SOFIE BIOSCIENCES awarded NCI Phase II SBIR contract to develop [18F]FAC PET

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SOFIE BIOSCIENCES, a leader in the field of Positron Emission Tomography (PET) imaging, including probes, scanners, and chemistry systems, announced today that the National Cancer Institute (NCI) has awarded the company a Phase II Small Business Innovation Research (SBIR) contract for approximately $1.5M over two years. This contract will support the further development of SOFIE's family of proprietary imaging probes, known as [18F]FAC, that measure the enzyme, dCK, which controls the rate of DNA production through the salvage pathway. Cancer drugs, like gemcitabine and others, use dCK to convert the drug into a pharmacologically active product that blocks the high rates of DNA replication for growth of malignant cells. One of SOFIE's objectives with [18F]FAC is to use PET imaging to allow physicians to search throughout the body for tumors that will respond to drugs that target dCK, thus enabling more patient-specific treatment selection.

The key barrier in the commercial distribution of [18F]FAC, as well as other probes, comes from the production of the probes themselves. While commercially available radiochemistry systems do exist, they are restricted in terms of chemical reaction conditions and lack reliability and ease of use. These limitations make it impossible to widely produce [18F]FAC. Building on the success of SOFIE's previous NCI Phase I SBIR, the Phase II contract will augment internal investment, allowing the company to move forward supporting multi-center clinical trials by creating a standardized manufacturing process through ELIXYS, the first ever three-reactor radiochemistry system for automated production of a diversity of probes.

"SOFIE believes that ELIXYS is the cornerstone in the development of a network of radiochemistry systems that seamlessly connect investigators across the US with the means to produce [18F]FAC for clinical trials. We imagine [18F]FAC as just the first in a line of extraordinary new PET probes that answer important questions about the biology of disease or to select the right therapy, and the ELIXYS network as the conduit to these probes becoming widely used," said Patrick Phelps, President & CEO.

Dr. Melissa Moore, CTO and Principal Investigator, will work in close collaboration with sub award investigator, UCLA Professor Dr. R. Michael van Dam, to further this technology. "I'm very excited to be part of such an innovative project, and believe that there is a real need to speed up the process from early PET probe development to clinical trials. We're so fortunate that the NCI believes both in the value of ELIXYS to help diversify the number of PET probes widely available for preclinical and clinical use and in the potential of [18F]FAC."

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