- Citius Pharmaceuticals Inc (NASDAQ:CTXR) collaborated with the University of Pittsburgh for I/ONTAK (denileukin diftitox or E7777) in combination with Merck & Company, Inc. (NYSE: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 (NYSE: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.
Lifecore Biomedical Provides Update For Development Portfolio And Timing Of Delayed Filings; Anticipates Reporting Its FY24 Q1 Results In Late October Or Early November, Pending Completion Of Its Annual Audit
Lifecore Biomedical, Inc. ("Lifecore" or the "Company"), a fully integrated contract development and manufacturing organization ("CDMO"), today provided an update on its delayed filings. The Company anticipates reporting
