Today, we are joined here in the studio by Vivesto. There's quite a lot of things that's happening in the company right now. They have published the top-line results from both its dog and cat studies, as well as presented that data now at two international veterinary oncology conferences, VCS in Minneapolis and WSAVA in Warsaw. With us in the studio today is Erik Kinnman, who is CEO of the company, as well as Teresa Fernandez Zafra, who is the CSO of the company. Welcome.
Thank you so much.
Thank you.
Mm-hmm. We'll begin with you, Erik. There's been a quite intensive couple of weeks. How would you summarize?
All right. Well, we've now delivered upon our plans to present top-line results in the dog study and the cat study, so we're very happy about that. We're even more happy that the results were very positive and shows the direction for the next step in the programs. We've confirmed safety and tolerability of the studies, and we're now starting to accelerate the business development activities as well. A lot going on.
Mm-hmm. Indeed, positive results confirming that you can continue the development of the Paccal Vet program. Apart from what you just said, what more takeaways can you take away from the study?
I think the most important confirmation that we got with this study is that we saw no hypersensitivity reaction. Paccal Vet, the active component in that paclitaxel, has previously not been possible to give to animals due to hypersensitivity or immune reactions. With our formulation, it's possible, and we have seen no such reactions. In addition to that sort of builds on the safety and tolerability that we observed in these studies, but also what we know since previous studies, where we've exposed more than 300 dogs to the compound as well.
Mm-hmm. Joining us here today as well from the Veterinary Referral Center of Central Oregon is also Dr. Kristen Couto. Kristen, from a veterinary oncologist perspective, where do you see treatment like Paccal Vet fitting into the management of dog with splenic hemangiosarcoma?
Hey there. Yeah, thanks. It's good to be here. I have had the opportunity to treat several dogs and cats, which we'll get into the cats later. The dogs did have splenic hemangiosarcoma, and I think that probably the biggest use is going to be probably twofold. One is going to be simply for dogs that cannot safely receive doxorubicin, which is currently what would be considered the standard of care chemotherapy treatment following splenectomy for splenic hemangiosarcoma, which has been shown to provide a survival benefit. But it is toxic to the heart, and certain dogs cannot receive it for that reason. There are also other reasons that certain dogs might not be able to receive it. So having another medication that has efficacy in this setting is going to be really valuable because previously we have not necessarily been able to offer reasonable, adequate treatment in that setting.
There isn't a known good alternative to doxorubicin that can provide efficacy. I think that that's going to be one of the main uses, and then the other use will simply be if we were to pursue the standard of care and proceed with doxorubicin and then there is a failure. It is always nice to have additional drugs to grab for, especially for a very motivated pet parent, so that would definitely be an alternative use as well.
Mm-hmm. More broadly, do you believe that there could be opportunities to evaluate Paccal Vet in other types of cancers as well?
Yeah, I think that that is obviously a very exciting opportunity. There are a lot of cancers that we treat in the clinic day to day that don't even have an established standard treatment option available. Part of the reason for that is probably because we just haven't found the right drug for that cancer. The opportunities are honestly endless in regards to that. Paclitaxel is used for a lot of human cancers, and so there could certainly be extrapolation from that data to see if we can get some benefit in our canine cancers. Mammary cancer, things like that, where we really just don't have any type of legitimate standard established treatment. I think that there are countless different diseases that it could be attempted for to see what works.
Mm-hmm. Thank you very much, Kristen. We'll have more questions for you shortly, but I turn now to Erik. With the results now of the dog study coming in and supporting also continued development, what is the next steps now for Paccal Vet, and how do you see the path towards a pivotal study?
Yeah. Well, that's exactly what we're looking at currently is the design of the pivotal study. We have an outline of that, obviously, as well. We do plan to interact with the FDA and EMA and maybe also other international regulatory agencies prior to starting a pivotal study. In parallel with that, we're also looking into starting commercial manufacturing process as well. We want to do this together with a partner who has complementary expertise and resources as well. We've initiated those activities also.
Cats and dogs, and we've talked about the dog study, and there's also the cat study to consider as well. I turn now back to you, Kristen. Here, the top-line result when it comes to cats, they were better. What stands out most to you when it comes to these results from a most clinical perspective?
Yeah, I think that the cat data, quite frankly to me, was a little bit more compelling. It was just really exciting to be able to use a medication in the clinical setting for many, many different types of cancer and see legitimate anti-cancer responses before our eyes, even within days of administration of the Paccal Vet for various forms of cancer. We were seeing some cancers just melt away. That was really exciting because as most people know that are in the field, there aren't necessarily a lot of chemotherapy medications especially that could be used, for instance, in the palliative setting for various forms of cancer. The cats that I had the opportunity to treat within the study probably realistically wouldn't have necessarily received treatment because we just didn't have a good standard treatment option for them.
It was exciting to see that we were able to provide this, but that we were also seeing anti-cancer responses. I think that that again is going to show a lot of opportunity for the feline patients that we treat in the clinic.
Thank you, Kristen. Teresa, these findings from a development perspective, what does that allow Vivesto to do next? What is the next clinical steps?
Yeah, just to build upon what Kristen has been mentioning. This is the first trial which is ever performed using Paccal Vet in cats. There has been a previous study using a conventional human formulation of paclitaxel, which unfortunately was not very well tolerated. For us, it was essential not only to just have an idea whether Paccal Vet could be efficacious, but also can it be tolerable by the cats. I think the study has shown that, and the doses achieved were much higher than in the previous publication with the other conventional formulation. Thanks to that, we now have data that can allow us to select the dosing for the next clinical studies and also have an idea on what cancer type we would like to focus on. Obviously, having an idea on the medical needs that Kristen has already highlighted.
Obviously, it was really good to hear that effects were seen across multiple tumor types. That would be the next clinical steps, focusing on a tumor indication and gathering more data there.
Returning to Kristen then. Compared to dogs, the treatment options for cats remain limited. How significant is the unmet medical need there? Most importantly, are you seeing more cat owners willing to pursue advanced cancer treatment today?
Yeah, that's a great question. I think that cats often are fairly far behind in regards to general treatment options available. There's a lot of focus just in veterinary medicine in general on dogs, and cats kind of seem to be left behind in a lot of these. That is certainly the case in veterinary oncology specifically. As compared to routine dog treatments, which we have a lot of very standard protocols for osteosarcoma, hemangiosarcoma, lymphoma. There really aren't necessarily good, well-established protocols for treating cat cancers even after surgery or something like that, probably with the exception of lymphoma, which is one of the most common cancers.
Being able to add an additional medication that might have anti-cancer activity against various forms of cancer might help us truly develop standardized protocols and meet the need of these families that are absolutely willing and interested in providing as aggressive of treatment as possible. I would say that many of my feline patient pet parents are very interested in being able to provide treatment. The main holdback is that we don't always have a standard excellent treatment option to offer them. So there's a really significant unmet need there in adding an additional drug to our arsenal that, as Teresa mentioned, was for all intents and purposes, in a clinical setting, very well tolerated, is very exciting.
To rehearse the question that I asked towards the end as well, are you seeing more cat owners willing to pursue advanced cancer treatment today?
Yes. It's always a little bit relative. I would say that quite frankly, I live in a place where there aren't as many cats, but the cats that I do see, they definitely are interested. They want to consider treatment. We just don't always have excellent treatment options to offer them. As we develop that, we are likely to be able to provide more aggressive treatment.
The data we've talked about here today, you presented at the VCS annual conference. Could you begin by telling us what reception you received from the event, as well as telling us why this is significant?
Yeah, I think that the general level of excitement just about bringing an additional medication into the clinic was where things were at the conference. I think most people are more excited and interested in being able to provide more cat-centric treatment because again, there's just that unmet need. Additionally, the idea of being able to provide Paccal Vet in a splenic hemangiosarcoma canine patient that cannot safely receive doxorubicin that might have efficacy, that also was exciting. People kind of wanted to talk about that. So I think in general, there's just a hope and excitement that we'll be able to bring this all the way through so that it can actually land in a clinical setting so that people will have the opportunity to be able to use it.
Teresa, you were at WSAVA in Warsaw. How was that?
Yeah, I would like to first mention that we are very happy that the abstracts got accepted both to VCS annual conference, but also for WSAVA conference. Basically, you have to always submit the studies you want to present, and an expert committee then selects whichever data and studies they think is interesting. It was really exciting that both studies were accepted for presentation at both conferences. Interestingly, at WSAVA, even the dog hemangiosarcoma Paccal Vet study was selected for an oral presentation. It was really well received. I got to interact with some veterinary oncologists after the session, and most of them, they knew Paccal Vet from previous development, and they were really excited to see that there is future work ahead and that development is still going on.
Another thing to highlight is also that the WSAVA conference was having a large focus this year on feline health. Interestingly, it is a broader conference as well, so it's not only for veterinary oncologists, but there was also veterinarians that are there, more general, that would be referring cats with cancer to the veterinary oncologists. Importantly for us, with our business development activities as well, there is a large presence of the industry partners and the big animal health companies, which also gave us the opportunity to make them aware about our program and our studies and the good data. It was really good. Really happy.
As we continue in talking about business development, Erik has previously highlighted the positive clinical data, of course, helps in discussing partner opportunities moving forward. Have the recent dog and cat studies strengthened that position and ongoing business development activities together with the Liberi Group?
Yes, absolutely. We were waiting for this data. We did, as mentioned, start the activities this spring and paused over the summer break, waiting for these data. So we're now accelerating all the activities together with Liberi Group. We are adding the top-line data information to those who have already received documentation previously, and that is also part of the documentation that the new outreach activities will include as well. Yeah.
And with your stage of development, what does the typical partner want to see?
Well, they will be very interested in the top-line data. In the top-line data, we have now confirmed efficacy. We have shown that compared to surgery alone, Paccal Vet actually doubles the survival, the overall survival. As mentioned previously, we do not see any hypersensitivity activity. We confirmed safety and tolerability. We have shown that this is a possible new drug. It is the first taxane that will be made available for dogs and cats with the appropriate documentation as well. This will all be very important. But they will want to see previous documentation as well and also see our plans in terms of what is the regulatory path to market approval. What should a pivotal study look like? We have that outline to present as well, and we also have interacted with potential manufacturers in terms of the commercial manufacturing process as well.
All this information taken together will then be of interest obviously for a partner. We have ideas about the commercialization as well, the pricing, the market size, and things like that. There is quite a lot of information, but the starting point will obviously be the top-line data that we just presented.
Mm-hmm. That is what partners want to see in you, but it takes two to tango. What do you want to see in a potential partner?
Ideally, we have spoken with some of the largest veterinarian companies as well, so when we are seeking the complementary expertise and the resources, obviously, that will be possible to provide from a major veterinarian medicine company. There are also larger players that are more regional. That is also a possibility, and you can sort of match that type of a partner as well. We know that there is great interest for documented veterinary products in both U.S. and Europe, but there is a growing interest also in Asia and Latin America. There could be players from these countries as well. We are quite open to the type of structure and the sort of size and the type of company, but preferably one of the major players.
Mm-hmm. Looking ahead then, what can investors expect from the Paccal Vet program in the coming six to 12 months?
Yeah, well, all in all, within six and 12 months, we should be able to strike a deal with one of these partners or it could be also several partners. In parallel with the partnering activities, we are preparing for the pivotal study as well, and we are talking to commercial manufacturers as well. All that information will be provided once we get it. We are still finalizing the dog and cat study, and information about that will come towards the end of the year is what we expect at least. We have one more thing, but this is outside Paccal Vet. That is our other program, Cantrixil, where we are looking at dog cancer cell lines. We will have data on that towards the end of the year as well. But that is for another meeting, I think.
That sounds like very exciting stuff. Thank you very much to Kristen, who is joining us remotely, as well as you, Erik, and also Teresa.
Thank you.
Thank you.