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120. Bull, Bear & Beyond – OSE Immunotherapeutics executive interview
5 Plays4 months ago
In this interview, Silvia Comis MD, chief clinical and medical research officer at OSE Immunotherapeutics, covers the company’s lead immuno-oncology candidate, Tedopi. She outlines the current unmet need in non-small cell lung cancer, as well as Tedopi’s clinical track record to date. She also discusses the ongoing registrational Phase III ARTEMIA programme, alongside several other Phase II programmes in different indications run by various academic groups. 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:
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Original interview published on 08/09/2025 and reposted as a podcast
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Transcript
Introduction to OSA Immunotherapeutics
00:00:07
Speaker
Hello and welcome to another Edison TV executive interview. My name is Aaron Atkar and I'm a healthcare care analyst here at Edison. Today we're joined by Dr. Sylvia Comis, Chief Clinical and Medical Research Officer at OSA Immunotherapeutics.
00:00:21
Speaker
OSA is a French biotechnology company focused on developing and partnering therapies in the highly promising therapeutic areas of immuno-oncology and immunoinflammation. Welcome, Sylvia. Hello.
00:00:33
Speaker
Great to be here today.
Exploration of Tadopi: OSA's Lead Program
00:00:36
Speaker
So as we've covered in our recent contents, OSA has a broad and diverse clinical development pipeline. But today we're going to focus on the lead immuno-oncology program, Tadopi.
00:00:46
Speaker
But before we get into that, Sylvia, to kick things off, can you briefly introduce yourself, your background, and tell us what originally drew you to work at OSA Immunotherapeutics? Hello, I'm Silvia Comis, Chief Clinical and Medical Research Officer at OSA Immunotherapeutics. I am a doctor by training.
00:01:04
Speaker
I worked in the pharmaceutical industry for around 30 years. in a range of international roles focused on clinical research and drug development, as well as the world evidence and medical affairs. I worked in various areas, including hematology, endocrinology, but my main focus for much of my career and has been oncology and particularly immuno-oncology.
00:01:36
Speaker
I joined OSE in December 2021. ah Because of the innovative thinking, I saw behind that immune oncology pipeline.
00:01:50
Speaker
And i saw a great potential here to make a difference for people living with some of the most devastating forms of cancer.
00:02:03
Speaker
as well as how that understanding of the immune mediated processes could also stimulate breakthroughs in other disease areas driven by this regulation of the immune system.
Non-Small Cell Lung Cancer Landscape
00:02:18
Speaker
So turning now to OSE's pipeline activities, could you outline the current treatment landscape in non-small cell lung cancer and touch upon some of the key unmet needs in the space?
00:02:30
Speaker
Nosumal cell lung cancer is the main indication we are leading with for Tedopi, primarily as a secondary line second line bonotherapy for ah patients with the HLA2 phenotype but with no actionable oncogenic drivers.
00:02:49
Speaker
We believe Tedopi has the potential to become a new standard of care for for these people. ah Lung cancer is an area of high unmet need worldwide because of its high incidence and high mortality with over 2.2 million of new cases diagnosed each year. And around 85% of these cases are no small cell lung cancers. Late diagnosis is a problem. More than 65% of subjects are diagnosed in stage three or four.
00:03:31
Speaker
And as a result, um around 18% all cancer deaths are due to lung cancer. Looking more specifically at the the US, EU5, Japan and China, by 2030, we are anticipating around 350k people per year to be on second line.
00:03:58
Speaker
therapy which is typically docetaxel, despite its limited efficacy and high toxicity. And of these people, around 220K would be expected ah to have progressed after at least six months of chemotherapy and immunotherapy with around 100,000 of them with the HLA2 phenotype. So that would be our population of interest.
Market Potential for Tadopi
00:04:29
Speaker
So looking now at the commercial side of things, what could be the market's opportunity for the lead immuno-oncology candidate Tadopi should it be successful with regulatory approval?
00:04:41
Speaker
ah There are many varied estimates of the total nosmosellin cancer market value in the early 2030s, ranging from more than $40 billion dollars to more than $66 billion. With Tadopi, we are aiming to treat a specific group within ah that population, the 100,000 people, and i just um I just mentioned, of course, in major and markets.
00:05:17
Speaker
It's complex to estimate the commercial ah value of treating that specific group of patients, considering trends in incidence, prevalence, outcomes, and the evolving and situation for treatment guidelines and reimbursement policies in different countries, in fact. So this is something we would look to refine with a commercial partner as we continue development of TIDOP in the coming years, working towards regulatory submission.
00:06:00
Speaker
Fantastic.
Tadopi's Mechanism and Benefits
00:06:01
Speaker
Could you talk to us now about TIDOPI's unique mechanism of action, the significance of it being in an off the shelf cancer vaccine, and then maybe touch upon some highlights from the clinical data obtained to date?
00:06:14
Speaker
TIDOPI is an off the shelf cancer vaccine, the most advanced cancer vaccine in clinical ah development. It can be used ah by patients who are HLA2 positive, which is around 45% population.
00:06:32
Speaker
Importantly, it does not need just-in-time production, requiring a tumor biopsy from each individual ah patient, giving advantages in terms of speed, cost, quality of life for patients.
00:06:48
Speaker
subjects for patients. Tedopi works by combining nine optimized neo-epitops, specific and peptide ah sequences of five tumor associated antigens that are frequently expressed in various types of cancers and these epitopes are key holes that are recognized by the t-cells of the immune system
00:07:27
Speaker
And these cells are supported ah by a 10th epitope that promotes universal TL pair response. This mechanism of directly activating T cells against the target cancer cell expressing these specific antigens is different, distinct from checkpoint inhibitors, which release the break of the immune system more generally. So a more broadly activation of the immune system, such as with the checkpoint inhibitors, on the other hand, can also lead to greater risk of of immune related adverse events so where the immune system can also potentially attack healthy tissues and organs. This means
00:08:26
Speaker
There is a strong rationale and to use Tadopi for people who have developed the secondary resistance after ah experiencing durable ah benefit with checkpoint inhibitors.
00:08:44
Speaker
Excellent.
Artemia Phase III Trial Updates
00:08:45
Speaker
So with Tadopi being OSC's most advanced clinical candidate, could you now update us on the current status of the programme?
00:08:54
Speaker
Our Artemia phase III clinical trial is is ongoing. As we reported at ASCO earlier this year, ah we we are making good progress on our plans to and recruit ah and at least participants across ah and more than in the Europe, of course, in the United States and in Canada. And these this is a key study for the registration of the DOPI as a second line monotherapy treatment in patients with no small cell lung cancer who have developed a secondary resistance to anti-PD-1, anti-PD-L1 immunotherapy and who have, of course, HLA-2 phenotype.
00:09:52
Speaker
The study is on track to collect the overall survival information by the end of 2027. And after cleaning and analysis of these data, we plan ah to report the top line findings in the first half of 2028.
00:10:18
Speaker
Artemia was built ah on positive findings in... third line obtained with the top in third line in osmo cell lung cancer and while tedopi was ah and concluded had those kids early because of the outbreak of the pandemic the analysis of ah data showed that a significant overall survival benefit with good quality of life compared to standard of care chemotherapies in patients with secondary resistance to checkpoint inhibitors.
00:11:08
Speaker
And that beyond this key study, Artemia. ah We ah work also with academic groups that are studying TIDOPI in three phase two clinical trials.
00:11:30
Speaker
In um a similar population in osmose cell lung cancer for one of these trials, however, including different lymphoma, artemia, also some patients with a more aggressive disease. and This will be Tedopi in combination with nivolumab or docetac cell. In another study in ah ovarian cancer,
00:12:00
Speaker
The group is investigating the therapy as monotherapy or in combination as maintenance therapy for ovarian cancer patients. other hand, at ASCO earlier year,
00:12:13
Speaker
on the other hand at oco earlier this year The top line findings on one year overall survival were presented for the the other study in pancreatic cancer in combination with Fulfiri, again, as maintenance ah therapy.
00:12:33
Speaker
Fantastic.
Key Upcoming Milestones for Tadopi
00:12:34
Speaker
So you've touched upon it a little bit just there. But before we wrap up today, could you just succinctly summarize some of the key upcoming catalysts and milestones for Tudopi that investors should watch out for?
00:12:46
Speaker
In 2026, we can expect the the readout of two phase two trials. For TED-OVA in ovarian cancer, this will be in Q2, 2026. And for COMBITED in non-small cell lung cancer in the second half of 2026.
00:13:13
Speaker
and We can also expect further ah reports on the progress of the Pivotal Artemia Study through 2026. As I mentioned, ah we plan ah to conclude that the the collection ah of overall survival information by the end of 2027 with top line findings to be reported in the first half 2028. So we have a lot to to look forward to with the TIDOPI over the next couple of years.
00:13:59
Speaker
And the nose muscle and cancer indication in particular, as said, is an area of high unmet need. ah And I am excited to see how the potential of TIDOPI will translate into positive clinical trial results.
00:14:24
Speaker
Thank you, Sylvia. It's been great to hear your thoughts. And, you know, we look we look forward to following the progress of the programmes.
Finding More Information on OSA Immunotherapeutics
00:14:30
Speaker
If our audience would like to learn more, please refer to our research on OSCE, which is freely accessible at edisongroup.com or refer to the OSCE website.
00:14:39
Speaker
Sylvia, thanks again for the discussion today. Thank you.