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spk01: Good morning and welcome to Oncolytics Biotech's third quarter 2021 conference call. All participants are now in listen-only mode. There will be a question and answer session at the end of the call. Please be advised that this call is being recorded at the company's request. And I would like to turn the call over to John Patton, Director of Investor Relations and Communication. Please go ahead.
spk03: Thank you, Operator, and good morning, everyone. Earlier today, Oncotics issued a press release providing financial results and corporate updates for the third quarter of 2021. A replay of today's call will be available on the events and presentation section of the Oncotics website approximately two hours after its completion. After remarks from company management, we will open the call for Q&A. As a reminder, various remarks made during this call contain certain forward-looking statements relating to the company's business prospects and the development and commercialization of Pella Rear Rep. including statements regarding the company's focus, strategy, and objectives, the company's belief as to the potential and mode of action of Pell Area Rep as a cancer therapeutic, the design, aims, and anticipated benefits of the company's current pending clinical trials, the company's plans and expectations regarding a potential registrational study, the company's plans regarding the expansion of Pell Area Rep's market and business development potential, and other statements related to anticipated developments in the company's business. These statements are based on management's current expectations and beliefs, They are subject to a number of factors which involve known and unknown risks, delays, uncertainties, and other factors not under the company's current control that may cause actual results, performance, or achievements of the company to be materially different from the results, performance, or expectations implied by these forward-looking statements. In any forward-looking statement in which Oncologics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith, Our beliefs have reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These factors include results of current or pending clinical trials, risks associated with intellectual property protection, financial projections, actions by regulatory agencies, and those other factors detailed in the company's filings with CDAR and the SEC. OnClinics does not undertake any obligation to update these forward-looking statements except as required by applicable laws. Now, I'll turn the call over to Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. Matt?
spk06: Thanks, John. And thanks to all who are joining us today to discuss our third quarter corporate update. Now, in addition to John, I'm joined by Tom Heinemann, our Global Head of Clinical Development and Operations, Andrew DiGadadaro, our Global Head of Business Development, and Kirk Look, our Chief Financial Officer. These past months were an important period of execution for Oncolytics. We achieved key objectives that advanced Pella down a clear path of a registrational breast cancer study while simultaneously furthering its development as an immunotherapy backbone that can enable the success of a wide range of agents across multiple indications. One of our most exciting recent highlights from these past months was actually announced earlier today in relation to new biomarker data from the first two cohorts of AWARE-1 breast cancer study. As a reminder, AWARE-1, together with our ongoing Bracelet-1 trial on HR-positive HER2-negative breast cancer, was designed to achieve three key objectives in order to answer questions that were posed by regulators and partners regarding the survival benefit observed in INV213, our prior randomized Phase II study that showed a near doubling of overall survival with Pellarerep in HR-positive HER2-negative metastatic breast cancer patients. These objectives were to confirm that Pellarear Rep works through an immunotherapeutic mechanism of action as suggested by the survival benefit in IND213, which became apparent about 10 months after the start of treatment. Second, determine if checkpoint inhibitors synergize with Pellarear Rep. And third, determine if changes in peripheral blood T cell populations could potentially serve as a novel blood-based biomarker to predict patient response to Pellarear Rep therapy. Now, on our recent earnings call, we walked through data showing that AWARE-1 had accomplished its primary goals and validated our broader clinical strategy by confirming Pella's immunological mechanism of action and demonstrating the synergy between Pella rear rep and checkpoint inhibition. With the data we are announcing today, which Tom will discuss in more detail, we have further support for these earlier conclusions and evidence that changes in peripheral blood T cell populations may be predictive of patient response to Pellarear Rep. This is an exciting finding that could potentially improve our chances of success in subsequent studies by allowing us to quickly identify the patients who are most likely to respond to Pellarear Rep therapy. It also has us well on our way to achieving the last of the three objectives I just laid out, which we expect to complete as part of our ongoing Bracelet One study. One important point to emphasize about the AWARE-1 data we have presented to date is that includes all patients in the first two cohorts, which evaluates Pella with and without checkpoint inhibition in patients with HR-positive HER2-negative breast cancer. Evaluation of these cohorts was the core objective of AWARE-1 as HR-positive HER2-negative is the breast cancer subtype we intend to examine in future registrational studies. As I alluded to earlier, the data from these cohorts has allowed the site to meet its primary objective, which has our lead program advancing down a clear path towards a registrational study. The last task we need to accomplish before advancing to such a study is the completion of bracelet one, which Tom will discuss shortly. As we look ahead for wear one, we have amended the protocol to keep all ongoing and future cohorts focused on evaluating Pella in patients with HER2 positive breast cancer. We are thus not proceeding with the where's one triple negative cohort, as we expect to generate an abundance of data in this breast cancer subtype for our ongoing IRENE trial, which evaluates Pellary Rep in combination with Insight's PD-1 checkpoint inhibitor, retifanilamab, in the metastatic setting, which is a less common subtype. This will allow us to advance our breast cancer program with efficiency while collecting data in each subtype of the disease. Beyond our lead program, we continue to strategically leverage collaborations with industry leaders and academia to unlock additional value by executing unstated milestones in our other clinical trials, such as IRENE and GOBLET, which also evaluate Pella in combination with a checkpoint inhibitor. Our efforts towards this goal are bolstered by the robust clinical data set demonstrating Pella's ability to act as an immunotherapeutic agent that trains immune cells to fight cancer. while simultaneously enabling their success by weakening or reversing the tumor defense mechanisms that drive checkpoint inhibitor resistance. Taking a broader view, this differentiated and broadly applicable mechanism of action positions Pella as a potentially immunotherapy backbone that can be an enabling technology for a range of immuno-oncology agents even before checkpoint inhibitors such as CAR T cells and bispecific antibodies. This provides a multiple of opportunities to further expand Pella's market and business development potential. In order to efficiently pursue these opportunities, we plan on utilizing a partner strategy. This will allow us to keep our primary internal focus on advancing Pella Rare Rep towards a registration in HR positive, HER2 negative, and metastatic breast cancer. We believe this strategy represents the best way to maximize the value Pella Rare Rep can generate for shareholders and patients. while ensuring we devote the necessary resources to our lead program. This will position the company to minimize risk as we work to efficiently execute on stated clinical objectives. With that, I'll now hand it off to Tom to talk a bit more in detail about our recent data and progress of our clinical programs. Tom?
spk09: Thanks, Matt, and thanks to all those listening on the call today. I'd like to start by first discussing the compelling AWARE1 biomarker analyses Matt mentioned. the results of which we announced for the first time today. These analyses focused on how Pella REAREP treatment, both with and without a checkpoint inhibitor, drive changes in peripheral blood T cell populations and how these changes correlate with cell TIL score in tumor infiltrating CD8 positive T cells, two metrics that are associated with favorable clinical outcomes. The goal of these analyses was to identify a potential blood-based biomarker that could be used to quickly identify patients most likely to respond to Pellaririb either before therapy or after an initial treatment cycle. I'm pleased to say that this goal was accomplished and that we've identified potential biomarkers that will be evaluated further in our Phase 2 Bracelet 1 trial. Now, I'll dive into the specifics of the latest data, which, as Matt mentioned, include all patients from Aware 1's first two cohorts. As a reminder, these cohorts enrolled patients with HR-positive HER2-negative breast cancer. Cohort 1 patients were treated with Pellin-Rear Rep and hormonal therapy, while cohort 2 patients received the same treatment regimen plus the checkpoint inhibitor, metisalizumab. A pooled analysis across cohorts showed a statistically significant decrease in peripheral blood T-cell diversity post-treatment due to the expansion and generation of new antiviral and anti-tumor T cell clones. To provide some context on what this means, you can think of T cell diversity as a measure of population heterogeneity. At baseline, there are many types of T cell clones that are represented in about equal numbers, each programmed to attack a different target when activated. When diversity is decreased, this means a larger proportion of the T cell population consists of a limited number of clones designed to attack a select number of specific targets. So, the fact that we are seeing a statistically significant decrease in diversity tells us that Pella rear rep treatment drives the T cell population towards antitumor and antiviral clones, providing further evidence of Pella rear rep's ability to train the immune system to fight cancer. Importantly, our pooled analysis across cohorts also showed a statistically significant association between pre versus post treatment decreases in peripheral blood T cell diversity and increased post-treatment cell TIL scores, and a statistically significant association between increased peripheral blood T cell fraction pretreatment and tumor infiltrating CD8 positive T cells post-treatment. Given the association between cell TIL score and tumor infiltrating CD8 positive T cells with improved clinical outcomes, we believe these are exciting findings. In addition to our findings from the pooled analyses, Comparative analyses of cohort 1 versus cohort 2 showed that the addition of atezolizumab enhanced pellet re-ereptility to generate and expand new antiviral and antitumor T cell clones. That the decrease in pre versus post treatment changes in peripheral blood T cell diversity with checkpoint inhibition in cohort 2 was greater than that seen in cohort 1 without checkpoint inhibition. a numerical association between decreased post-treatment T cell diversity in the peripheral blood and treatment-induced increases in tumor-infiltrating CD8-positive T cells in cohort one. This association reached statistical significance in cohort two with the addition of a T cell ligament. Collectively, our latest AWARE-1 data first demonstrate PellaReRef's immune-based mechanism of action and its ability to synergize with checkpoint inhibitors. They also add to the robust data set, showing that the study met its primary endpoint and the Pella-REAREP treatment increased cell TIL scores, increased infiltration of CA-positive T cells into tumors, weakened tumor defense mechanisms by reversing immunosuppressive tumor microenvironment, and dramatically up-regulated PD-L1 expression. Notably, many of these desirable effects were enhanced by the addition of checkpoint blockade. With these latest, we now have compelling evidence suggesting that changes in peripheral blood T cell populations are predictive of responses to Pella ReRap therapy and potentially serve as a basis for a blood-based biomarker in subsequent studies. This could improve our chances of success by allowing us to select those most likely to respond to therapy. Looking forward, the AWARE-1 data we announced today provide our lead breast cancer program with further momentum on its clear path towards a registration study. The next and final major step on this path is the completion of the ongoing Bracelet1 trial. As a reminder, Bracelet1 was designed in collaboration with Pfizer and Merck-Sorono to support the overall clinical benefit observed in the IND213 study and to investigate the potential of changes in T cell populations to serve as a clinical biomarker. Its design is essentially identical to that of IND213, with two key exceptions. First, it is exclusively enrolling HIV-positive, HER2-negative breast cancer patients, the population in which we saw the most pronounced overall survival benefit in IND213. And second, it includes an additional study arm to evaluate the safety and efficacy of Pellarearip in combination with Pfizer and Merck-Sorono's anti-PD-L1 checkpoint inhibitor, Lavencio, We are particularly excited about this study arm given the AWARE-1 data showing synergy between Pellarear Rep and anti-PD-L1 therapy. This suggests that by adding checkpoint inhibition, we may be able to further improve upon the impressive survival benefit observed in IND2 and 3 patients treated only with Pellarear Rep and chemotherapy. Since dosing its first patient in 2020, my colleagues at Oncolytics and our investigators at Precog, the world-renowned organization managing the study, have done an excellent job rapidly advancing the Brace of One study towards completion. While the surge in COVID cases driven by the Delta variant over the summer caused brief disruptions at some clinical sites, our team was able to quickly adapt to keep the trial moving forward. Thanks to their talent and dedication, we were able to maintain momentum in this important program and are on track to finish enrollment at Brace of One either late this year or in the first quarter of next year. As we mentioned earlier in the call, the completion of Brace With One is the last major step on our path towards a registrational study in breast cancer. We expect the data we generate from Brace With One, together with the data we already have from Aware One, to inform the design of this study while simultaneously providing additional insights that will further position us to take advantage of pellagry reps potential across additional cancer populations. Lastly, before I hand the call off to Andrew, I just wanted to speak briefly about some very interesting preclinical studies that were presented at the International Conference on Immunotherapy-Radiotherapy Combinations. These studies evaluated various treatment combinations of Pella-Riorep radiotherapy and anti-PD-1 therapy in mice with two bilateral tumors, each located under the skin on a different side of the body. Radiotherapy and or Pella-Riorep treatment was delivered locally to one tumor, denoted the primary tumor, while the second tumor, which was denoted the abscopal tumor, was not directly exposed to either therapy. Results from the studies showed that compared to single-agent radiotherapy, the Pella-Riorep radiotherapy combination led to more animals surviving, which reached statistical significance when anti-PD-1 therapy was administered systemically. Additionally, these increases in survival were accompanied by increased infiltration of anti-cancer T-cells in both the primary and abscopal tumors, which is indicative of synergistic immunotherapy effects of the PellaReRap radiotherapy combination. These compelling findings, together with our prior clinical data and preclinical results showing that PellaReRap synergistically combines with agents such as CAR-T cells, bispecific antibodies, PARP inhibitors, and CDK4-6 inhibitors, highlight PellaReRap's potential as an enabling technology that can enhance the efficacy of a wide range of therapies beyond checkpoint inhibitors. In order to pursue Pellarerib development in combination with agents beyond checkpoint inhibitors, we plan to utilize a partnership strategy so that we can maintain our focus on our lead breast cancer program and the execution of our ongoing clinical trials. Now, to speak a bit more about this partnership strategy, as well as our broader business development efforts, I'll hand it off to Andrew. Andrew?
spk02: Thanks, Tom, and thanks to all who have joined us on today's call. Before I elaborate further on Tom's point, I'd like to first discuss some of our work leveraging collaborations with industry leaders to expand Pellar Rear Rep's potential therapeutic impact by developing it in combination with checkpoint blockade and indications beyond HR-positive HER2-negative breast cancer. This work is embodied by several ongoing trials. These include our trial with BMS, Evaluating PelorioRef Up to Evo Combination Therapy Multiple Myeloma. Irene, which is a Phase II study, Evaluating PelorioRef in Combination with Insights PD-1 Checkpoint Inhibitor Redifanlimab in Metastatic Triple Negative Breast Cancer. And Goblet, our Phase I-II trial, Evaluating PelorioRef in Combination with Roche's PD-L1 Inhibitor Atezolizumab in Patients with Metastatic Pancreatic, Metastatic Colorectal, and Advanced Anal Cancers. We are very pleased with the progress we've seen in each of these studies. Patient dosing was initiated in Goblet last week, while Irene and her multiple myeloma study are on track for interim safety updates by the end of the year. With each of these trials, we aim to leverage the immunotherapeutic effects Pellarearup has demonstrated in AWARE-1 and other clinical studies. These effects can reverse the tumor defense mechanisms that limit the efficacy of checkpoint inhibitors. By doing this, we believe we can address a pressing unmet need and tap into a large commercial opportunity, as the checkpoint inhibitor market is expected to reach $55 billion by 2025, despite less than one in five patients responding to these therapies. The combination of the unmet need and the commercial opportunity for agents that can enhance the efficacy of checkpoint inhibitors has driven large pharma's growing interest in this space. This interest bolsters our efforts to execute on our BD strategy as we work towards the goal of securing a global clinical and commercialization partnership. By engaging large pharma companies in the collaborative trials I just discussed, we are able to take a proven approach in pursuit of this goal, as trials such as these have typically preceded past deals. Shifting gears a bit, I'd like to highlight some recent progress made by Adelaide Nortai, our partner who is working to develop and commercialize Palaurea Rep in China, Hong Kong, Macau, Singapore, South Korea, and Taiwan. Our partners at Adelaide recently announced that they dosed the first patient of bridging clinical trial, evaluating the safety, tolerability, and preliminary efficacy of Pelorirap plus Paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer. This bridging trial uses a treatment regimen that is similar to that previously evaluated in the Pelorirap-Paclitaxel cohort in IND213. The bridging trial will enroll approximately 15 to 18 patients, with the results expected to allow Adelaide to include data from our North American IMD-213 and Bracelet-1 trials in a future submission to Chinese regulators. This work, therefore, is intended to accelerate Pella Rear Rep's clinical development in Adelaide's principal jurisdiction. Pella Rear Rep's advancement in China is significant, as the country has a rapidly growing biopharmaceutical market that is currently the second largest in the world. Breast cancer is the most common cancer among women in China, with over 416,000 cases and more than 117,000 deaths reported in 2020. Through our continued partnership with Adelaide, we have set ourselves up to capitalize on the significant opportunity represented by this large market while minimizing risks and clinical costs. Lastly, before handing it off to Kirk, I'll build on a point Tom made earlier regarding a strategy to develop Pello Rear Rep as an enabling technology for therapeutic agents beyond checkpoint inhibitors. In order to do this, we are aiming to identify high-quality partners that will take the lead on this development pathway and assume the research responsibilities and costs associated with it. Our efforts here are supported by emerging preclinical data and our clinical results demonstrating Pello Rear Rep's ability to reverse immunosuppressive tumor microenvironments and recruit cancer-fighting T-cells into tumors. These have allowed us to foster collaborations with biotechnology companies and academic institutions, such as Leiden University, who we're working with to evaluate PelorioRep by specific antibody combinations in preclinical studies. While we remain interested in these collaborative efforts and the data we expect them to generate, I should once again emphasize that our primary focus remains on our lead breast cancer program and the execution of our stated clinical objectives. To ensure we maintain this focus, we plan to continue leveraging our relationships with distinguished collaborators such as Roche, Pfizer, Merck-Sorono, BMS, Insight, and Adelaide-Norti as we work to execute on our goals. We're very pleased with the results the strategy has produced to date and believe it has us poised for sustained success. With that, I'll turn the call over to Kirk Luck, our CFO, to discuss our financial results for the third quarter. Kirk?
spk04: Thanks, Andrew, and good morning, everyone. It's my pleasure to report that Oncolytics continues to remain in a strong financial position as we advance our lead breast cancer program towards a registrational study and execute on additional clinical and corporate objectives. Our cash and cash equivalents as of September 30th, 2021 is $48.1 million compared to $31.2 million as of December 31, 2020. Based on our current projections, we expect our financial runway will extend into the middle of 2023. Now our operating expenses for the third quarter of 2021 were $2.9 million compared to $2.5 million in the third quarter of 2020. This change is largely due to higher non-cash share-based compensation and investor relations activities. Research and development expenses for the third quarter of 2021 were $3.3 million compared to $3.9 million the same period last year. Now this change was largely due to lower manufacturing related expenses as we completed a CGMP production run in the third quarter of 2020. This was partially offset by higher R&D compensation related expenses in support of our expanded clinical program and increased research collaboration activities including CAR T therapy and bispecific antibodies. The net loss for the third quarter of 2021 was $4.9 million compared to $6.7 million in the third quarter of 2020, which included an FX gain of $1.2 million for the third quarter of 2021 compared to a loss of $0.5 million for the third quarter of 2020. This equated to a net loss of $0.09 per share for the 2021 period and a net loss of $0.16 per share for the 2020 period on a consolidated basis.
spk06: that i'll hand it back to matt matt thank you kurt now before we move on to q a i'd like to reiterate how impressed i've been by the talent the dedication and the nimbleness of the athletics team over the past few months as the pandemic continued to evolve with the surge of the delta variant this past summer they were able to seamlessly adapt and keep our development programs efficiently moving forward thanks to their efforts we're heading towards 2022 with positive momentum and robust clinical and preclinical data sets that demonstrate PellareoRep's vast immunotherapeutic effects. By leveraging these effects, we believe we can develop PellareoRep as a backbone therapy that will combine synergistically with checkpoint inhibitors and a broad array of additional immuno-oncology initiatives. As we work towards this goal, we will remain primarily focused on our lead breast cancer program while selectively engaging partners and collaborators to advance our efforts in other areas. We expect this to allow us to maintain an optimal benefit-risk balance and achieve our regular cadence of catalysts. These include reporting interim safety updates from Irene and from our multiple myeloma trial evaluating Pella in combination with proteasome and inhibitor later this year, as well as the completion of enrollment in bracelet one, which is expected in late 2021 or the first quarter of 2022. Looking ahead, I remain excited about our prospects as we head towards the end of the year. Our lead program is advancing down a clear path towards a registrational study, while several other clinical and preclinical programs advance in parallel. We have a strong team that has consistently executed under the ever-evolving circumstances of the pandemic, and we are well-positioned to generate value for our shareholders as we work towards our ultimate goal of improving the lives of cancer patients. With that, I'd now like to open the lines and take some questions. Operator?
spk01: Thank you, sir. Ladies and gentlemen, if you would like to ask a question, please press star followed by one on your touch-tone phone. You will then hear a three-tone prompt acknowledging your request. If you would like to withdraw your question, simply press star followed by two. And if you're using a speakerphone, we ask that you please lift a handset before pressing any keys. Please go ahead and press star one now if you have any questions. And your first question will be from John Newman at Canaccord. Please go ahead.
spk05: Hi, guys. Thanks for taking my questions. Congrats on all the progress here. I just had two this morning. The first one is, could you describe how you might incorporate the biomarker analysis from AWARE-1 that you discussed today into some of your other ongoing studies? And the second question on Goblet-1, I just wondered if you could remind us of the dosing duration here and any potential color you could give us on timing of the clinical data in the future.
spk06: Sure. Hey, John, how are you, by the way? Thanks for the question. So, the data today, just to kind of contextualize it, when we talk about diversity of our T cell repertoire, Really, if you can just imagine an aquarium full of multicolored fish, so you have red fish, blue fish, yellow fish, green fish, white fish, black fish. If they're equally represented, it's pretty diverse. You look into it and it's like, wow, it's a spectrum of what have you. Now, if all of a sudden the red fish population explodes by like 100 fold, those clones of those red fish just amp up, the diversity drops. And that's really what this data is telling us. We get a massive increase in the clonality of these redfish that, you know, to carry on the illusion, these are anti-tumor clones. So the clonality shoots up and the diversity drops. What this allows us to do with a simple blood draw is we can do a three mil draw at, you know, as early as two to three weeks. And if we see this drop in diversity and this increase in these new T cell clones, This is correlating very strongly with positive cell till. We've demonstrated it correlates very positively with overall survival in pancreatic cancer. So what that allows us to do is stratify these patients. So basically, this is a very easy way to enrich or follow up on the patients that are deriving of benefits. And really, this will be verified with bracelet. But we've now seen this in breast cancer and pancreatic cancer. and it really becomes the focus of the goblet study as well. So what it allows us to do in the clinical testing phase is to run much smaller studies that are much more nimble because we can follow the patients that are having the desired immunological effect. And what's nice about this is the reproducibility of it. We're seeing this across indications in the clinical setting we're also seeing this in animal testing so this appears to be a very strong effect that is indicative of response in preclinical clinical and across indications so we're very excited about it from a commercial perspective this is also very nice for the patients because immunological agents like ours it often takes you don't see you know dramatic changes in PFS you see dramatic changes in overall survival But these patients are dealing with a finite window of opportunity. So we can tell as early as two to three weeks if they're deriving the benefit that we're looking for, which allows payers to accept agents like ours much more readily because we can tell which patients are responding and which ones aren't. And from the patient perspective, if they're not seeing the desired vaccination effect, we can get them off our therapy and onto something else that might be you know, more successful for them because we really are moving towards a tailored approach to oncology. So, this approach, it'll be verified with bracelet and will form a basis for our phase three. What's also nice about this approach is in pancreatic cancer, and again, we'll see more of this in bracelet, at baseline, if we see very little immunological activity, if there are very few T cell clones, if there are no predominant clones or no variation in the ratio of these clones, it really just speaks to the fact that they don't have much immunological reserve left because of pre-treatments with chemotherapy and radiotherapy. And we know they're poor candidates, so we can eliminate those patients onto the clinical setting before we even treat them. So again, it creates smaller, more robust clinical data for us. And I think dramatically improves our chances of success in the clinical. Breast cancer is tough because it is so heterogeneous, but if we can identify the patients that are likely to respond, it levels the playing field and I think gives us a dramatic improvement in our ability to be successful. Now, for your second question, duration of treatments, I'm going to push Dr. Heinemann under the bus. Tom, can you speak to Goblet a little bit for Dr. Nimel?
spk09: Yeah, sure. Can you hear me okay? Yeah, you sound great. Oh, great. Good. So, yes, so keep in mind that the GOBLET study is a platform study in which we are treating patients with four different types of GI cancers. And so the treating regimens, the treatment regimens are a little bit different depending on the type of cancer. So patients will be treated with either, all patients will be receiving pelorirap and atezolizumab. In a couple of the cohorts, patients, for example, with pancreatic cancer or with third-line colorectal cancer will also be receiving standard-of-care chemotherapy. And so the treatment regimens vary a little bit. Patients will be receiving PelorioRep weekly and etizolizumab according to its normal administration schedule, and then chemotherapy as appropriate, and they will continue to be treated on the study. as long as the investigators believe they are deriving benefit from the treatment.
spk07: Okay, great. Thank you. Sure.
spk01: Any further questions, Mr. Newman?
spk07: No, that's all. Thank you.
spk01: Thank you. Thanks, John. Your next question will be from Patrick Kirkhill at HC Wainwright. Please go ahead, Patrick. Hi.
spk08: Good morning, and congrats on all the progress. I have a follow-up question on the potential for a combination of Pella plus CAR T. I'm wondering if there is a preference for moving forward with autologous CAR T cells or allogeneic CAR T cells. And secondly, what tumor type or types do you believe would be ideal for this combination of Pella plus CAR T? And finally, what's the status of any discussions around a potential collaboration?
spk07: Hi, Patrick. Thanks for the question.
spk06: We're actually exploring both autologous and allergenic CAR-T. And the reason for that is I think the recent CRISPR data with allergenic looks fantastic. But I think for the next five to 10 years, autologous CAR-Ts are going to be dominant in this field. So I think we're running things in parallel. In terms of targets, We're looking really at the solid tumor market. I think we're speaking with potential partners around hematopoietic indications as well because of the ability of the virus to ramp things up so dramatically in the CAR-T setting. Professor Vial presented data earlier this year that, you know, the problem with CAR-Ts is they are very short-lived. What he demonstrated is loading the CAR T cells with virus would increase their activity and their persistence. And importantly, as they started to diminish, you could give a booster of the virus to basically re-engage or repopulate those CAR T populations. So that has implications obviously in solid and liquid tumors. So we are really looking at both. In terms of our solid tumor targets, The study that we're doing, AWARE-1, really allows us to look at whether the virus is active in breast cancer beyond HR-positive disease. So really the focus now is looking at HER2-positive. The work that we did with biospecifics with Layton University really pointed to the fact that targeting HER2 was a very good area for us. I think not only beyond the CAR-T, I think you will likely see us move into a HER2 positive bispecific approach with the CAR-Ts. In terms of our discussions, we have active collaborations with multiple parties in the CAR-T space. We're looking to get additional information out in the form of a manuscript here in the very short term, but it's an area we're very excited about because, again, What AWARE and Bracelet One are teaching us is the virus is a very good immune adjuvant. It is very good at expanding T cell populations. It is very good at recruiting them to swallow tumors. So I think you can see us, the collaborations we're looking at now have a strong emphasis on breast cancer, gastric cancer, and non-small cell lung, which are, I think, areas of interest for everyone in terms of the CAR T space. Back to your other question, we are doing autologous and allografts, but I think ultimately the autologous will be replaced just because, you know, if you can get an off-the-shelf CAR T that's applicable for everyone after you fix the HLA and apple typing, I think it becomes very attractive because it basically becomes just a standardized immune-based assay. But I don't think they're there yet. We've talked with KLLs in the area. They're suggesting we're probably looking at a five to 10 year horizon for that to eclipse the autologous. But we do want to get our foot on our door. We want to capture some IP. We want to, I mean, it's the gold rush right now. We want to make sure that we've staked out our land and have a strong presence in the area. So we are very active in this space. And as I said, we're collaborating with multiple partners at this point and numerous academic groups.
spk07: That's helpful. Thank you very much. Oh, thank you.
spk01: Thank you. And at this time, I would like to turn the call back over to Dr. Coffey. Please go ahead, sir.
spk06: I just wanted to thank everyone for their time and attention. We're very excited about what we're seeing in the clinic. We're very excited about our partnership with Adelaide Nortai now that they've, you know, taken our results and have moved them into, you know, one of the fastest growing oncology markets. We're very pleased with The goblet study, it hit the ground running like you wouldn't believe. We're approaching the end of bracelet one, which will give us a readout next year, final data on aware one. The aware one data, I think, exceeded our expectations in terms of the biomarker, the ability to demonstrate that it is killing cells through an immunological mechanism. So we're looking forward to the next 12 months, and we're very excited about keeping everyone up to date with the progress as it becomes available.
spk07: Thank you, sir.
spk01: Ladies and gentlemen, this does conclude your conference call for today. Once again, thank you for attending. And at this time, we do ask that you please disconnect your lines. Have a good weekend.
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