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Iovance Biotherapeutics Inc
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Welcome to the Iovance Biotherapeutics’ Second Quarter 2023 Financial Results and Corporate Update Conference Call. My name is Shannon 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, Senior Vice President, Investor Relations and Corporate Communications at Iovance. Sara you may begin.
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 Executive Vice President, Commercial; Dr. Friedrich Finckenstein, our Chief Medical Officer; and Jean-Marc Bellemin, our Chief Financial Officer. Dr. Brian Gastman, Executive Vice President, Medical Affairs; and Raj Puri, our Executive Vice President, Regulatory Strategy and Translational Medicine are avail available for the Q&A Session.
This afternoon, we issued a press release that can be found on our corporate website at iovance.com, which includes the financial results for the three and six months ended on June 30, 2023 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 and transactions, 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 undertake no obligation to publicly update any forward-looking statements. With that introduction, I will turn the call over to Fred.
Thank you, Sara. Good afternoon everyone. I am pleased to highlight several important milestones [indiscernible] answering the second quarter of 2023 and more recently. Our Biologics License Application, or BLA, for our cell therapy lifileucel in advanced melanoma, was accepted by the U.S. Food and Drug Administration or FDA for six-month priority review and granted a PDUFA date of November 25, 2023. In the acceptance letter, the FDA also informed us that they do not intend to host an advisory committee meeting and that no major review issues were identified. Lifileucel if approved will be the first cell therapy for the treatment of melanoma in addition to the first individualized one-time T-cell therapy for solid tumor cancer.
During the priority review process, we have continued to collaborate with the FDA as they have reviewed this nucleus of treatment for advanced melanoma patients with limited options. We remain confident in our prospects for approval given the unmet medical need, our strong clinical data and our positive interactions with and feedback from the FDA. As we approach our PDUFA date we are building capacity and staffing our Iovance Cell Therapy Center, or iCTC to supply our projected demand for lifileucel launch. In addition, our field teams are proceeding as plan with on-boarding and site readiness activities for our authorized treatment centers or ATCs to treat the first lifileucel patient as soon as possible upon approval.
I would also like to highlight that we are now a commercial stage company after closing our transaction to acquire Proleukin, an IL-2 product used as part of the cell therapy regimen in May. We are integrating Proleukin into our organization as we prepare to launch lifileucel so that we can offer two important parts of the TIL regimen. As noted in today’s press release, we recognize some revenue for the first time from Proleukin sales and expect to realize more significant revenue with the launch of lifileucel. Owning Proleukin also provides us with full control of the IL-2 supply chain and logistics surrounding TIL therapy, and we expect lower clinical trial expenses and future costs of goods for lifileucel.
Beyond our regulatory and commercial readiness activities for lifileucel, our robust TIL therapy pipeline includes seven active clinical trials with the potential to strengthen and broaden our mission to be the global leader in innovating, developing, and delivering TIL therapies for people with cancer across multiple solid tumors.
In frontline melanoma, our confirmatory trial, TILVANCE-301, has begun randomizing patients and remains poised to be well underway upon a potential approval of lifileucel later this year. We have also made significant progress across our trials in non-small cell lung cancer, NSCLC. We recently announced positive clinical and regulatory updates related to IOV-LUN-202, our registrational single-arm Phase 2 in post-anti-PD-1 lung cancer.
At the upcoming World Congress on Lung Cancer or WCLC in Singapore, we look forward to presenting detailed data from Cohort 3A of our IOV-COM-202 trial in anti-PD-1 naïve lung cancer. The Cohort 3A data supports our strategy in upcoming trial in frontline lung cancer. This trial in frontline lung cancer can also potentially serve as a confirmatory trial to support an accelerated approval based on the IOV-LUN-202 trial.
As we prepare to launch lifileucel Iovance now has almost 600 employees with experience in developing commercializing oncology and cell and gene therapy products. I look forward to addressing your questions later during this call and will now ask Igor to present our manufacturing updates.
Thank you, Fred. It has been a productive first half of the year at iCTC, we are preparing for the commercial launch of lifileucel and building the manufacturing organization to supply lifileucel to patients upon approval while providing supply for our clinical trials and supporting extended access. We are committed to operational excellence and have provided TIL therapy for more than 600 patients to date with a consistent manufacturing success rate of more than 90%. Our capacity and hiring plan remain on track to support our forecasted demand at launch. The iCTC is expected to supply most of the commercial TIL therapies upon approval with our contract manufacturers providing further flexibility to optimally balance capacity and patient demand. We'll look to establish TIL as the next paradigm shifting class of cancer therapy and the iCTC is currently built to supply TIL products for more than 2000 patients annually.
Additional existing shelf space at iCTC can also be built out to ultimately supply TIL products for more than 5,000 patients annually from this facility. Longer term, our vision is to build capacity for more than 10,000 patients annually by adding new facilities as well as streamlining and automating manufacturing processes.
Intellectual property or IP is also a critical component to Iovance that supports and protects our proprietary manufacturing processes and know-how. We currently own at least 60 granted or allowed U.S. and international patents including Gen 2 patent rights that we expect to provide exclusivity into 2038. Extensive detail on Iovance [indiscernible], it is available on our corporate website and within our annual report on Form 10-K.
I would now like to hand the call over to Jim Ziegler to highlight our commercial launch preparations. Jim?
Thank you, Igor. At Iovance, we are pioneering TIL therapy with the potential to transform the practice of medicine in advanced melanoma and additional solid tumors. Our experienced commercial and cross-functional teams with deep cell therapy experience are building the foundation for a strong lifileucel launch, while integrating Proleukin to offer as a supportive part of the TIL regimen.
Commercial launch readiness is on track as we approach our 25 November PDUFA date. Today I will highlight onboarding for our authorized treatment centers or ATCs, private and public payer engagement and commercial operational readiness activities. First, we are well positioned to achieve our goal to onboard 40 ATCs within the first 90 days. We are actively working with ATCs to operationalize their TIL service line capabilities and to ensure multidisciplinary teams at each center are ready to administer the lifileucel treatment regimen upon FDA approval.
A significant number of ATCs are currently participating in the onboarding process and we believe they are excited about offering TIL therapy. This high level of enthusiasm after our ATCs is reflected by significant investments of time and resources to develop their TIL service line and to prepare for anticipated demand and capacity needs among advanced melanoma patients. Fed capacity, for example, is assessed during our onboarding process. Our targeted ATCs report sufficient inpatient hospital beds to accommodate and support lifileucel and other cell therapies.
We are also piloting our Iovance care's enrollment scheduling and chain of identity and chain of custody capabilities in training curriculum. We are encouraged as ATCs have provided positive feedback on our customer centric Iovance cares design and build.
Turning to market access, our reimbursement strategies are on track to ensure timely and appropriate access for patients upon approval. Our market access team continues to engage the key national and regional payers who are responsible for approximately 90% of covered lives. Based on our payer interactions we expect coverage consistent with label and similar to recent CAR Ts. For Medicare patients hospitals already have reimbursement established under DRG 018, which provides more appropriate payment immediately upon launch. As we prepare for launch, I want to acknowledge our cross-functional teams who are committed to ensure patients can be treated at ATCs and have access to reimbursement for lifileucel upon approval.
I will now pass the call to Friedrich Finckenstein, our Chief Medical Officer to highlight our clinical progress.
Thank you, Jim. Today I would like to summarize recent updates with our TIL therapy pipeline and next generation technologies. I'll begin with TILVANCE-301, our registrational trial for accelerated and full approvals of lifileucel in combination with pembrolizumab in frontline advanced melanoma. TILVANCE-301 is also designed as confirmatory trial to support full approval of lifileucel post-anti-PD-1 advanced melanoma. The first patient was randomized in the second quarter and TILVANCE-301 remains on track to be well underway at the time of the potential approval of lifileucel later this year. We also continue to activate global sites and key geographies with a large presence of melanoma patients and the potential for strong enrollment.
In non-small cell lung cancer we have six cohorts across three Iovance studies to investigate multiple treatment regimens in various populations and stages of disease. This afternoon I will highlight our IOV-LUN-202 registrational trial in post-anti-PD-1 non-small cell lung cancer patients, as well as the anti-PD-1 naïve non-small cell lung cancer patient Cohort 3A in our IOV-COM-202 basket trial.
Last month, we reported regulatory and clinical updates for our registration of Phase 2 LUN-202 trial in post anti-PD-1 non-small cell lung cancer. At a Type B Pre-Phase 3 meeting, the FDA provided positive regulatory feedback that the design of the single arm Phase 2 IOV-LUN-202 trial may be acceptable for approval of LN-145 TIL therapy and post anti-PD-1 non-small cell lung cancer. Cohorts 1 and 2 include our registrational population of EGFR, ROS and/or ALK mutations negative patients who have progressed on or after chemotherapy and anti-PD-1 therapy. For patients with actionable genomic mutations other than EGFR, ROS or ALK we will require at least one line of an FDA approved targeted therapy is indicated. Based on the regulatory discussions, we completed a preliminary analysis of the Registrational Courts 1 and 2in the IOV-LUN-202 trial. We are very pleased with the initial ORR and durability from this analysis. Confirmed ORR by RECIST version 1.1 was 26.1%. All six responses were ongoing at the time of the data analysis, including one complete response and five partial responses. The median duration of response or DOR was not reached and the ongoing responses ranged from 1.4 plus to 9.7 plus months.
Looking ahead, we are amending the protocol to enroll a total of approximately 120 patients within Cohorts 1 and 2. Enrollment is already underway at more than 40 active clinical sites in the U.S., Canada and Europe, and we expect to fully enroll our registrational cohorts in the second half of 2024. Based on the FDA feedback, we plan to pursue accelerated approval based on the LUN-202 trial, a planned trial in frontline advanced non-small cell lung cancer, which we will discuss with FDA later this year is designed to serve as the confirmatory trial. Our strategy in frontline advanced non-small cell lung cancers proceeding in parallel; we plan to report detailed data from Cohort 3A of the IOV-COM-202 trial at the upcoming World Conference on Lung Cancer. Cohort 3Q is investigating our TIL therapy LN-145 in combination with pembrolizumab in patients with advanced non-small cell lung cancer who are naive to ICI treatment.
We reported positive top line results from Cohort 3A in a corporate update earlier this year. In the press release, confirmed ORR by RECIST 1.1 was 47%, eight responders out of 17 patients, including two ongoing complete responses or CRs. Responses were observed regardless of PD-L1 status and safety was consistent with other studies of Iovance's TIL therapies in combination with pembrolizumab. We have been very pleased by the response rate and durability observed so far. In the distinct clinical subsets in Cohort 3, ORR was 80% in five patients who were treatment naive and 43% in seven patients who had progressed after chemotherapy. ORR was 58.7% when combining the 12 patients in the treatment naive of post chemo EGFR wild-type populations, these results inform the design and target population of our planned frontline Phase 3 study.
In addition, we were encouraged to observe one complete response among the five patients with EGFR mutation for the tumors and progression after prior treatment with TKI, who typically do not respond to pembrolizumab alone. At WCLC, we plan to report durability and additional Cohort 3A data in approximately the same number of patients. The initial results will be published in an abstract in August 16th. Then an updated data analysis with additional duration of follow-up will be included in the oral presentation on September 11th. We are also preparing to meet with FDA this year to discuss the Cohort 3A data and our proposed registration trial for lifileucel and frontline advanced non-small cell lung cancer patients, which is designed to support full approval in frontline non-small cell lung cancer and to service confirmatory trials supporting full approval in post anti-PD-1 non-small cell lung cancer.
Our goal is to improve frontline non-small cell lung cancer therapy by adding TIL therapy to standard of care pembrolizumab maintenance therapy administered after completion of the initial chemoimmunotherapy. Our confidence in this approach is supported by the encouraging responses and response durations with the TIL pembrolizumab combination in Cohort 3A compared to standard of care benchmarks even without chemotherapy. In cervical cancer enrollment momentum continues in our expanded Cohort 2 in the ongoing C-145-04 trial. Based on FDA feedback this cohort is investigating lifileucel following progression on or after chemotherapy and anti-PD-1 therapy to support regulatory submissions.
We are also excited about our next generation approaches to optimize TIL therapy. Several of these programs incorporated genetic modification utilizing the gene-editing TALEN technology, licensed from Cellectis to inactivate immune checkpoint proteins that inhibit anti-tumor response. Our lead candidate IOV-4001, a PD-1 inactivated TIL therapy is studied in our first inhuman IOV-GM1-201 trial in patients with previously treated advanced melanoma or non-small cell lung cancer. Additional candidates using, using the TALEN technology, which include multiple inactivated immune checkpoint targets are expected to enter clinical development in 2024.
I am available during the question-and-answer session. For now, I will hand the call over to Jean-Marc to discuss our first half and second quarter 2023 financial results.
Thank you, Friedrich.
My comments will summarize the high level financial results for the three and six months ended on June 30, 2023. More details can be found in this afternoon's press release as well as in our SEC filings.
Iovance add $317.3 million in cash, cash equivalents, investments and restricted cash as of June 30, 2023 compared to $478.3 million as of December 31, 2022. Our use of cash during the period included the firm consideration to acquire worldwide rights for Proleukin from Clinigen when the transaction closed in May. The front payment was fully financed with existing cash on end of approximately GBP167.7 million or approximately US$200 million, as well as approximately GBP2.4 million or approximately US$3.1 million for certain Proleukin inventories. We have also continued to strengthen our balance sheet and remain appropriately founded as we add towards potential commercialization of lifileucel later this year. In July, we raised estimated net proceeds of approximately $161.4 million from a common stock public offering. We continue to prioritize our investments and effectively manage expenses including inclusive of the proceeds from the offering, our current cash position is sufficient to fund our commercial launch preparations, internal manufacturing, clinical pipeline expansion and operating plan until the end of 2024.
Transitioning to financial results, net loss for the second quarter ended June 30, 2023 was $106 million or $0.47 per share compared to net loss of $99.3 million or $0.63 per share for the second quarter ended June 30, 2022. Net loss for the six months ended June 30, 2023 was $213.3 million or $0.98 per share compared to net loss of $191 million or $1.21 per share for the same period and the June 30, 2022. Following the completion of the Proleukin acquisition in May, we recorded revenue for the first time in the second quarter and anticipate significant revenue for Proleukin to begin after the launch of lifileucel. Revenue for the second quarter and six months ended June 30, 2023 was $0.2 million comprised of product sales of Proleukin. There was no revenue for the second quarter and six months ended June 30, 2022.
Cost of sales for the second quarter and six months ended June 30, 2023 was $2.1 million. Cost of sales related entirely to Proleukin including $1.9 million of non-cash amortization of the acquire intangible assets for developed technology. There was no cost of revenue for the second quarter and six months ended June 30, 2022. Research and development expenses were $85.8 million for the second quarter ended June 30, 2023; an increase of $12.9 million compared to $73.4 million for the same period ended June 30, 2022. Research and development expenses were $169.1 million for the six months ended June 30 2023; an increase of $27.4 million compared to $141.7 million for the same period ended June 30, 2022. The increases in research and development expenses over the prior year periods were primarily attributable to growth of the internal research and development team, facility related and internal research programs costs and the initiation of our Phase 3 TILVANCE-301 trial, which were partially offset by a decrease in stock based compensation expense.
Selling, general and administrative expenses were $21.9 million for the second quarter ended June 30, 2023; a decrease of $4.4 million compared to $26.3 million for the same period ended June 30, 2022. Selling, general and administrative expenses were $50 million for the six months ended June 30, 2023; an increase of only $0.3 million compared to $49.7 million for the same period ended June 30, 2022. The decrease in selling, general and administrative expenses in the second quarter of 2023 compared to prior year periods was primarily attributable to the capitalization of expenses associated with the Proleukin acquisition upon the transaction close.
Decrease in other costs are explained by the timing of related spend compared to the prior year period, including marketing, advertising, licensing and insurance costs partially offset by cost associated with the growth in the overall business. The minor increase in selling, general and administrative expense in the first half of 2023 compared to the prior year period was primarily attributable to growth of the internal general and administrative and commercial teams offset by decreasing legal fees and other costs. As of June 30, 2023 there were approximately 224.7 million common shares outstanding.
I will now end the call back to the operator to kick off the Q&A session.
Thank you. [Operator Instructions] Our first question comes from the line of Peter Lawson with Barclays. Your line is now open.
Great. Thank you for taking my questions. Maybe a quick question just around I guess Jean-Marc, just around the cash runway you said come into the end of 2024 and I thought the prior guidance was early 2025, if that was one, if I got that right and two, if there are any changes internally you were thinking through?
Thank you, Peter. Thanks for the question. Actually we were guiding before first half of 2024 and with recent ways of $160 million, let's say $162 million net proceeds, we are adding two quarters, so that's why we are commenting around into the end of 2024. Of course, this will depend also so on the revenue generated by Proleukin on one-side and lifileucel on the other side, but let's say we have two proctors [ph] more than what we indicated before.
Perfect. Thank you. And then as we think about the upcoming data World Lung, just if you can tell us about the number of patients and in particular, I guess the follow up time that we see in the abstract versus the presentation?
Yes, Peter, that's still embargoed under the rules until next week, but there'll be I think substantial follow up in the abstract and even more follow up at the conference. I think it will be significant compared to what you've seen from us typically.
Good. And is that also the case in the number of patients, not just follow up time?
No, it's primarily follow-up time as you're going to see. We're not going to see a huge increase in number of patients in those – in the abstract or in the presentation.
Perfect. Thanks so much. I'll jump back into the queue.
Thank you. Our next question comes from the line of Michael Yee with Jefferies. Your line is now open.
Hey guys, thank you for the questions. Congrats on all the progress. We had two; one was thinking about the anticipated launch, which I know you guys are excited about, and I went back to my old YESCARTA CAR-T numbers and looking at them $264 million or so. And was just trying to understand, do you generally anticipate because of easier reimbursement and the codes as well as preparation for all the coverage that you talked about. This should be a strong launch and potentially better than some of the things that they had to deal with on the CAR-T side? Maybe just talk to that a little bit as people think about the launch?
And then second question is following up on the lung cancer data; can you just remind us how to put in the context of 47% overall response rate in first line? Do you want to be similar to chemo combo? Do you want to be better? Is it about durability or one-time treatment? Can you just kind of put that into context versus what is already out there for first line and that would help us see the advantages of your therapy? Thank you.
Yes. Mike, we do think that our launch can be considerably stronger than what we may have seen from the CAR-T products. I don't know exactly what product you're referring to, but as a general matter we've gotten every – the stars are more aligned for us than they were at the time of the CAR-T launches because just the more navigable reimbursement landscape. For example, we've got the Medicare MS-DRG code already established for lifileucel. We've learned a lot from their experience in terms of capacity planning, site on-boarding, how to target individual centers and get them up and running, manufacturing capacity and so on. So yes, just a general matter we anticipate a stronger launch. We can, if I missed your point there, I could have Jim follow up with you on that.
On the long data, I'd be looking as your benchmarks in particular for Cohort 3A, we're looking at the first two subgroups, which we call the ICI naive and the chemo refractory subgroups. And the comparators for those are the KEYNOTE-407 and KEYNOTE-189 trial, which showed ORRs in the 48% to 58% range with mDORs in the seven to 11-month range. So you're looking at TIL plus pembro plus chemo being superior to that.
Perfect, thank you.
And you quoted by the way to that Mike; you quoted 47% ORR that's the ORR across all three subgroups. The ORR in the two subgroups that are comparable to that is 58.3 Fredrick mentioned that during his comments earlier.
Got it. Thank you for clarifying that.
Thank you. Our next question comes from the line of Tyler Van Buren with TD Cowen. Your line is now open.
Hi, I have a question on the lifileucel launch. So I'm curious what in reference to what the KOL mentioned on the call that you guys recently hosted. I'm curious to see what you guys exactly are doing to overcome the challenges of under education among the physician community to facilitate more efficient referrals upon launch?
Yes. For that one probably Jim and Brian to speak up there and just give a little bit of summary of what we're doing to work on referral patterns.
Sure. This is Jim. 60% of the patients are in the community, so referrals are going to be very important for us beyond the initial months of launch. Here what we're doing is taking data-driven approaches to understand existing referral patterns as well as build an understanding of where these patients are in the community. We'll use personal promotions, i.e., the sales force to go out and talk to the physicians with a high concentration of advanced melanoma patients, and then we'll use cost-effective non-personal promotions to expand our reach and frequency to educate on lifileucel among community practices.
Okay. Thanks so much.
Thank you. Our next question comes from the line of Colleen Kusy with Baird. Your line is now open.
Hi, good afternoon. Thanks for taking your questions and congrats on all the progress. So as we're within now a number of months of, of expected approval; do you have any sense of pent-up demand at this stage? And is there any segmentation of the patient population in the market that you'll prioritize in the early portion of this launch based on patient characteristics or things like of that nature?
Yes. Let me – let me add a few comments and then Jim can jump in here. We have a pretty good sense of pent-up demand. It's quite significant. We run an expanded access program, which we can – which gives us some feel for how the demand is out there, plus for contact with all the investigators and patient advocacy groups constantly.
Jim, do you want to see if you can take the rest of that question?
Sure. Hi Colleen. We do a very robust segmentation based upon claims data here in the U.S. market. So on the ATC side, we segmented based upon the volume of patients and we've identified our Top 20, 40, 60, et cetera, ATCs as well as patients that are concentrated in the community. Because we have studied the CAR-T market quite extensively, we know that there's a concentration of patients at the top centers. So those are the targets that we're going for first. And as we have those patients enter the treatment paradigm for lifileucel, we'll start to expand out into the community.
That's helpful. Thank you. And then any more details you can share on how many centers are participating in the site on-boarding process? And can you maybe just share any more details on what that process looks like for centers?
Sure. I won't be able to share the exact numbers, but I will reinforce our goal is to launch with targeted 40 centers within three months of approval, and we are on track. What I will say is that there are more centers that are participating in the on-boarding. So I think it is reflective of the unmet need and the excitement, again, amongst the ATCs.
And I'm sorry, Colleen, can you repeat that second question?
Just any more details you can provide on what that process looks like for centers and how long that might take and how onerous that is?
Sure. There's some administrative things that we do like IT checks to make sure that the firewalls are compatible for our systems. But the heaviest work is really our medical affairs team which works with the centers on their capabilities to understand and build workflows, SOPs, make sure that order sets are defined. The whole process, if a center is fully engaged can be relatively short. If it's a center that's got a lot of competing demands, it could take a bit longer. For centers that are entering the process right now, I'm confident that they could, if they are fully committed, be ready for launch.
That's very helpful. Thanks for taking our questions.
Thanks Colleen.
Thank you. Our next question comes from the line of Yanan Zhu with Wells Fargo. Your line is now open.
Hi, thanks for taking our questions. I was wondering if you could give some broad stroke characterization of the ongoing BLA for lifileucel? In general, how is the process going? Are you at or nearing the mid-cycle review stage? Any concerns that might have arise? And also when might you have a date for pre-approval inspections? Thank.
Yes. Hi, Yanan. Yes, we're – it's going well right now. You asked that the mid-cycle we passed period now things continue to go well, still no AdCom, they have been pretty clear with us from the GetGo's that there aren't any major review issues. We won't comment publicly on when pre-licensing inspections will occur, but they typically occur later in the process, that's something obviously company like Iovance and our CMOs have to prepare heavily for. So we're working very hard on that right now. But otherwise, it's going very well. The FT is very engaged. We've got a lot of back and forth. It's very productive and we think that things remain on track for the PDUFA date of November 25, 2023.
That's terrific to hear. Thanks for that update. Then I do have also a couple of questions on the – I have LUN-202 and the pivotal program? And I was just wondering any additional color from your interaction with FDA for that setting? What kind of ORR and DOR is the agency looking for, for a pivotal data set? Or in other words, what might be the bar for approval and success for that trial? And could you also talk about the powering assumption for this 120 patient study and whether there's any opportunity for interim update? Thank you.
Yes. Friedrich, do you want to take that one?
Sure, yes, thanks. Good questions. So I think, one thing that we have to keep in mind is, is whenever we're talking about single arm data like this one FDA always stresses that they will look at the totality of the data in oncology studies, that's oftentimes because that's the relevant endpoint that you can actually appropriately address with a design like this response rate. But they will also heavily look at duration of response and safety. So there is really no single – there's no single number that that FDA will tell you if you – if you – if you beat that, then you have yourself a game. It's really the totality of the data and they're looking at how, what you are presenting when you submit is comparing to available care. Right now, again for response rates that means docetaxel, docetaxel ramucirumab might be – might be something that they're looking at where as you have a range of ORRs, but you have definitely short durability of responses.
And that's something that they're looking at, which is exactly why we are excited about the data in LUN-202 right now, where the durability looks really promising. And safety is obviously an aspect as well. In a study like this with a single-arm design, you would usually not do an interim analysis because it's really the final data that give you the totality of data that is informative. You wouldn't necessarily stop based on in between read with a smaller sample size.
Does that answer your question?
Yes. Yes. It does. It does. I was also lastly wondering, are you in a position to comment whether those patients who were in response – who had a response and were ongoing as of the data cutoff, are still in ongoing response? Thanks.
Yes. I can – I can respond to this. What we shared just a short while ago was very hot off the press. So that the dataset that we – that we disclosed was basically cut just a couple of days prior to what we shared it. So that maybe that gives you a good idea on, on where we stand on that.
Got it. Thanks for all the answers.
Thank you. Our next question comes from the line of Reni Benjamin with JMP Securities. Your line is now open.
Hey, good afternoon guys. Thanks for taking the questions and congrats on the progress. Maybe just starting off, this might be for Jim, you talked about the 40 ATCs? Jim, about how many patients do you – do you figure each, I don't know ATC could handle in a month or in a quarter? I think you mentioned that bed capacity is sufficient. Can you maybe help quantify what sufficient is according to each of these ATCs? And do they – do they vary significantly, for example, the Top 20 versus the Top 40 versus the Top call it 60 or 80 in terms of capacity or are they all right around the same?
Hi, Randy, thanks for the question. It's terrific question. So we’ve looked at both the CAR T market as well as our own data. What we know is that there is a concentration, so the number is going to vary. Your top centers are going to have more patients compared to centers that are beyond 40 to 60, et cetera. And therefore bed capacity is going to vary to some degree. What I am not saying is that all hospitals will always have sufficient capacity, but in general, as we've engaged the ATCs they have reported that they would have sufficient capacity.
In our corporate slide deck, we provided some numbers both from HHS in the health data.gov, which characterizes hospital capacity overall and then our own internal team as we've been engaging with these ATCs for a while now, we engage them on the number of beds, often broken down to the various levels, various floors. So when I say that hospitals have sufficient capacity, it's based upon both of these data points.
Got it. And just sticking with sales and marketing for a second, how big is the sales and marketing team right now? And by the time November 25 comes along, how big will it be?
Sure. I won't give you a specific number, but we're probably in the 30 plus range right now. About half of my team members come with previous cell therapy experience including nurses and advanced nurse practitioners who have actually joined us from the ATCs themselves. I have a number of very experienced nurses who have actually onboarded and helped to treat patients on CAR T. So I have got a lot of experience on the team.
In terms of the onboarding right now, the existing team between commercial and medical affairs is sufficient to drive the onboarding process. So it won't need to hire the actual sales team until we get a little bit closer.
Got it, okay. And you guys provided a little bit of a goalpost for the non-small cell pivotal study in terms of completing enrollment and at the call it second half of 2024. Can you give us any sort of sense as to how the cervical cancer trial is going and whether you have an idea as to when enrollment may complete there?
No, we haven't guided on that study – obviously we had to restart that entire program after the approval of pembrolizumab in frontline setting and other companies had to withdraw their BLAs. So, it is going, we tried to leverage the existing sites and it's running, but it's not the type of study where we can project enrollment right now. We are trying to just enroll as fast as we can and now this new patient population has been created by the approvals.
Got it. And it's just one final one for me. As we think about the next generation pills, genetically modified pills, how should we be thinking about it in terms of how those products exist with the what will hopefully be currently approved TIL products? And how do we think about potential cannibalization or is there a way to position those second generation drugs so that both can kind of coexist in the same commercial space?
Well, if you are asking about the second generation and beyond drugs that we're developing based on the TIL platform at Iovance, we don't necessarily have to cannibalize our indications, we can develop those other genetic related TIL therapies, for example, into different indications. It's not like we have to continuously launch into melanoma. There is plenty of solid tumor indications out there that look to be promising that show some signs of responsiveness to either ICI or pills or combined, but need additional efficacy to get over the hurdle and that would be where we're focused. And not necessarily is the same indications that we would be seeking approval in or getting approval in continuously launch into melanoma.
There's plenty of solid tumor indications out there that look to be promising that show some signs of responsiveness to either I c I or pills or combined, but need additional efficacy to, to get over the hurdle. And that would be where we're focused, and that necessarily, not necessarily is the same indications that we would be seeking approval in or getting approval in, in the near future.
Terrific. Thanks for taking the questions.
Thank you. Our next question comes from the line of Ben Burnett with Stifel. Your line is now open.
Hi, good afternoon. This is Carolina Ibanez Ventoso on for Ben Burnett. Thank you for taking our question. In a scenario where lifileucel gets approved and you treat initial bolus of melanoma patients who have already progressed on an anti-PD-1, and then separately, lifileucel is also available in combination with pembro – through the TILVANCE trial. How do you think physicians will treat newcomers? Will they treat new coming patients with a sequence of pembro and then if the patient progresses with lifileucel, or do you think there will be situations where doctors may want to try to hit the tumor heart from the onset with lifileucel and pembro combination?
So, it's a good question. We will have this Phase 3 study up and running, and it's a clinical trial. So I would – we anticipate the majority of doctors will be wanting to treat their post-PD-1 patients on lifileucel commercially approved, which is going to be much more available than what one can get from a clinical trial setting.
However, sites that have access to the trial or a more – have a deeper understanding of how ICIs and TILs combined might be interested in using the TILVANCE study probably more preferably. And that's why we'll have it open in the United States as well as outside the U.S. to drive that involvement.
Okay, understood. And then a quick clarification question for Jean-Marc. On the cash guidance, the extension to second half of 2024, does it include any potential revenues from Proleukin and lifileucel?
Yes. We are taking into account only Proleukin revenue at this stage because of course we cannot – although we are very positive about the approval, we don't want to take a lifileucel revenue into account. So it's only Proleukin that I take into account in my projection.
Okay. Makes sense. Thank you so much.
Thank you. Our next question comes from the line of Asthika Goonewardene with Truist. Your line is now open.
Hi guys, thanks for taking my questions and I'll echo my positive sentiment for the progress being made here. First off, I'd like to want to direct a question at Fred. Fred, when we spoke last at our symposia cell conference a couple of months ago when we discussed centers building capacity, you mentioned that some centers were building capacity at about to treat about 25 or more patients a month. So I want to just maybe check back in with you on this. Can you quantify what proportion of these 40 centers that are – that you are targeting the first three months after approval are gearing up the capacity to treat this number of about 25 patients a month? Is it a majority, a significant proportion, or a minority? And then I've got a couple more questions.
Yes. So that Jim partially answered that question a little bit earlier. There's a slide in our deck, I believe it's Slide 38. It has in it some data that we collected. And that's where the 25 number is coming from that I would've mentioned at the conference when you were there speaking. It is basically the number, it's the average number of beds for target ATC per month suitable for lifileucel patients. That's what these number is. So, obviously that's an average and you're going to have a minimum and maximum there. And there's a whole series of statistics there, but that's the average. We have the data, we're trying to keep some of it confidential because some of it's confidential to sites, but the average is about 25 beds per target ATC per month for suitable for lifileucel patient.
Like Jim said earlier, there could be some that are lower, there could be some that are higher, the big centers are going to have more. It all comes down to the amount of investment the hospital's making in its BMT, CAR-T and total service lines.
Got it. And then when you've stress tested your production facility and gone full production, about how many bags of cells can you manufacture full capacity?
We haven't disclosed how much we can manufacture in what you're calling stress tests. We do things called capacity demonstrations as part of what we do to demonstrate to the regulatory authorities that we can manufacture at scale here. And what we've done so far is consistent with what we've disclosed for the site, the sites, both Iovance and our CMO, in terms of the capacities that we're projecting for the market. So if you go to our deck and look at the number of patients we say we can accommodate at our facilities, you could assume that we've got capacity that's within those boundaries or ramping up to those boundaries. We haven't put the exact number out, but that's something that we were focused very much on internally and work with FDA on.
Got it. Okay. and then I don't know if Raj is available on the call here, but I appreciate that hasn't been a request for an adcom, but maybe if Raj can comment based on experience, what would be a scenario that would that would prompt the FDA to ask for an adcom?
Hi this is Raj. So thanks for the question. I don't expect that FDA will seek any ad outcome at this point based on our, as Fred mentioned earlier in the call, that we have a frequent interaction with the FDA and it's all it's a routine as a part of the PLA review process. Nothing we have identified or FDA so far that will take it to adcom. It's late in the review cycle. And so I'm not expecting any adcom at this point.
Great. I like the confidence there, Raj. And then last one, if I can to Frederick on 4001 is there any possibility of an update this year's? Apologies if I missed this, if you mentioned this earlier, but that's my last question. Thanks guys.
I think we have answered the question. We haven't provided guidance on timing on updates on that study, so I think bear with us. We will when once there's something to update on.
Got it. Thanks so much, guys.
Thank you. Our next question comes from the line of Joe Catanzaro with Piper Sandler. Your line is now open.
Hey everybody thanks for taking my questions. Maybe a couple follow-ups on a couple things that's been covered. Maybe first on cervical. Does another FDA interaction need to happen there to firm up some things? Or is the challenge simply around projecting timelines because of enrollment pace?
And then second question just wondering if you could say anything about the progress you've made on TILVANCE-301 and whether you have expectations that the FDA might ask for a status report of that trial ahead of the November PDUFA? Thanks.
Yes, I can take those. So in cervical it's more about the, the size of the patient population. It's not a large patient population than it is about regulatory interactions. We've already had a lot of regulatory interactions at FDA on that. We feel pretty comfortable where we're, that doesn't mean we won't have additional interactions leading into a potential BLA there, but we need to focus right now on just enrolling.
With respect to TILVANCE-301 the F D A remains in close contact with us about that study to make sure it's well underway and we feel quite comfortable with where we are, what we disclose to them. They do ask about that, and we have given them updates.
Okay, great. Thanks for taking my question.
Thank you. Our next question comes from the line of Mara Goldstein with Mizuho. Your line is now open.
Great. Thanks so much. I had a question on the LUN-202 study, and then just to follow-up on Proleukin. On the study, you're going to enroll PDL-1 patients with scores greater than 1% and less than 1%. Are they pres stratified into set numbers or is it all comer?
No, it is going to be a total sample size of 120 we're going to across the two cohorts.
Okay. So there's no particular number of one versus the other in that trial?
No, but we expect it to be relatively evenly balanced.
Okay. And then just can you help us understand a little bit about Proleukin ex obviously commercialization with lifileucel given the revenue that you recognized in the short period of time that you were open relative to the COGs and just how we should think about that on a go forward basis?
So you're asking – Mara you're asking about ex-U.S. revenues without lifileucel?
Yes in terms of focusing on Proleukin.
Yes. So Proleukin outside the United States is priced at relatively modest numbers right now. And the sales were not particularly high. So, that's not something we look at as a major revenue driver for us. That's what you're asking. Now, what upon launch of lifileucel that could become more significant, but it's still a lot different outside the U.S. than it is in the U.S. because the pricing difference.
Right. But it's still on its own profitable correct?
Outside the U.S. is it profitable? I don't know. It can make a profit on outside the U.S. but it's nowhere nearly what's the United States.
Okay. All right. Thank you.
Thank you. Our question comes from the line of Kelsey Goodwin with Guggenheim. Your line is now open.
Hey, good afternoon. And thanks for taking my question. I guess first, could you just remind us maybe of the efficacy bar in cervical cancer, kind of given the evolving landscape that you mentioned, and especially since the last time we saw a data cut there. And then maybe just to confirm, based on your interactions with the FDA, are we still leaning towards the label, including the pools data of cohorts two and four? And that's it for me. Thank you.
Yes. While I take the second part and then I'll hand Friedrich to take the first part. Yes, the FDA has given us favorable feedback, including the pre-BLA meeting on the pool data. And so yes, we do continue to think that there is a possibility we can get that on the label, a good possibility that we'll have some indication of pool data on the label. That's something we're working towards, obviously.
Friedrich, do you want to take the question about the bar for cervical?
Sure. The bar is low. Where we are right now, where we are basically similar to how we have seen this happen in lung cancer where check point inhibition has moved into frontline in combination with standard of care chemo. Now the post-PD-1 and the post frontline setting is wide open again. The data that are available from times where folks were then looking at second and third line therapy with for cervical cancer with other chemotherapeutics either monotherapy or other combinations were pretty dismal with response rates reported between like between 3% and below 10%. So the bar is really low and the unmet medical need is high.
Great. Thank you.
Thank you. And I'm currently showing no further questions at this time. I'd now like to turn the call back over to Fred Vogt for closing remarks.
Thank you again for joining the Iovance Biotherapeutics second quarter of 2023 financial results and corporate updates conference call. We've had an exciting start to 2023 with the acceptance of the BLA, the close of the Proleukin agreement, important updates in lung cancer while delivering on our key regulatory commercial [indiscernible] pipeline activities.
I am grateful for the patients, physicians and regulators as well as our employees and cross-functional teams in advancing our mission to be a global leader in TIL therapy. I would also thank our shareholders and covering analysts for their support. Please feel free to reach out to our Investor Relations team for follow-up. Thank you.
This concludes today's conference call. Thank you for joining. You may now disconnect.