Good morning, everyone. Hello, and welcome back to the H.C. Wainwright's twenty-sixth Annual Global Investment Conference. I'm Luis Santos, a healthcare analyst at H.C. Wainwright, and it is my pleasure to introduce to you our next speakers, Kirk Look, CFO of Oncolytics, and Christophe Degois, VP, Business Development. Christophe, Kirk, welcome. It's a pleasure.
Yeah. Thanks, Luis. We really appreciate the opportunity at H.C. Wainwright to present today. This has been another outstanding conference from our end. Lots of opportunities to meet investors and talk about our story and provide updates. So do appreciate the opportunity. Thanks.
So let's start with an overview of and background of Oncolytics, a biotechnology company developing its lead candidate, Pelareorep. I think we can go by pela, going forward.
That'd be great. Yeah.
An Intravenously delivered oncolytic virus that is being used as immunotherapeutic in late-stage development in Oncology. Can you tell us more how you chose this to be your lead candidate and the work that you've been developing around it?
Yeah, for sure. So originally, the technology came out of the University of Calgary. It was Matt Coffey's doctoral thesis, and, you know, what he saw early on were just some interesting attributes with pela, and he hypothesized that, you know, pela could impact and, you know, actually kill cancer cells and impact the disease, while not harming healthy cells. And so with that hypothesis, we, you know, we put into place, you know, some early-stage studies. We saw some single-agent activity in breast cancer in an early safety study. And then also we saw, in pancreatic cancer, we saw some landmark survival data that was quite interesting. You know, we saw one-year and two-year survival that we just weren't seeing in the standard of care.
And you know so just presented a signal that was quite interesting. And what we've found with you know working with the FDA getting their guidance over the years working with Roche and with Pfizer and with just a much better understanding of the immune system we really learned about pela and how it can... and how it works and the mechanism of action. And what we now understand is we have a better understanding of the immune system. We now understand that pela creates an immune response both an innate and adaptive immune response and it also changes the tumor microenvironment. And in doing that we kind of create that cold tumor hot concept.
It also signals the immune system to come rushing to the site of disease, and it's actually the immune system that does the heavy lifting in terms of impacting cancer and killing cancer cells. And so with that, you know, with that understanding, that better understanding, you know, we saw some statistically significant survival data coming out of breast cancer. We put a plan into place where we were gonna develop breast cancer and then also pancreatic cancer. And so with our foundational data in the breast cancer space, the statistically significant survival data, we started BRACELET-1. And our BRACELET-1 study was meant to update the patient population, was to, you know, confirm what we saw in the earlier study, and then help us define a registration path.
And I think most people are aware, we announced some interesting data at ASCO last year, not this past ASCO, but the ASCO before. And we saw it impacted PFS, and we saw you know an improvement in overall response rate, as well as median PFS. And we're now taking that data. We're on the cusp of the overall survival data. We expect that to be announced imminently, and we'll take that, and we'll using an accelerated approval concept, we'll push the breast cancer opportunity through a registration path that way. In terms of pancreatic cancer, again, we saw landmark survival improvements. Better understanding of the mechanism of action allowed us to put in place the GOBLET platform study, and we saw some really very strong response data coming out of the first cohort in GOBLET.
That got, you know, our KOLs and investigators quite excited, and we have commenced working with the Global Coalition for Adaptive Research, GCAR, and with them, we anticipate putting together a registration path in pancreatic cancer, looking at gemcitabine nab-paclitaxel, plus the addition of atezolizumab, to see if we can, you know, make an impact in pancreatic cancer. But on top of that, because of the excitement coming out of the KOLs and our investigators, we've also got selected for a grant that has allowed us to look at the other standard of care in pancreatic cancer, being modified FOLFIRINOX. And so we commenced that cohort this year, and we're excited to see some safety data later on this year or early next year, and move that forward to see if we can repeat the signal with the gemcitabine nab-paclitaxel.
So, you know, we're super excited. We're sitting here today with two, you know, I think, well-defined paths to approval in two meaningful cancer indications: metastatic, late-stage metastatic breast cancer, as well as pancreatic cancer.
Great. So I heard many programs, so this is a great overview. We have data coming imminently from breast cancer phase II program. It seems like that could lead to a registrational program. Also a registration, potential registrational path in solid tumors coming from GOBLET, and that would be in pancreatic cancer. So we're gonna just dwell a little bit more on those. But before, can we just talk a little bit about the platform and pela itself? You would you know, being an oncolytic virus, that is an immunotherapeutic, being used as an immunotherapeutic, why did you choose reovirus compared to other types of virus, such as AAVs or others?
Yeah, that's a great question. So what we have found is pela. Well, first and foremost, it's naturally occurring, so we don't have to modify pela in any way. There's some real benefits to that. You know, one, you know, just in terms of safety and just the handling that's required at the site, at the treatment sites, just makes it a lot easier. But more importantly, because it's naturally occurring and just some of the attributes with pela, we've been able to administer it in an IV setting. So it's IV administration, and that's really, you know, for us, it's a huge competitive advantage. Because we can administer IV, it allows us to target not just the primary disease, but also metastatic disease as well.
So we can work in late-stage indications. We can kind of pela searches out and seeks out the metastatic disease because it, you know, is looking for a source for replication. And it opens up, you know, a much greater opportunity, commercial opportunity for us compared to, you know, our competitors who are, you know, trying to move into, you know, an IV administration concept, but they're largely stuck with intratumoral administration. So they need to be able to access the disease, and you can just kind of think about that commercially. You know, how does that translate into an unmet medical need and a commercial opportunity? And it's challenging. The metastatic space allows for that. And then just it targets cancer cells.
You know, it just has the natural ability to target and infect cancer cells, and it leaves the normal cells alone. So because of that, it's a very safe, relatively speaking, it's a safe treatment paradigm. And it focuses on the cancer and the tumor microenvironment, and leaves the natural cells and the normal cells alone. And so just finally, you know, the impact of that is just twofold. So, you know, because of pela's replication, it causes a T-cell response. We get an expansion of existing T-cells that recognize pela and, in some cases, the tumor, and it expands those T-cells. But it also, through the adaptive immune response, it creates new T-cells that have learned to recognize the tumor.
But in addition to that, because of the change in the tumor microenvironment that's caused by the use of pela, it signals the T-cells to come to the site of the infection. And so you're drawing these T-cells, the new and the existing T-cells, into the site of the tumor, and then it allows the immune system to recognize and do the heavy lifting and the heavy cancer killing.
That's great. Thanks for that overview. And for the lead program in breast cancer, it's phase II development, and it's in phase II development for HR-positive, HER2-negative metastatic breast cancer. Could you tell us a little bit more about the actual unmet need here and why you chose to go through this path?
Yeah, I'm happy to answer that. So I mean, if you followed, you know, the breast cancer, metastatic breast cancer in the last couple of years, obviously, the treatment paradigm has changed, you know, dramatically, especially, you know, with the approval of a new antibody-drug conjugate. So what we see is there's a significant opportunity because based on new data, you know, published at ASCO, we anticipate that ER/HER2, you know, the lead antibody-drug conjugate, targeting HR-- I mean, targeting HER2, is going to move, you know, first line after your typical endocrine therapy. So then, you know, when you think about that, you say, "Okay, what's where is pela going to fit?" There's definitely, you know, a need because this patient, even if, you know, ER/HER2 has proven significant efficacy, this patient ultimately, you know, will still relapse.
And then, you know, what are the option? The option now are chemotherapy, and we think that we can provide a much better option, putting, you know, pela plus, paclitaxel, and in these patients. On the other hand, also, there's a significant number of patient that won't be eligible, you know, for antibody-drug conjugate, especially the ER/HER2-null, which is a new category. And, and also, you know, some patient may not tolerate, you know, the antibody-drug conjugate. So we believe that if you combine, you know, this patient that won't tolerate or won't be eligible, plus a patient, you know, that will relapse after, you know, ER/HER2, we're considering an addressable population of roughly 55,000 patients. So that, we believe, is a very significant opportunity.
And, you know, when you see, these are early results, but when you see our results in terms of PFS, in particular, that we've shown already, we see a significant, you know, advantage, you know, for these patients. So we're very, you know, optimistic about the potential for this drug.
There's more data coming in the next, Oh, you said imminently? So in the next couple of months?
Yeah, so we reported interim analysis for overall response rate as well as for PFS last year at ASCO. Not this past ASCO, but the year before. We've been waiting on the, you know, required number of events to do the overall survival analysis. And just as part of the protocol, that analysis is done at the point in time where you have enough events or two years after the last patient was enrolled. So we met that two-year time point at the end of May. And so we've been, you know, working through the data, you know, auditing it, monitoring it, getting updated patient status in order for us to do the analysis. We're now in the midst of the analysis.
About the development path that you're gonna pursue, have you met with the FDA? When do you plan to meet with the FDA, and what are you looking for reaching alignment?
Yeah. So we have met with the FDA a couple of times, last year, 2023, and then again, this year, in May, where we, you know, presented our data at the time and our thoughts around, path forward to approval. What we presented to the FDA was a, you know, a phase II concept, a large phase II concept, you know, kind of using the recipe that's been used, you know, quite a number of times. Ibrance is a good example. Enhertu, as well, is a good example of how a phase II, the size of about one hundred and eighty to two hundred patients, can be powered in a manner that if you reach certain endpoints, that the powering is sufficient to seek accelerated approval, with the promise of a confirmatory study.
And so that's the path that we're looking to take. We got some [audio distortion] feedback from the FDA in May. We reported that in Q2 of this year. And really, the you know the FDA, you know, as you know, Christophe mentioned in terms of our patient population, you know, they you know they recognized and accepted our patient population as we presented. So looking at, you know, those patients who are ineligible for Enhertu for one reason or another, and those that have failed Enhertu, they, you know, they're fine with the PFS as being an endpoint. Obviously, they want OS as well to be in, to be part and parcel of that protocol design. Then we had a really good discussion on what's clinically meaningful to the FDA.
And so, you know, we'll take that into consideration, and that will help us, you know, scope the phase II and give us confidence that if we meet the standards that we set, that we, you know, we'll, you know, be able to make a submission for accelerated approval. Now, of course, the FDA never will tell you that they'll approve anything. It's always, you know, a function of the data, a function of the, you know, that moment in time. But we came away feeling very confident that our path is an appropriate one for Oncolytics and has a real potential to be successful.
Sounds great. You did mention the pancreatic cancer program, that was part of the GOBLET, which is in multiple solid tumors, and the data that you've presented so far has been promising. Can you tell us a little bit more about that?
Yeah. So, you know-
Also, excuse me, in the-
Yeah
... in the context of the standard of care as well, and why did you choose this combination that you're going forward, particularly?
Yeah, for sure. So some of our early-stage studies in pancreatic cancer looked at, you know, gemcitabine, nab-paclitaxel. And so we developed, you know, a pretty, pretty good, you know, bolus of data in that combination. GOBLET, the interesting thing about GOBLET is it looks at, you know, the addition of a checkpoint inhibitor. In this case, it's Tecentriq or atezolizumab. And so, you know, the thought being that if we can turn cold tumors, which a lot of these GI cancers are, we can turn, especially pancreatic cancer, if we can turn those cold tumors hot, that we could then bring, you know, some synergies to the addition of a checkpoint inhibitor. And that's started to play out in the GOBLET study.
Cohort 1 was our first cohort into pancreatic cancer with the combination of gem/nab-paclitaxel along with atezolizumab. And we saw just some real compelling response rate data, which was the endpoint for this Simon two-stage study design. And it was so strong, we saw a tripling of almost a tripling of response rate in 13 patients. And, you know, it was so strong when talking to our KOLs and our investigators, you know, they just pushed us to find a randomized setting and see if approval, you know, would be possible, rather than, you know, delaying the registration path. We, you know, entered into a collaboration with the Global Coalition for Adaptive Research this year, and they're, you know, a group that does adaptive research.
One of their focuses is on pancreatic cancer, and it made a lot of sense to work with them because they just, you know, have a network of sites, they have a network of investigators, KOLs, in this particular indication to try to find an adaptive design that would help us get across the finish line in pancreatic cancer again in an effective and efficient way. On top of that, the other standard of care in pancreatic cancer is modified FOLFIRINOX. The Pancreatic Cancer Action Network, or PanCAN, got involved, and they awarded us a grant for $5 million that's allowed us to then investigate whether or not we have a signal using the second standard of care. We've commenced that cohort this year.
We expect some safety data late this year, early next year, and then we'll start to see efficacy data in the middle of 2025 that we're hoping to report on. We bring that all together, and we think we have an opportunity to corner the late-stage pancreatic cancer market, you know, especially if what we've seen with GEM is consistent with and is repeatable with FOLFIRINOX. And we're pretty excited that we could really make an impact on pancreatic cancer.
In pancreatic cancer, we're using the two most widely used chemotherapy, so the gem nab-pac and FOLFIRINOX.
Yes.
There's a potential that both will be successful.
To be really meaningful, yeah. Yeah, well, absolutely.
And, I'd like to open the floor to questions, either on breast cancer, on pancreatic cancer, pathway forward. Well, can we discuss a little bit the pathway forward for pancreatic cancer?
Yeah, for sure. Yeah. So, what we plan to do and what we are doing with GCAR is we're going to the FDA with an adaptive design that will look at the standard of care gemcitabine nab-paclitaxel plus pela plus tislelizumab in a phase III setting that would, you know, be established to be sufficient for a formal full approval.
That's what I found.
We anticipate going to the FDA late this year, early next year with that submission. We'll probably file that submission in Q4. Whether or not we meet with the FDA is a function of the FDA. From there, we'll be able to, you know, scope our next steps and be able to come to the market with the plan going forward.
All right. So again, two registrational- two potentially registrational paths-
That's right
... in these large indications, very, very high unmet need and data incoming. It's gonna be a pivotal year next year, and, we're looking forward to it.
The remaining of this year. Yeah.
The remaining of this year with the BRACELET-1 data.
Yeah.
So stay tuned. Christophe, Kirk, thank you so much.
Thank you.
It was a pleasure, and thank you for attending.
Thanks very much.
Thank you. Thank you.
Thank you. I really appreciate it.