University of Miami has a very robust phase one and experimental therapeutic center. We have a new center called Griffin Cancer Research Building, which is a dedicated phase one source, phase one clinic, as well as infusion clinic. And why we say this is that we have a dedicated focus for developing newer drug development, a lot of them in immunotherapy, oncolytic viruses as well...
University of Miami has a very robust phase one and experimental therapeutic center. We have a new center called Griffin Cancer Research Building, which is a dedicated phase one source, phase one clinic, as well as infusion clinic. And why we say this is that we have a dedicated focus for developing newer drug development, a lot of them in immunotherapy, oncolytic viruses as well. So this was one of the trials, which is Seneca Valley virus trial, SVV001, in combination with ipilimumab and nivolumab. Now the rationale is that Seneca Valley virus is an oncolytic picornavirus. It has particular activity on the TAM8 receptor, and it is found that it can significantly improve outcomes for immunotherapy, which is ipilimumab and nivolumab. Now, we selected the patient population of high-grade neuroendocrine carcinoma, including small cell lung cancer. And in high-grade neuroendocrine carcinoma and small cell lung cancer, this patient population is really unique. The reason is that they do not have a lot of existing therapeutics to help with. It’s also very difficult pathology and biology to treat. Now, Seneca Valley virus has already shown lots of preclinical data showcasing that it can work really well in such tumor populations as well. And there was a preclinical model and preclinical study which showed, particularly when PD-L1 plus CTLA-4 combination is done in combination with oncolytic virus, outcomes were significantly better. So there have been also preclinical models which have already been done, which when including PD-L1 plus CTLA-4 combination with oncolytic virus, the outcome significantly improved. And there have been some clinical studies as well, which have shown that there is some activity as well. So based on this rationale, this is the first trial which is evaluating this combination of ipilimumab and nivolumab with oncolytic virus. We are going through the dose escalation phase right now. We are giving oncolytic virus through intratumoral injection in collaboration with interventional radiology at the University of Miami. And then nivolumab is given in the standard format to this patient population. In this, it’s a trial in progress, so we are not sharing the results out, but the clinical trial is still ongoing, accruing, and we are going into dose escalation and dose expansion phase very soon where we’ll be giving this oncolytic virus at multiple doses as well. So a lot to come in future meetings of the results as well.
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