Christopher Bullock Presents QV Bioelectronics at LSI Europe '23

Transcription

Christopher Bullock  0:06  
Brain tumors are one of the great unsolved challenges in modern medicine. The most common primary brain tumor, glioblastoma, has no cure. And despite highly intensive treatment consisting of surgery, chemotherapy, and radiation, fewer than 5% of patients will still be alive five years after their first diagnosis, with the average survival just 14 months. This puts glioblastoma firmly amongst the worst cancers in terms of clinical outcomes. The reason for this is the surgery unavoidably leaves behind residual cancer cells in the surrounding brain tissue that do not respond to chemotherapy or radiation. And over time, those residual cancer cells come back to form new tumors that will sadly, and inevitably lead to the death of the patient. There is a clear and urgent need for new and innovative treatment approaches to address those residual cancer cells. And in the last 20 years, there's only been one form of therapy that is showing significant promise in changing the status quo. We call it electric field therapy. And QV Bioelectronics is developing the world's first of its kind, implantable electric field therapy device. Our protective technology enables our device grace to be easily surgically implanted into any patient, regardless of the shape, size and location of their tumor. From that position within the brain, it's able to deliver the therapeutic electrical fields continuously focally and directly to the site of the residual cancer cells. So how these work is we apply specific frequencies of electrical stimulation that do not affect neuronal activity, but interrupt the process of cancer cell division, or mitosis, which then pushes those cells into apoptotic cell death. Crucially, this is a biological process, we're not heating or ablating the tissue, and it does not affect the healthy brain tissue. There is an incumbent device on the market that requires patients to wear a cumbersome and highly visible external device for 18 hours a day, with a plethora of issues relating to that external design. Despite those issues, that device made over half a billion dollars in sales last year from treating just 15% of the US glioblastoma population. By contrast, grace as an implanted device overcomes the quality of life issues that might result from the therapy and is able to commence treatment immediately after surgery. And it's a well known fact that the earlier you treat cancer, the better patients do. But most importantly, it enables the treatment to be delivered continuously 24 hours a day. In our preclinical work and state of the art in vitro models of glioblastoma, we've been able to show the importance of achieving that 24 hour a day treatment. When you compare to 18 hours a day as the benchmark for what the incumbent device is able to do. We see four times greater cell death with the 24 hour treatment that grace will deliver. One of the reasons that glioblastoma is so hard to treat is the huge amount of genetic variation within the cancer. And crucially, we see that this effect is replicated across the most aggressive genetic phenotypes of glioblastoma. It's also a result supported by clinical data. So in the phase three clinical studies of that existing device, they were able to show that the electric fields when used alongside the standard of care increased the five year survival of these patients from just 3% to 13%. That isn't model data. That's actually how many patients were alive five years later. And in context, that is huge. No emerging drugs, no other clinical trials with other therapies have been able to achieve anything like those survival numbers. But crucially, there was also a proportion of patients within that trial who were receiving treatment for 22 or more hours a day the equivalent of what grace will be able to deliver. And the five year survival for those patients was nearly 30%. So that's more than double the average, which was based on about 18 hours a day of treatment, and a tenfold increase on the current standard of care. There's a clear relationship between the compliance with the therapy and the outcomes for these patients. So our focus is on fixing the usability of the tree. treatment to enable this treatment to be delivered continuously in all patients. So how does our device work, we had to come up with a way of interfacing with this surgical cavity within the brain that's a different shape, size and location in every patient. In order to do that, we've developed a unique patented gel electrodes that comes within a prefilled syringe that allows us to form the electrical contact with that cavity in three dimensions. From that point, we then spread the electrical fields throughout the tissue to some MRI compatible counter electrodes that receive the electrical fields. And the whole system is powered by a wirelessly rechargeable IPG, similar to those used in deep brain stimulation. Where possible, we've tried to leverage existing neurosurgical techniques in the design of grace and that neurosurgical knowledge comes from my co founder Richard, who is a practicing neurosurgeon. And my own background is as an engineer specialized in neuro technology. Board level, we're joined by decades of cumulative experience in medical device development. And we have a full time team with expertise in all of the key disciplines needed to bring grace to the market. To date, we've been able to show worldleading performance of our injectable electrode with a particular focus on compatibility. With MRI imaging. We've also using state of the art models of glioblastoma have been able to show in vitro preclinical evidence equivalent to that of a blockbuster chemotherapy drug. And we've shown the safety of grace with implants with active stimulation in cheap. A more recent development is we've developed precision medicine techniques that allow us to target the stimulation to best optimize the therapy depending on the genetic phenotype of a patient's tumor. Looking forwards, we're continuing to work to develop worldleading understanding of the mechanism of action of this therapy, which one day, we believe will allow us to translate grace to address other forms of brain cancer, which would make the total addressable market 38 billion US dollars a year. Right now, our main focus is on ongoing development of the device. And moving into preclinical GLP validation with the intention of starting first in human clinical studies in q1 2025. I'm here today because we're raising a Series A rounds with a purpose of funding that the GOP validation and as well as to complete feasibility clinical trials. And we'd be looking to raise a series B round in 2026 on the back of that clinical data, which would fund pivotal clinical trials and commercialization. In summary, I'd like you to remember cuvee electronics as a company striving to deliver longer, better quality lives to brain tumor patients. Our protected innovation enables us to access a $4 billion a year market in glioblastoma that is not well served by the only incumbent. For too long. patients with brain tumors have been let down by existing treatment options. We are working hard to change that situation. Thank you very much for listening. And if anyone would like to learn more, please do come and find me around the conference. Thank you