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5. Bull, Bear & Beyond – Medigene: executive interview
6 Plays1 year ago
Medigene (FSE: MDG1) is a publicly listed, Germany-based, immuno-oncology platform company focused on the development of T cell receptor (TCR)-guided therapies with the aim of effectively eliminating cancer. Medigene has a broad and active pipeline focused on a range of modalities. Notably, lead programme MDG1015 is a first-in-class, third-generation T cell receptor-engineered T cell (TCR-T) therapy, for which, the company recently received US FDA clearance for its investigational new drug application for multiple solid tumour indications. MDG1015 is expected to enter the clinic by end-2024, subject to additional financing.
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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 30/09/2024 and reposted as a podcast
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Transcript
Introduction to Metagene and Leadership
00:00:07
Speaker
Hello, I'm Sue Romanoff from Edison Group. Today I'm joined by Kirstie Crame, MD, the Head of Clinical Strategy and Development of Metagene, a German biotech with a platform focused on immunotherapies.
00:00:20
Speaker
Welcome, Dr. Crame. Thank you so much for the introduction, Sue. So Metagene is a leader in the field of precision immuno ah immunology, developing TCR-guided therapies for cancer.
00:00:34
Speaker
Could you highlight how you're differentiated? Absolutely. Thank you for the question. I think what's very differentiating about Metagene, and that's kind of where it all starts from, is that we have quite a long history. The company was founded 1994. And in 2014, our current CSO, Professor Dolores Schindel, came on board and really developed the company into what we are doing now, focusing on precision oncology and targeted immunotherapy.
00:01:02
Speaker
And she's really dedicated her whole life to understanding deep T cell biology, tumor immunology, and that really shines through in all the work that we do now.
Innovations in TCRs and Collaborations
00:01:14
Speaker
think our thresholds, benchmarks, and the standards that we uphold within the company when we deliver natural TCRs with exceptional safety, specificity, and sensitivity um is something very unique.
00:01:28
Speaker
And the reproducibility of our data, being able to deliver not one TCR against one HLA type, but one TCR, and I should probably tell you T cell receptor, um against ah multiple targets. um And they all deliver this high sensitivity, spensivicity, and safety. It's very unique.
00:01:47
Speaker
And I think that this is supported by the partnerships that we have with BioNTech, Regeneron, and Wishi Biologics, which was most recently announced, which really supports the value of these TCRs that we find.
00:02:02
Speaker
And we also have some very... partnerships with very renowned institutions, academic institutions like the Helmholtz in Munich, the Technologian University in Munich, and the NIH, the National Institute of Health in the US, where we have close collaborations and really working with great scientific minds.
00:02:20
Speaker
And then in addition to this, we have a very broad and modular end-to-end platform that supports us in all the work that we do, but hopefully we can touch upon that later.
Focus on TCR-Guided Therapies
00:02:29
Speaker
So you have an active pipeline. Could you provide an overview of your key programs?
00:02:36
Speaker
Absolutely. So I think maybe just take one step back first before I answer your question. So we really focus on TCR guided therapies and multiple modalities that are guided by cell receptors because T cell receptors have this ability to very specifically and very sensitive sensitively target those tumor cells and whatever is coupled to the TCR will get delivered to the tumor side.
00:03:01
Speaker
And cancer as disease is not a disease that, unless you are one of the patient's with very early stage disease when you are diagnosed, that goes away or is really cured by one modality. So we need multiple modalities and each patient might need their own sequence of modalities to really get to a deep remission or potentially a cure in the future. And that's what we're all waiting for.
00:03:26
Speaker
So we developed these T cell receptor guided therapies and we've over the past years mainly focused on cell therapies.
Therapy Programs Overview
00:03:35
Speaker
That is our 1015 program, which targets certain protein called cancer testis antigens. And then our KRAS program, which is our 20XX program, which is a different type of protein expressed in tumor cells that T cell receptors can target.
00:03:48
Speaker
And those were both in autologous settings, so where we use patients' own cells ah to add our TCR to, and then we give them back to the patient as a treatment. We've recently announced that we're also looking at the allergenic setting, and that means that we can use healthy donor cells to add our T cell receptors to. And this just means that we can have the therapy available quicker for patients because we don't have to harvest patient cells first before we go there.
00:04:15
Speaker
And the third modality that we're we've announced working on and our most recent collaboration with Bushy Biologics focuses on T cell receptor T cell engagers. So where we're trying to couple the patient's own immune system with our TCRs to the tumor. So really directing the immune system where to go.
00:04:36
Speaker
And that's the extent of our pipeline currently announced. We're very excited if I can elaborate a little bit more on our lead program, which is MediGene 1015 with our recent IND approval, which is in the in the US. We've granted approval by the regulatory authorities there to move this project to the clinic.
00:04:55
Speaker
And we'll be looking to open this the the clinical study by the end of this year. We've had a really smooth interaction with the FDA, which is the regulatory authority in in the US, which was great to see that they're also poised to move these therapies to patients.
00:05:14
Speaker
And we've seen really the promise that these TCRT therapies hold with approval of TIL therapy, which are non-engineered cells in 2023. Yes, 2023.
00:05:27
Speaker
three yes twenty twenty three And then recently, this year, the first TCRT therapy that was approved in solid tumors, which shows really the ability that these cells have and and might give to patients. But we also saw from that clinical data that there is a clear need to improve ah both the depth and duration of the responses provided to patients.
00:05:48
Speaker
and But we also want to move beyond orphan indications, and orphan indications are very rare indications that affect very few patients each year. And to give an example, the approval targets about 1,000 patients annually in in the U.S. alone. And Medigine 1015 will be able to target 200,000 patients globally um if we see that it works, of course, in all those indications.
00:06:13
Speaker
But I think that's a very differentiating thing for that therapy. To speak a little bit about the therapy itself, it's a... first first, sorry, third generation, really first in class therapy where we not only use a naked TCR, but we give that TCR and the the T cells that it's on really armoring and enhancement because tumor microenvironment, so the tumor itself, really has the ability to stop your immune system from working. And we need it to work because we need it to clear the tumor.
00:06:43
Speaker
So by adding armoring and enhancement elements to this therapy, we're able to help these cells exert their function when they get to the tumor. And a third thing that this therapy really focuses on is what we call the drug product. So after we have harvested the cells, we have put the TCR onto the cells, you need to make sure that these cells are really still fit and able to exert their function. It's a living therapy cell therapy, which is incredibly exciting, but you need to take care of for the cells that you're giving back to the patient.
00:07:13
Speaker
So by the way that we manufacture these cells, we do this in a very short timeframe, which of course is good to patients because the quicker they can get treatment, the better. um But also it makes that we have this really unique drug product composition as we refer to it with very fit cells. So I think that is the novelty and differentiation of this specific therapy.
00:07:35
Speaker
Broader indications, armoring and enhancement are unique TCRs and then that drug product composition So this this got us very excited and we've really seen when we speak to investigators that this is also resonates with the investigators in the sites. And we've been really um incredibly fortunate to ah be able to announce at least here that one of the sites that we'll be working on, ah working with is the Fred Hutch Cancer Institute in in Seattle, which is a very renowned cancer institute and our PI, Dr. Zen, is the associate professor there and in the University of Washington as well. So um really a key opinion leader in the field that will be leading the efforts in the US on this trial. So very excited to move this program to the clinic and work with the sites there.
Platform Adaptations and Partnerships
00:08:27
Speaker
so So you have this exciting end-to-end platform addressing the challenges and the development of TCRT therapies. Can you share some of its capabilities and how it's different from your competitors?
00:08:40
Speaker
Definitely. Thank you for the question. um our end-to-end platform is really modular so we can apply it through all the stages of development where we're working. um It's also important that it's not a fixed platform that remains the same throughout the years.
00:08:57
Speaker
It really keeps up with the state of art. You can see in our recent years how much publications have come out and how much new technologies have been added to support really efficient ways of generating TCRs and T cell receptors or supporting the ah multiple modalities all through a manufacturing all the way through clinical development.
00:09:21
Speaker
And as an example, we recently announced our Unitope and Tracker, which is a very noble way of being able to identify specifically cells that express our T cell receptors. And this can be done in different ways.
00:09:37
Speaker
and It was never 100% accurate. And this is a very new approach. state-of-the-art technology that has allows us to accurately track these cells. And this is very important because this is a question that we get more and more from regulators with more and more scrutiny. that during During development, we're able to specifically tell which cells are the ones that express a receptor, which don't. And we can take it all the way through clinical development. And in the future, we'll be able to say within patients,
00:10:03
Speaker
how many cells wear our cells through this technology. So it's just an example of one of the technologies that really supports um the development and through all the way that we do from targeted identification, tc TCR generation, through to clinical development.
00:10:20
Speaker
Yeah, and you touched on this a little bit, but, ah you know, congratulations on your partnered programs with Regeneron, BioNTech, and also with WUJI Biologics. I think that external validation is really helpful and encouraging in this tough macro environment.
00:10:37
Speaker
Could you ah provide a background on some of these programs? Certainly. so we're indeed very proud to have such partners and scientific minds that support what we already believe and and see in our labs.
00:10:53
Speaker
For the Beyond Tech deal, we have a multi-year, multi-TCR collaboration with Beyond Tech who really see the value of our TCRs and who will, or who is planning to move at least one of our prime TCRs into the clinic.
00:11:07
Speaker
With Regeneron, we also work on the cell therapy side where one of our mage TCRs is currently in the clinic in Asia through JW Therapeutics. And we're very interested to see a clinical data coming out from that trial, which again will very much support our but yeah how our TCRs function in the clinic, which is of course what we're doing this for.
00:11:29
Speaker
And then our most newly announced collaboration with WUSHI Biologics is our Medagine 3010 program. where we're able to really benefit from complementary expertise on our side with the 3STCRs and their WUSHI proprietary platforms. Again, having multiple modalities is incredibly important for cancer patients, and they'll be guided by our TCRs, which we consider to be optimal binders, and will be very sensitive and specific in finding those tumor cells.
00:11:57
Speaker
Right. I mean, you're you're pretty busy, so we've covered a lot. ah is Is there a way you can briefly recap some of the key milestones and catalyst investors should look for in the next 12 18 months?
Future Milestones and Clinical Trials
00:12:09
Speaker
Yes, I think I'm incredibly excited about the the upcoming year, year and a half. As Head of Clinical Development, having a first program with MediGin 1015 going to the clinic end of this year is something I very much look forward to.
00:12:25
Speaker
So the clinical data that we're targeting, the early clinical data from that trial, we're targeting to announce near the end of 2025, which will be a big milestone for the company.
00:12:36
Speaker
Also advancing our KRAS library, which is the other autologist cell therapy programs that we have in our pipeline. We'll be advancing those towards IND stage, now where we'll make certain announcements about achievements along the way.
00:12:50
Speaker
For the 3010 program with WISHI Biologics, the outcome of our proof of principle study, we'll be talking about that in the in the upcoming half year to a year and further updates on our partnering with both strategics and renowned academic institutions. I think we have some really exciting things that we'll be able to talk about more in future.
00:13:11
Speaker
Yeah, I'm looking forward to those. Thank you, Dr. Crane, for the update. Thank you all for joining us here today. If you'd like to learn more about Medigine, please refer to edisongroup.com. Thank you. Thank you so much, Sue.
00:13:22
Speaker
Thanks.