The safety and efficacy of DiKineTM products have been clinically validated by two of Evive’s products:
- F-627, a recombinant human G-CSF-Fc dimer, once per chemotherapy cycle injection is as efficacious and safe as G-CSF, which requires 5 injections per chemotherapy cycle.
- F-652, recombinant human IL-22-Fc dimer, has also been shown to be safe and efficacious as weekly injections in treating acute graft-versus-host disease (aGvHD). The U.S. FDA granted F-652 orphan drug status for the treatment of aGvHD in October 2019.
- F-652 has also been shown to be safe and efficacious as weekly injections in treatment of acute alcoholic hepatitis (AH).
- F-899, recombinant long-acting growth hormone with targeting dosing frequency of 10-14 days.
Another advantage of the DiKineTM platform is that it leverages a proven safety profile from the mammalian cell-based (CHO) expression system. Compared to bacteria-expressed cytokine or hormone therapies, the eukaryotic system provides folding and modifications of DiKineTM assets closer to their endogenous counterparts, optimizing safety, particularly in minimizing immunogenicity concerns.
Long-acting Bi-specific Platform
Evive’s other signature technology platform, the long-acting bi-specific platform, provides significant flexibility to place domains that recognize two different epitopes or antigens of choice, with the affinity of choice, thus generating dual-targeting therapeutic assets on demand.
The antibodies are manufactured in CHO cells and have proven very potent in vitro and animal models. Multiple products are in preclinical and clinical stages of development.