Good morning, and welcome to the Transgene Virtual Key Opinion Leader Event. At this time, all attendees are in a listen-only mode. A question and answer session will follow the formal presentations. If you'd like to submit a question, please use the written Q&A text box at the bottom of the webcast player. To our analysts joining us live, please use the raise hand feature to indicate you have a question. 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.
With that, Alessandro, I'll now pass it to you.
Thank you. Good afternoon and good morning, everyone. If we can move to the next slide. It is a pleasure to share with you our progresses in our individualized neoantigen therapeutic vaccine that you know is our main program. We are focusing on this program since the last three years. We have made significant progresses, not only with our leading asset TG4050, but as you are going to hear today on the new program, that is TG4070, in non-small cell lung cancer. It is a pleasure to have with us today a leader in the oncology space, that is Professor Nicolas Girard, who is a Professor of Thoracic Oncology at Institut Curie in Paris. Also other people of Transgene will join me as we present the advances in our portfolio. If I can go to the next slide.
Next slide, please. This slide summarize essentially our two 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 this INTV in this patient population. We have recently completed the randomized phase II study in the same patient population, and we expected to deliver the data of the randomized phase II part of the study by Q1 2028. We just announced the beginning of a new project, TG4070. That is our second MVA-based INTV in resected non-small cell lung 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 us, it's MVA. It is about having a tool that allow us to detect the predictive neoantigens that afterwards we insert in the viral vector. As you know, for TG4050, 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 head 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 operable head and neck, we will use their algorithm to continue the development of TG4050. The third pillar is VacDesignR. That is in-house computational engine that optimize the genetic design of the MVA vector. This is very important in order to have the right gene inserted into the viral vector.
We have a scalable manufacturing in-house. You remember we started TG4050 with the CEF process based on chicken embryo fibroblast. For the phase III study that we potentially plan after the availability of the phase II data, we will use the 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. The data from TG4050 is summarized in this slide. This is the two-year disease-free survival data that you are familiar with. We observed 100% of patients being disease-free at two years, 73% of patients having an immunogenicity in terms of the novel response to the neoantigens that we inserted into the viral vector.
We observed the durability in terms of the immunogenicity at 12 months after the end of therapy, and the safety profile was very good. We are going to share the three-year disease-free survival data during the next quarter in 2026. As soon as the data 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 asset for non-small cell lung 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, 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, we will have the opportunity to give you a quick overview on this new platform. 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. These are the two main differences for TG4070. What is important that with TG4070, Transgene is going to kind of control all 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 INTV.
In the next slide, you see just a quick recap of our myvac portfolio. TG4050, TG4070. The next step for TG4050, as I say to you, is to have the first immunogenicity data on phase II patients towards the end of 2026. The two-year disease-free survival during the first quarter 2028. As I mentioned, we intend to transition to cell line manufacturing process for upcoming trials. For TG4070, of course, we are going to start the randomized phase I study as we speak. We have been already received the approval from the health authorities, and the next step will be the initiation of the centers. We will update everyone on when we can deliver the first information on the trial as soon as we have a sense on the recruitment. This is going to happen, I would say, by the end of the year, beginning of next year.
As I mentioned, with this new integrated platform, that takes into consideration the in-house predictive tool, but also the cell line manufacturing. We can also think in the future to initiate additional trials in a new indication and potentially also in collaboration with a potential partner.
I guess now I hand over to Nicolas Girard for the presentation of 4070 trial. Nicolas, up to you.
Sure. Thank you. I'm Nicolas Girard. I'm the Head of Thoracic Oncology at Institut Curie in Paris, and the PI for the TG4070 trial in non-small cell lung cancer. Next slide. This is a study that is conducted in non-small cell lung cancer, which is obviously a very frequent cancer. The 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. 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, here this is a very clear and disruptive approach with the opportunity of the vaccine. Next slide. As I highlighted, very frequent cancer, non-small cell lung cancer is the main subtype of lung cancer and resectable disease, which is about 20% of the patients as of today, should increase in the future with lung cancer screening. 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. We do surgery, we may continue immunotherapy. We know that if there are some remaining cells in the tumor specimen, there is a high risk of recurrence, and this is something that happens in more than 60% of the patient.
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. 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, 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. 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. Usually, there is remaining tissue for that. Next. Staging. Here we are dealing with resectable tumors. As of today, maybe 25%-30% of the patients overall, but we know that this is increasing with lung cancer screening in the countries where lung cancer screening is implemented in the world population, such as the Netherlands. We see that most of 60% of lung cancers are diagnosed with resectable stage.
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. Resectable tumors, it is a relatively small tumor in the lung together with lymph nodes, but lymph nodes that are still in the lung or in the mediastinum, but homolateral to the primary tumor. Next. Surgery is mostly based, as of today, on video thoracoscopy, which may be done manually or with the help of a robot, so robotic surgery. Most of the patients undergo lobectomy, which is a resection of one part of the lung. In some cases, pneumonectomy may be done, but it's becoming very rare. There is a shift towards even more limited resection, what we call the sublobar resection.
Only with the resection of a segment, not the whole lobe, to maintain, for the patients, a good respiratory function and condition. Obviously, IT tools have been developed for the follow-up of these patients. 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 a patient based on the stage, which is the size of the tumor and the extent to the lymph node, each time the tumor grows by one centimeter, you lose 10% of five-year overall survival. For 1 cm tumor, the five-year survival is around 90%, 2 cm , 80%, 3 cm , 70%, 4 cm , 60%, and so on.
Each time you have nodes immediately adjacent to the tumor or in the mediastinum, you lose 30% chance of five-year overall survival. Surgery is obviously a standard of care, but it's not enough, and many patients will show disease recurrence and will die from the evolution of those recurrences, which are mostly metastatic recurrences. Next. The standard of care as of today is neoadjuvant chemoimmunotherapy, meaning that we deliver before surgery, a combination of chemotherapy and immunotherapy, the kind of treatment that will stimulate the immune responses while the tumor is still in place. When we do that, three cycles, three injections every three weeks, so this is a two-month treatment with three injection of chemo plus immunotherapy. It's better than doing only chemotherapy. This is what is shown on this landmark CheckMate 816 trial.
We reduce by 40% the risk of disease recurrence, we decrease the mortality by 30%. This is a very clear benefit with the addition of immunotherapy to chemotherapy. Okay. As of today, chemoimmunotherapy is the 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. When we look at the surgical specimen, as you can see on the picture, we see that in a quarter of the patients, 24%, we have a complete disappearance of cancer cells, which are replaced by inflammation, immune cells, and necrosis. When we do immunotherapy before surgery, in a quarter of the patients, we have this complete pathological response, a complete disappearance of cancer cells.
Those patients, next slide, are the patients who are cured. These are the continuous line. Patients with a complete pathological response, a pCR, actually, they have no events. They do not show disease recurrences, and they do not die during the follow-up. Those patients are clearly cured. The point is that 75% of the patients do not have this complete pathological response. Those patients, these are the dotted line, actually have a high risk, still a high risk of recurrence. Even if adding immunotherapy may improve the outcomes, we see that at five years or let's say at three years, we have 60% of the patients who show disease recurrence and the risk of death is around 40% at five years.
Clearly, the patients with complete pathological response are cured, but the 75% of patients without a pathological complete response have a high risk of disease recurrence. 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 E.U., U.S., and Japan. Clearly, those patients have a high risk. 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 immunotherapy for a more prolonged time, adjuvant immunotherapy. Maybe we can escalate with other drugs such as antibody-drug conjugates, such as targeted treatments, but this is with the cost of toxicity and side effects. As of today, we don't know even if some clinical trials are ongoing.
Next. This is where we want to focus this trial. The phase I study, it will be around 30 patients. We will include those patients with Stage 2 to 3b non-small cell lung cancer. The patients will be randomized after surgery to receive either nivolumab, which is immunotherapy, adjuvant nivolumab, or nivolumab plus the vaccine, the TG4070. We are focusing on the patient population eligible to neoadjuvant chemoimmunotherapy 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 and the EFS at 18 months. Okay. It will be a randomizations two to one, 20 patients for the combo and 10 patients with nivolumab alone.
Next. We selected sites in France with a high volume, especially surgical volume. My institute, together with Institut Gustave Roussy, Hôpitaux de Marseille , the Oncopole de Toulouse, the University Hospital from Strasbourg and Rennes. These centers in the real world, the registries of patients receiving neoadjuvant chemoimmunotherapy are the top centers in terms of patient volume. We expect a high feasibility for this phase I trial.
Next. I think that's it, and I will take the questions at the end.
Thank you, Dr. Girard. Now I hand over to Jules Deforges , a Project Bioinformatics Leader at Transgene, who will speak around our in-house platform, SNIPER.
Okay. Thank you. Next slide, please. Yes. 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 and blood are collected and sequenced. At this stage, the sequencing data is analyzed by our in-house AI-driven bioinformatics pipeline, SNIPER, for specific neoantigen identification and prediction of elicited response. SNIPER identifies tumor-specific mutations and selects the neoantigens 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. The selected neoantigens are incorporated into the viral vector using our VacDesignR platform to design optimal expression cassettes. We move into manufacturing to produce the personalized vaccine that is released and administered to the patient.
In summary, SNIPER sits at the heart of this process, directly driving selection of the therapeutic targets included in TG4070 vaccine. Next slide, please. Yeah. 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 and normal DNA sequencing data. 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 neoantigen through prediction of binding and presentation by the patient's HLA molecules.
Finally, these different features are integrated into a proprietary scoring framework, which ranks neoantigens based on both tumor expression and predicted immunogenicity. This allows us to select the most relevant targets for vaccination. Overall, SNIPER enables a highly selective and data-driven approach to neoantigen selection. This pipeline is now validated and integrated into our personalized vaccine program.
Next slide, please. I think I will hand over now to Simone, who will present the manufacturing aspect in more detail.
Hi, thank you for joining us here. I'm the Chief Technical Officer at Transgene. Could you go to the next slide? We are designing currently manufacturing to scale to a platform, we're 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 embryo fibroblast. It's an excellent process. It works very well. It has a downside. It's a primary cell line. It's not quite as robust as a clonal cell line, and it is not quite as suitable for very large scale indications with high unmet medical need. We are moving to an avian cell line, which is growing in suspension, is serum-free, and it's highly efficient to grow MVA.
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 to the 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 where it's 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 luxurious situation to have a GMP manufacturing facility, and we have produced for two clinical trials, and we have delivered a very good product to the patients. We keep using this, but at the same time, by moving to the cell line, we can add a second GMP manufacturing facility that is a CDMO to our manufacturing capabilities that allows us to increase flexibility and again, robustness. The current turnaround time is matching what 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. With the cell line, we will use the cell line process for the phase I for non-small cell lung cancer because the expectations on turnaround time are higher for the non-small cell lung cancer indication. I will pass on.
Yes. Thank you, Simone. I would just like to conclude to give some highlights on the recent announcement on the Monkeypox vaccine that we are developing initially in a preclinical setting and then potentially in a clinical setting in a healthy volunteer. If we can go to the next slide, please. We consider the MVA 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 Monkeypox, 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 vaccinia virus. In addition, the 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. As I mentioned, the persistent risk of emerging poxvirus bioterrorism threats, combined with limited manufacturing capacity and also, importantly, a declining population immunity following the cessation of routine Smallpox vaccination, highlights for us the need for additional scalable vaccine solution alongside currently approved reference MVA-based Monkeypox, Smallpox vaccine. You know it is the vaccine currently approved by Bavarian Nordic.
By seeking to develop a cell line-based preventing vaccine against Monkeypox and Smallpox, we are leveraging multiple manufacturing innovation that Simone has very well summarized. Initially developed to improve myvac platform to address an important public health need. This innovation can be applied to the prevention of Monkeypox and also potentially other orthopoxviruses. 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. We came up with this new vaccine produced on cell line that represent the next generation of vaccine against Monkeypox and Smallpox. It is, again, based on our MVA platform. It includes the cell line, and it has the potential to diversify supply and significantly expand vaccine availability to support outbreaks, stockpiling strategy, and future biothreat responses.
We have presented the preclinical data in mice and monkeys at the World Congress on Infectious Diseases last week in Barcelona. I'm not sure we have this slide, but essentially what we showed is that TG-MVA in cell line is able to have a similar efficacy and immunogenicity and safety in comparison to the reference approved vaccine developed by Bavarian Nordic. This data, of course, gives us the rationale to continue the development of this vaccine in healthy volunteers. As we speak, we are planning to prepare the organization to launch a randomized trial in healthy volunteer, to compare our TG-MVA in cell line versus the reference developed by Bavarian Nordic. Next slide, please. This is just to summarize our value proposition from Transgene today. Tomorrow, the organization could evolve further.
Today, priority is, of course, on the myvac platform, TG4050 in head and neck cancer, 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. Again, we will communicate the more precise timelines as soon as we will have a sense on the screening and recruitment in the new phase I trial. Of course, this platform is also able eventually to expand to further indications in oncology in the context of the INTV field that, as you know, start to emerge as a potential next immuno approach for early cancer patients.
Then the Monkeypox opportunities, Smallpox, Monkeypox opportunity. Really, you have to see it as an opportunity to contribute to the potential growing need in the community for biosecurity programs and preparedness for pandemic and regional endemic and pandemic situations related to Monkeypox. 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 hand over to the operator, I guess, for the questions. Operator, please.
Yes. Thank you, Alessandro. At this time, we'll be conducting a question and answer session with our four speakers. As a reminder to our audience, please use the Q&A text box at the bottom of the webcast player if you'd like to submit a question. Please hold for a brief moment while we pull for questions. Our first question comes from Tom Rosenfeld at Intron Health. Please go ahead, Tom.
Hi, everyone. Thank you for the presentation. Good afternoon. My question is for Jules. Jules, so far, what have you benchmarked SNIPER against? Have you run it retrospectively on TG4050 patient samples? If so, did it select the same neoantigens, and did it rank them in the same order?
Okay. To answer, thanks for the question. SNIPER's performance has been validated according to the standard in the industry on including assessments against the external public benchmark from the TESLA consortium, for example. TESLA is a large international initiative designed to compare neoantigen prediction pipelines across multiple teams and using the same data sets. 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.
Yeah. Thank you. 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, maybe I would ask Alessandro to guide me here.
Yeah. Maybe I take this question. We don't want to put the two platforms in competition. As you know, for us, both platforms are critical and are important, so we want to keep the two platforms separated, NEC for head and neck and SNIPER for all other indications. Comparison between these two platforms is not kind of considered for us a priority.
Okay. Yeah. Thank you.
What is important, again, is that SNIPER platform compares very well with the standard. Jules mentioned what we have done, that it is a kind of the standard approach when you want to validate a new platform in terms of the neoantigen identification.
Sure. That makes complete sense. Then just to follow up off the back of that, strategically, do you expect to use the in-house AI software going forward over third-party software for any new developments under the myvac platform?
Strategically, we would like to use SNIPER for all indications that we will plan in the future, with the exception of head and neck tumors. As I mentioned, we signed a license agreement with NEC for the use of their platform for the resectable head and neck cancer indication, the indication that we are testing as we speak in the ongoing randomized phase II study.
Great. Thank you so much.
Thank you for asking.
Thank you for the questions, Tom. We have a question here from Martial Descoutures at ODDO BHF. 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?
Perhaps I take the first part of the question. The myvac platform, first of all, it's a viral vector-based platform, right? Therefore, of course, by itself, we differentiate it from other platforms that are in development in the INTV space, like the mRNA platforms developed by Moderna, BioNTech, or the DNA or peptide-based platform developed by other companies like, for example, Evaxion. We think that around the vector, there is already, per se, potential differentiation. Of course, the data will tell us, but certainly there is a significant difference between these platforms. In terms of our myvac program, we are the only one being in early setting head and neck, and that's something that potentially give us a competitive advantage versus all other colleagues working with other platforms in this very interesting INTV space.
When we compare TG4050 versus TG4070, we don't want to do any head-to-head comparison. That's not our priority. We want really to focus on TG4050 for head and neck and TG4070 for all other indications, given that these two platforms are different with regards to the tools that we use to identify the neoantigens, and also are different vis-à-vis the tumors that we are going to treat. Therefore, the right comparison will be almost, I would say, impossible. You just have to consider these two programs really separated with two different business cases.
For TG4050 around the head and neck, the medical need that exist in the community, in the operable head and neck cancer patients, and TG4070 around the non-small cell lung cancer today, but tomorrow also potentially around other indications where the medical need still exist in early setting despite the availability of standard immunochemotherapy regimen in perioperative setting. That's the way I would approach your question.
Dr. Girard, do you have anything to add with regards to non-small cell lung cancer?
More specifically, in non-small cell lung cancer, there are other strategies integrating vaccines, especially the INTerpath trial developed by MSD in a kind of similar situation but also kind of different situation in earlier stages. This is one of the differences. Again, here we believe we combine this adjuvant component with the same neoadjuvant component based on nivolumab, where the INTerpath trial with this V940 trial focus on the adjuvant part. That's clearly not exactly the same setting. Here we are integrating the whole 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.
This is, obviously, when you focus only on adjuvant, you have a higher risk of over-selecting the patients, having heterogeneity in the selection of the patients, and this probably explains why the trials with immunotherapy have been negative. Obviously we have to see the results of these vaccine trials. Here, the advantage with this design that we are proposing for non-small cell lung cancer is integration of this adjuvant component with the same neoadjuvant component.
Great. Thank you, Alessandro and Dr. Girard. Martial's second question, have you identified biomarkers that could help select the patients most likely to benefit from TG4070?
Dr. Girard, perhaps first.
Can you repeat that question? Sorry.
Yes. Have you identified biomarkers that could help select the patients most likely to benefit from TG4070?
Well, no. This is a personalized vaccine, so the 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. 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. I have a question here for Simone. "How shorter patient-to-patient turnaround time for the avian cell line was measured?" They're wondering.
The avian cell line is one part of the whole process. The patient-to-patient cell line is influenced by sequencing, synthesis of plasmid and other things. The current target is 91 day.
I would perhaps say that the current turnaround time that we have fits very well with the head and neck cancer patient, but also with the non-small cell lung cancer patient based on TG4070 trial design and the patient and tumor characteristics. Of course, we are also continuing to optimize the turnaround time, and we expect to further reduce it in order to serve patients even better.
Yes.
Great. Thank you both. The next question, which limits in tumor types to be cured with your platforms do you see?
It's an INTV platform is based on the profile of the tumor of patients. Based on that profile, the genetic profile, based on somatic mutations, we prepare the vaccine. You can think about this type of platform for all patients that have a medical need in early setting, because we think that a vaccine approach is better suited for early stage patient at risk of relapses, as we are doing for non-small cell lung cancer, as we are doing for head and neck. You can imagine that this type of platform can be used throughout the full spectrum of early setting cancer patients that have a significant risk of relapsing. Gastric cancer is an example, triple negative breast cancer is an example, bladder cancer.
Perhaps all kind of tumors. Right? I think that what 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 you give an INTV in combination or not with a checkpoint inhibitor. 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. Yep.
Great. Thank you. We have a few questions here from John Vandermosten at Zacks. His first one, how many antigens generated by SNIPER are used in a developed vaccine? Is it, one, a fixed number, or does it depend on the specific patient/indication?
I guess I answer, and then perhaps, Jules, if you want to add anything, please. Our target is 30, neoantigens that can be accommodated in the MVA viral vector. Of course, we have generated a vaccine with a lower number of neoantigens because it depends on the specific tumor, specific specimen that we have from the hospital, from the surgeon. Of course, we try to do the best to reach that 30 neoantigen target. That is a cutoff that we have established empirically, because the MVA can welcome a significant number of neoantigens. We allow also for a lower number.
Jules, anything else that you want to say?
No, I fully agree, and I don't have any additional comments.
Thank you.
Great, John's next question, what are the mechanistic synergies between checkpoints and TG4070?
It's not only TG4070. I would say INTV and checkpoint inhibitors. Right? The checkpoint inhibitor has the power to really remove the break that exists between the tumor and the T cell. Right? That's a beautiful kind of arm that is useful, can be leveraged by an INTV, because an INTV continues to develop new clones, new T cells against different neoantigens. 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 neoantigens, you have a synergy between the two. Right? You increase the diversity that is leveraged then ultimately by the checkpoint inhibitors. Right?
That's a big thing for patients, we think. Right? Of course it has to be demonstrated prospectively, if you look at the data from Moderna, although in another indication in melanoma, they clearly show that in a randomized phase II study, that there is a potential synergy when you combine an INTV with a checkpoint inhibitor.
Great. Thank you. We have time for one last question. 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?
Okay.
Simone, Can you take it?
Yes. Because we go on the cell line, it allows us to automate. The automation 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. The key in robustness is the less problems occur during manufacturing, the faster we can be, because we manufacture without deviation, which allows for fast release time. Then full automation, if we achieve what we want, it would be a full release on exception, fully digitalized, fully AI used. Not machine learning, more AI, like Jules uses, less ChatGPT, and then allowing for efficient releases.
Great. Thank you. This concludes our Q&A session. I will turn it back to Alessandro for some quick closing remarks.
Thank you, and thank you to everyone that attended this webcast. Thank you for the support. Moving forward, we are convinced that INTV may be part of the transformative approach in immunotherapy for cancer patient. Thank you again, and enjoy the rest of the day.