Celcuity Teams Up With MD Anderson, Novartis, Puma Biotech To Study New Drug Regimen In Breast Cancer

Celcuity Inc CELC has announced a clinical trial collaboration with the MD Anderson Cancer Center, Novartis AG NVS, and Puma Biotechnology Inc PUMA to conduct a Phase 2 clinical trial.

  • The open-label Phase 2 trial will evaluate the efficacy and safety of two targeted therapies, Novartis' Tabrecta, a c-Met inhibitor, and Puma's Nerlynx, a pan-HER inhibitor, in patients with previously treated metastatic HER2-negative breast cancer selected with Celcuity's CELsignia Multi-Pathway Activity Test.
  • Under the agreement, MD Anderson will serve as the sponsor, and Celcuity will fund the patient-related trial costs.
  • Tabrecta and Nerlynx are currently approved by the FDA to treat non-small cell lung cancer and HER2-positive breast cancer, respectively.
  • Celcuity expects to obtain interim results 12 to 15 months after the protocol is activated and final results 12 to 15 months later.
  • Enrollment will begin in the second quarter of 2021.
  • Price Action: CELC shares are up 6.3% at $ 14.62 in premarket on the last check Wednesday.

Posted In: breast cancerPhase 2 Clinical TrialBiotechNewsHealth CareFDAGeneral