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spk03: Daniela, if you want to chime in. So these patients, as you mentioned, were heavily pre-treated. They got multiple lines of treatment. And so if they had not received seclidemset, you would not have seen that stable disease. These patients typically, without treatment, unfortunately don't live that long. So the stable disease, if you will, for these patients would have been less than a couple of months or less. what happens with these patients is once they fail all standard treatments, especially for FET, translocated sarcoma, there is no specific one treatment. So they may either get back on some chemotherapy, which is usually very toxic for these patients. Again, I think for a single agent to show stabilization for greater than, majority of the patients, greater than six months, gives us a very good early signal. If you remember, in that advanced solid tumor, they were very late-stage patients. In our current expansion phase, we have limited the number of prior lines of treatment they could receive, so they could receive up to three prior lines of treatment, which means that we could enroll a fourth-line patient. So we hope that if you enroll patients that are early lines of treatment, we would expect to see a longer stabilization of disease, which will translate into a longer... progression-free survival. That's the strategy we are following, using the phase one data to inform us on which patient population to further explore in the phase two. And so based on that, we currently have this expansion phase, which has two different FET translocated sarcomas, one for myxoid and the other one for FET specifically.
spk06: Okay. All right. Thank you very much. I appreciate all the answers, and again, congratulations for the quorum. Thank you.
spk01: Your next question from Mike King, FHC, Wainwright. Your line is now open.
spk00: Hey, good afternoon, guys. Thanks for the thorough update. Just a lot of my questions have been asked and answered. We just wanted to get a clearer understanding about the the role that secludemstat would play in conjunction with pembrolizumab. I think you mentioned in your comments, David, that ovarian and endometrial cancers were your target indications. Are these going to be first line, or where would you see the combination of pembrolizumab and secludemstat fitting in? Thanks.
spk03: This is Nadeem. The current study that we are exploring is obviously in the relapse stage, relapse refractory stage patients. As you know, these patients specifically in that trial don't have a good therapeutics available. As we start seeing, and it's a phase one dose expansion trial, so the first thing is to determine the recommended phase two dose of the combination. Once that's determined, then we will move into early lines of patients. This trial will also provide us proof of concept, generally, of combinability of seclidempstead with a checkpoint inhibitor. And as you can imagine, if this is a positive trial, if we get to an appropriate recommended phase two dose, we can then further explore in other tumor types where either checkpoint inhibitors are used or checkpoint inhibitors have failed to show significant responses or progression-free survival. So from our perspective, this is a proof-of-concept study that will show whether acyclic Dempster can be combined with a checkpoint inhibitor, and if so, what is the recommended phase two dose? So this could potentially open doors for us to explore other tumors where checkpoint inhibitors have either been used or currently being investigated.
spk00: Nadim, can you... elaborate a little bit on what the target patient population might look like. And the reason I'm asking is because there have been other studies where, you know, a purported active molecule, whether it's IDO or, you know, arginase or glutaminase inhibitors combined with a checkpoint in a single arm study. And then when those studies go to randomized stage, the you know, the effect size fade. So are you going to try to do anything in terms of study design in order to ensure that, you know, the real benefit above checkpoint alone is due to second with the M-STAT? Maybe you can elaborate a little bit on that, or is that still a work in progress?
spk03: Yeah. So this particular study that I mentioned earlier, it's an investigator-sponsored study, so the sponsor is Honor Health. We are providing support financial and some obviously product support. What you are asking about strategy of where to explore, so I understand if you have, the best way to approach this would be, in my mind, if we were to explore this theoretically, we could look into patient population that have had prior checkpoint inhibitors, and have stopped responding to see if you could re-sensitize them to checkpoint inhibitors, right? And that is some of the preclinical work is ongoing to actually look at that specific question. So again, if I think if we were to zoom in if you were to develop therapies in the checkpoint space, the unmet need is where checkpoint inhibitors, patients who have received checkpoint inhibitors and they have no further therapies available. So again, you know, we are looking into this preclinical. If the preclinical data supports, then we will further explore it in the clinic.
spk00: Okay, thanks for the color on that. I just wonder one quick follow-up. And that is, will there be some biomarker work done in conjunction with the clinical studies? Thank you.
spk03: Yes. So all our studies have biomarker component.
spk00: Great. Thanks.
spk02: And for the last question from Hunter Diamond of Diamond and Equity, your line is now open.
spk04: Hi, everyone. Congrats on the earnings. So I had a quick question related to epigenetics and expanding the pipeline. I know I've asked about that before, but any ideas you have about, you know, other epigenetic assets or expanding outside the existing pipeline would be great.
spk05: Hunter, this is David. Great to hear from you. Hope you're doing well. I'm happy to comment. So we haven't really talked about pipeline activities on calls previously. But given that we are beginning to talk about it at the investor conferences, we thought we'd tee it up for today's discussion. First of all, we're not limiting ourselves to just considering epigenetic programs. We do happen to have, I think, some expertise in the LSD1 inhibition space, and that's why we launched our discovery phase program in a second-generation LSD1 inhibitor. Now, the other interesting thing that has happened to us over the past three to four, five months, as we've been communicating, Sekla Demstad advancing in the clinic, and more importantly, the strength of our financial position, we've had a number of companies reach out to us proactively to talk about their assets. for whatever reason they're unable or unwilling or they just don't want to advance and develop on their own. And they've been talking to us about possibly getting involved in helping them or bringing the product outright on board into Solaris. So your question about building a pipeline, yes, there's an epigenetic component. You know, we've certainly learned a lot about epigenetics. I would consider us, you know, experts or pretty close to experts. on the LSD-1 space, but given our financial strength, we've had the opportunity to take a look at a number of opportunities that are not necessarily in the epigenetic space. So I think the best way to answer your question in a short phrase is, yes, LSD-1, we're all over that. We have a lot of people coming and talking to us right now, and we'll just need to keep you informed at a later date to see whether or not something bubbles to the top and we decide to take action on it.
spk04: Great, great. Appreciate the update. That's all I have on my end. So again, congratulations on the results.
spk05: All right. Thanks for calling in. Be safe.
spk02: And there are no further questions. I would like to turn it back to David Arthur for the conclusion of the call.
spk05: As you heard from today's discussion, You know, Solaris is continuing to fire on all cylinders. I'm really proud of the team and I'm really proud of what we've been able to accomplish. Our clinical trials are actively enrolling patients across five different segments. We've added to our list of clinical trial sites that is only going to enhance our ability to enroll patients and get the clinical data that everybody's looking for into your hands as soon as possible. We've reached new research agreements and additional preclinical research is actively underway to explore our scaffolding properties and how that can identify new cancer indications where we can further improve and add to the treatment options that are available. And underlying all this and supporting this activity is our strong financial foundation. So you couple that with the hard work and the dedication of our employees and the support we receive from our shareholders, and we are really confident about where we're sitting right now. Without all these people I've just mentioned, Solaris would not be where it is today. So I'd just like to close by thanking everyone for your time and attention today, and I extend my sincerest wishes of good health to all. Be safe and thank you.
spk02: And this concludes today's conference call. Thank you everyone for participating. You may now disconnect.
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