Technology Platforms

DiKineTM

Evive’s signature DiKineTM platform is a mature and versatile platform that manufactures therapeutic dimeric human cytokines, hormones or their agonist/antagonists with significantly extended circulating half-life to boost clinical efficacy. The DiKineTM platform has been implemented at Evive’s Beijing GMP manufacturing facility which supplies fully GMP-compliant materials for clinical development and commercial production worldwide.

 

Cytokines, hormones and their antagonists have long been used in clinical settings and have demonstrated significant benefits for patients with various diseases. However, these small proteins face significant challenges, as prohibitively frequent, or continuous, administration is necessary due to their short serum circulation half-life. This becomes a barrier for achieving the full clinical benefit from these therapies due to patient compliance, especially for our most vulnerable pediatric patients. Evive’s DiKineTM assets significantly extend the circulating half-life of cytokines, hormones and their antagonists by taking advantage of the long serum half-life of the Fragment Crystallizable (Fc) region of antibodies. Evive’s DiKineTM products are cytokine-, hormone- or antagonist-Fc homodimers that function without the need for such frequent dosing. Results from multiple completed Phase II and III trials have demonstrated that DiKineTM products are efficacious with weekly or biweekly administration.    

The safety and efficacy of DiKineTM products have been clinically validated by two of Evive’s products:

  1. 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.
  2. 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.
  3. F-652 has also been shown to be safe and efficacious as weekly injections in treatment of acute alcoholic hepatitis (AH).
  4. 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 Multi-specific Antibodies Platform

Evive’s long-acting multi-specific platform, serves as the basis of many of the products in Evive’s pre-clinical product pipeline. The platform builds upon ItabTM, a partner platform that has historically yielded two products that have successfully entered human clinical trials. The platform provides significant flexibility to adapt to mono-targeting and multi-targeting agonists or antagonists, and is being used to quickly evaluate and develop new drug molecules.