Hello, and welcome to the Transgene first half 2022 financial results and business update call. My name is Courtney, and I'll be your coordinator for today's event. Please note this call is being recorded, and for the duration, your lines will be on listen-only. However, you will have the opportunity to ask questions, and this can be done by pressing star one on your telephone keypad.
If you require assistance at any time, please press star zero and you will be connected to an operator. I will now hand you over to your host, Lucie Larguier, Head of Investor Relations, to begin today's conference. Thank you.
Thank you and hello, everyone. During our call today, Hedi Ben Brahim, CEO of Transgene, will provide you with an overview of the remarkable progress we have made during the period. After this, and during the Q&A session, Jean-Philippe Delord, Chief Financial Officer, Éric Quéméneur, Chief Scientific Officer, Maud Brandely, Chief Medical Officer, and Steven Bloom, Chief Business Officer, will be available to answer all your questions.
Before I turn the call over to Mr. Ben Brahim, I'd like to remind everyone that today's discussion contains forward-looking statements which are subject to a number of risks and uncertainties. If you're listening to this webcast via the Internet, you will not be able to ask questions. If you wish to ask questions, please make sure you join us via one of the set of conference call numbers that are available in today's press release.
With this short introduction, I now turn over the call to Hedi Ben Brahim.
Thank you, Lucie, and welcome everyone. Thank you very much for joining today's update call. The first part of 2022 has been a truly exciting period for Transgene. We have made remarkable progress this year, and I will focus today on this important accomplishment. First, let's start with our HPV positive vaccine, TG 4001. You know TG 4001 is ongoing at the randomized phase II trial.
It's designed to demonstrate the contribution of TG 4001 plus avelumab versus avelumab alone in population of patients that do not receive prior therapy with checkpoint blockers. It's an event-based design, which means that we need 37 PFS events to launch the analysis. To date, more than 50 patients have been enrolled, which should be sufficient to reach required numbers of events on schedule.
We are following the evolution of the event on a day-to-day basis, and I'm able to confirm that the outcome of this interim analysis will be communicated in Q4 2022. What can you expect from us to report in terms of data on TG4001? You understood that it's an adaptive design with a number of patients that can evolve depending on the actual results of the interim analysis.
We will communicate on this number of patients required to achieve statistical significance of the primary endpoint. Another way of looking at this is that the lower the number of patients required, the bigger the difference between the two arms at the time of interim analysis. You will not see a PFS value, as communicating this outside the IDMC will deteriorate the statistical significance of this endpoint.
Looking at the number of patients of the trial will give a proper idea of the nature of the data. If these final results are positive, we aim at continuing the development of TG4001 with a registration trial in anogenital cancers. We look forward to telling you more about the future of this trial. I remind you that the previous data obtained were very encouraging.
At our upcoming R&D Day on September twenty-seventh, we plan to communicate updated data from the previous trial for TG4001. This session will be presented by Professor Delord from the Oncopole in Toulouse. Let's move now to our neoantigen vaccine, TG4050. TG4050 is now in two ongoing phase I trials that are generating data on TG4050 as a single agent.
New data were presented at AACR and ASCO earlier this year, which are very robust when compared to competition. It gives us the ability to generate data on TG4050 as a monotherapy in ovarian and head and neck cancer. We have confirmed that TG4050 remains well-tolerated and that it displays robust immunogenicity.
The induction of immune responses is particularly efficient with 100% of patients evaluated at data cutoff date showing a specific cellular response. On top of it is associated with lesion regression, so it's very robust data that are consistent with ctDNA analysis that we've shown at ASCO. Enrollment has been completed for the two trials, underlining the attractiveness of the candidate for the clinician and the patients.
I remind you that in the ovarian cancer trial, we have to wait for the patients to show signs of asymptomatic relapse, and this event triggers the administration of TG4050. In the head and neck cancer trial, half of the patients are randomized to receive TG4050, and the other half will be monitored until relapse. In these two trials, our aim is to extend the remission period for the patients.
An update on future data will be provided at our R&D day, where we will have the pleasure to welcome both lead investigators to discuss TG4001. That's Christian Ottensmeier and Matthew Block. We reviewed the therapeutic vaccine on the oncolytic virus side. We have also achieved great progress with our two candidates since the beginning of the year.
TG6002 continues to demonstrate the robustness of our patented virus backbone, which support our Invir.IO platform and our intravenous claim. In the intravenous trial, we are generating new data that was presented at ESMO last year and that we are very excited to present at ESMO this Sunday, September 11. It will especially show details on the two schedules of administration, especially the intensified scheme of administration.
The poster will focus on PK/PD, and it will answer the question of neutralizing antibodies. With the systemic intravenous route, we have shown remarkable safety, replication of the virus within tumor cells, expression of the transgene in the tumor, so that confirms the mechanism of action. This is particularly important with regard to our AstraZeneca collaboration and the company's future developments.
In the intrahepatic arterial trial, so this is the local regional route. The last patient of phase I has been enrolled. Data are being gathered and analyzed, and we'll be able to present them in the first half of 2023. Demonstrating efficacy with intravenous and or the local regional routes would considerably extend the potential addressable market of oncolytic viruses.
Based on the comprehensive data package which we are putting together, we will assess the best way forward for TG6002. By then, we are very happy to meet you at ESMO this Sunday at noon. If you are in Paris, please come and see the poster. Regarding our other oncolytic virus BT-001, that is being co-developed with BioInvent. The progress has also been very impressive over the year.
In the ongoing phase I, we assess the intratumoral administration of BT-001 as a single agent. The initial data we've already shared have shown good safety, the persistence and the replication of the virus in the tumor, the expression of the anti-T cell response within the tumor, and first signs of efficacy. Today the dose escalation keeps going, and we have announced that we plan to start phase Ib, which means the combination with pembrolizumab in the second half of this year.
This is within the frame of the clinical collaboration with MSD, as we've announced. This is a great collaboration with our colleagues at BioInvent. It's aimed at demonstrating that vaccinia viruses are ideal cargos to bring immune modulators within the tumor and restore the immune competence of the tumor microenvironment.
It aims at increasing and improving responses to anti-PD-1 drugs. At our R&D day at the end of September, we will also review our exciting oncolytic portfolio together with Adel Samson, who is very active in investigating this field in the clinic and who has a wide experience with vaccinia viruses. After having reviewed the products, let's talk about finance.
The P&L in H1 2022 is in line with our expectations and reflects the acceleration of our clinical trials. At the end of June, we had EUR 42.8 million in cash and cash equivalents. That gives us a financial visibility until the end of 2023, which means that we can deliver all our key anticipated milestones.
I'm confident that the upcoming trial results will demonstrate the potential of changing portfolios of immunotherapy by generating significant benefits for patients with the aim of creating value for our shareholders. There is just a few more days to wait until the presentation of our poster at ESMO. That's Sunday noon. Very happy to welcome you there if you are in Paris. With that, we'll now take your questions.
Thank you. As a reminder, if you would like to ask a question on today's call, please press star one on your telephone keypad. Please ensure your line is unmuted locally and you will be advised when to ask your question. That was star one on your telephone keypad. Our first question comes in from the line of Dominic Rose calling from Intron Health. Please go ahead.
Hi, this is Dominic from Intron Health. Thanks for taking my questions. I've got two. Question one is on the phase 2 data for TG4001. Is there any possibility that the drug could be eligible for the accelerated approval pathway in the U.S.? And if so, could the interim readout data be fileable? Question two is on the Tasly Biopharmaceuticals shares. I noticed there was no update on them this quarter. Just wondering whether there's a plan for them and whether they're factored into your financial runway guidance. Thanks.
We will review the data. It's in Q1, so it's coming quite soon now. The objective is to get positive data to be able to continue the program and then plan a new trial. We don't expect that the results would enable an accelerated filing based on this data because it's not a registration trial. What is very important to remind is I think that we will be still the first one to release phase II randomized trial data in this indication. I hope the sooner this product advances, the better for patients. It's also very important to be ahead of competition, and it's really the case here. If you
On the second question, I'm sorry, Dominic, but the line is really not very good on our end, and I didn't understand it.
Yes, that's no problem. It's concerning the Tasly Biopharmaceuticals.
Okay.
Okay. Dominic, regarding Tasly Biopharmaceuticals, there's no public information yet on the actual process, so we still have our fair share in our assets with the valuation of roughly EUR 20 million now. We consider that we will find a way to monetize these shares in the 18 months period.
Thank you. The next question comes in from the line of Martial Descoutures calling from Oddo. Please go ahead.
Thank you. Thank you very much for taking my question. Good evening, everyone. It will be really brief. I would like to understand what does it mean that there's a complete inclusion for both the working with the TG4050. Maybe could you give us more details on this inclusion in this current environment? What is the anticipated lag between this last inclusion and the initiation of the treatments for the patients? I would have another question concerning the TG4052. I would like to hear you on your feedback post the ASCO Congress, and if you see maybe a new competition in this segment.
Maybe what are the feedbacks from the prescribers on the neoantigen vaccine evolution? Thank you very much for your answer.
Thanks for your question. It mean that we said that the inclusion is now finished. It mean we had really interest from both the clinicians and the patients. It mean that now we are not enrolling anymore in these two trials. That will enable us to treat the target number of patients at least, who are 13 in the ovarian cancer and 30 in the head and neck cancer. In the head and neck, it's randomized. 15 are getting the treatment right away and 15 are in the control arm. In the ovarian cancer, we are treating patients after first they had complete response by the first line of treatment, so surgery and chemotherapy.
We treat them at the moment of asymptomatic relapse, meaning that there are some signs of relapse that are either an increase of the CA-125, which is a recognized prognostic marker in the blood for the ovarian cancer or the appearance of microlesion in the ovaries. Today, I mean, initial plan was that the 12 months PFS is 50%. We see a strong variability among the patients for this time of relapse. We try to give a clear forecast about when the last thirteenth patients would be treated. We are getting initial data. So far we have treated five patients. We have shown interesting scientific activities on two of the first patient.
The second trial which is head and neck, here we also have to first wait for complete response for the patient. Then we treat. Since there is no comparable marker as CA-125 that we have in ovarian cancer, we treat the patient three months after the confirmation of the complete response. Here the timeline is a fixed one for the patients. Here also the inclusion is finished. We are waiting for the necessary number of patients to have the complete response and then confirmation and then the three months to treat them. During that time, we have plenty of time to produce the treatment.
It's not the right day today, but in the near future, we'll share an update on that they're ready there regarding the number of patients treated, randomized for the head and neck cancer and then the next milestone. Regarding the new competition segment, I think it's very interesting to see that we have other companies looking at this field. It's true that neoantigens attracts a lot of attention. The key differentiating point that we bring is that we are immunotherapy, whereas many of our competitors are in combination with PD-1, which is fine, but when we see sign of activity where it come from. In our trial, we are sure that the activity comes only from our product.
On top of that, we do our trial in several countries: the U.S., France, and U.K., in several hospitals. Some of our peers do that in only one hospital. I think we've put an additional challenge and more interest in our trial. I think that the data is coming progressively for our peers and ourselves. We know it's still an emerging field, so we need to strengthen the phase I data, move to randomized phase II. We think we have a lot of differentiation with what I call already the fact that the virus can induce both innate and adaptive immunity, that we can put all neoantigens in one virus, that we are working with NEC, which is dedicated artificial intelligence project to accompany us.
Very happy to compare with the peers, but very proud of our achievements when we compare to them.
Thank you.
The next question comes in from the line of Olga Smolentseva calling from Bryan, Garnier & Co. Please go ahead.
Good evening. Can you hear me well?
Yes, we do. Thank you again.
Great. Thank you for taking my questions. Firstly, on TG4001, I'm just curious what patient population you're currently seeing being recruited in the study. If KEYTRUDA approval in the first line for PD-L1 positive cervical cancer would sort of necessitate stratification of the patient by PD-L1 status. Then maybe how would you define success in the study versus standard of care, considering basically the basket nature of the study? I would have a follow-up. Thank you.
Thank you. It's great. Maud is on?
Yes, Maud is on the line.
Yes. Maud, if you want to.
Yes.
Answer the question.
Yes, for sure. The patients who are included at the present time are presenting with different types of anogenital cancer, can be cervix cancer, where indeed pembrolizumab is approved in combination with chemotherapy in first line. Also anal cancer, where chemotherapy is still at that time the standard of care, and also more or less frequent tumor types like vulvar and vaginal cancer. We are stratifying in our trial on the location of the primary tumor. We'll be in a position to see the activity in the two arms depending on the location of the primary tumors.
As you may know, at the moment, except for cervical cancer, in the other indication, there are some recommendation in the U.S. through the NCCN guidelines to use pembrolizumab or nivolumab, but they are not approved specifically in those indication. There is still a space for improvement in these in those very nasty cancers. I would add that we characterize with a sample biopsy at the time of the inclusion, and we characterize the expression of PD-L1. In the initial part, the part one of the phase II trial, we did not see any impact on PD-L1 expression on the response we observed, so it was regardless of PD-L1 expression.
Great, thank you. Maybe a few words on your expectations for how to define the success of the study, again, considering that those are multiple patients with different tumors.
Well, as I said, we are stratifying on tumor location, so we will be in a position to have a significant number of patients for each indication. Of course, our expectation is to have the improvement in progression-free survival, which is a primary endpoint, observed in each tumor type. There is no reason why, and we have seen that in the previous part of the phase II, the non-randomized part.
We have seen that independent of the location, because the nature of this cancer is linked to the presence of HPV. We have seen response in the cervix, in vulvovaginal, in anal cancer, any kind of tumor. We believe that we will see this improvement whatever the tumor location.
Olga, we have not communicated. We said that the primary endpoint is the PFS. We have not communicated on the target that we set in the trial. I remind you that in the previous data we shared, we have doubled the standard of care in the non-randomized trial. If we are in this area of course, that would be a great achievement, but we have not communicated the precise data.
That's very helpful. Thank you. Maybe a few words on TG4050. Just curious what kind of additional data from the phase I study we might see later this year? Maybe specifically, would you be able to share with us percentage of neoantigen specific CD8 T-cells of the total T-cell lymphocyte count?
What do you want to answer?
the percentage of neoantigen-specific CD-
Yeah.
CD8 T-cells from the total T lymphocyte count. Maybe a few words on how would you define the clinical path forward for forty/fifty? Any color on what would be taken into account here?
Well, as Hedi Ben Brahim indicated, what is important for us is to test TG4050 as a single agent, so no confusion with the potential impact of an anti-PD-1, number one. Number two, we designed the trial so that we could detect sign of antitumor activity.
Most specifically in ovarian cancer, we are able to measure the impact on CA-125 and assess the presence of radiological images and their disappearance. That's for ovarian cancer. In ovarian cancer we had a randomized trial, and we can assess the proportion of patients who relapse in each arm. The arm with immediate vaccination versus the arm with observation and vaccination at the time of relapse.
That we are really expecting in turn because indeed, measuring, I agree with you, the size of the response to a neoantigen, the proportion of CD8 T-cell specific for the neoantigen, which, as this is something we are assessing all the time, and we will of course see the bulk of data we have already published by additional data on the new patients we have enrolled.
But from my standpoint, maybe I am biased because I am a physician, but it's so important, you know, to have that supported by clinical activity. That's why we are conducting in parallel this clinical assessment of patients and along with assessment of immune response and specific CD8 response.
Is that okay for you as a response to your question?
Sure. That's very helpful. Thanks a lot.
Thank you.
The next question comes in from the line of Arsène Guekam, calling from Kepler Cheuvreux. Please go ahead.
Hello, gentlemen. Do you hear me?
Yes, we do, Arsène. Yeah.
Hello. Thank you for taking my question. I have two. First of all, I would like to know something general. You release interesting data so far from engineered drugs with your platform. On some additional data are expected soon. The main point for me is your ability to convince pharma to partner. Against this backdrop, what is your view on potential partner and when?
What kind of data do you need to sign? I saw that you recently hire a new CBO, so I think you will contribute to this objective. The second question will be more easy to answer is how do you explain the increase of G&A expense here, and what do you expect for the second half? Thank you.
Thank you for the two questions. Indeed, partnering some of the assets is one part of the strategy, but we also want to continue to create value and push some of the products forward. Every time we have data, we are also challenged, of course, to getting more and more data. We'll see every milestone can be important. We are very proud, for example, to show activity immunotherapy for our TG 4050. Here being the first on TG 4001 to bring randomized phase II data, I think could be a triggering event. We indeed already have this partnership with AstraZeneca that is very important for us.
Here we were able to have a very important partnership based in 2019, on which was more promise than really hard data at the time. Indeed we have a great new chief investigator, Steven Bloom, who is based in U.S. and already has brought us much bigger visibility in front of pharma, and I'm sure this will be transformed in the future into a very interesting deal. Jean-Philippe Del?
Yes. Concerning the increase in G&A expenses, as you have mentioned, we have recruited a new CBO, so it has a direct impact in our G&A expense as you can imagine. The second main reason is the fact that we have granted new free share last year and that had an impact in the first half of this year.
Okay. Thank you.
Thank you.
We currently have no further questions coming through. As a final reminder, if you would like to ask a question, please press star one on your telephone keypad now. There are no further questions coming through, so I shall hand the call back across to your speakers for any closing remarks. Thank you.
Thank you. Thank you for listening and your great questions today. I really believe that, with our very attractive proprietary clinical and pre-clinical product portfolio, Transgene is ideally positioned to deliver multiple milestone in the 12-18 months, and can be seen as a key innovator in immunology. We are confident that by successfully delivering our programs and strategy, we will be able to generate significant value and improve options to patients. We'll be happy to see you Sunday at ESMO for our poster by noon. Don't forget our R&D day, September 27. With this, I would like to conclude today's call. Thank you very much and goodbye.
Thank you for joining today's call. You may now disconnect your handsets.