AFFINERGY, LLC — Department of Health and Human Services SBIR Phase I: 102

Description

SUMMARY ABSTRACT Dendritic cell DC therapy represents a new and promising immunotherapeutic approach for treatment of advanced stage cancers with DC vaccines already approved for use in advanced prostate cancer and more than DC based vaccines in the clinical development pipeline for other cancers In particular the US market for cancer vaccines including DC based vaccines is set to expand tremendously at a CAGR of from $ million in to $ billion by This highlights the need to develop clinical grade technologies for collecting DC precursor cells and generating DCs for cancer vaccination Typically DCs are differentiated from monocytes which are isolated from peripheral blood mononuclear cells using different methods including plastic adherence counter flow elutriation and immunomagnetic selection or depletion of cells Of these techniques immunomagnetic selection of CD monocytes is the most commonly employed technique in the clinic While this technique results in a relatively pure population of monocytes as compared to the other techniques the recovery yield of monocytes is low Also the use of antibodies to purify monocytes makes it cost prohibitive for large scale production of monocytes In addition all the above mentioned techniques are unable to isolate monocytes from whole blood and require a density gradient step prior to isolation of monocytes thus increasing costs time and technical skill involved Thus there is an unmet need to develop a simple rapid and efficient method capable of isolating a highly pure and quiescent population of monocytes directly from whole blood Affinergy has identified a family of peptides that bind specifically to monocytes while not binding to the other blood cells When conjugated to magnetic beads these peptides can directly isolate monocytes from whole blood and result in high recovery and purity without any additional processing steps At the conclusion of Phase I we will have established a rapid and efficient method for purifying monocytes from whole blood and demonstrated that the enriched monocytes are capable of differentiating into DCs In Phase II we will optimize large scale production of peptide conjugated beads establish shelf life and storage conditions and demonstrate the feasibility of our technique to purify monocytes at a larger scale Project Narrative Dendritic cell vaccines are now being widely explored for the treatment of cancer necessitating the development of optimal methods for large scale production of these cells from monocytes However current methods for isolating monocytes result in sub optimal monocyte yields and purity and require increased processing time and costs To address this challenge Affinergy is developing a peptide based magnetic bead technology for rapid and direct isolation of pure and quiescent monocytes from whole blood