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198. Bull, Bear & Beyond – Herantis Pharma: executive interview
2 Plays4 days ago
In this interview, we speak to Antti Vuolanto, CEO of Herantis Pharma, and Henri Huttunen, the company’s CSO. We discuss the latest developments for lead asset HER-096, including the Phase Ib trial readout, the supplementary biomarker programme outcomes and plans for a subsequent Phase II trial. We also cover the company’s latest fundraises as well as key upcoming potential catalysts and milestones for investors to watch out for.
Herantis Pharma is a Finland-based clinical-stage biotechnology company focused on developing disease-modifying therapies to stop or reverse the progression of neurodegenerative diseases.
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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.
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Transcript
Introduction and Overview of HER96
00:00:07
Speaker
Hello and welcome to Edison TV. My name is Aaron Atkar, Healthcare Research Analyst at Edison. Today we are joined by Antti Valanta, CEO of Herantis Pharma and Henry Houtenen, company's Chief Scientific Officer.
00:00:21
Speaker
Today we're going to discuss the latest developments for clinical candidates HER96, which is a potential disease modifier for Parkinson's disease. Antti, Henry, thanks for joining
Understanding Parkinson's Disease and Current Challenges
00:00:30
Speaker
today. So first of all, to set the scene, can you summarize the unmet need in Parkinson's disease and how Herantus is its lead clinical candidate has been designed to address this?
00:00:41
Speaker
Yeah, so um Parkinson's disease is a progressive neurodegenal neurodegenerative disorder that affects only ah over 10 million people globally.
00:00:53
Speaker
The current treatments treat symptoms by relieving by by replacing or mimicking dopamine, but they do not do not address the underlying neurodegenerative processes that drive the disease.
00:01:11
Speaker
And as a result, the patients continue to experience worsening of the motor and non-motor functions over time. So there is and a major unmet clinical need and therefore there has been over the years many attempts to to develop disease-modifying therapies to restore the dopaminergic neurons and their activity.
How HER96 Targets Parkinson's Disease Mechanisms
00:01:36
Speaker
ah Our lead candidate, ER96, has been really designed to address this unmet clinical need. And it it is based on the activity of a neurotrophic factor called CDNF. um um ah that we have also studied earlier and and CDNF addresses um the proteostasis imbalance and and also addresses neuroinflammation and and mitochondrial dysfunction.
00:02:07
Speaker
However, the the major challenge with CDNF was that it it it was an intracranial product. And now with HERN96, we captured the full activity of the of the CDNF, but we can use subcutaneous administration. And now we have just recently um released phase one data, with which really shows that we we do have a biological response
Potential Impact of HER96 on Parkinson's Progression
00:02:31
Speaker
to the treatment. So so we believe that herald-9 disease can really um modified the disease, um slow or even stop the progression of of Parkinson's disease. um So ah we believe that we are currently in a way in the forefront of the development of this new era of Parkinson's um ah treatments.
Phase 1b Study Findings on HER96
00:02:55
Speaker
Fantastic. So moving on then to how the lead candidate is fended in the clinic. We'll come on to some of the biomarker data, but could you recap maybe first of all, the phase 1b readout from October last year?
00:03:06
Speaker
Yes, so um during the second half last year, we completed a Phase 1b study. um This was a continuation to a previous Phase 1a study that was a single ascending dose study in healthy volunteers.
00:03:20
Speaker
So in the in the Phase 1b study, we recruited 24 people with Parkinson's um who received subcutaneous doses of HER96 twice weekly for four weeks.
00:03:33
Speaker
The primary endpoint of this study was safety and tolerability. And the secondary endpoint was related to um how HER96 is distributed and metabolized in the body, so-called pharmacokinetics.
00:03:46
Speaker
And then we had a large number of exploratory biomarker-related outcomes. the The primary endpoint was met. um that The drug was clearly safe and well tolerated. There were very few systemic adverse events and most adverse events were related to the injection site, which is of course expected for an injectable product.
00:04:08
Speaker
um And these ah these adverse events were mostly mild and transient. um So we're very happy with that primary endpoint outcome. And regarding the secondary um outcome measure,
00:04:20
Speaker
ah related to pharmacokinetics, we again were able to demonstrate ah blood-brain barrier penetration in in and in patients. um Previously, we we also had that from healthy volunteers. So now we can see very clearly um that the cerebrospinal fluid presence of HER96 and those levels are are according to our expectations. And those levels um seem to be right and to be taken towards phase two.
Biomarker Program and Its Support for HER96
00:04:50
Speaker
Fantastic. So coming on now to the biomarker program, which was also a key component of the clinical development to date. These outcomes were presented in January earlier this year, right? So could you outline maybe some of the key takeaways from this update and maybe touch upon how those results support the mechanism of action as a potential disease modifier?
00:05:09
Speaker
Absolutely. um So the goal of of the biomarker part of the phase 1b study was was to demonstrate biological response to HER96 for the first time in in in the human body. um And one challenge, a big challenge there was was that um there are no established biomarkers related to the target pathway, which is the so-called unfolded protein response pathway.
00:05:33
Speaker
So because there are no established biomarkers, we actually had to do a lot of legwork and exploratory work here, which was generously supported by by the Parkinson's UK and Michael J. Fox Foundation, and which allowed us to go really broad in in the in the biomarker exploration.
00:05:51
Speaker
um So with more than 2.5 million data points collected from these 24 subjects, we were able to finally conclude that there is clearly a biological response to to the treatment, both peripherally, meaning in in the sort of like the the body overall, and and then then in the surface spinal fluid as well, which is of course then part of central nervous system.
00:06:18
Speaker
And these ah responses are are clearly linked to the mechanism of action relating to to markers um related to proteostasis, protein homeostasis and shortly, and and and also mitochondrial function, which is appears to be a critical component of of this functional recovery effect that the HER96 has. So we're very happy with that outcome.
00:06:46
Speaker
It really provides an important de-risking um ah piece of data on our journey from phase one to towards phase two.
Plans for Phase 2 Trial of HER96
00:06:55
Speaker
Excellent. So then moving on, what can you tell us about the design of the upcoming phase two trial?
00:07:02
Speaker
Yeah, so um we're currently um working on the design, um which which would be a sort of like logical next step. And and obviously, the next step relates to the first first ah um yeah first assessment of efficacy in in in human patients. So in this study, we would be looking looking at signals, early signals of of efficacy in early stage Parkinson's patients.
00:07:30
Speaker
um So exact design is still is still being worked out, so we can't disclose too many details, but we can already kind of foresee that the study will be roughly around 100 patients, um fairly early stage Parkinson's. The dosing would be again twice weekly. We would be dosing for somewhere from six to 12 months, possibly. And the study would be run entirely in Europe and in selected European clinical centers.
00:08:04
Speaker
Excellent.
Funding and Preparations for Phase 2
00:08:05
Speaker
We're looking forward to seeing the next updates. Moving on now to the finance side of things. Herantis recently announced a directed share issue um alongside a grant from Horizon Europe.
00:08:16
Speaker
So can you share some of the details on those, please, and what they mean for the company? Yeah, so first of all, the 4.2 million um private placement that we um conducted in early early February, that of course extends our our cash runway, allows us to continue with the phase two preparations and of course allows us to to really put together the resources required for the phase two. And there, as we have discussed also earlier, we are looking at ah partnerships with pharma. We are looking at um discussions with with investors and and also grant financing. And there, of course, on that front, we have been ah very successful as we just announced 8 million euro grant for the phase two conduct. And that's really kicking in once we start the patient treatments in phase two. And and in that consortium, together with Herantys, we have several university hospitals leading sites in Europe and also an imaging site
00:09:28
Speaker
So that's a ah very good support for Herantys and of course very competitive um financing and and winning this type of grants after rigorous evaluation is a quality stamp on what we are currently doing with Herantys and what are our our goals.
Strategic Partnerships and Future Steps
00:09:50
Speaker
Fantastic. So look, before we wrap up today, could you maybe summarize the key catalysts and milestones that investors should watch out for across the next, say, 12 to 18 months? Yeah, of course, ah very important is to finalize the phase two design. As Henry mentioned, we are fairly advanced there. We expect to be able to disclose more details in the in the coming months. And There, of course, one key component is also the discussions with pharma that we are currently having. ah So as many times explained, we have been really active in in in ah pharma discussions. We are continuing those in ah in a in a very good way. and And let's see where we might end up with with those during the coming months also, whether they there is a contribution for for phase two as as well.
00:10:44
Speaker
and And we continue also um discussions with ah patient organizations, Parkinson's UK, Michael J. Fox, potentially some others with their support for phase two program, um the potential of of ah ah even patients. additional non-dilutive financing or contribution to potential equity financing that ah remains to be to be seen. But really the this spring and and ah continuing towards the end of the year, we will in a way build the the
00:11:19
Speaker
operational package together for for phase two and then then of course after that um running the phase phase two efficacy trial is is of course very key for the for the company and phase two data will be ah an important inflection point for for Herantis but also for Parkinson's patients. So I think there will be many exciting news coming from Herantis in the coming months.
00:11:45
Speaker
Okay, fantastic. Really looking forward to seeing the programme advance.
Conclusion and Further Research on Herantis Pharma
00:11:48
Speaker
That brings us to a close for today. But if our audience would like to learn more, please refer to the Edison website where we have our research on Herontus freely accessible. Antti Henry, many thanks again for the insightful discussion.
00:12:00
Speaker
Thank you.