Transcript
Speaker: Hello, and welcome to this Edison TV executive interview with OSE Immunotherapeutics. We are joined by Mark Lebozek, CEO, and Marcus Koppel, the company's chairman. Welcome both.
Speaker: Hello. Thank you, Aaron. It's a pleasure to be here. So the business focus has shifted to focus on the company's most promising programs. Before we dive into some of the details, can you remind us of this new strategic plan to create multiple opportunities for value creation? Oh, certainly, Aaron. at Last December, we presented a three-year strategic roadmap for 2026 to simple.
Speaker: its logic is simple concentrate our resources on our two late-stage assets, Lucifurkidamab and Tidopi, where we see the greatest value for our shareholders and deliver a series of catalysts along the way.
Speaker: The plan rests on four opportunities for value creation. First, the complete to complete the Artemia phase 3 trial of Tidopi in lung cancer at limited cost to the company.
Speaker: Second, take glucifilkidamab into a rare disease, chronic barchitis, as our first indication and our entry point into orphan diseases and gastroenterology. Third,
Speaker: Develop a subcutaneous formulation so that Lysverkidamab can compete in ulcerative colitis, the large indication. And fourth, maintain our scientific leadership. Tadopi gives us an independent late-stage opportunity in oncology with a phase III readout expected in early 2028.
Speaker: What ties it together is the idea that Lusvacidimab is a pipeline in a drug. One molecule with one manufacturing process, one safety database, and one patent estate can create value in several immune-mediated diseases.
Speaker: Each new indication builds on the investment we have already made. For a company our size, this is far more capital-efficient way to build a portfolio than adding molecules one at a time.
Speaker: From an execution standpoint, focus has meant clear choices. We have concentrated our teams on the programs that deliver catalysts within the plan, and every euro we spend is tied to a milestone.
Speaker: At the same time, our research engine continues to generate the signs for future rare and large indications at limited cost. Fantastic. So it is particularly exciting to see the broader plans for lestratikimab. Could you summarize its latest results in the clinic in ulcerative colitis and outline how the subcutaneous formulation is progressing?
Speaker: Yeah, yeah, of course. So we ah released data ah last year in 2025 on a phase two, which is called cotikis on 134 patients, and which is and ah quite a significant ah proof of concept a clinical trial. And what is extremely positive, that's not just me who said that, but also the KOLs like ah ah Bruce Sands at Mount Sinai Hospital or Laurent Perrin-Biroulet at Northwestern, is that the beauty of lucebatequimab, it has delivered efficacy on all the parameters and in two doses at 450 milligrams and 850 milligrams compared to placebo. And what is absolutely ah amazing is that the long on the long term, ah this product is working better and better.
Speaker: So the beauty of it is that it's a pure antagonist of IL-7 receptor. So it binds to the receptor and it stays there. So we have a series of data regarding the receptor occupancy.
Speaker: meaning that this compound stays there for a long time. And the beauty of it is that it's not targeting anything else, like yeah typically what is called the healthy immune system that helps the and the body to recover, so the tissue to recover. And that's exactly what we have observed in this phase two on 134 patients.
Speaker: and thirty four patients So now we're preparing a subcutaneous formulation because all those data have been gathered through an ah intravenous formulation, and which was great. But the challenge is that now patients yeah in those in this large indication, which is ulcerative colitis, have access whether to oral formulation or to subcutaneous formulation. And of course, this is way more comfortable for them to have whether oral or subcutaneous. So we have initiated that. It will be clinically validated at the end of the second quarter of 2027. And once we have that, then ah we could ah reopen the discussion with series of ah big pharmaceutical companies we have talked to in 2025. which we're super interested in ah backing up in the further clinical trials in Yosetopicholitis, but with a subcutaneous formulation.
Speaker: Excellent. Thank you. We understand as well that there is a strong rationale for Lusfetikimab's expansion into chronic pouchitis. So could you outline some of the plans there for the phase two trial?
Speaker: Yeah, a chronic cruchitis is a great opportunity because typically there is no FDA approved drug ah for the moment. There is one drug which is approved in Europe.
Speaker: It's a a drug room and developed by um a Japanese pharmaceutical company. ah with some ah toxicity issues and with some limited also efficacy. ah The rationale for Lusvertikimab in Pouchaitis at scientific level is very strong.
Speaker: ah We know that there is an overexpression of this ah receptor, of the IL-7 receptor in this context of Pouchaitis. ah The population we're targeting is about 45,000 patients in Europe, US, and Japan. ah And it's a rare indication. So it means that probably if we're successful in clinical development, we could get a price that would be appealing ah for us. So the plan that we have ah set and that is about to to be launched is to do a first proof of concept trial that would deliver data, ah ah the first data by the end of 2027. So in in know and about a year. So it's very it's very um appealing to ah to us because ah this is consistent with the stock market timing. It's a 47 patient and a clinical trial. We make a first cohort of 17 patients.
Speaker: And if we have at least one ah positive event, then we move to the next stage. So this is where where we are today. We have built this plan with a group of KOLs, about 12 KOLs, who are supporting the the the product itself and also the the the choice of Puchitis, which is clearly an unmet medical need today.
Speaker: Okay, so taking a step back now, cancer vaccines have been in the headlines recently with the encouraging readout from Moderna-Merc. That was a personalized vaccine, though, whereas Tadopi, we understand, is off the shelf. So what read across, if any, is there to OSE's lead cancer vaccine program? And how is that program progressing?
Speaker: The two approaches are very different. The Moderna and the MAC product is an individualized mRNA-based therapy manufactured for each patient from their own tumor, and it was tested after surgery melanoma.
Speaker: Tadopi is an off-the-shelf vaccine of 10 optimized neoepitopes targeting tumor antigens shared across several cancers for patients who carry an HLA-2 marker.
Speaker: So, the direct read-across is limited. Artemia Our pivotal phase 3 trial compares DDoPi to Duxentacel and 363 HLA-positive patients with metastatic non-small cell lung cancer and secondary resistance to immune checkpoint inhibitors.
Speaker: Enrollment is on track to complete by the end of this year. The futility analysis is event-driven, and because death events have occurred more slowly than expected, it is now planned for the first quarter of 2027. Top-line results are still expected in
Speaker: What the Moderna and Merck results do, does tell us, is important. After many years of skepticism, a cancer vaccine has succeeded in a phase three trial. That supports the principle behind Tadopi.
Speaker: And an off-the-shelf vaccine has real practical advantage. There is no need to sequence each tumor or wait for individual manufacturing, which matters for patients with advanced disease, and it scales far more easily.
Speaker: I believe Tadopi remains underappreciated. Beyond artemia, the TDOFA phase two triad in recurrent ovarian cancer met its primary endpoint with TDOPE in combination with pembrolizumab.
Speaker: The COMBITET phase two results in lung cancer will be presented at ESMO in October and patients already have access to TDOPE through an early access program, mainly in France.
Speaker: So finally, in your own words, could you outline the key upcoming catalysts that investors should watch out for across the next 12 to 18 months? Yes, sure. And this is one of the beauty of this ah of this company and and the the reason why I have joined as CEO last year. So just a a quick look back at what the we have announced since I joined as a CEO. We have identified new indications for our leader compound, Luce Verti Kimab.
Speaker: We have ah had ah an IDMC independent data monitoring committee for pivotal phase three artemia with our immunotherapy in cancer.
Speaker: and We have ah issued a positive readout in ovarian cancer at ASCO ah in May 2026. and We have secured a bridge financing to prepare a further equity raise ah in June. So we have announced that in June.
Speaker: And ah we also have a positive um and announcement from a a clinical partner ah program with Veloxys. So that's a rich news through since ah the the beginning of the of the year.
Speaker: And for the next 12 to 18 months, we'll have a lot of things to to to share with with you. In a few days, we'll have and an additional phase two readout, which is called COMBITED, that will be presented orally at to ESMO this time, so the European Oncology Congress.
Speaker: And that would be the second time that we have an oral presentation in a national congress, the first time at ASCO for ovarian cancer, and in October ah for a committee in non-small cell lung cancer.
Speaker: So we're very proud of that. and Then we'll have give the full enrollment of patients of artimia by the end of the year. and which is absolutely ah fantastic. It's 363 patients. So it's ah it's ah once again, it's a registrational phase three.
Speaker: In the first quarter, we'll launch the chronic chuchitis clinical trial. So that that will be a new announcement. ah Then we'll have ah in in the in the first quarter ah the interim analysis um the for futility in artemia, our cancer vaccine, in non-small standalone cancer.
Speaker: and In June, we'll have ah the subcutaneous formulation ah validation, clinical validation on healthy volunteers. ah and And then we'll have the um the final ah the interim readout of chronic fruichitis in the second half of the year. so and And then, of course, in 2028, the final readout of Artemia, our registrational phase three. So this is a very rich news flow. And assuming that we have ah enough capital to do so, we could generate a lot of additional data thanks to those two compounds, which have the capacity to ah address ah so multiple indications.
Speaker: Excellent. Well, we're very much looking forward to following the progress. That brings us to a close, but if our audience would like to learn more, we direct them to the Edison website where our research is freely accessible. Mark, Marcus, thank you both for your time today.
Speaker: Thank you so much. Have a great day. It's been a pleasure. Thank you.
