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12-10-15/CC: CEO STEVE KING – OPENING COMMENTS:
Thanks as always to all of you who have dialed in, and to all of you who are participating via webcast today. I’ll start by saying that we are making great progress in our broad overall development strategy for bavituximab. The strategy is to establish the potential of bavituximab in combination with current & evolving standard of care drugs, with both chemotherapy and immuno-oncology combinations in multiple cancer indications. Our goal is to drive to meaningful clinical data points in each of these areas by early 2017. In accordance, today’s development discussions will focus on these efforts, including upcoming completion enrollment in the SUNRISE trial which is evaluating a chemotherapy combination, and, as SUNRISE wraps up, our plans for a smooth transition of the key SUNRISE clinical sites directly to the next Phase II lung cancer trial evaluating an IO combination. In addition, we are expanding our potential cancer indications through initiation of a Phase II/III metastatic breast cancer study. All of this while continuing to work through several other clinical trial concepts actively under development or initiation in the new year.
On the development front, I’m pleased to report today that we are nearing completion of enrollment in the cornerstone of our bavituximab development strategy, our Phase III SUNRISE trial. In fact, with over 90% of the expected enrollment complete, we currently have sufficient patient enrollment based on the assumptions of the study to allow the trial’s planned interim evaluations and final readout based on the primary endpoint of overall survival. Having said that, we do expect to complete enrollment of at least the pre-specified 582 patients over the coming weeks. At this point, the next big milestones really are the interim data analysis from the study, expected to take place during early & mid 2016, with trial unblinding expected toward the end of 2016. Joe will add little more color to the up coming milestones for the SUNRISE trial during his prepared remarks.
For me, what has now become the most important thing at this point in our broader strategy is to engage our best enrolling sites from the SUNRISE trial toward a smooth transition to the new Phase II study that will evaluate bavi in combination with AstraZeneca’s anti-PD-L1 antibody durvalumab. We have a golden opportunity here to maintain continuity for our lung cancer program by continuing almost seamlessly working with our high enrolling sites and key investigators in essentially the same, even in extended, patient population with the inclusion of squamous non-small cell lung cancer patients. I have personally had the opportunity to meet with key investigators all over the globe and there is a lot of enthusiasm for continuing to work with Peregrine and bavituximab in the new study. Based on feedback so far, we expect that the new study could enroll even more quickly than the SUNRISE trial and the best way to ensure that is to get off to a quick start, again keeping us on track for data from the new study by early 2017. This would give us two nice sets of data in NSCLC to work with.
Equally exciting is the Phase II/III metastatic HER2- breast cancer study that we are looking forward to starting by year-end. I say exciting because the new trial design has a solid clinical data basis, and our previously completed Phase I & II trials in a patient population in these new treatment options. While we don’t have the same benefit as we do for the lung cancer program of rolling right from one study into another, the team has been working diligently to get the study started by the year-end, giving us additional enrollment months, which again can put us on track for some meaningful clinical data from the study by early 2017.
The company is also working diligently on a number of other studies, including our other collaboration with AstraZeneca, evaluating a combination of bavi with chemotherapy and adding in again their durvalumab antibody in multiple solid tumor indications. So, conceptually, “get an immune response going with chemotherapy & Bavi, and then keep it going with durvalumab”.
In addition, we are working toward initiating an earlier stage breast cancer study, as well as a number of other concepts that are in development. So, stay tuned for future clinical developments. Taken together, these clinical efforts, along with the plethora of preclinical & translation collaborations evaluating new combinations, new potential indications, and further validating our immune mechanism of action has a potential to add substantial value over the coming year. We expect a steady flow of scientific & clinical presentations over the coming year as we continue to learn to more about the potential bavituximab.
Oh, and by the way, today we also announced another record revenue quarter from our biomanufacturing business, with our new Myford manufacturing facility just ready for GMP production, which can help spur even more future growth for the business, not the least of which is getting ready for bavi commercial production. Rob & Paul will add more detail and discuss the continued growth for our mfg. business shortly. To say that these are busy times at Peregrine is an understatement.
