Here is the last intel from AACR that I have left, I think.
Poster #274: Bavituximab lymphocytes in a patient-derived 3D ex vivo system of lung cancer was very interesting lymphocytes in a patient-derived 3D ex vivo system of lung cancer was very interesting to me even more so due to my talk with Nikoletta Kallinteris. She turned out to be a Senior Scientist of Translational Research reporting to Joe Shan, Peregrine. You will see her name, the 6th one on the author list right before Joe’s, on the poster/abstract. She has been with Peregrine for almost 2 years and moved there from Boston where she worked for another small biotech company. She said she was very impressed with Bavituximab and its MOA and wanted to be involved and study it. Jay Carlson told me that when he first met her and he welcomed her she told him that she chose Peregrine, so she must have been in demand.
Now to the real point; this was new to me and I’m excited that Peregrine is doing it. She is tasked with building a database of biomarkers for Bavituximab. She is gathering the characteristics/levels of immune check point proteins (like PD-L1, CTLA-4, Tim3, etc) and cytokines (like TNF-a, IL-6, IL-10, etc.). She is doing that from all the patients in SUNRISE and any other blood and tissue samples that they gathered and are continuing to gather in other trials. I asked how close she might be, admitting that I expected it would be a number of years, to getting any biomarker approved by the FDA. She replied that it would take 7500 samples of any biomarker before FDA would accept it. Wow, that will take some time. However, she said, and Steve King later repeated, that this data would be valuable to a potential partner even now as far as proving how good Bavi really is.
One of the things she was excited about was building data for what she called an Immuno Score. She was using data from the diagnostic biopsies that all the patients had that led to the diagnosis of their cancer. That would allow them to pick better responding patients (better subsets) for future trials as they would use that similar to way they use ECOG and other scores. I googled immune score and this result led me to believe that she may be contributing to the overall global development on that metric:
The Immunoscore® - as a new possible approach for cancer classification.
Over the past few years, the area of immune regulation at the level of the tumor microenvironment has gained a forefront position in cancer research. At the same time, advances have been made in the development of an immune score, called "Immunoscore"®, as a prognostic factor.
In an effort to promote the Immunoscore in routine clinical settings, a worldwide task force was initiated by Dr Galon.
The working group composed of international expert pathologists and immunologists identified a strategy for the organization of a worldwide participation by various groups for the validation of the Immunoscore
An immune-classification of tumors was proposed based on an immune score, performed by the quantification of two lymphocyte populations (CD3/CD8, or CD3/CD45RO, or CD8/CD45RO), both in the core of the tumor and the invasive margin of the tumor, to establish prognosis of clinical outcome in patients [11]. Importantly, this immune-classification has a prognostic value that may be superior to the AJCC/UICC TNM-classification.
This all should be interesting to biopharm, especially.
