In light of a recently announced phase 2a study, data as well as an up to SEK 30 million deal with Exoma Royalties, BioInvent will be joining us. Standing next to me is Martin Welschof, as well as Andres McAllister. Welcome.
Thank you very much.
Martin, I think we'll begin with you. Could you tell us a little bit about BioInvent and perhaps what is going on right now at the company? What is currently up to date?
Absolutely. BioInvent is a company based in southern Sweden. We are an immune oncology company, currently roughly 120 people. Quite an integrated company in that sense. We not only do antibody discovery, target discovery, we also do our own manufacturing, our own formulation, and clinical development, which is really like a powerhouse in immune oncology. In that sense, we currently have five programs and six clinical trials. We recently had a couple of news, as you were saying. We had good phase 2a data for both of our lead programs, BI-1206 and BI-1808. I believe we'll discuss that later in more detail with Andres. In addition, we were able to monetize an encore asset.
The Exoma Royalties agreement that you referred to, it's a SEK 30 million deal, SEK 20 million upfront, SEK 10 million on a milestone, which is then once the second indication is approved. Maybe I'll give a little bit of background here. This is based on a deal that we did in 2003. Exoma had very dominant IP that BioInvent needed at that time. Under this cross-license, they got access, Exoma got access to our antibody library technology. They then did a deal with Takeda that generated this antibody that is now in phase 3. Exoma is basically now consolidating their royalty and milestones. We are monetizing at a time point where it makes a lot of sense to us, since we could use the money now very well to push our core assets forward.
Everybody knows that sometimes phase 3 clinical trials fail, and then there would be nothing.
Could you elaborate a little bit on the SEK 10 million that is conditioned to the milestone? What is the milestone from Exoma's perspective?
Yeah, so basically, they have initiated a clinical phase 3 for the first indication, but already announced that they also will do a second indication. That has not been started yet, but will be started soon. Once this second indication is approved, then we will get the SEK 10 million. The important thing for us is the SEK 20 million that we will get upon signing the deal. Yeah.
Let's go further down then, as we now turn to Andres. When it comes to the data you were able to announce regarding your phase 2a study, this is for the candidate BI-1206. It's in combination with Rituximab and Calquence for non-Hodgkin's lymphoma. Can you tell us what sort of data you were able to present, as well as your impressions on the results?
Yeah, so one of the things I've been worried very much about is trying to generate safety and efficacy data at the same time, which is not always the case. You can generate drugs that are very efficacious, but that have problems with safety. We give a lot of consideration to that. Perhaps because one of the reasons is that we work and we target the tumor microenvironment, which is what happens inside really the tumor, our drugs have proven to be very safe, well tolerated, and in addition to that, quite efficacious. The data that we're presenting shows that when you combine these three drugs, one is Rituximab, which is a drug that is very commonly used to treat these patients, but they become resistant with time. One of the things we are adding with our drug is to avoid that resistance.
In addition to that, we are adding another drug, which is also very widely used in the community to treat those patients. With this triplet, we can accomplish very high response rates. People respond very frequently to treatment, which is very good, even if they have been treated with those drugs in the past, in particular with Rituximab. We obtain very high response rates, comparable to the best-performing drugs in the space, such as bispecific antibodies, et cetera. We get very good response rates and a very safe and convenient way to treat these patients, which is a very important factor that you need to put in the equation. We are very happy about that because the response rates that we are getting are very competitive in this space. Aside from being efficacious, they are safe and convenient.
One important point there maybe also to inject regarding the positioning. Especially non-Hodgkin's lymphoma, the patient population is very frail. They're elderly and very frail. What you need is exactly the combination that Andres was referring to. That means good efficacy. Equally important is the safety, as you said at the beginning, because otherwise those patients wouldn't benefit really.
Are you more confident now heading into phase 2b and perhaps even phase 3 than you were before?
We are definitely. We will generate more data. This is just the first part of the study. We are continuing. We're recruiting patients. As soon as we have a larger data set, we will, of course, we need to show that all these trends continue in the right direction. Now we are more confident than we were a few months ago, and we will be more confident in the future. The trend is where we want it to be. That's what's important.
Another candidate is BI-1910, also heading now towards the phase 2a after a successful phase 1. Can you tell us a little bit about that? Are you as confident there? What are the steps you expect to take?
Yeah, so 1910 will be moving into phase 2a, as you say, but perhaps more importantly, BI-1808. That is the one that is ahead of the pack. That is, by all accounts, the first in class or the first drug that is being developed for that particular target in the world. We are very happy and excited about that. More excited we are about the data that that has generated. We have seen, we had reported recently last year, single-agent activity, so monotherapy activity in solid tumors. Now what we are reporting is very interesting data in a very difficult-to-treat tumor type. It is called T-cell lymphoma, cutaneous T-cell lymphoma. That is a high unmet medical need. There are no good drugs to treat those patients. We have a very safe, and the responses that we have seen are quite impressive.
For the time being, in very, very advanced patients. To see those very, very advanced patients that have seen every treatment available to them, to see them respond to a new treatment is very impressive. That has generated a great deal of interest in the investigators that are participating in the study. We anticipate that this will only go in crescendo. We are very excited. As you probably mentioned, we recently obtained a Fast Track designation, which is a priority review system offered by the FDA, which basically allows you to have very frequent conversations with the FDA, to have, if you meet the criteria, access to being able to have accelerated approval, et cetera. You basically partner with the FDA so that you do the best development possible for that drug because there is a high unmet medical need.
We're super excited, enthusiastic about what we're seeing, and very happy about that.
Indeed, BI-1808 has gotten a Fast Track designation, but it also has an orphan drug designation. I'm curious about that. When you have both designations, what does that change in terms of the trials?
Yeah, they're actually different things. Orphan drug designation basically protects the lifespan of the drug farther into the future. You have an extended protection, so you can exploit the uniqueness of your drug for a longer period of time. Fast Track designation is basically, as I mentioned before, a way so that your drug is considered a preferred drug. The review times are shorter. The exchanges with the FDA can be more frequent. They basically help you in developing the drug in the best possible way. It should open the way to get approval based on phase 2 data, which is very important because it shortens the timelines to be able to market the drug tremendously. That's the important.
In sort of simple terms, then you get it to market quicker, and it's also protected in the market for longer.
Correct. Yes.
Martin, I think we could turn to you now as we head into the rest of the year, 2025, from a more broad perspective for all of BioInvent. What is the current plan there?
Yeah, basically to move ahead with the broad portfolio that I briefly described at the beginning of our conversation. Just to summarize, now we have the updates around the two lead programs, 1808 and cutaneous T-cell lymphoma, 1206 and non-Hodgkin's lymphoma. There will be also an update coming soon for 1206, and we did not discuss that at all, and solid cancer, which is also quite interesting, where we have also achieved interesting data. During the second half of this year, we will have further updates around 1808 because we are not only developing this as a single agent, but also in combination with pembrolizumab. There will be an update around that. You mentioned 1910. Also during the second half, we will have further single agent data for 1910, but also combination data.
BI-1607, which is our second anti-FCγRIIb antibody besides BI-1206, there we also will have the first data set by the end of the year. We will be very busy. Obviously, this relates to the broad portfolio that we have, which is very unique for a European biotech company.
And Andres, if we talk from a purely trial perspective, what highlights do you expect for the rest of 2025?
As I mentioned, for BI-1808, we are actually pursuing the recruitment in order to make that a more robust data set. We need to work a little bit on the regimen, and the, excuse me, on the dose optimization, make sure you're giving the patients the right dose. That is something called Project Optimus. We're obviously taking that into consideration for BI-1808 in cutaneous T-cell lymphoma. All the other trials are recruiting very well. I am particularly excited about what Martin just mentioned, which is BI-1206, the same drug, but now in combination with pembrolizumab. We are doing that in solid tumors. Given the already very exciting data that we've seen, we have already moved, we're moving into the phase 2a part of the study. We will be doing that in lung cancer, in melanoma.
There are a number of possibilities that open to us now as possibilities. One of them is to, since we are really changing what happens inside the tumor, treat that in earlier stage of treatment, in particular for lung cancer, which is a huge, important indication. The problem is the most frequent type of cancer. We could impact the way you treat those patients. I think that is a huge upside and potential, very important inflection point for the company.
We will be excited to hear more. Martin Welschof and Andres McAllister, thank you very much for being here and answering our questions.
Thank you.
Thank you.