and patients through every step of their TIL journey. Our goal is to deliver a best-in-class cell ordering, chain of identity, chain of custody and patient support program for launch.

I will now pass the call to Friedrich Finckenstein, our Chief Medical Officer, to highlight our clinical progress.

[Dr. Friedrich Finckenstein, Chief Medical Officer]

Thank you, Jim. Today, I would like to share recent updates for our TIL clinical programs. We have made great strides in evolving our TIL technology platform to incorporate additional therapies and technologies to address more cancer patients and new tumor types and indications. The important proof of concept for TIL in combination with pembrolizumab in multiple solid tumors as well as our IND-enabling work to proceed to clinical trials with IOV-4001, are two prime examples of our platform expansion and commitment to innovation.

Our strategy for TIL in combination with pembrolizumab and checkpoint inhibitor naive patients expand upon the initial opportunity for lifileucel monotherapy after checkpoint inhibitor therapy. In an April 2022 press release, we announced updated clinical data for lifileucel in combination with pembrolizumab from Cohort 1A in our IOV-COM-202 trial. In melanoma patients who are naive to immune checkpoint inhibitor therapy, the overall response rate was 67%. 8 out of 12 patients had a confirmed objective response, including three complete responses and five partial responses. Overall, a complete response rate for this combination or above published response rates for pembrolizumab in frontline melanoma.

Based on the promising clinical data and to offer possible benefit from TIL therapy to more melanoma patients, we are working with our internal teams and key opinion leaders to finalize the design for a Phase III trial. We currently expect this trial to begin at the end of this year and look forward to providing updates as available. In addition, we are advancing our first genetically modified TIL therapy candidate, IOV-4001, into the clinic. During the first quarter, the FDA allowed our IND to proceed for IOV-4001 for previously treated advanced melanoma or metastatic non-small cell lung cancer.

IOV-4001 is a PD-1 inactivated TIL therapy that incorporates the TALEN gene editing technology licensed from Cellectis. Preclinical results for IOV-4001 were recently presented in a poster at the American Association for Cancer Research Annual Meeting, or AACR. In the Murine model of melanoma, the antitumor activity of IOV-4001 was superior to non-edited TIL product, whether alone or in combination with an anti-PD-1 antibody. We are excited about the potential for IOV-4001 to deliver TIL and PD-1 inhibition within a single therapy and look forward to starting a first-in-human study with IOV-4001 later this year.

Turning to our strategy for treating non-small cell lung cancer. We're currently enrolling second-line non-small cell lung cancer patients in the IOV-LUN-202 trial at 30 sites. We recently amended the trial protocol to broaden the patient population, a reflection of real-world practice and the unmet need in non-small cell lung cancer. This amended protocol also provides flexibility around the timing of tumor harvest as well as around therapy prior to TIL infusion, which may inform new practices for patients across solid tumors.

To elaborate on our medical education and outreach efforts, I will hand the call to Madan to discuss.

[Dr. Madan Jagasia, Senior Vice President, Medical Affairs]

Thank you, Friedrich. Our medicine affairs team has a depth of experience in oncology with long-standing relationships with many of our key opinion leaders. Over the past two years, our medical affairs team has been active in engaging centers and physicians of our Iovance TIL therapy. These interactions include scientific exchange at individual and small group meetings or during medical conferences. In total, the team has interacted with approximately 500 health care providers, or HCPs. Among these HCPs, 70% are dedicated to hematology/oncology, 20% are cell therapy specialists and the remaining 10% are surgeons.

Our medical affairs team also leads a publication and scientific communication strategy and execution at Iovance. Our goal is to present and publish clinical data and engage with physicians so that we can attract top centers to participate in our clinical trials, increased scientific awareness, drive patient recruitment and increased share of voice for Iovance TIL therapy within the oncology and cell therapy communities. In 2021 alone, our clinical trial data presentations represented 136 patients across four tumor types.

The venues included three major medical meetings, AACR, ASCO and SITC, and one manuscript, which was melanoma Cohort 2 data in the Journal of Clinical Oncology. In addition, our Iovance medical affairs team has interacted with more than 100 centers as we work cross-functionally to facilitate onboarding activities at the authorized treatment centers. Among these centers, 60% are designated cancer centers for the National Cancer Institute and/or Member Institutions of the National Comprehensive Cancer Center Network. The remaining 40% are a mix of academic and large community networks.

I will now hand the call over to Jean-Marc to discuss our first quarter 2022 financial results.

[Jean-Marc Bellemin, Chief Financial Officer]

Thank you, Madan. My comments will reflect the high-level financial results from our first quarter of 2022. Additional details can be found in this afternoon's press release as well as in our SEC filings.

I will begin with the strength of our cash position. As of March 31, 2022, Iovance held $516 million in cash, cash equivalents, investments and restricted cash compared to $602.1 million on December 31, 2021. Our cash usage from operations included certain annual payments totaling $16 million. We maintained prior guidance that our cash position is sufficient to advance our operating plan into 2024, including pipeline development and expansion, commercial manufacturing readiness and launch preparation.

Moving to the income statement. Our net loss for the first quarter ended March 31, 2022, was $91.6 million or $0.58 per share. This compared to a net loss of $75.4 million or $0.51 per share for the first quarter ended March 31, 2021. Research and development expenses were $68.3 million for the first quarter ended March 31, 2022, an increase of $12.4 million compared to $55.9 million for the first quarter ended March 31, 2021.

The increase in research and development expenses over the prior year period was primarily attributable to the growth of the internal research and development team, including stock-based compensation expense to support our ongoing and planned pipeline activities as well as increased facility-related costs.

General and administrative expenses were $23.4 million for the first quarter ended March 31, 2022, an increase of $3.8 million compared to $19.6 million for the first quarter ended March 31, 2021. The increase in general and administrative expenses compared to the prior year period was primarily attributable to the growth of the internal general and administrative team, including stock-based compensation expense, an increase in marketing, intellectual property and legal expenses as well as the build-out of our new corporate headquarter office and information technology infrastructure to support pre-commercialization, launch readiness and our overall growth.

As of March 31, 2022, there were approximately 157.2 million common shares outstanding. With the strength of our balance sheet and by managing our focused investments across the pipeline, launch readiness and internal manufacturing, we are well positioned to execute our operating plan while continuing to align our spending with our corporate priorities.

I will now hand the call back to the operator to kick off the Q&A session.

[Operator]

[Operator Instructions] And our first question comes from the line of Madhu Kumar with Goldman Sachs.

[Madhu Kumar, Goldman Sachs]

I guess our first one is, again, kind of a simple one looking at the calendar. How should we think about the cadence of events in terms of the release of Cohort 4 topline data vis-a-vis this July pre-BLA meeting and the August BLA submission?

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

Madhu, it's going to be part of that process. We can't really give any more guidances to that. But effectively, as part of that process, we're trying to get the BLA in, and we're trying to talk more about Cohort 4 and complete the process of filing the BLA at the same time. So really, I wouldn't think about it as any particular cadence. It should come in as soon as we're able to go.

[Madhu Kumar, Goldman Sachs]

Okay. And then on non-small cell and cervical cancer, how should we -- you mentioned you plan to have regulatory interactions to discuss kind of making registrational cohorts? In both indications, what do you see as the effective population for unmet need where either TIL monotherapy or TIL plus PD-1 blockade kind of makes sense as a line of therapy for whom you could have a registrational cohort?

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

Well, both of the occasions, you have the post checkpoint population available where there's significant unmet medical need today. So that's sort of the short answer to your question. There's obviously much finer points, and we can talk more about the details of each study. And hopefully, after getting our strategy together and regulatory input and sorting out our plans here, we can talk more about this, but that's the general approach. And then, of course, we've got frontline studies running in combination with pembrolizumab as well to look at earlier lines of therapy, as you normally do in oncology trade development.

[Madhu Kumar, Goldman Sachs]

Okay. One last question I got was maybe scientific/philosophical one. How do you think about PD-1 knockout TILs as compared to TILs plus PD-1 as they kind of -- in terms of therapeutic avenues, like where would one -- the PD-1 monoclonal antibody combination make more sense? Where would a PD-1 knockout TIL population make more sense? And I guess kind of which raises the question, how much of TIL efficacy is from the initial TIL product versus kind of epitope spread?

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

Well, let me take the first part of your question, then we can talk a little more about efficacy as we go here. And Madan and Friedrich can jump in as well, if needed. It's untested as of today, but we do believe that knocking down the gene within the T cell may lead to a more efficacious TIL and a more efficacious MOA for PD-1, PD-L1 blockade.

There's a number of reasons for this, and there's a number of advantages to knocking down the gene as opposed to giving the patient a antibody. For example, better penetration of the TILs into a tumor stroma layers in the microenvironment as opposed to an antibody, and separately, you can -- that's an efficacy side argument. But on a toxicity side argument, you could argue that less off target effects from the TIL having a knockout versus the antibody being systemically delivered.

On the idea -- on the question of where the TIL efficacy comes from, Steve Rosenberg's Lab has published a lot on this, and it's generally believed that the efficacy of TIL therapies occur in the early period after administration. Although obviously, we see -- from a clinical perspective, we see responses that can originate later after some time. You can have SP convert to PR and that kind of thing, but Rosenberg's imaging studies from back 20-plus years ago now show TIL trafficking rapidly the lungs and then the tumor and then generally show signs of tumor clearance early in the process.

Madan or Friedrich, do you want to add anything to that?

[Dr. Madan Jagasia, Senior Vice President, Medical Affairs]

Yes. This is Madan. Just to comment, I think even in the post-TIL infusion TCR persistence, right, in a non-genetically-edited TIL, the TCR, the clonotypes that are persisting have the potential of getting exhausted with repeated antigenic stimulation. But once you knock out the PD-1, the immune surveillance capability of these genetically-edited TILs may hypothetically be much more superior to the current TILs that we have. Again, as Fred said, it's untested, and we have to get into the clinic to test all these hypotheses.

[Dr. Friedrich Finckenstein, Chief Medical Officer]

As you probably saw, Madhu, we're about to get into the clinical net. So that's something that's imminent. Our clinicaltrials.gov posting went up yesterday.

[Operator]

And our next question comes from the line of Michael Yee with Jefferies.

[Unidentified Analyst]

This is Dennis on for Mike. Two for me. One on the BLA, can you discuss any other gating factors we should be thinking about? Like assay validation or project in CMC? What else needs to happen between now and when you submit in August? And then my second question is on single-line lung cancer. I mean you talked about using the LUN-202 study as a registrational. Do you need to include a docetaxel arm? Or can you get approval on just ORR? Or do you think you need PFS?

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

Sure. Why don't I take the first one and Friedrich, can you take the second one? On the validation on -- activities like validation and anything else we do in the CMC sphere to get ready for the BLA, we're not talking about the details of this publicly, but you can assume that a lot of that's happening has already happened, and we're making great progress as we've already completed most of those tasks.

There is a tremendous amount of work to be done here, but nothing that rises to the level of the potency assay situation that we were in before, where there was less gating item type of thing there that we had to resolve. So the teams at Iovance, employees at Iovance and all our partners are working really hard to get all these things done. Yes, there's tons of validations. There's tons of PPQs and comparability and all the stuff that needs to be run and succeed, but that's stuff that we think we can handle.

Friedrich, do you want to talk a little bit more about LUN-202 and docetaxel as a comparator and registrational against -- study registrational?

[Dr. Friedrich Finckenstein, Chief Medical Officer]

Yes, sure. Good question. So one thing to keep in mind here is that the FDA is happy to review single-arm data. It looks as single-arm clinical trial data in a somewhat different way than randomized studies, and we'll have preferences for where they would prefer which type of data, but they are looking at single-arm data. They are looking at those data in the context of risk-benefit assessed by the totality of the data, which does include available therapy at that time. But they are generally happy to look at that data.

Keep in mind, docetaxel, it is not a great drug. It's not popular with non-cancer doctors. It has low response rates, short durability, a lot of toxicity. So there certainly is an unmet medical need and that does certainly support bringing single-arm data forward with the FDA. Generally, we'll look at that.

One thing to add. Let me just add one more time. The other point to add is, we're not -- because it's not a combination therapy, right? In a combination therapy that then gets a little more complicated because the FDA usually likes to look at data that will identify and pinpoint the contribution of components. Our therapy is the monotherapy that you can compare with historical data from available therapy.

[Operator]

Our next question comes from the line of Peter Lawson with Barclays.

[Peter Lawson, Barclays]

Just kind of curious on just going back to the kind of sequence of events for the BLA submission. When will we get the first feedback from the FDA regarding that when we can see that?

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

Peter, probably the first real feedback comes at the time of acceptance of the BLA, which is 60 days after submission.

[Peter Lawson, Barclays]

Got you. And would there be any commentary around the alignment around the potency assay?

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

I can't say for sure what FDA is going to say at that stage. But typically, at that stage, they're going to tell you that the BLA has been accepted and then later during the review process, they may -- they typically make requests where they could ask for more details about all sorts of things, including assay information. And we think we've addressed all that upfront and our goal is to address all that upfront with the idea that any request to come in or simply need we dealt with.

[Peter Lawson, Barclays]

Got you. And then as that communication kind of unfolds or your keep us in the loop of like how that communication is evolving, whether you need additional questions, et cetera. Is that the plan?

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

I think we'll probably get a lot of questions about during that period, Peter, as you can imagine, but we'll do our best to keep everybody informed. I don't think companies typically go blow-by-blow as everything comes in from the FDA. But I'm sure you'll hear us talk about this as people check in -- let's say, it's November on the earnings call and people are checking in on how things are going, and we'll hopefully be able to give some updates as to how we see the BLA review progressing at that stage.

[Peter Lawson, Barclays]

Got you. And then just the final question just around when the BLA is submitted, will we get kind of more information around the potency assay? And will we see, I guess, IP filings as well around the potency assays?

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

Ultimately, we'll see IP filings. I can't tell you exactly when because it's a little sensitive right now. But as you probably know, that filings eventually become public typically around 18 months or greater after the first priority date. So there's some -- there could be information out there at some level. I don't think that -- I've tried to caution analysts to think that we're going to put details out on some of the stuff that is competitively sensitive, and I think we'll probably continue to talk about the quarter.

[Operator]

Our next question comes from the line of Colleen Kusy with Baird.

[Colleen Kusy, Baird]

Have you received confirmation of the scheduling of the July meeting? Or what is the likelihood that might slip and could further delay your BLA filing?

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

Colleen, we don't -- a pre-BLA meeting is a type B meeting. So they're requested 60 days in advance. We're not putting out details exactly what's going on there, but right now, the July timing is, we just announced it. So we're very comfortable with that timing.

[Colleen Kusy, Baird]

Okay. That's helpful. And what is your latest understanding on whether the BLA submission in late line melanoma would support accelerated or a full approval?

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

We don't know for sure. We think that with the size of the data set we're coming in with, with Cohort 4 and Cohort 2 being sort of, there's a good chance of full approval, and we've spoken about that a few times on calls recently. We do have the option of the Phase III study that we've been talking about also serving as a confirmatory trial should that need to be there. So we're planning for every scenario.

[Colleen Kusy, Baird]

Okay. Great. And one more follow-up, if I can. The comments on the call around potentially using a CMO, if needed upon launch. Would you expect that, that would be driven more by limited capacity at the iCTC early on or more due to any sort of indication you're seeing of high demand at launch?

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

It's probably a demand at launch issue first. We're trying to learn as much as we can from the launches of the two BCMA CAR-Ts right now and just make sure we've got a really, really flexible footing when we go to launch. So the iCTC obviously bears the brunt of the capacity, but having the CMO available to help is going to just allow us to potentially do better than what happened with some of the -- with two BCMA products selling with Abecma.

[Operator]

Your next question comes from the line of Tyler Van Buren with Cowen.

[Tyler Van Buren, Cowen]

The first one on Dr. Puri, great to have you on board, and congratulations on the new role. I'd love to hear why you decided to join Iovance at this stage in your career and the confidence you have in lifileucel receiving approval? And then the second question is related to LN-145 in lung cancer. When should we expect to get the next data update with earlier-stage second-line patients? Could we get an update later in the year?

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

Sure. Why don't you take the second one? Go ahead. Raj, go ahead, why don't you take the first one. I'll come back around if you want to it, too. Go ahead.

[Dr. Raj Puri]

Yes. I just want to say after a significant number of years at the FDA, 19 as Division Director, I was interested in the better career goals. And I see that T cells, TILs a great potential for solid cancer compared to other modalities such as checkpoint inhibitors or CAR-T cell, which only works in the hematological malignancies and checkpoint inhibitors had limited effect on 15% to 20% of the cases.

So vast majority of the patients with solid cancer has no other option, and TIL cells with the broad reactive T cell CD4, CD8 cells have a great potency to -- in the solid cancer. So I think that was one of the main goal to join the Company, and Iovance is an important of this therapy. So that's the reason I joined the Iovance.

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

And then with respect to LUN-202 and data possibly later this year, we haven't said specifically. Obviously, we're trying to optimize enrollment in that trial and get more data there to bolster what we think of a clean efficacy signal until therapy announcement for lung. And if we get some data that we think is worth putting out, I think we would try to put that out as soon as we can. We try to do that specifically with lung last year. So all I can say, there is just hang tight and let us continue to enroll and generate data.

[Operator]

Our next question comes from the line of Mark Breidenbach with Oppenheimer.

[Mark Breidenbach, Oppenheimer]

Just a quick one for me with respect to the new trial of IOV-4001. Can you just remind us why the protocol is focused on melanoma and non-small cell lung cancer only and is not inclusive of some of the other tumor types? You've investigated TIL therapy. And also, will this trial kind of be competing at all with the LUN-202 trial in terms of trying to enroll the same types of lung cancer patients? Or are they more or less distinct populations?

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

Friedrich, do you want to take this one?

[Dr. Friedrich Finckenstein, Chief Medical Officer]

Yes, sure. Good question. Thanks. So there's really two strategies here in the same trial. Number one, the cohort on melanoma patients is an opportunity to enroll and generate clinical data fast because we know there is demand for access to TIL therapy. This is an attractive new approach really promising based on the preclinical data and the rationale that Fred and Madan spoke about earlier. So we'll be able to generate data in a population that they know very well based on our own data and the academic data, which then allows us to compare and draw some conclusions as soon as possible.

So that's really the strategy for melanoma here. Non-small cell lung cancer is a really important indication in tumor type for us. We have generated data in Cohort 3b that indicates activity in TIL therapy and non-small cell lung cancer. We hope that with the technological approach of PD-1 knockout, we are improving on both response rates and duration. And in addition, if you look at the population, we are going to a broader patient population than the population we're targeting in LUN-202, both in regards to allow the numbers of prior therapy as well as drive mutations in the patient's tumor.

So there is really an opportunity to and take another shot at those later line patients and start and exploring activity and driver mutation positive patients. Around -- so that also speaks to your question about overlap with the existing study for melanoma, we do think that because we are going to enroll rather quickly, but there's little risk of overlap with other efforts in melanoma that are taking.

[Operator]

And our next question comes from the line of Mara Goldstein with Mizuho Securities.

[Unidentified Analyst]

This is Jerry on for Mara Goldstein. So first is also on IOV-4001. How do you anticipate prioritizing the two melanoma and a CLC cohorts?

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

How do we anticipate prioritizing? They're both going to be open at the same time, and they're different patient populations and different investigators. So we -- I kind of view them as equal priority, but Friedrich just mentioned a little bit earlier that we do expect melanoma to enroll rapidly because of the demand in that area right now. So I can't tell you for sure exactly how enrollment will go in one versus the other, but it shouldn't roll faster, I would think. That doesn't mean we're prioritizing it.

[Dr. Friedrich Finckenstein, Chief Medical Officer]

These two cohorts are open simultaneously. They're expecting different enrollment rates, but there's really no overlap or competition. We're certainly not held back by having limited manufacturing slots or anything like that. So we don't -- we don't have to derive which patient is next because of any sort of concerns around having to for these patients. So there is no need to prioritize based on that.

[Unidentified Analyst]

Got you. Next one is on LN-145. With the slight trial protocol change, do you expect the similar strategy to be able for other tumor types as well?

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

Are you talking about LUN-202?

[Unidentified Analyst]

Yes.

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

Yes. Yes, there is going to be potential for that, yes.

[Operator]

Our next question comes from the line of Ben Burnett with Stifel.

[Ben Burnett, Stifel]

Just a couple of commercial questions. I guess, first, is there any color you can provide just at this point in terms of securing IL-2? Just commercially, will this be procured kind of on an as-needed basis real-time or otherwise? And I guess how confident are you that your IL-2 supplier can handle the initial commercial demand?

[Jim Ziegler, Senior Vice President, Commercial]

This is Jim Ziegler. We've met with the folks from Clinigen that supply IL-2 in the past. As you know, they're going through a transition right now. We'll be working with them as we approach our BLA and coordinating forecast needs with them to ensure that we have supply -- adequate supply across the board. We have looked at all of the potential ATCs that we're working with and all of them basically have the ability to order IL-2 with their current wholesalers.

[Ben Burnett, Stifel]

Okay. So they would order IL-2 on their own. You wouldn't be ordering IL-2 and then supplying it yourselves?

[Jim Ziegler, Senior Vice President, Commercial]

Correct.

[Ben Burnett, Stifel]

Okay. Okay. And then if I could, just another question really, I guess, just on the sort of the patient journey that you're expecting, if lifileucel is approved. I guess like specifically, do you -- are you expecting cardiac and pulmonary functions that need to be verified? And if so, does that happen -- does it happen after the biopsy is taken?

[Dr. Madan Jagasia, Senior Vice President, Medical Affairs]

This is Madan Jagasia. It's a very valid question. So the conduct of the clinical trial, patients have to obviously meet eligibility criteria prior to the tumor harvest. I suspect that will be the same pattern of practice once we are in the commercial landscape. HCPs will need to ensure the patients have adequate cardiopulmonary reserve before they go in for a tumor harvest, which then subsequently leads to the TIL cell therapy. So that's a pretty standard practice in the world of stem cell therapy, in the world of CAR-T cell therapy as well today.

[Ben Burnett, Stifel]

Got it. Okay. And would they -- I guess, would they go through those tests again after the manufacturing process when it's ready -- when TIL fusion is ready?

[Dr. Madan Jagasia, Senior Vice President, Medical Affairs]

Not necessarily. Obviously, they have had any further cytotoxic therapy, which may influence their cardiac or pulmonary reserve, which is highly unlikely given the agents that are in use for metastatic melanoma. So typically, it is done once. And unless the clinical situation changes, it's typically not repeated.

[Operator]

Your next question comes from the line of Asthika Goonewardene with Truist.

[Unidentified Analyst]

This is Ghanashyam for Asthika today. Just one question on lung and then one on cervical. So on the 202 study protocol amendment, if you gather resections for a patient they haven't yet progressed, how do you determine when to manufacture TIL product? And will you guys have TIL manufactured and stored somewhere until needed?

[Dr. Madan Jagasia, Senior Vice President, Medical Affairs]

Yes. This is Madan. Good question. So I think what you're referring to is what we alluded to as a pre-progression resection. So yes, the patients will have -- their tumor resected and the TILs manufactured. We expect most of these patients to eventually progress because the chance that a patient is going to "respond for perpetuity" and non-small cell lung cancer is very small. So we do expect most of these patients to progress on their frontline therapy and does the probability of using the TILs that have been manufactured approaches at a very, very high number.

[Unidentified Analyst]

And would that be a gating factor from presenting data from the study? And any other gating factors that you can mention in terms of just presenting the data would be very helpful as well.

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

No. That should not be a gating factor for data from the study. We view that as actually something that we think will lead to improved enrollment and more flexibility, and it could be something that we explore, like I said earlier, and other indications, too.

[Unidentified Analyst]

Okay. Great. And then on cervical cancer, when can we expect an update just on the regulatory discussions that you've been having with the FDA? It seems like based on the cadences, these earnings releases that you've been talking to them for somewhere between like two to five months. And yes, when can we get an update on that?

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

Bear in mind that the announcement with pembrolizumab approval came at the very end of last year. So Yes, it's been a few months, but it does take some time to get in front of the regulator and then also build a strategy. So we haven't guided to a specific date here because we don't have one yet, but we are working hard on cervical, and hopefully, we'll be back with more information soon.

[Unidentified Analyst]

The final one, would you expect a similar sort of timeline with longer? Is there anything different there versus your conversations on cervical?

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

There are separate conversations. And so I can't say the timelines would be the same, but it's similar in the sense that we're having those discussions separately with the FDA and setting the strategy for those things. But other than that, I can't really link them.

[Operator]

Your next question comes from the line of Reni Benjamin with JMP Securities.

[Reni Benjamin, JMP Securities]

I think I heard this right. I'm not sure in the prepared remarks, I believe you said that there would be data at ASCO and SITC. If I did hear that right, can you give us an idea as to what are the most likely trials that might be updated at those conferences?

[Dr. Madan Jagasia, Senior Vice President, Medical Affairs]

This is Madan. So I think what we mentioned in the prepared statement is our data that we had presented in 2021 at ASCO, SITC and AACR on the 136 patients across four tumor indications.

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

And we do have a site for ASCO coming this year, which you can see, but we can't really say much more about that right now.

[Reni Benjamin, JMP Securities]

Okay. And then with the potency assays, I'm just kind of curious, are those assays already integrated into the new iCTC facility? Or is that something that's done sort of outside the facility?

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

That's something that we do at our facility, and we can do it elsewhere as well, but that's something that the facility -- Reni, I can't remember if you joined us for any of our open houses, but if you have come and seen it, you'll see it's fully integrated in terms of QC and that includes the ability to do the potency matrix that we talk about a lot.

[Reni Benjamin, JMP Securities]

Yes. Got it. Okay. That makes sense. And then just a couple of other ones. I don't know if you've mentioned this in the past, but how are you thinking about a potential sales force? And how big could it or small could it possibly be?

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

I think you can think of it on a comparison basis to the existing cell therapy field forces for the other CAR-Ts. The way that we'll be operating is through the potential authorized treatment centers, there's a pretty high concentration of care and then the community referrals will come in through the ATC. So I would say, if you benchmark the current CAR-T field forces, you're right in the ballpark.

[Reni Benjamin, JMP Securities]

Okay. And then I guess one final one for me. It has -- in your discussions with the regulatory agencies, have they brought up anything in particular that could be a review issue? Or do you think that since this is the first time that a TIL going through that it's most definite that you'll have ODAC panel?

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

We don't know that for sure. It's possible because it is the first therapy in this class that we could get in a committee -- advisory committee. But TIL therapy is also very well known, and it's well known from NIH and NTI experience as well as plenty of other academic centers experience, and we've got tons of data at Iovance, too. So that doesn't mean we have to get advisory committee, we may not get one. So your -- to the bigger part of your question, basically, are there any other things? No. Right now, we feel pretty comfortable with our timings and all the things we're doing. We have to -- obviously, it's -- for biotech, it's a big thing that follows first BLA, so we have to execute on that. But other than that, we think we're in good shape.

[Operator]

And I'm showing no further questions. So with that, I'll turn the call back over to Interim President and CEO, Fred Vogt for any closing remarks.

[Dr. Fred Vogt, Interim President and Chief Executive Officer]

Thank you again for joining the Iovance Biotherapeutics First Quarter 2022 Financial Results Conference Call. It's an exciting time to be part of Iovance as we move towards our first BLA submission, continue our ongoing clinical trials and expand our growing TIL pipeline into new clinical trials, including the clinical trial of IOV-4001 that just posted to clinicaltrials.gov yesterday.

I would like to recognize the patients and physicians who are participating in our clinical studies as well as our employees and cross-functional teams for their hard work in moving TIL therapy forward. I would also like to thank our shareholders and covering analysts for their support. Please feel free to reach out to our Investor Relations team if you wish to follow up.

[Operator]

Ladies and gentlemen, this concludes today's conference call. Thank you for participating, and you may now disconnect.