Thursday, March 10, 2016 7:29:29 AM
Here is some of what was said about Bavi:
So on this side of our business; it is business as usual supporting our clients with their developments and commercial production needs. On the development side, it is a transition time for our bavituximab program. While the results of the interim analysis from the SUNRISE study are unfortunate, and it is a setback for our chemotherapy combinations with bavituximab, it is by no means the end of the program.
For starters, we have not yet completed patient follow-up in the SUNRISE study with the goal of learning as much as we possibly can from the trial.
At this point, our goal for the study is to obtain data from the trial that can potentially be critical in how we move the chemotherapy combination program forward and even information that can help guide the overall program, which patients to particularly well know study, what were their characteristics, these are just a couple of examples of the many types of questions that we want to attempt to address as we wind down the SUNRISE trial. So that we can tailor patient selection in future studies.
As we generate this data, we will be able to share it at the appropriate time in the future. After advancing the program, we are as excited and confident as ever about the immuno oncology combination potential of bavituximab.
As you may recall, this was already the counterpart to the chemotherapy combinations based on a completely different mechanistic synergy namely to start an immune response in patients lacking a good immune response and then prolong the immune response by blocking the PD-1 PD-L1 pathway that can counteract a strong immune response in patients.
This combination hypothesis is still completely intact. We have generated a significant amount of translational and pre-clinical data demonstrating that bavituximab has the potential to enhance the activity of checkpoint inhibitors and our goal for the coming year is to bring many of these concepts into the clinic and to demonstrate the potential of bavi in this important area of cancer therapy.
With our I-O combination program having been underway for sometime, long before the SUNRISE results, we have formed collaborations with some of the leading I-O players in the world.
A collaboration with AstraZeneca to study bavi with their PD-L1 inhibitor durvalumab, a collaboration with researchers at Memorial Sloan Kettering Cancer Center to study novel combination of bavituximab with I-O agents, a collaboration with National Comprehensive Cancer Network or NCCN to run multiple clinical studies focused on I-O combinations, and at some of the 26 leading cancer centers in the US that are part of the network with significant involvements, as part of the program from key opinion leaders at those institutions all in addition to our long time collaborations at the University of Texas Southwestern Medical Center that will continue to be active in pushing forward I-O combinations.
The main difference with the SUNRISE results in hand is that the I-O combination program has become our major area of clinical focus and as such, we are working with all of our collaborators to redefine the program in order to have a cohesive and comprehensive strategy that ties together the efforts of all of our collaborators that will allow us to rapidly advance the program.
The strategy will involve study designed to answer specific questions about particular patient populations where we already have evidence that bavi may have the biggest impact allowing us to more quickly generate data that we can build on as we advance the program.
