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1. Percheron Therapeutics – executive interview
5 Plays3 days ago
How attacks play outIn this interview, Percheron Therapeutics CEO Dr James Garner discusses the company’s recent pivot to immuno-oncology and the rationale for licensing HMBD-002 as its lead programme. He outlines the potential of HMBD-002 as a novel VISTA-targeting checkpoint inhibitor, its differentiated positioning and the positive preclinical and clinical data reported to date. Dr Garner provides further insight into the ongoing preparatory work for the upcoming Phase II trials in 2026. He also discusses the company’s strategic approach to financing the upcoming studies, and development plans beyond Phase II.
Percheron Therapeutics is a clinical-stage biotech developing next-generation immuno-oncology therapies focused on novel checkpoint pathways, beyond PD-1/L1 and CTLA-4. Its lead asset, HMBD-002, is a first-in-class monoclonal antibody targeting VISTA (an immune checkpoint receptor highly expressed in myeloid cells) and is designed to overcome resistance to existing checkpoint inhibitors.
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Transcript
Introduction to Edison TV and James Karner
00:00:07
Speaker
Hello everyone and welcome to Edison TV. My name is Jyoti Prakash, a healthcare care analyst here at the Edison Group.
Shift to Immuno-Oncology: In-Licensing HMBD002
00:00:14
Speaker
We are joined today by James Karner, the CEO of Percheron Cerepeutics and ASX-listed biotech, which has recently pivoted focus to immuno-oncology with the in-licensing of HMBD 002, a novel Vista targeting checkpoint inhibitor.
Reasons Behind Percheron's Pivot to Oncology
00:00:31
Speaker
Welcome James. again It's great to be here. Great to talk to you, James. To start off, James, congratulations on in-licensing HMBD002, which is a novel, potentially first-in-class checkpoint inhibitor.
00:00:47
Speaker
What drove this pivot for Percheron towards immuno-oncology, and how did you settle this particular asset?
00:00:57
Speaker
Well, Josiah, I think our journey has has really been one of trying to seize victory from the jaws of defeat. we We had a late stage trial failure in December of last year, and it left us looking for new asset around which to rebuild our our company.
00:01:13
Speaker
We didn't specifically look solely at oncology. we and We continue to think of ourselves as an oncology and rare diseases company. But of course, the reality is about half of all the deal flow out there is oncology. About half of all the investment into the life sciences industry is oncology.
00:01:29
Speaker
So if you're if you're in the market for a new asset, oncology looms large.
Selecting HMBD002: A Standout Opportunity
00:01:33
Speaker
But also, I think for all of us working in drug development, or for everybody who invests in drug development, it's really where the opportunity to make a big difference in the lives of patients looms greatest.
00:01:45
Speaker
And so there was a natural gravitation to to that space. We reviewed over 100 assets as part of our search, and this was by far the standard. out ah we We loved the quality of the work that been done on it. We could see a clear path to take it forward.
00:02:02
Speaker
And we were really appreciative of the fact that they completed a successful phase one study, and we had some good clinical data in hand. So this was a standout opportunity.
Exploring VISTA as a Novel Target
00:02:11
Speaker
We were really excited to bring it into our company. And as you say, it's given us a new lease of life as an oncology business.
00:02:17
Speaker
And James, when we think of oncology and maybe checkpoint inhibitors in particular, we think of Keytruda or Optivo, which are huge blockbuster drugs. How is HMBD002 different?
00:02:30
Speaker
And can you tell us a bit more about Vista, the protein it is targeting? Yeah. Well, Vista is an immune checkpoint regulator. So just like the PD-1, PD-L1 axis that Keytruda and Optivo target,
00:02:47
Speaker
Vista is a newer target. It was only first described about 13, 14 years ago, and one that's still not quite as well understood as some of the more heavily prospected targets like PD-1.
00:03:00
Speaker
um But it's a particularly interesting target because it seems to be almost ubiquitously expressed on a very, very wide range of cancers. And it seems to have ah in common with PD-1 very central role to in the immune response to cancer.
00:03:19
Speaker
um But intriguingly, it also seems to be linked to resistance to existing immunotherapies to, for example, PD-1 inhibitors such as pembrolizumab and nivolumab. So it it has, um ah you know, a lot of really interesting potential around it.
The Significance of HMBD002 as an IgG4 Antibody
00:03:35
Speaker
And so we think it's I think ever since ah drugs like Keytruda and Optivo became mainstream, people have been looking for the next ah immune checkpoint target. And I think Vista has a, very very solid claim to be that next target um and we yeah we very much hope so.
00:03:55
Speaker
That's great James and we also see that HMBD002 is a IgG4 antibody versus some of the other VISTAs which are in development which are targeting IgG1.
00:04:07
Speaker
So what is the significance of this? Yes this is one of the things that at first sight seems to be a question of scientific nuance And that actually potentially seems to be quite important.
00:04:20
Speaker
So as we all know, antibodies of of which which is the class of drugs which HMBD002 belongs, as well as drugs like Keytruda and Optiva belong.
00:04:31
Speaker
um Antibodies come in different types. And now IgG1 antibodies are what we've tended to use in cancers. And they are just like the antibodies that our body produces. They're designed to destroy things. They latch onto a tumor cell and destroy it.
00:04:48
Speaker
and And if it's a target that's just expressed on a cancer cell, well, that can be very, very helpful. But what we're actually trying to do with a lot of immunotherapies is not so much to destroy cells per se, but in fact, to modulate the activity of the immune system.
00:05:05
Speaker
We're trying to make quite subtle changes in terms of how the immune system reacts to the cancer. And an IgG4 antibody, which has less of this destructive effect, less of what we call antibody-dependent cellular cytotoxicity, ADCC, an IgG4 antibody can be a much more subtle instrument for for modulating the immune system.
00:05:26
Speaker
As it happens, both Keytruda and I believe Optivo are IgG4 antibodies. So we're in good company.
Phase One Study Insights on HMBD002
00:05:33
Speaker
And as you say, just about everybody else who's trying to produce a Vista antibody has produced IgG1 antibodies. so We've seen some real safety concerns with many of these drugs.
00:05:44
Speaker
So far, touch with 48 patients worth of clinical data, we have not seen those concerns with our drugs. So on the face of it, it looks like this is a real point of differentiation. You mentioned the safety profile of HMBD002.
00:05:59
Speaker
It has successfully completed a phase one dose escalation study where it was tested both as monotherapy and in combination with Keytruda. What were some of the key highlights from the study and when can we expect the full data to be released?
00:06:16
Speaker
We're hoping to have the full data in hand I want to say within the next couple of months. It's a little bit vague at the moment, but ah because this is a licensed drug, we don't have full control of of everything at the moment. But I expect within the next couple of months, we'll be able to share full data with with investors. But um we've already been able to share some highlights. And ah the key things with these, first of all, the drug was very, very safe and well tolerated, in fact,
00:06:45
Speaker
It was so safe and well-tolerated that we were not actually able to establish a maximum tolerated dose. that There just weren't enough toxicities. Now, sometimes with a drug, that can be a concern because it can suggest that the drug just isn't doing very much.
00:06:59
Speaker
But we've got some quite good pharmacodynamic data, which shows that the drug is indeed acting on the immune system. It is doing what it's supposed to do. So um so it it looks like the therapeutic window, the the space in which the drug can operate between where it becomes effective and where it becomes toxic, that window is large. And that's a godsend for a cancer drug because many of the drugs we develop in cancer are quite toxic and it can really limit their use. so that's one key thing. um The second thing is that the phase one study actually included some combination with pembrolizumab, with Keytruda.
00:07:35
Speaker
20 of the 48 patients in the study were in combination. And really it doesn't look any different in terms of toxicity in the combination than it does as a monotherapy. There's just no additive toxicity between the two drugs. And that's great because that makes us feel really comfortable about combining this with drugs like Keytruda.
Phase Two Trial Plans and Approaches
00:07:55
Speaker
And then finally, we we, yeah, this was a study done in advanced cancer patients, which is normal. It was done in a whole range of different tumor types. And that always makes it very, very difficult to infer efficacy signals from these kinds of studies.
00:08:10
Speaker
But we did see a number of individual patients who certainly seemed to be on drug and stable and doing well for much longer than we would expect on the basis of the natural history of their disease.
00:08:22
Speaker
So it's it's really just hints at the moment, but there are definitely some good hints that the drug is is having an impact for some patients. We'll be picking through that data in particular over the next couple of months to to really kind of understand that signal. But on the face of it, a drug that looks extremely safe and well tolerated and with some potential um glimpses of efficacy. And that's a nice place to be at the end of phase one.
00:08:45
Speaker
Great. um We've seen our checkpoint innovators such as Keytruda target multiple indications, be successful in multiple indications. You have also recently reported positive preclinical data in head and neck cancer and triple negative breast cancer.
00:09:01
Speaker
Can we expect to these to be the target indications for your phase two trials? And will you be testing this drug as monotherapy or in combination? we we're literally working through those kinds of questions as we speak. um And both of those are real opportunities for us.
00:09:23
Speaker
Head and neck cancer can be a complex one just because it's such a heterogeneous tumour. and There's so many different subtypes there. um And so we're we're just a little wary of that. And especially because that data, that preclinical data was specifically in combination with radiotherapy and we need to just work out a little bit how we would approach that in a clinical trial setting. So high interest, but it might end up being something a little bit more in the nature of a side project.
00:09:52
Speaker
Triple negative breast cancer is of huge interest. We may try and do just a little bit more work to understand how we can focus the patient population. And then beyond that, there's there's a number of other cancer types that we're really interested in where we think this drug can have real potential.
Funding Strategies and Commercialization Partnerships
00:10:07
Speaker
some of those um Some of those areas of interest take us down the path of using the drug as a monotherapy. Some of them point us towards combination use with a whole range of different drugs. So potentially with pembrolizumab, but potentially with radiotherapy, potentially with an EGFR inhibitor.
00:10:23
Speaker
um There's really an embarrassment of riches with this drug. And actually our problem is not so much working out what to do with it, but but it's trying to narrow this um huge smorgasbord of opportunities to a couple that that we think are most likely to succeed.
00:10:38
Speaker
The next question is related to to financing, which is always a major consideration when it comes to drug development. oh How do you plan to fund the phase two trials, especially given that it's immuno-oncology and these trials can get super expensive?
00:10:54
Speaker
um So how do you plan to fund these trials is my first question, and what would be your strategy beyond phase two in terms of commercialization and subsequent development?
00:11:06
Speaker
um To answer the second part of that question first, um I think it's probably fair to say that we have no great ambition to become a commercial pharmaceutical company, in other words,
00:11:17
Speaker
We don't really see ourselves selling this drug into the market. um Never say never, but I think we'd be wise to recognize our limitations, and I think that may not be the most natural path. So we will be looking to partner this drug with a larger company at some stage, of one or more larger companies at at some stage.
00:11:37
Speaker
I think some clinical proof of concept data will enable us to maximize the value of that transaction for shareholders. Our focus is very much how do we get that clinical proof of concept data, some clinical evidence that the drug is efficacious as economically and as quickly as possible.
00:11:57
Speaker
And that's really what we're focused on now in our phase two study. Now, where we're thinking about some quite innovative designs that I think potentially would let us do this work, perhaps a little more economically than is commonly the case.
00:12:11
Speaker
We, um as of our last financial statements, which are as of 30th of June, we did it have 10.2 million Australian dollars in the bank. um We stand to receive, obviously, the full benefit of the Australian government's R&D tax incentive, where we can get 43.5 cents in the dollar back from the from the government.
00:12:30
Speaker
um So that, in effect, leverages the money that we have. And, some you know, like every company in our position, we're alert to things like grant funding the opportunities.
00:12:41
Speaker
And then, of course, we're a pre-revenue listed biotech company. So recourse to capital markets is always there as an opportunity. It's not something that we anticipate making very heavy use of at this stage. I think we can get a lot of work done um with not much more than the resources we have. So we're we're really working to try and at least get some some runs on the board before we start thinking about very substantial financing activity. Great. That's very insightful. Thanks, James.
00:13:10
Speaker
And just to wrap up, you plan to commence the first the phase two trials from 2026 onwards. What can investors look forward to in the run-up to these trials?
00:13:22
Speaker
think there's... There's a couple of things that are relatively near term, actually, that I think will will potentially be really kind of important points for investors. The first is that we'll be getting full ah phase one data, which we'll share with the market as soon as we have it. As I say, we're expecting that somewhere probably in September, October timeframe.
00:13:42
Speaker
And so we don't yet have all that data in hand, so I don't really have any pointers. It is a phase one safety study, so to manage expectations that probably won't be blinding insights here, but um I think that will be really important data, particularly in terms of putting the drug on the radar for investors and for a potential future part good potential future partners.
00:14:04
Speaker
So that's one thing. Second thing is that we plan sometime, yeah know maybe ah a month or two later, sort of in a fourth quarter timeframe, to share details of our plan phase two. three i We want to be in a position to come out and say, here is the study, here's what we're going to do, here's the cancer type or types that we're focused on, and perhaps even here's some indication of of the economics the study.
00:14:26
Speaker
And I think that will really make plans real for for investors. That's really where they can see, well, here's where this goes, and here's how we start to value it. And then I think um beyond that, investors will see quite a lot of sort of progress milestones, yeah the sort of soft pointers as we as we start to kind of engage CEOs, as we- CROs, as we start to form our team, as we start to to do all the work in the run-up to a study, um I think investors will start to see us picking up the pace. We're in a little bit of a planning phase at the moment, which is not always the most exciting time for the market.
00:15:03
Speaker
But once that switches into an implementation phase, I think it- that there's a steady flow of um operational milestones that start to come through. And again, I think that's really where where the rubber hits the road and where things get exciting for investors. And I think that will be coming up in in a matter of months. So I think it's ah it's a really exciting time for the company.
00:15:22
Speaker
Thank you, James, for talking to us today. We look forward to following your progress with this asset. For more information, we direct our audience to the Pursheron Therapeutics website and edisongroup.com, where we plan to publish an initiation note in September.