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.
Evive’s other signature technology platform, the Immuno-Therapy antibody (ITabTM) platform is fully developed to produce therapeutic bi-specific antibodies to address unmet medical needs in immune oncology. The ITabTM 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.
Evive currently uses the ITabTM platform to develop CD3-based T-cell engaging bi-specific antibodies to induce T-cell mediated cytosis of cancerous cells directly. Evive plans to take advantage of the tremendous flexibility that ITabTM provides to develop products for indications outside of oncology, such as inflammatory disorders and infectious diseases.
ITabTM antibodies are manufactured in CHO cells and have proven very potent in vitro and animal models. Multiple ITabTM products are in preclinical and clinical stages of development.