Earnings Call Transcript
IOVANCE BIOTHERAPEUTICS, INC. (IOVA)
Earnings Call Transcript - IOVA Q1 2022
Operator, 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. 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 CEO
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, for 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, 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%. Eight out of twelve patients had a confirmed objective response, including three complete responses and five partial responses. Overall, a complete response rate for this combination is 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, increase scientific awareness, drive patient recruitment, and increase 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
And our first question comes from Madhu Kumar with Goldman Sachs.
Madhu Kumar, Analyst
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 CEO
Madhu, it's going to be part of that process. We can't really give any more guidance on 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.
Madhu Kumar, Analyst
Okay. Regarding non-small cell and cervical cancer, you mentioned plans for regulatory discussions about creating registrational cohorts. In both areas, what do you see as the appropriate population with unmet needs where either TIL monotherapy or TIL combined with PD-1 blockade could be considered a viable treatment option for a registrational cohort?
Dr. Fred Vogt, Interim President and CEO
Well, both of those occasions 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 are 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, Analyst
One last question I have is more scientific or philosophical. How do you view PD-1 knockout TILs compared to TILs combined with PD-1 in terms of therapeutic options? In which situations would it make more sense to use the PD-1 monoclonal antibody combination, and when would a PD-1 knockout TIL population be more appropriate? This also raises the question of how much of TIL efficacy is due to the initial TIL product versus epitope spread.
Dr. Fred Vogt, Interim President and CEO
Let me address the first part of your question, and we can discuss efficacy further as we proceed. Madan and Friedrich can also contribute if necessary. As of now, it remains untested, but we are optimistic that reducing the gene within the T cell could improve the effectiveness of TIL and enhance the mechanism of action for PD-1 and PD-L1 blockade. There are several reasons for this, along with benefits to gene reduction rather than administering an antibody. For instance, TILs might penetrate more effectively into the tumor stroma layers compared to an antibody. Additionally, from a toxicity perspective, one might argue that using TILs with a knockout could lead to fewer off-target effects than if the antibody were delivered systemically. Regarding the source of TIL efficacy, Steve Rosenberg's lab has published extensively on the topic, and it is generally understood that the effectiveness of TIL therapies is strongest shortly after administration, even though responses can sometimes emerge later. Historical imaging studies by Rosenberg indicate that TILs quickly migrate to the lungs and then to the tumor, typically demonstrating signs of tumor clearance early in the process. Do you want to add anything, Madan or Friedrich?
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.
Operator, Operator
And our next question comes from the line of Michael Yee with Jefferies.
Unidentified Analyst, 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 CEO
Sure. I'll answer the first question, and Friedrich can address the second one. Regarding the validation and activities in the CMC area for the BLA, we're not disclosing specific details publicly, but you can assume that a lot of progress has already been made, and we've completed most of the necessary tasks. While there is still a significant amount of work ahead, it's not as critical as the potency assay issue we faced previously, which was a more pressing concern. Our teams at Iovance, along with our partners, are working diligently to accomplish these tasks. There are indeed numerous validations, PPQs, and comparability tests that need to be completed successfully, but we believe we can manage all of that. Friedrich, would you like to elaborate on the LUN-202 study and the use of docetaxel as a comparator in the registrational study?
Dr. Friedrich Finckenstein, Chief Medical Officer
Yes, that’s a good question. It's important to note that the FDA is willing to review single-arm data. They evaluate this type of clinical trial data differently from randomized studies, and while they have preferences for the type of data they prefer, they do consider single-arm data. This is assessed in terms of risk-benefit based on all available data, including existing therapies at that time. Overall, they are generally receptive to such data. It’s worth mentioning that docetaxel isn’t an ideal drug; it’s not favored by non-cancer specialists due to its low response rates, short durability, and significant toxicity. This creates a clear unmet medical need, which supports the submission of single-arm data to the FDA. Additionally, because our therapy is a monotherapy rather than a combination therapy, it simplifies the process, as the FDA typically seeks to clarify the contributions of various components in combination therapies. Our treatment can be directly compared to historical data from existing therapies.
Operator, Operator
Our next question comes from the line of Peter Lawson with Barclays.
Peter Lawson, Analyst
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 CEO
Peter, probably the first real feedback comes at the time of acceptance of the BLA, which is 60 days after submission.
Peter Lawson, Analyst
Got you. And would there be any commentary around the alignment around the potency assay?
Dr. Fred Vogt, Interim President and CEO
I can't predict what the FDA will say at that point. However, typically at that time, they will confirm that the BLA has been accepted, and during the review process, they usually request more information on various items, including assay data. We believe we have addressed all these concerns in advance, and our aim is to handle everything upfront so that any requests that arise can be managed effectively.
Peter Lawson, Analyst
Got you. And then as that communication kind of unfolds, are you going to keep us in the loop of like how that communication is evolving, whether you need additional questions, etc.? Is that the plan?
Dr. Fred Vogt, Interim President and CEO
I anticipate there will be many questions about that period, Peter, and we will do our best to keep everyone updated. Typically, companies do not provide detailed updates on every aspect as they receive information from the FDA. However, we expect to discuss this further during the earnings call in November, when people will likely check in on the progress, and we hope to provide updates on the BLA review status at that time.
Peter Lawson, Analyst
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 CEO
Ultimately, we will see IP filings. I can't specify when, as it's somewhat sensitive at the moment. However, filings usually become public approximately 18 months or more after the first priority date, so there might be some information available. I have advised analysts to be cautious in expecting us to release details on certain competitively sensitive matters, and we will likely continue to focus on discussing the quarter.
Operator, Operator
Our next question comes from the line of Colleen Kusy with Baird.
Colleen Kusy, Analyst
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 CEO
Colleen, a pre-BLA meeting is a type B meeting that requires a request 60 days in advance. We are not providing specific details about what's happening, but we have announced the July timing and are very comfortable with it.
Colleen Kusy, Analyst
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 CEO
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, Analyst
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 CEO
It's likely that the initial issue revolves around demand at launch. We're working to gather insights from the launches of the two BCMA CAR-T therapies and ensure that we are well-prepared for our own launch. While the iCTC will handle the majority of the capacity, having the CMO available will enable us to potentially improve our performance compared to the sales of the two BCMA products alongside Abecma.
Operator, Operator
Your next question comes from the line of Tyler Van Buren with Cowen.
Tyler Van Buren, Analyst
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 CEO
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, Executive Vice President, Regulatory Strategy and Translational Medicine
I spent 19 years as Division Director at the FDA, and I was looking for new career opportunities. I believe that T cells and tumor-infiltrating lymphocytes hold significant promise for treating solid cancers, especially when compared to other treatments like checkpoint inhibitors or CAR-T cells, which mainly target blood cancers and have limited efficacy in 15% to 20% of cases. This leaves most patients with solid tumors without effective treatment options. TIL cells, which include broadly reactive CD4 and CD8 T cells, have great potential in solid cancers. This was a primary reason for my decision to join the company, as Iovance plays a crucial role in this therapy.
Dr. Fred Vogt, Interim President and CEO
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. 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, Operator
Our next question comes from the line of Mark Breidenbach with Oppenheimer.
Mark Breidenbach, Analyst
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 CEO
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 that's 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 and 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. Additionally, 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 take another shot at those later line patients and start exploring activity in driver mutation positive patients. As for the overlap with the existing study for melanoma, we do think that because we are going to enroll rather quickly, there is little risk of overlap with other efforts in melanoma that are taking.
Operator, Operator
And our next question comes from the line of Mara Goldstein with Mizuho Securities.
Unidentified Analyst, Analyst
This is Jerry on for Mara Goldstein. So first is also on IOV-4001. How do you anticipate prioritizing the two melanoma and CLC cohorts?
Dr. Fred Vogt, Interim President and CEO
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. 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 are 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 have to derive which patient is next because of any sort of concerns around having to prioritize these patients.
Unidentified Analyst, Analyst
Got you. Next one is on LN-145. With the slight trial protocol change, do you expect the similar strategy to be able to apply for other tumor types as well?
Dr. Fred Vogt, Interim President and CEO
Are you talking about LUN-202?
Unidentified Analyst, Analyst
Yes.
Dr. Fred Vogt, Interim President and CEO
Yes. Yes, there is potential for that, yes.
Operator, Operator
Our next question comes from the line of Ben Burnett with Stifel.
Ben Burnett, Analyst
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, who 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 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, Analyst
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, Analyst
Okay. And then if I could, just another question regarding the patient journey you anticipate if lifileucel is approved. Specifically, are you expecting that cardiac and pulmonary functions will need to be verified? If so, will that occur 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, Analyst
Got it. Okay. Would they go through those tests again after the manufacturing process 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, Operator
Your next question comes from the line of Asthika Goonewardene with Truist.
Unidentified Analyst, 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 who hasn'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' in non-small cell lung cancer is very small. So we do expect most of these patients to progress on their frontline therapy, and thus the probability of using the TILs that have been manufactured approaches a very, very high number.
Unidentified Analyst, 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 CEO
No. That should not be a gating factor for data from the study. We view that as actually something that will lead to improved enrollment and more flexibility, and it could be something that we explore, like I said earlier, in other indications, too.
Unidentified Analyst, 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 CEO
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 to 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, Analyst
The final one, would you expect a similar sort of timeline with lung? Is there anything different there versus your conversations on cervical?
Dr. Fred Vogt, Interim President and CEO
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, Operator
Your next question comes from the line of Reni Benjamin with JMP Securities.
Reni Benjamin, Analyst
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 CEO
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, Analyst
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 CEO
That's something we perform at our facility, and we can also do it elsewhere. If you have attended any of our open houses, you would see that it is fully integrated in terms of quality control, which includes the capability to conduct the potency matrix that we often discuss.
Reni Benjamin, Analyst
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 CEO
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, and 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, Analyst
Okay. And then I guess one final one for me. 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 CEO
We don't know that for sure. It's possible since this is the first therapy in this class that we could be reviewed by an advisory committee. However, TIL therapy is well recognized based on experiences from NIH, NTI, and many academic centers, and we also have a lot of data from Iovance. This does not guarantee we will have an advisory committee; we might not. Regarding your broader question, at this moment we are quite comfortable with our timelines and everything we are working on. For biotech, following the first BLA is crucial, so we need to execute on that. Other than that, we feel we are in good shape.
Operator, 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 CEO
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, Operator
Ladies and gentlemen, this concludes today's conference call. Thank you for participating, and you may now disconnect.