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Citius Pharma Inks Clinical Collaboration For I/ONTAK Combo Regime in Solid Tumor Settings

  • Citius Pharmaceuticals Inc CTXR collaborated with the University of Pittsburgh for I/ONTAK (denileukin diftitox or E7777) in combination with Merck & Company, Inc. MRK Keytruda (pembrolizumab) for recurrent or metastatic solid tumors.
  • The investigator-initiated trial at UPMC is an open-label, Phase 1/1b study consisting of two parts. 
  • Part I is a dose escalation study of four cohorts and is expected to enroll 18-30 patients. 
  • Part 2 is a dose expansion study of approximately 40 patients to evaluate the safety and tolerability of the recommended combination dose of I/ONTAK and pembrolizumab. 
  • Related: Citius Pharma To Spinoff Late-Stage Oncology Asset Into New Publicly Traded Firm.
  • The study will also investigate the alteration of the immune microenvironment within tumors and peripheral blood. 
  • Secondary endpoints include the objective response (complete response plus partial response), progression-free survival, and overall survival.
  • University of Pittsburgh dose-ranging study is expected to begin in the fourth quarter of 2022.
  • Additionally, Citius is collaborating with an investigator-initiated study at the University of Minnesota (UMN). 
  • This Phase 1 dose-finding study to evaluate I/ONTAK before Novartis AG‘s NVS Kymriah (tisagenleucel) CAR-T therapy for diffuse large B-cell lymphoma (DLBCL) enrolled its first patient in May 2021.
  • Price Action: CTXR shares closed 6.84% higher at $1.25 during after-hours trading on Thursday.

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