Sofie to receive U.S. patent for novel PET probes

Sofie Biosciences, Inc., offering a comprehensive range of products from pre-clinical PET imaging systems to new PET molecular imaging probes to better understand human disease, has been told that a U.S. Patent (8,101,740) will be granted by the United States Patent Office on technology that has been exclusively licensed to Sofie. The patent covers a family of novel PET probes, known as [18F]FAC.

Positron Emission Tomography (PET) is a molecular imaging technology that utilizes minute amounts of labeled molecules ("probes") to target and measure biological and pharmacological processes. Basic scientists can use the same probes to examine cells and mice, as physicians do in patients to visualize and characterize the biology of disease, monitor its progression, and evaluate therapeutic efficacy.

Basic and clinical scientists at UCLA invented this novel PET probe, [18F]FAC, which was created by a slight modification of the drug molecule, gemcitabine, one of the most common drugs for cancer.  Cancer cells lack the normal checks and balances to limit cell growth.  [18F]FAC provides an in vivo imaging assay of cell growth known as the DNA salvage pathway.  Tumors use the salvage pathway to provide high rates of DNA replication for their uncontrolled growth of cells containing malignant instructions.

[18F]FAC measures the enzyme, dCK, which controls the rate of DNA production through the salvage pathway. Cancer drugs like gemcitabine use dCK to convert the drug into a pharmacologically active product that blocks the high rates of DNA replication for growth of malignant cells, and induces DNA damage in cancer cells. One of Sofie's objectives with [18F]FAC is to use PET imaging to allow physicians the means to search throughout the body for tumors that will respond to drugs that target dCK (like gemcitabine and other drugs), thus enabling more patient-specific treatment selection.

Cells of the immune system also use the salvage pathway to replicate activated immune cells in response to pathogens in the body and show differential uptake of [18F]FAC when they are activated. Such a non-invasive imaging test could help physicians more effectively examine and measure the activity of immune system throughout the body.

"[18F]FAC is a remarkable imaging probe. It specifically targets a single enzyme, dCK, and when that target is removed, the signal is absent. [18F]FAC displays rapid in vivo transport into cells, dCK dependent accumulation, sufficient in vivo stability, and because of trace amounts of [18F]FAC used, no evidence has been found for neither pharmacologic effects nor the toxicity in humans. Making [18F]FAC available for broad use in both academic and commercial research communities is the next step in the milestones of the imaging probe segment of Sofie's business," said Patrick Phelps, Sofie's President and CEO. The instrumentation arm of Sofie provides technologies for [18F]FAC production and pre-clinical PET imaging to facilitate and simplify the use of [18F]FAC and other PET imaging probes in academic and commercial research.

Sofie has obtained an exclusive license from The Regents of the University of California. Three investigational new drug (IND) applications have been approved for [18F]FAC and two analogs, and clinical trials have been initiated.