C2N Diagnostics has entered into a collaborative research and a supplier agreement with Cambridge Isotope Laboratories (CIL), through which the latter firm will supply the former company with highly enriched stable isotopes. The isotopes in question are key reagents to C2N’s platform of Stable Isotope Labeling Kinetic (SILK™)-based biomarkers, which, according to the company, have shown promise for detecting Alzheimer’s-associated pathology early on—before the onset of clinical symptoms—and for measuring treatment responsiveness in preclinical and clinical drug studies.
Under the terms of the agreement, C2N will receive from CIL an undisclosed upfront payment, commercial milestone fees, future supply guarantees of stable isotopes, and large quantities of GMP-grade stable isotope (13C6) labeled leucine (L-Leucine). The L-Leucine will be used in future upcoming clinical validation studies involving C2N’s SILK-based tests. CIL also plans to make what it calls a "significant investment" in its own infrastructure and manufacturing processes, which the company says will ensure its ability to meet the future demand of stable isotopes that will incorporate into C2N’s tests.
"Stable isotopes...offer great sensitivity for tracking the in vivo metabolism of proteins implicated in diseases like Alzheimer’s," C2N CEO Joel B. Braunstein, M.D., said in a statement. "This makes them highly desirable diagnostic reagents. As we expand the use of our SILK-based biomarkers beyond research services and into clinical diagnostic applications, CIL will be an instrumental partner to help us qualify our test kits and to produce L-Leucine under GMP scaled-up conditions."