Pipeline

Core Technology


All Aurimune products are built around a 27nm gold nanoparticle core. Gold was chosen because it is known to be safe, has a flexible chemistry including forming covalent bonds, and can be manufactured with scale and precision under GMP conditions. All Aurimune products contain Tumor Necrosis Factor 𝛼 (TNF). CytImmune uses a patented gold peg ylation technology to prevent Aurimune removal by the reticuloendothelial system (RES).

The Aurimune family of nanomedicines includes our first generation nanomedicine, CYT-6091,  and several second generation, multifunctional nanomedicines. Second generation Aurimune nanomedicines also deliver anti-cancer agents including chemotherapies, targeted small molecule drugs, and large molecule biologics.

Pipeline

 

Legend: Gold boxes are completed phases of development. Blue boxes are phases for which funds are currently being raised. 

  • CYT-6091 (Aurimune platform): Phase Ib/II ready – first indication — pancreatic cancer
  • CYT-21625 (Aurimune + Taxol): Ready for IND-enabling toxicology study
  • CYT-5620 (Aurimune + Pro-Apoptosis Agent): Successfully formulated and tested in preclinical models
  • CYT-61000 (Aurimune + IFNg): Successfully formulated
  • CYT-81000 (Aurimune + doxorubicin): Successfully formulated and tested in preclinical models
  • 89ZR-CYT-6091 (Aurimune theranostic): Successfully formulated

Products are protected by more than 30 patents issued, allowed or pending; includes coverage in the US, European Union, Japan and Canada. CYT-6091 would be the first and only vascular disruption agent approved for use in cancer patients

Completed and Proposed Clinical Trials for CYT-6091

  • A Phase I Clinical Safety Trial of CYT-6091 as a monotherapy was conducted at the National Cancer Institute, Bethesda, MD. No SAEs or DLT were reported. No Maximum Tolerated Dose (MTD) was observed.
  • CytImmune is seeking to begin a Phase Ib/II Clinical Trial for systemically delivered CYT-6091. A 2-arm efficacy study, testing CYT-6091 + gemcitabine and Abraxane, will be conducted pancreatic cancer patients.
    • Pancreatic cancer was chosen because CYT-6091 has demonstrated success in multiple genetically engineered pancreatic cancer mouse models. (PNET and PDAC
    • We anticipate achieving orphan drug designation, which provides 7 years market exclusivity
    • Based on preclinical studies, we anticipate seeking breakthrough drug designation, allowing market entry after a Phase II clinical trial.

Completed and Proposed Clinical Trials for CYT-21625

  • NCI is currently evaluating CYT-6091/CYT-21625 for its Experimental Therapeutics Program (NExT), a public private partnership. For more information about the NExT Program can be found here.