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117. Bull, Bear & Beyond – OSE Immunotherapeutics executive interview
5 Plays4 months ago
In this interview, Sonya Montgomery, chief development officer at OSE Immunotherapeutics, covers the company’s lead immuno-inflammation candidate, lusvertikimab. She outlines the current unmet need in the therapeutic areas of ulcerative colitis and inflammatory bowel disease, as well as lusvertikimab’s clinical track record to date. She also discusses potential next steps for the programme, including OSE’s recently announced predictive biomarker, the potential of lusvertikimab to overcome the current therapeutic ceiling, and what a precision medicine approach might look like. She concludes by highlighting the key upcoming catalysts and milestones that investors should watch out for.
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About ‘Bull, Bear & Beyond’
Bull, Bear & Beyond': features candid conversations with senior executives and from our own team of experts from across industries, exploring strategy, innovation, and the opportunities shaping their markets and 60-second pieces are a compressed summary of content designed to convey our message in a single, easily shareable hit.
About Edison:
Edison is a content-led IR business. We believe quality investment content should inform all investors, not just brokers. Our mission: engage and build bigger, better-informed investor audiences for our clients.
Edison covers 50+ investment trusts, read about them here: https://www.edisongroup.com/equities/investment-companies/
Original interview published on 01/09/2025 and reposted as a podcast
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Transcript
Introduction and Guest Welcome
00:00:07
Speaker
Hello and welcome to Edison TV. My name is Aaron Atkar and I'm a healthcare care analyst here at Edison. We're joined today by Dr Sonia Montgomery, Chief Development Officer here at OSC Immunotherapeutics.
00:00:18
Speaker
OSC is a French-based biotech company covering the broad areas of immuno-oncology and immuno-inflammation. Welcome Sonia. Hello, nice
Focusing on Lusvetikimab
00:00:26
Speaker
to join you. Thanks. So going to focus today on OSC's lead inflammation program, Lusvetikimab.
00:00:32
Speaker
But before we get into that, Sonia, first, could you briefly introduce yourself, your background and tell us what drew you to OSC?
Dr. Montgomery's Career and Role at OSE
00:00:39
Speaker
Sure. I'm Dr. Sonia Montgomery. I'm Chief Development Officer at Oseanian Air Therapeutics.
00:00:44
Speaker
Throughout my career, I've led clinical development and translational medicine at both large pharma and smaller biotechs, both in North America and here in Europe. Over the past 20 years, I've designed and delivered development programs to study new therapies from bench to bed bedside and And these have included therapies such as small molecules and biologics, as well as genetic therapies and advanced therapies. um I think my focus has been really looking at diseases where there's true unmet medical need. And I've also had the opportunity to collaborate with partnerships and with large pharma, as well as with institutions such as Oxford University and Karolinska Institute.
00:01:28
Speaker
Since joining OSEA Mino Therapeutics, I've had oversight to the portfolio strategy, which allows me the opportunity to balance the portfolio and also to look to generate value for our key stakeholders, which includes both both investors as well as, of course, patients. And I think what really attracted me to OSE was being able to come in and work in immunointheric immunotherapies with a company who has this really deep expertise in that area that's delivering a first in class set of pipeline opportunities and and in and using a technical innovation. OK, sounds good.
00:02:05
Speaker
So what would you say is OSE's main area of opportunity?
Therapeutic Potential for Ulcerative Colitis
00:02:09
Speaker
I think the appeal for me is that we have the ability to deliver therapies with new technologies that are novel mechanisms of action that can either activate or downregulate the immune system and help these patients with true unmet need.
00:02:23
Speaker
So turning now to OSE's main pipeline activities, can you talk us through the unmet need in ulcerative colitis and IBD? Sure, ulcerative colitis or UC is what's known as an inflammatory bowel disease or an IBD. And patients um generally are diagnosed when they're young adults and that can continue throughout their life.
00:02:44
Speaker
They are very much impacted by physical symptoms and they also experience a higher risk of colorectal cancer that's associated with the severity of their disease or the amount of inflammation. So hence we look for therapies that can target and address that inflammation.
00:03:00
Speaker
um There's about 5 million people with UC worldwide, um of which about three oh more than 3 million are in Europe and Japan. um And about half of those are living with what we describe as moderate to severe disease, which means it's really impactful on their day-to-day life. um There's many ah new therapies, new agents that are being developed to address this immune inflammation. um However, there's a widely acknowledged therapeutic ceiling where only 25 to of patients who are treated with these agents experience clinical remission with their first with their first line of treatment. And then of those, only about half of them are able to maintain that benefit over time. and maintain that remission. So there's there is still a good amount of of on that need.
00:03:50
Speaker
Perfect. So following on from this, can you talk to us about the potential market opportunity in the
Market Potential for Ulcerative Colitis Therapies
00:03:55
Speaker
space? From a commercial perspective, estimates put the market at over $7 billion with a 4% compound annual growth rate. So it's ah it's a disease that's expanding and increasing in diagnosis um across the world. um There are other factors that impact the disease, such as genetics or environmental conditions for patients, so that you know the way that they their lifestyle and or where they live. Sure. um So there's not there's not one line of ah of of therapy that will solve this for all patients. So so there are there are there is space for multiple lines of therapies. and However, um you know if you can have a treatment that's established as a first line treatment, That would, of course, provide a significant advantage from a commercial perspective.
00:04:39
Speaker
um Based on OZE's research so far, we believe Lusvetikimab has the potential to represent an opportunity of up to three billion across seven major markets by focusing on as a first line therapy and potential subpopulations.
Lusvetikimab's Phase II Trial Results
00:04:53
Speaker
So Lusvetikimab recently completed a phase two trial in ulcerative colitis.
00:04:59
Speaker
you talk us through some of the key takeaways from from from that trial? Absolutely. We studied Lusveticumab in the Coticus Phase II clinical trial, and we included 134 people who had that moderate severe ulcerative colitis definition, so patients with ongoing symptoms who had not responded to either the standard of care or to biologics.
00:05:21
Speaker
um We had an induction phase of 10 weeks where patients received either a low dose or a high dose of Lusfetikuma, 450 milligrams or 850 milligrams or placebo. And we had those patients were randomized. We then assess them at the start and then at week 10 and look to see how their disease progressed over that 10 weeks. um What we found was that we had a clinically and statistically meaningful result at week 10, where on the primary endpoint, so the the endpoint for efficacy that we assessed, which was the modified Mayo score, we saw a difference in the combined population of the Lisfratikima patients of a drop in one point on severity
00:06:02
Speaker
on that um MMS score as compared to placebo, so patients who are not receiving any any additional therapy. um We also looked at clinical remission, and that is the both the symptoms that patients are experiencing as well as looking at, you know, is there healing in their um colon tissue, so looking on biopsy. And um at 10 weeks, we saw that 16% of patients who received Luzriticumab saw that clinical remission of their symptoms, and only 4% of the placebo patients experienced that. So there was a nice difference and a clinically meaningful difference between our treated population of Luzriticumab and the placebo group.
00:06:40
Speaker
um We then offered to patients um the opportunity to continue if they chose and do an open, what's called an open label extension. And at that point, all patients went on to the high dose of Lisfiticumab, the 850 milligrams. Almost all patients chose to continue, which we like on which we like to see.
00:06:58
Speaker
um and ah and And then after that further 24 weeks of of treatment at the high dose, we saw that more than 90% of the people who had resolved their symptoms at the end of the induction phase or at that week 10 time point maintained that remission of symptoms through that extra six months. And that um ah those who hadn't responded at, 61% of those who hadn't responded at week 10 did actually manage to achieve symptomatic remission in ah in that in that population on one receiving luzriticumab at the high dose. um We saw also when we looked at the placebo patients, and they then started on for the first time luzriticumab at that week 10 time point, then continued for an additional 24 weeks on luzriticumab, 82% of those patients achieved symptomatic remission by the end of the OLE.
00:07:49
Speaker
um We also, of course, really important to assess safety and tolerability in in a clinical study. And um we saw that there was no difference to placebo in um a serious adverse events through the induction phase. And we also saw a similar good safety profile throughout that open label extension period with all patients on the high dose.
00:08:11
Speaker
I would say the takeaway for me of that open label extension is that we continue to see benefit on symptoms through week 14 and then nice maintenance throughout that additional six months.
New Biomarker for Clinical Response
00:08:22
Speaker
Okay. So looking ahead, can you talk to us about the predictive biomarker potential to overcome the therapeutic sealing and what a precision medicine approach might look like? Yes. So we announced in June of 25, so this year, um a new biomarker that we've identified that um when we see it positive in a subpopulation is predictive of a higher clinical response based on the Cotique's data.
00:08:49
Speaker
ah We have research and translational groups that um took a foundational model and utilized data, a broad amount, millions of patients' data with an inflammatory disease um diagnosis and trained it using um AI, and then from that, utilized the data from the Kotika study to be able to characterize a predictive biomarker that supported clinical remission in these patients.
00:09:18
Speaker
We found that of the 30% of the patients who in the study had this positive predictive biomarker, they had a 59% rate of clinical remission, which when we compare to that therapeutic ceiling of 25% to 30%, obviously is is a much higher population percentage. um Importantly, no one who was negative for the biomarker experienced clinical remission in that first 10 weeks. So I think what's what's that sensitivity of that biomarker supports that patients wouldn't, by being selected with the biomarker, necessarily miss out on an opportunity for treatment. So I think that's quite important when you're developing a biomarker. um I think it also kind of reinforces or supports the potential for lizardicumab as a first-line therapy in that subpopulation and as a monotherapy. um And with... the commercial advantage that that it brings to to a company.
00:10:15
Speaker
So thanks very much.
Future Developments for Lusvetikimab
00:10:17
Speaker
Before we wrap up today, could you just briefly summarise for us the key upcoming catalysts that investors should watch out for? Well, looking specifically at this reticumab, we are taking all of the data that we've acquired through our Phase II program, including the predictive biomarker data, and we are developing the next program, a Phase II B study, where we would look to ah characterize the dosing regimen and dose, um look to integrate subcutaneous formulation into the program, And subject to securing necessary financing, of course. And we'd also look to confirm this predictive biomarker and see, you know, across the broad population, do we, you know, what does our clinical remission rates look like, as well as do we then confirm that we have this subpopulation where we can achieve this breakthrough population. therapeutic sealing. As, of course, ah progressing to pivotal studies is more costly and they're much bigger, on generating the state in a Phase 2b study would support partnering through those Phase 3 pivotal programs that would then lead to potential for registration.
00:11:26
Speaker
Great. So what does this all add up to for Lusvitikimab?
Lusvetikimab's Market Differentiation
00:11:30
Speaker
With the data we have generated to date, we are confident that this multi-billion dollar market segment is one with potential for a differentiated new novel mechanism of action ah therapy like Lusvitikimab.
00:11:43
Speaker
Thanks very much. That's all the time we have today. But if our audience would like to learn more, please take a look at the research we have accessible at eddistongroup.com. Sonia, thanks very much for joining me today. Lovely speak you.
00:11:53
Speaker
Bye. Thanks.