With regards to objective 1, we employed established animal models of spinal fusion and osteonecrosis to demonstrate the disease-mitigating activity of our Developmental Candidate, autograftWNT.
With regards to objective 2, the mechanism of L-WNT3A action has been demonstrated in ex vivo, non-GLP pharmacology studies.
With regards to objective 3, we have completed characterization of the non-GLP substance, WNT3A drug product, and the drug product, L-WNT3A. Methods for reproducible and scaleable research grade production of the drug substance WNT3A, and the drug product, L-WNT3A, have been developed (see below for details). A serum free process has been achieved.