Transgene SA (TNG) Earnings Call Transcript & Summary

Good morning, and welcome to the Transgene virtual key opinion leader event. At this time, all attendees are in a listen-only mode and a question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this call is being recorded, and a replay will be made available on the Transgene website following the conclusion of the event. Before I turn the call over to Alessandro Riva, Transgene's Chairman and Chief Executive Officer, I'd like to remind everyone that today's discussion contains forward-looking statements, which are subject to multiple risks and uncertainties. And with that, Alessandro, I'll now pass it to you.

Thank you, and good afternoon and good morning, everyone. If you can move to the next slide. So it is a pleasure to share with you our progress in our Individualized Neoantigen Therapeutic Vaccine that is our main program, and we are focusing on this program since the last 3 years, and we have made significant progress, not only with our leading asset TG4050, but as you are going to hear today on the new program, that's TG4070 in small -- in non-small cell lung cancer. So it is a pleasure to have with us today a leader in the oncology space that is Professor Nicolas Girard, who is Professor of [ Traci Oncology and instate ] Paris, and also other people of Transene will join me as we present the advances in our portfolio. So if I can go to the next slide. Next slide, please. So this might summarize essentially our 2 main programs in the Individualized Neoantigen Therapeutic Vaccine, TG4050, I guess you are familiar with this program. in head and neck patients. We have, as you know, completed the randomized Phase I study. We presented the data last year at ASCO that underscore a very important proof of concept for [ design in this ] patient population. And we have recently completed the randomized Phase II study in the same patient population and we expect to deliver the data of the randomized Phase II part of the study by Q1 2028. And we just announced the beginning of a new project, TG4070. That is our second NDA-based [ NTV ] in resected [ normalcy ] cancer patients in combination with the checkpoint inhibitor, in this case, is nivolumab. In the next slide, you see the key pillars related to TG4050 Essentially, it is about having a viral vector for [ uses -- ] it is about having a tool that allow us to detect the predictive [ new ] antigens that afterwards, we insert in the viral vector. And as you know, for TG40750, we use the tools from [ NEC ]. And we have recently announced that we signed a license agreement with [ NEC ] to use their tool for the [ operable ] and neck cancer patients from now on. In other words, after the randomized Phase II, if we decide to move forward to the development of TG4050 in [ Opera Nick ], we will use their algorithm to continue the development of TG4050. The third pillar is [ VAC ] design that is in-house computational engine that optimize the [ genetic ] design of the [ MVA ] Director. This is very important in order to have the right gene inserted into the viral vector. And then we have a scalable manufacturing in-house. You remember we started TG450 with the CEF process based on [ chicken and fibroblast ]. And now for the Phase III study that we potentially plan after the availability of the Phase II data, we will use this cell line process that is expected to be very good for automation, scaling for multiple indication. And also it can contribute to the turnaround time. The next slide, please. So the data from TG4050 is summarized in this slide. This is the 2-year, this is free survival data that you are familiar with. We have served 100% of patients being -- this is [ 32 ] years. 73% of patients having an immunogenicity in terms of de novo response to the [ new ] antigens that we inserted into the viral vector. And we observed the durability in terms of the immunogenicity at 12 months after the end of therapy. And the safety profile was very, very good. We are going to share the 3-year disease-free survival data during the next quarter in 2026. And of course, [ sessions the debt ] is available, you will be informed according to the classic process. In the next slide, you see the pillars around the TG4070. Again, this is new assets for non-small cell and cancer but also for potential additional indication. If you remember the previous slide, where I described the pillars for TG4050, essentially TG4070 differentiate from TG4050 for two reasons. Number one, the tools that we use to predict the [ neoantigen ]. And for this program, but also for the additional potential new program that we will set up at Transgene, we use an in-house platform that we call SNIPER. And then we will have the opportunity to give you a quick overview on this new platform. And also, as you can see in this slide, we are going to start from the Phase I with the cell line manufacturing process that will represent for us the first proof of concept for cell line manufacturing process in patients. So these are the two main differences for TG4070. But ultimately, what is important that with TG4070, Transgene is going to kind of over control or single steps of the production of the Individualized Neoantigen Therapeutic Vaccine, which will give us, of course, more leverage to speed up the development of our [ TV ]. And in the next slide, you see just a quick recap of our myvac portfolio. So TG4050, TG4070, the next step for TG4050, as I said to you, is to have the first [ immunicity ] data on Phase II patients towards the end of 2026. The 2 years, this is free survival during the first quarter 2028. And then as I mentioned, we intend to transition to [ selling ] manufacturing process for upcoming trials. For TG4070, of course, we are going to start the the randomized Phase I study as we speak. And the next step will be -- we have been already received the approval from the health authorities. And the next step will be initiation of centers. And then we will update everyone on when we can deliver the first information on the trial as soon as we have a sense on the [ recent], and this is going to to happen, I would say, by the end of the year, beginning of next year. And as I mentioned, with this new integrated platform that takes into consideration, the in-house as a predictive tool, but also the cell line manufacturing, we can also think in the future are to initiate additional trials in a new indication and potentially also in collaboration with a potential partner. I guess, and now I hand over to Nicolas Girard for the representation of 4070 trial, Nicolas, to you.

Sure. So I'm Nicolas Girard, I'm the Head of [ Torticologyat and seduce ] in Paris and the PI for the TG4070 trial in non-small cell lung cancer. So next slide, So this is a study that is conducted in non-small cell lung cancer, which is obviously a very frequent cancer, first cause of cancer-related deaths worldwide. We estimate that lung cancer with early stage, which is where the trial will be conducted at a stage where the disease is amenable to surgery will increase together with the development of lung cancer screening programs. We know that in this patient population, even if we do surgery and we complete surgical [ resection ] of the tumor there is a high risk of recurrence. And this is where we believe that escalating and intensifying the adjuvant setting is meaningful and will provide a survival benefit. We know that, obviously, this is a competitive landscape. But here, this is a very clear and disruptive approach with the opportunity of the vaccine. Next slide. So as I highlighted, very frequent cancer, non-small cell lung cancers and main subtype of lung cancer and [ vegetable ] disease, which is about 20% of the patients as of today, should increase in the future with lung cancer screening, and this is where the trial will be conducted. In most of the patients before surgery, we give the patients immunotherapy to stimulate immune responses against the cancer cells. Then we do surgery, and then we may continue with immunotherapy. But we know that if the patient -- if there are some remaining [ sales ] in the tumor specimen, there is a high risk of recurrence. And this is something that happens in more than 60% of the patient. So at the end, even if this is a situation where we can expect [ curative intent ] treatment, the actual outcome is poor with limited long-term survival. Next. So non-small cell lung cancer is obviously a quite complex setting. It's very frequent. We estimate more than 50,000 new cases every year in France. This is about 7,000 patients eligible to surgery. The diagnostics is quite complex and rely on biopsy. We do also molecular biology in those patients. And surgery is a standard of care for those localized tumors. We may use systemic therapies for more advanced tumors. But here, this is the main treatment for those patients, is surgery. Next. Obviously, when we see an abnormal imaging where we may suspect lung cancer, there is a kind of rush to make a final diagnosis to look at the extent of the disease. And this is based on additional imaging. We do the biopsy to confirm non-small cell lung cancer, do some biomarkers and then choose the treatment strategy that will be applied to a given patient. So here at the time of diagnosis, there is a kind of emergency. We need to go pretty fast to start the treatment, engage the biopsy and the collection of tissue from the tumor to make the diagnosis. And usually, there is a remaining tissue for that. Next. Staging. And here, we are dealing with resectable tumors. So as of today, maybe 25%, 30% of the patients overall. But we know that this is increasing with len cancer screening in the countries where lung cancer screening is implemented in the whole population, such as Netherlands, we see that the most of 60% of lung cancers are diagnosed with resectable stage. So this population is clearly increasing with the implementation of lung cancer screening, which is a reality in many developed countries in Europe, in the U.S., in Canada and other countries. So resectable tumors, it is a small -- relatively small tumor in the lung together with lymph nodes, but to [ let note ] that are still in the lung or in the [ media Snam ], but emolateral to the primary tumor. Next, [ Terry ] is mostly based as of today on [ Videotracoscopy ], which may be done manually or with the help of a robot, so robotic surgery. Most of the patients undergo lobectomy, so -- which is a reduction of one part of the lung. In some cases, nomonectomy may be done, but it's becoming very rare. And there is a shift towards even more limited [ reaction ], what we call the [ sublobalresection ]. So only with the reduction of a segment, not the [ world Lobo ] maintain for the patients, a good respiratory function and conditions. And obviously, IT tools have been developed for the follow-up of these patients. So this is a very clear pathway for the patients with resectable non-small cell lung cancer, surgery is the goal. And most of the patients, next slide, will actually receive perioperative treatment, meaning systemic treatment before or after surgery. Why? This is because when we look at the actual survival of the patients based on the stage, which is the size of the tumor and the extent to the lymph node, each time the tumor grows by 1 centimeter, you lose 10% of 5-year overall survival. So for 1 centimeter tumor, the 5-year survival is [ to sentiment 80%, 3 centimeters, 70%, 4 centimeters, 60% and so on]. Each time you have [ note ] in the immediately adjacent to the tumor or in the [ mediastinum ]. you lose 30% chance of 5-year overall survival. So surgery is obviously the standard of care, but it's not enough. And many patients will show this is [ recurrence ] and will die from the evolution of those recurrences, which are mostly [ met and static ] recurrences. Next. So the standard of care, as of today, is a neoadjuvant [ chemo immunotherapy ], meaning that we deliver before surgery a combination of chemotherapy and immunotherapy, so kind of treatment that will stimulate the immune responses while the tumor is still in place. And when we do that, 3 cycles, 3 injections every 3 weeks, so this is a 2-month treatment with 3 injections of [ chemo place ] immunotherapy; it's better than doing only chemotherapy. This is what is shown on this [ landmark Checkit 816 ] trial. We reduced by 40% the risk of disease recurrence, and we decrease the mortality by 30%. So this is a very clear benefit with the addition of immunotherapy to chemotherapy, okay? And as of today, [ chemoimmunotherapy ] is a standard of care and reimbursed in all the European countries, in the U.S., in China everywhere. Next. What is very interesting is that how it works. It works through a major immune response that is induced in the tumor. And when we look at the surgical specimen, as you can see on the picture, we see that in 1/4 of the patients, 24%, we have a complete disappearance of cancer cells, which are replaced by inflammation, immune cells and necrosis. So when we do immunotherapy before surgery in a quarter of the patients, we have this complete pathological response, a complete disappearance of cancer cells. And those patients, next slide, are the patients who are cured. These are the continuous line patients with a complete pathological response, [ PCR ]. Actually, there are no events. They do not show disease recurrences and they do not die during the follow-up. So those patients are clearly cured. But the point is that 75% of the patients do not have this complete pathological response. And those patients, these are the dotted line, actually have a high risk, still high risk of recurrence. Even if adding immunotherapy may improve the outcomes, which is at 5 years or -- let's say, 3 years, we have 60% of the patients who who show disease recurrence. And the risk of death is around 40% at 5 years. So clearly, the patients with complete pathological response are cured, but the 75% of patients without [ patelgical ] complete response have a high risk of disease recurrence. So this is where we want to focus and improve the outcomes of these patients. Next, Clearly, this is a target population for the trial. We estimate it's around 25,000 patients in the U.S. and Japan. And clearly, those patients have a high risk. And as of today, there is no standard of care for this group of patients. We don't know what to do in the postoperative setting. We may continue not for a more prolonged time, so adjuvant immunotherapy, maybe we can escalate with other drugs such as antibody drug conjugates, just targeted treatment, but this is with the cost of toxicity and side effects. And as of today, we don't know, even if some clinical trials are ongoing. Next, so this is where we want to focus this trial. So the Phase I study, it would be around 30 patients. So we will include patients with -- will include those patients with Stage II to IIIb non-small cell lung cancer. The patients will be randomized after surgery to receive either nivolumab, which is [indiscernible] adjuvant nivolumab or nivolumab plus the vaccine, the TG4070. We are focusing on the patient population eligible to neoadjuvant chemotherapy plus immunotherapy and on the patients without complete pathological response. The primary endpoint is the safety and tolerability of the combination. Obviously, we will look at efficacy on the [ EFS ] at 18 months, okay? So it will be a randomization 2:1. So 20 patients for the combo and 10 patients with nivolumab alone. Next, So we selected sites in France with a high volume, especially surgical volumes. So my institute, together, [indiscernible], the University Hospital from Strasbourg and [ these ] centers in the real world registries of patients receiving neoadjuvant chemo immunotherapy are the top centers in terms of patient volume. So we expect high feasibility for this Phase I trial. Next. And I think that's it, and I will take the questions at the end.

Thank you, Dr. Girard. Now I hand over to [indiscernible] project by [ informatics leader angina ], who will speak around our in-house platform SNIPER.

Okay. Next slide, please. Yes. So before going into SNIPER, let me first walk you through the full personalized vaccination workflow for TG4070 from patient sample to treatment administration. We start with sample collection during surgery, where tumor tissue [ on ] blood are collected and sequenced. At this stage, the sequencing data is analyzed by our in-house AI driven [ by informatics ] pipeline, SNIPER, for specific neurotigene identification and prediction of [ DCT ] response. SNIPER identifies tumor-specific mutations and select the neurotogenes most likely to induce an immune response in the patient. The results are then reviewed by experts to ensure the quality and robustness of the analysis. And the selected neoantigens are incorporated into the viral vector using our [ VAG ] designer platform to design optimal expression [ assets ]. Then we move into manufacturing to produce the personalized vaccine, that is released and administered to the patient. So in summary, SNIPER sits at the heart of this process. directly driving selection of the therapeutic targets included in TG4070 vaccine. Next slide, please. Yes. So let me now take a closer look at how SNIPER works in practice. It operates in four main steps. First, SNIPER identifies tumor-specific mutations by comparing tumor [ on normal ] DNA sequencing data. Then it integrates RNA sequencing data to retain only mutations that are expressed in the tumor to ensure the biological relevance of the targets. SNIPER also leverages multiple models to evaluate the [ immunogenic ] potential of each new antigen through prediction of binding and presentation by the patient's [ HLA ] molecules. And finally, these different features are integrated into a proprietary scoring framework, which ranks neoantigens based on both tumor expression and predicted immunogenicity. And this allows us to select the most relevant target for vaccination. So overall, SNIPER enables a highly selective and data-driven approach to neoantigen selection. And this pipeline is now validated and integrated into our personalized vaccine program. And next slide, please. So I think I will hand over now to Simone, who will present the manufacturing aspects in more detail.

Thank you for joining us here. I'm the Chief Technical Officer at Transgene. And could you go to the next slide? 5 So we are designing currently manufacturing to scale to a platform, and we're having a big change in -- doing a big change right now that is going to a scalable cell-line process. Currently, on our previous clinical trials, we did on CEF, which is [ chicken or ] fibroblast. It's an excellent process. It works very well. It has a downside at the primary [ satellite ]. It's not quite this robot robust as a clonal cell line, and it is not quite suitable for very large-scale indications with [ tie ] unmet medical need. We are moving to an [ Avianca ] line, which is growing in suspension in serum-free, and it's highly efficient to grow MDA. It's also improving the robustness, which allows us a shorter turnaround time, which is very critical for the individualized process. In addition, we can easier industrialize and automate, and that allows us to go to the scale. There is no impact of existing data. It's a pure [ CMC ] change, and all existing clinical data can be used for our processes. The key point is we're moving to the cell line to create more value by being scalable, the faster lead time and [ be ] very critical. As it is a clonal cell line, the robustness is much higher, and it's identical. Every process becomes identical that allows us to automate the whole process. A fully automated process becomes transferable, which allows us an expansion in different geographies and a fast growth to market or Phase III needs. Could you go to the next slide? Currently, we're in the very [ luxury ] situation to have a [ GMP ] manufacturing facility, and we have produced for 2 clinical trials, and we have delivered a very good product to the patient. We keep using this, but at the same time, by moving to the cell line, we can add a second [ GLT ] manufacturing facility that this is CDMO to our manufacturing capabilities. that allows us to increase flexibility and again, robustness. The current turnaround time is matching with patients need, but it is always attractive in personalized medicine to be faster. The cell line and the increased robustness is making this easier, and we have a strong lead time reduction plan implemented, and we are working on this, and we're advancing on this. Yes. So with the cell line, we will use the [ sell-in ] process for the Phase I for non-small cell lung cancer because the expectations on turnaround time are higher for the non-small scale lung cancer indication, multiple cell lung cancer indication. And I will pass on.

Yes. Thank you, [ Simon ]. I just would like to conclude that to give some highlights on the recent announcement on the monkeypox vaccine that we are developing initially in preclinical setting and then potentially in a clinical setting and [ inherit ] volunteer. If we can go to the next slide, please. So we consider the [ MBA ] cell line platform an ideal opportunity to develop the next generation of monkeypox, smallpox vaccine and to address the future supply gaps that currently exist in the community in the context of the biosecurity programs across Europe and United States of America and also in the context of potential pandemic preparation against [ bank ] and eventually also the smallpox. As you can see, it is for us an opportunistic approach for the simple reason that, as you know, [ MVA ] per se is designed to protect against monkeypox and smallpox and also diseases caused by [ vaccine virus ]. In addition, this [ synergy ] with the cell line manufacturing makes the production more scalable and therefore, as I mentioned, overcoming the current significant industrial limit that the community is facing again, in the context of the biosecurity program and potential preparedness for a potential pandemic. Next slide, please. right. So as I mentioned, the [ percent ] risk of [ emerging box ] vehicles bore combined with limited manufacturing capacity and also importantly, a declining population immunity following this [ session ] of routine small box vaccination highlights for us the need for additional scalable vaccine solution alongside currently approved reference [ VA-based ] and [ monkey boxes ], [ small post ] vaccine it is the vaccine currently approved by Babaka Nordic. By seeking to develop a cell line base preventing vaccine against the monkeypox and smallpox, we are leveraging multiple manufacturing innovation that [ Simon ] has very well summarized. Initially developed to improve [ MVAC ] platform to address an important public health need, this innovation can be applied to the prevention of monkeypox and also potentially other [ auto pox ] viruses. And you can see approximately based on the public information, the need is quite high, based on what you see in this slide. In the next slide, please, so we came up with this new vaccine produced on [ cell line ] that represented the next generation of vaccine against monkeypox [ as ballparks ]. And it is, again, based on our [ NDA ] platform. It includes [ the line ] and it has the potential to diversify supply and significantly expand vaccinability to support outbreaks, [ stop filing ] strategy and future biothreat responses. We have presented the preclinical data in mice and monkeys at worldwide conference for infectious disease last week in Barcelona. And I'm not sure we have this slide. But essentially, what we showed is that [ TG NBA in Celine ] is able to have a similar efficacy and immunogenicity and safety in comparison to the referenced, approved vaccine developed by [ vanartic ]. So this data, of course, gives us the rationale to continue the development of this vaccine in healthy volunteers. And as we speak, we are planning to prepare the organization to launch a randomized trial in healthy volunteers to compare our [ TGA ] is [ line ] versus the reference developed by [ lari ]. Next slide, please. So -- and this is just to summarize our value proposition in Transgene today and tomorrow, the organization could evolve further. But today, priority is, of course, on the [ myvac ] platform, TG4050 in [ adnecancer ], the randomized Phase II data that will be available in Q2 2028, TG4070, this new program that is starting as we speak, in non-small cell lung cancer patients with the data that will be available in the near future. And again, we'll communicate the more precise timelines as soon as we will have a sense on the recruitment, the screening and recruitment in the new Phase I trial. And of course, this platform is also able to eventually respond to further indications in oncology in the context of the INTV field that, as you know, start to emerge as a potential next [ immune ] approach for only cancer patients. And then the monkeypox opportunity, small [ pupaeupportunity ], we are yet to see it as an opportunity to contribute to the potential growing need in the community for biosecurity problems and preparedness for pandemic -- regional endemic and pandemic situations related to monkeypox box. I guess this is the last slide. If I'm right, can you go to the next one? I think it's the last one, we can then -- and over to the operator, I guess, for the questions operators.

[Operator Instructions] So our first question comes from Tom Rosenfeld at Intron Health.

Everyone presentation. My question is for [ us. Joel ]. So far, what have you benchmarked SNIPER against? And have you run it retrospectively on TG4050 patient samples? If so, did it select the same new antigens and did it rank them in the same order?

Okay. So to answer -- thanks for the question. So SNIPER performance has been validated according to the standard in the industry, including assessment against the external public benchmark from the [ Tesla Consortium ], for example. So [ Tesla ] is a large international initiative designed to compare Neogen prediction pipelines across multiple teams and using the same data sets. So using this benchmark, we could confirm that SNIPER ranks among the top-performing pipeline to really validate its ability to identify and prioritize immunogenic [ neoantigens ]. I don't know if that answers your question.

Yes. And then just the second part, have you run SNIPER on the TG4050 patient samples and were they comparable to the [ NEC ] platform results?

Yes. I don't know if this is something I can disclose. So maybe I would ask Alessandro to guide.

I take this question. We don't want to put [ a platform ] in competition. As you know, for us, both platforms are critical and are important. So we want to keep the two platforms separated and for [ head and snapper ] all other indication. Therefore, comparison between these two platforms are not kind of considered for us a priority. And what is important, again, is that SNIPER platform compares very well with the standard. And as [ you ] mentioned, what we have done is a kind of the standard approach when you wanted to validate a new platform in terms of the neoantigen identification.

That makes complete sense. And then just a follow up off the back of that, strategically, do you expect to bring -- do you use the in-house AI software going forward over third-party software for any new developments under the [ Miba ] platform?

Yes, we -- strategically, we would like to use SNIPER [indiscernible] for all indications that we will plan in future with the exception of head and neck tumors. And as I mentioned, we [ saw in ] a license agreement with [ NEC ] for the use of their platform for the [ resectable ] are cancer indication, the indication that we are testing as we speak in the ongoing randomized Phase II.

Yes. Thank you for the questions, Tom. So we have a question here from [ Marshall Decorist Auto BHF ]. So he has two questions. I'll start with the first one. There are several personalized cancer vaccine programs in development. From your perspective, what makes TG4070, truly different, both compared with TG4050 and with competing approaches?

So perhaps I take the first part of the question. So I mean the myvac platform, first of all, it's a viral vector-based platform, right? So -- and therefore, of course, by itself, we differentiate from other platforms that are being developed in the [ IT ] space, like the mRNA platforms developed by [ Mode, Biotech ] or the DNA or peptide-based platform developed by other companies like, for example, [ vaccine ]. So -- and we think that around the [ director ], there is already per se, potential differentiation. Of course, data will tell us. But certainly, there is a significant difference between these platforms. So then in terms of our myvac program, we are the only one being in [ resetting at ] neck. And that's something that potentially give us competitive advantage versus all other colleagues working with other platforms in this very interesting R&D space. And then when we compare TG4050 versus TG4070, we don't want to do any head-to-head comparison, right? So that's not our our priority. We want really to focus on TG4050 for [ Eden NTG4070 ] for all other edification. Given that these two platforms are different with regards to the tools that we use to identify the the neoantigens and given -- and also a different vis-a-vis the tumors that we are going to treat, therefore, the rate comparison will be almost, I would say, impossible. You just have to consider these 2 programs really separated with 2 different business cases. For TG4050 around the [indiscernible] neck, the medical need that exists in the community in the [ open ] cancer patients, TG4070 at around the non-small cell lung cancer today, but tomorrow also potentially around other indications where the medical need still exists in all [ resetting ] despite the availability of standard in [ monochemoregimen ] in perioperative setting. So that's the way I would approach your question. And Dr. Girard, do you have anything to add [ we get to not Marcella ]

Yes. More specifically, in onslancer, there are other strategies integrating vaccines, especially the [ Intera ] trial developed by [ MSD ] in kind of similar situation, but just a kind of different situation in earlier stages. So this is one of the differences. Again, here, we believe we combine this adjuvant component with the same [ Negrin ] component based on nivolumab where the [ interatrial ] with this [ 940 ] trial focused on the adjuvant part. So that's clearly not the same -- exactly the same setting. Here, we are integrating the [ world ] patient pathway, including the neoadjuvant component. And this is probably the way to go with this perioperative approach combining neoadjuvant and adjuvant. We know that the pure adjuvant strategies, as of today, are negative with immunotherapy. So this is -- obviously, when you focus only on adjuvant, you have a higher risk of select -- overselecting the patients having heterogeneity in the selection of the patients. And this probably explains why the trial with immunotherapy have been negative. So obviously, we have to see the results of this back in trials. But here, the advantage with these designs that we are proposing for non-small cell cancer is the integration of this adjuvant component with the same nethean component.

So [ Marshall's ] second question, have you identified biomarkers that could help select the patients most likely to benefit from TG4070?

Can you repeat that question, sorry?

Yes. So have you identified biomarkers that could help select the patients most likely to benefit from TG4070?

Well, no, it's a personalized vaccine. So I mean that biomarkers are part of the vaccine by itself. It's highly personalized. In terms of biomarkers, we know that the patients without a pathological complete response are the patients with a higher risk in the control arm. So this is -- focusing on these patient populations allows probably to identify quite early a potential benefit of the combination. And this is what we want to do in this Phase I study.

Great. Thank you, Dr. Girard. So I have a question here for [ Simon ]. How short are patient-to-patient turnaround time for the [ Avian ] cell line was measured, they're wondering?

So we have -- so the Avian cell line is one part of the whole proposed the patient-to-patient cell line is influenced by sequencing synthesis of plasmid and other things. The current target is 91 days.

And [indiscernible] said that the current talking around time that we have fits very well with [ the deck ] cancer patients, but also with the non-small cell lung cancer patient based on [ TG070ier ] design and in the patient tumor characteristics. So -- and of course, we also continue to optimize the turnaround time, and we expect to further reduce it in order to serve patients even better.

Great. The next question, which limits and tumor types to be cured with your platforms do you see?

I mean the [ TV ] platform is on the the profile of the tumor of patients and then based on the profile, the genetic profile based on [ sematic ] mutations [ with ] prepare vaccine. So you can think about this type of platform for all patients that have a medical [ leader ] in only setting because we think that vaccine approach is better suited for early-stage patients at risk of relapses as we are doing for small cell lung cancer, as we are doing for head and neck. So you can imagine that this type of platform can be used throughout the full spectrum of [ all ] setting cancer patients that have a significant risk of relapsing. And gastric cancer as an example, [ triple-negative breast cancer ] example blood cancers in that. I mean, I'm a -- all kinds of tumors, right? So -- and then I think a bot is important also is to see whether tumors that are very well recognized to be immunoresistant like head and neck, like pancreas becomes kind of immunosensitive when when you give an [ NTV ] in combination or not, [ we ] made a checkpoint it. So more to follow, but certainly is a very interesting field. Dr. Girard, do you have anything else to...

No, I agree with what you said, no additional things to add.

Great. Thank you. So we have a few questions here from [ John Vandermosten at Zacks ]. His first one, how many antigens generated by SNIPER are using a developed vaccine? Is it, one, a fixed number? Or does it depend on the specific patient/indication?

So I guess, I answer and then [ Peat ], if you want to to add anything, please. So our target is 30 neoantigens that can be accommodated in the [ NBA biter ] vector. And of course, we have generated [ back still ] with a lower number of [ new antigens ] because it depends on the specific tumor, specific specimen that we have from the hospital, from the surgeon. And of course, we try to do the best to reach that 13 neoantigen target that is a cutoff that we have established empirically because the [ NBA ] can welcome a significant number of new antigens. But we allow also for a lower number. And [ Jule ], anything else to we want to say?

No, I fully agree, and I don't have any additional comments.

Great. And John's next question, what are the mechanistic synergies between checkpoints and TG4070?

I can -- I mean, it's not only for them. I would say [ TV ] and checkpoint inhibitors, right? So the checkpoint inhibitor has the power to really remove the break that exists between the tumor and T cell, right? So -- and that's a beautiful kind of arm that that is useful or can be leveraged by an [ NTV ] because an [ NTV ] continues to develop new [ class ], new T cells against different new antigens. And therefore, ultimately, there is a profound synergy in a kind of tumor microenvironment where the break between T cell and the tumor is not anymore there. If you increase the T-cells that go against the [ new ] antigens, you have a synergy between the two, right? So you increased the diversity that is leveraged then by ultimately, but by the checkpoints [ bits]. And that's a big thing for patients, we think, right? So of course, it has to be demonstrated prospect. But if you look at, I mean, the data from Moderna, although in another indication in melanoma, they clearly showed in a randomized Phase II study that there is a potential synergy when you combine a [ TV ] will be the checkpoint base.

Great. Thank you. So we have time for one last question. So manufacturing is often viewed as one of the key challenges for individualized cancer vaccines. How does your scalable manufacturing process help address turnaround time, cost and broader expansion potential?

Yes. So because we go on the cell line, it allows us to [ bottom is ] the optimization allows us to reduce manpower and cost significantly. In addition, it is a vaccine, it is less complex than cell therapy, and that makes it also simpler to expand. . And the [ key ] robustness is the less problems occur during manufacturing, the faster we can be because we manufacture without deviation, which allows for faster release time. And then full automization, if we achieve what we want, it will be -- would be a full release on exception, fully digitalized, fully AI used, I mean, not machine learning, more AI like [ fuel ] users, less [indiscernible] and then allowing for efficient releases.

Great. Thank you. So this concludes our Q&A session. I'll turn it back to Alessandro for some quick closing remarks.

Yes. Thank you, and thank you all to to everyone that attended this webcast, and thank you for the support. Moving forward, we are convinced that [ INTV ] may be part of the transformative approach in immunotherapy for cancer patients. Thank you again, and enjoy the rest of it today.