Berubicin: Anthracyclines inhibit the topoisomerase II enzyme to disrupt DNA and RNA synthesis by intercalating between base pairs of the DNA/RNA strand, thus preventing the replication of rapidly growing cancer cells.

About Berubicin

Berubicin is a novel, synthetic, second-generation anthracycline-based topoisomerase II inhibitor engineered to circumvent the the BBB and overcome MDR.  Berubicin has been administered to humans in 4 clinical trials to date.  

Anthracyclines inhibit the topoisomerase II enzyme to disrupt DNA and RNA synthesis by intercalating between base pairs of the DNA/RNA strand.

Berubicin was Evaluated in a Late-Stage Global Clinical Trial for the Treatment of Glioblastoma Multiforme (GBM)

Summer of Primary Analysis

  • Showed clinically relevant outcomes comparable to Lomustine across multiple endpoints1
  • Safety profile continues to be favorable, including the absence of anthracycline related cardiotoxicity
  • Analysis of outcomes are ongoing, including advanced imaging review, PK, and clinical endpoints

Ongoing Analysis of Outcomes

  1. Did not demonstrate a statistically significant difference in overall survival, the primary endpoint

Program Highlights

  • Evaluated in multiple Phase 1 and Phase 2 studies
  • Fast Track Designation
  • Orphan Drug Designation with 7 years market exclusivity in the U.S.
  • On-going GBM trial.

References

  • 1. Zielinski, R., Cardenas-Zuniga, R., Poimenidou M., et al. Neuro-Oncol. 2021; 23 (6):1