Initial presentation that will last for approximately 10 minutes, and following this we will take questions. If you have a question you would like to submit, please do so using the Q&A panel within Zoom. To begin, I will hand it over to Leslie. Please go ahead.
Thank you. I apologize for some of our technical issues. Can everyone see my screen?
Yeah, just go full screen on that, Leslie. Perfect.
Let's see if I can... You got it? All right. Okay. Thank you, everyone, for joining this very important webinar to talk about our newest collaboration with JW. With me today, I have Dr. Bradley Glover, an incredibly experienced Chief Operating Officer who has worked at Kite, who sold to Gilead for $11 billion, Genentech, Roche, Cellularity, and so on. We have Dr. John Bian that has really improved some of our clinical programs. He's a hematology oncologist by training, having worked at Fate, Lyell, Juno, and Genentech, and of course Ursula McCurry, who's our Chief Clinical Operations Officer, having worked at Amunix, who sold to Sanofi for billions, as well as Genentech, Exelixis, and SuperGen. An incredibly experienced team. Between all of us, we have roughly over 18 FDA-approved drugs that we've shepherded through the market. On cryolytics, we're here to talk about that today.
Brad, I'll have you take over the presentation.
Perfect. Thank you. On this slide, we explain the shift in paradigm that our product oncolytics really represents. Traditional oncology requires matching a therapy to a tumor's natural target. With our product oncolytics, we actually flip that approach. Instead of finding a tumor that fits the therapy, we make the tumor fit the therapy. Our engineered CF33 virus delivers the CD19 gene, "painting" the CD19 onto tumor cells and converting them into targets for CD19 CAR T cells and other CD19-directed therapies. Next slide. Perfect. This slide illustrates two mechanisms of action that really activate once CF33 CD19 infects a tumor cell. First, you have replication and oncolysis. The virus replicates inside the cancer cell and only the cancer cell and ruptures it. The step two is immune redirection.
The infected cell expresses CD19, making it visible to CD19 CAR T cells and other moieties, other therapies. This mark-and-kill approach is what we test clinically with JW. Next slide.
It's interesting, the journey of oncology. We have preclinical data that we were able to publish quite widely with combination with Cellularity's allogeneic CyCART19 T cells, as well as Eureka's autologous artimus and Aravella's INKT. We inevitably chose our combination clinical study with Blincyto, which is marketed bispecific by Amgen because it was a marketed product and it was available to us at the time, and the dose escalation continued. We had our eyesight on an auto CAR T combination because scientifically it made the right sense.
That's perfect. You know what we're announcing today is that we're entering into strategic collaboration with JW Therapeutics, and they're the developer of an approved commercial CD19 CAR-T therapy called Carteyva. Together, we'll combine our oncologics with Carteyva in refractory solid tumors. The program begins with preclinical combination work, followed by a phase one investigator-initiated trial in China. This will be the world's first clinical attempt to combine a synthetic antigen oncolytic virus with an approved CD19 CAR-T for solid tumors. Let's do next slide. Really, and one of the powers here is that oncologics is really partner agnostic. Once tumors express CD19, they become targetable by CD19 CAR-T cells, monoclonal antibodies, bispecifics, and any emerging modality. The commercial opportunity is substantial. I mean, the CAR-T is a $3 billion market, and it's growing to $23 billion.
Solid tumors represent the bulk of this with about 90% of the global oncology market. Oncologics is a first-in-class platform that really enables our CD19 therapies in solid tumors. This collaboration is an important milestone for us that advances us toward that first clinical trial in this approach.
Thank you for the presentation, Leslie and Bradley. As mentioned, we will move into some questions now based on what has been submitted via email and live. As a reminder to participants, if you have a question you would like to submit, please do so using the Q&A panel within Zoom. The first question I have is for you, Leslie. What made JW Therapeutics the right partner for this combination approach?
As we announced today, this strategic collaboration with JW Therapeutics to evaluate our oncolytic virus in combination with JW's marketed CD19 autologous CAR-T product, Carteyva, in solid tumor is an important one. We'll start the preclinical work as early as we can and finish that up and go right into a phase one. Really, JW is the right partner because they have an approved CD19 CAR-T therapy, Carteyva. They have operational manufacturing and clinical excellence, and their commercial execution has been shown to be excellent. We are very excited. They are the ideal partner to explore what we believe is a first-in-class strategy for treating difficult solid tumors.
Thank you. The next question's for Bradley. Can you explain the mark-and-kill strategy for solid tumors that this collaboration is designed to evaluate?
Sure. No, no problem. Some of this I went over in the slides, but basically the CF33 CD19 oncologics platform, it's engineered to selectively infect and replicate in tumor cells and induce the expression of CD19 on a cell surface. This makes those tumors targetable by CD19 CAR T cells, which historically have worked in blood cancers. Our collaboration with JW allows for the evaluation of that mechanism using a clinically and commercially validated CD19 CAR T product in solid tumors. This is our core scientific rationale, and we're really excited to explore it with JW.
Leslie, Imugene's previously announced to the market that CF33 and the oncologics programs would shift to a partnership-driven development with moderated internal investment. How does today's agreement affect that strategy or reflect that strategy?
Yes. This collaboration is the direct impact of those prioritized decisions. It directly aligns with our strategy, as we outlined in our recent quarterly report. We are refining our investment focus towards programs with near-term milestones and that CF33 and oncologics would move forward through collaboration, outlicensing, or joint ventures. Today's collaboration is a perfect, perfect example of our efforts for capital-efficient manner, and all the while creating a path for high-value data generation, meaning developing our products with leaner and less resources and time.
Thank you. Another one for you, Bradley. How does this collaboration fit into Imugene's capital allocation priorities? Can you briefly outline Imugene's role versus JW's in the planned development stages?
Of course. You know, I think if I get all that question, it fits exactly with our strategy that we just shared, that Leslie just shared. Our primary internal investment remains Azercel, and our innovative oncologics program, we're advancing that through partnerships with managed internal spend. Under this collaboration, Imugene provides the oncologics virus and leads defined preclinical work, while JW supplies the CAR T product and sponsors the phase I IIT in China. Development starts with preclinical in vitro and in vivo studies, and if those are supportive, we would move into the IIT with JW's premier clinical centers in China.
Thank you. Does this collaboration influence or impact the Azercel program in any way?
The programs are entirely complementary and independent. Azercel continues advancing toward its late-stage regulatory interactions and expanded enrollment in our CAR T naive patients, which is consistent with our recent announcements. We've seen overall response rates over 80% and complete response rates ranging from 45%-60%, depending on scan timing. This JW collaboration is about expanding our leadership in immuno-oncology. It's across modalities, including allogeneic cell therapy and oncolytic virus therapy.
Thank you. Leslie, you touched on it a little bit during the presentation, but what are the next steps now that the collaboration has been announced?
Absolutely, we move right into executing the preclinical work already covered in the agreement. As always, we will update the market with data as we progress the combination and this beautiful collaboration.
Thank you. There's been a couple of questions come through just with regards to some previous collaborations around CD19. What makes this JW collaboration different from those?
I think, as I stated earlier, this is an autologous CAR T that's approved in China, which makes it quite attractive. Their manufacturing, their excellence in operation, as well as execution, makes them the right partner and the right now partner.
Thank you. Does Imugene still retain 100% ownership of its CF33 intellectual property?
Absolutely. 100% worldwide.
Thank you. Just looking at some of the questions coming through. I know it's a bit dangerous with crystal ball gazing, but a couple of questions around just what sort of timeframe that we're looking at in terms of the stages from here and potential commercialization down the track.
Like all development products in cancer, if it shows great results, you can expedite some of the development paths. Once we get the preclinical results, we'll likely go right into a phase one in China where we'll do an expeditious development. If we get all of the regulatory pathways right, we could expedite market or pivotal study. It's all about data.
Thank you. Another question that's come through is, where is the JW product approved?
In China.
Thank you. Next question is, when is a human clinical trial expected to start in China?
We will start the preclinical work. If we had to crystal ball it, we're going to try to move through that as expeditious as possible as early as 2026. What did you say, Brad?
Yeah, I mean, yeah, crystal ball it really. I mean, it's as quickly as we can move. I mean, I think JW and Imugene are well motivated to get this into the clinic as soon as possible, but it's going to be really based on the outcome of the preclinical work that both parties are very excited about. We will see, and as drug development progresses, we can provide additional updates to the market.
Thank you. Another common question in this situation is whether the company has had any concerns around potential IP breaches being in China.
JW is a stand-up company, and Imugene is, we have enough lawyers and protection around our IP. We feel pretty confident that there will be no breaches.
Thank you. How does approval, would an approval in China translate to the US market? Would separate US FDA trials be required, and how does that look?
That is actually happening more frequently now than ever where they have China approval first before they move into the US I could see that scenario being well played out with this combination.
Thank you. Leslie, I'll turn it back to you and Bradley for any final comments.
Thank you. This collaboration reflects the strength of our science and our disciplined strategy. We're quite excited to advance this novel approach for solid tumors and excited for the patients as well.
I guess from my perspective, yeah, thanks. We are going to continue to execute across all of our portfolios. As I highlighted a second ago, Azercel advancing rapidly with a positive FDA meeting and now this collaboration. It provides new momentum for oncologics. We do look forward to keeping investors and shareholders updated as appropriate.
Great. Thanks for the questions, everyone, and your participation. That's all for today, and we'll look forward to keeping you posted going forward. Thank you.