Thank you, Celia.
We'll start the same way. Maybe you could talk a little bit about BioInvent and your role as the Chief Scientific Officer.
Right. So BioInvent is a company that develops antibodies that activate the immune system to reject and cure cancer. I'm the Chief Scientific Officer, meaning my responsibility is coming up with new targets and antibodies, and actually ways of activating the immune system differently compared to the available drugs to, again, reject cancer.
So what's the overall vision of BioInvent's work? What's the aim?
Right. So the vision, I think, would be to bring the clinical benefits of cancer immunotherapy, again, that same approach of activating the immune system to reject cancer, to more and ideally, of course, all cancer patients. Remember, this is the only drug class that is able to reject cancer and induce cures in greater than 30 different types of cancer. That's truly remarkable.
So cancer is a crowded field. There are other actors. So what puts you apart from your competitors?
Yeah, great question. So one of the things that we have developed in the company is an approach, a target-agnostic, function-first approach that allows us to generate antibodies without knowing beforehand which targets they target. So I think we've been quite fortunate in using this approach to generate antibodies to new targets via new mechanisms that have a very promising activity. And this is, of course, what people are buying into when they consider our company. Yeah.
You often emphasize an integrated research engine with in-house GMP manufacturing. How does this strengthen the ability of the company to deliver?
Yeah, yeah, so in multiple ways, it's a very dynamic industry, as everybody here will know, so having internal production capabilities means we can shift our productions from one program to another, actually even within a program. For example, with our BI-1206 antibody, we had originally developed an IV approach. We were able to very shortly in time develop a subcutaneous approach. We heard from Martin, and I think another speaker today. There was a recent approval by the FDA for pembrolizumab, one of the best-selling drugs in cancer immunotherapy, to be used as a subcutaneous formulation. Those are two examples.
You've recently had some fairly big news coming out of BioInvent, a strategic shift where you prioritized 1206, which you mentioned here, and 1808, and then you are pausing some earlier stage programs. Could you just explain the rationale behind this move a little bit?
Yeah. So, I mean, firstly, I think we had always said we believed in a diversified portfolio. And when the time was right, we would prioritize the right programs. So what's happened lately is, of course, that we've seen some very compelling signals of activity in those two most advanced programs. It's no secret that the markets are a bit tougher today than they were yesterday. So for many reasons, it really does make sense to push these two most advanced, exciting, and promising programs.
And I'm actually going to pop in a question that we've got here because it fits with what we're talking about. So what sort of message would you like patients and stakeholders to take away following this restructure? What's the most important thing for them to bear in mind?
Yeah. I think, firstly, now is the time to focus. We are focusing on the two most advanced programs. Importantly, having said that, we are retaining discovery capabilities. Remember, BioInvent is a company that has historically been very successful, actually, in striking collaborative deals with major pharma at early stages, in fact, before we had any antibody at all to work with. So those are some important messages. Yeah.
So turning then to the pipeline and your clinical progress, could you just talk us through the most important data that concerns the two assets that you are now focusing, 1808 and 1206?
Right. So coming up over the next year, by the end of this year, we'll be disclosing some data on combinatorial activity, hopefully on our 1808 antibody used with pembrolizumab. So that's an example of hopefully the antibody being safe and providing signals of activity in that sort of holy grail type of setting. In H1 next year, we'll have further single-agent data in CTCL coming out. So CTCL is a small indication that would allow for the 1808 antibody to have a direct path towards registration, which is, of course, very important for any drug. So having both holy grail potential and having a way forward that's attractive and can be handled by the company. On the 1206 side, by H1, I think next year, and well, during the next half of next year, we'll have first data from the triplet combination.
So here we have seen some very interesting effects by combining our data with another type of drug, rituximab. Now we're adding a third component to this, and the idea being this should be a safe cocktail with similar powerful activities compared to some of the most potent bispecifics and cell therapies, but being safer. So that's something to look out for. And then we have a very interesting recent, well, effort, which is going to be to combine 1206 with that same antibody, pembrolizumab, in the first-line setting. So this is a type of setting that is known to respond to immunotherapy, although not all the patients respond. So we think we have a good chance of enhancing better responses in that type of setting. So that'll be really interesting to follow.
And so you have a Fast Track for 1808, and you have an Orphan Drug Designation for 1206. How important are these for the way forward?
Yeah, I think that those are very important things with respect to getting the drug to the market effectively. So this will allow us to engage more intensely with the regulators and getting better feedback, and of course, also getting some designations that can help get approval quicker. All of this is, of course, data-driven, as is always the case in this game. Yeah.
You mentioned that BioInvent has a history of doing validating deals, and you have in the past with, for example, big pharma players like Pfizer and AstraZeneca and so on. How do these deals strengthen your current operations? Are there more deals like this coming up, if you can say anything? How do you work with this type of deals?
Yeah, yeah. So we've been very fortunate to have these kinds of deals, actually, across all of what we've done lately in the clinical programs, meaning the big players. They sponsor us with our drugs without us giving up any rights so that the companies do get the first glimpse. Now, these drugs are expensive. So if you're a small biotech and BioInvent's 100-plus employees, it really makes it possible to actually test for that combinatorial activity. So while we're very proud that we have single-agent activity with our 1808 antibody, in the end, and ultimately in cancer, there will be combination therapies that are needed. So we get to essentially demonstrate two very important things at the cost of, well, perhaps a bit more than one.
In terms of commercial opportunities, thinking then about your two lead assets, where do you see the largest commercial opportunities for them?
Clearly, the largest opportunities are in solid cancers. So make no mistake about that. Again, it is important to have single-agent activity and to be able to bring your drug to the market. So once it's there, having good signals and being able to then perhaps, hopefully, fill that holy grail is super important. So again, we seem to have at present both in our two different programs.
We turn to the financial side of things a little bit, maybe not your strongest area. Now I'm asking a CSO about CFO things.
That's right.
You showed your Q2 a net profit thanks to the XOMA royalty deal that you did, and you have a strong international shareholder base. How would you say that the financial position supports the strategy through the next value inflection point?
Yeah. So I think I will take the easy way out. Essentially, it will make possible those readouts that I just told you about. So by the end of next year, we may be in a position where we have further data supporting the high frequency of responses, which will enable getting us to the market in perhaps with 1808 and in a smaller indication, but also illustrating and pointing to a likelihood of getting responses in that solid cancer holy grail type of setting. So extending the runway and then being a bit focused is very much what we're doing currently.
So what would you say are the main value inflection points for an investor to look out for in the next, say, year and a half, two years?
Yeah, I think that's kind of what I tried to say. So we've claimed good indications of high frequencies of responses with a triplet in 1206. So more data to solidify that. With 1808, we had seen single-agent activities in the solid cancer setting. And now is the time to sort of look also for perhaps combinatorial activities, be mindful of the limited number of patients we have seen. But the drugs being safe, whatever we develop needs to be safe. So we get more data from more patients. If they're still looking safe and we have any of those things, actually, I think BioInvent is going to be a super interesting company.
Let's see what the.
It already is.
Let's see what the audience have here. Are you conducting Bi- and Tri- and constructs expanding beyond the combination strategy?
Say that again, please.
I will let you read it because wondering if you're conducting Bi- and Tri-, and then there might be a word missing.
Buy-and-try constructs. I think it may relate to new types of antibody variants, bispecific antibodies, or perhaps even trispecific antibodies. So again, we are retaining discovery capabilities, and we do have efforts, although more focused and reduced compared to yesterday. That would involve these types of molecules. Importantly, you need to consider a target and what it is you need to achieve. Sometimes it's perfectly fine and even better to have a monospecific antibody. In other cases, you will need a bi or even perhaps a trispecific. I hope that was an intended question.
What about a co-development of companion diagnostics, which we've heard about earlier today?
Yeah. So understanding what's to combine your antibody with, and in cases where you're seeing single-agent activity, which patients to treat are super critical, a first step of a companion diagnostic in understanding what is it that you want to measure. An example of this is, for example, the 1206 program. We're very fortunate that other people have already sort of validated this target as being predictive of outcome when you're treated with rituximab. So I'm referring to three independent clinical studies, which have all shown that this target, when expressed on the tumor cells, is a negative factor that predicts lack of response to rituximab. So with our mechanism, we would expect to, in such patients, actually be able to then reinvigorate and reinstall responses to rituximab. So that's an example of a biomarker. Yeah.
I think we will call it there and say thank you so much.
Okay. Thank you.