On April 11, 2024 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, reported that the University of Minnesota Masonic Cancer Center intends to expand their ongoing investigator-initiated Phase 1 trial of LYMPHIR (denileukin diftitox) in combination with FDA-approved CAR-T products for the treatment of B-cell lymphomas (Press release, Citius Pharmaceuticals, APR 11, 2024, View Source [SID1234642018]). The ongoing study, led by Dr. Veronika Bachanova at the University of Minnesota (UMN), will include an additional study site at City of Hope (COH), a world-renowned cancer treatment and research institution, with Dr. Matthew Mei as the principal site investigator at COH. City of Hope is one of only 53 National Cancer Institute (NCI)-designated comprehensive cancer centers in the U.S.
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"We are encouraged by the scientific community’s interest in exploring the potential benefits of LYMPHIR beyond cutaneous T-cell lymphoma, for which a Biologics License Application is currently under review by the FDA. We are very excited to support UMN’s expansion of its study to City of Hope as distinguished oncologists Dr. Bachanova and Dr. Mei conduct innovative research to evaluate LYMPHIR in combination with CAR-T treatment," stated Dr. Myron Czuczman, Chief Medical Officer of Citius. "This first-of-its-kind study will evaluate the potential value that transient depletion of T-regs within the tumor microenvironment by LYMPHIR has upon CAR-T-based anti-tumor activity," added Dr. Czuczman.
"This trial is designed to augment lymphodepletion prior to CAR-T cells by administration of targeted immunotoxin against IL-2 receptor-positive regulatory T-cells. The lymphodepleting chemotherapy augmented with LYMPHIR was combined with all three standard of care CAR-T products for diffuse large B-cell lymphomas in second or third line of therapy. We look forward to welcoming patients from City of Hope as we expand the trial and evaluate the maximum tolerated dose," stated principal investigator Veronika Bachanova, MD, PhD, Division of Hematology, Oncology, and Transplantation, Department of Medicine, University of Minnesota.
Citius is collaborating with the University of Minnesota (UMN) in this investigator-initiated study. This Phase 1 dose-finding study to evaluate LYMPHIR prior to CAR-T therapies tisagenlecleucel (KYMRIAH), axicabtagene ciloleucel (YESCARTA), or lisocabtagene maraleucel/BREYANZI), in patients with B-cell lymphomas (BCL) (NCT0485525) was initiated in May 2021 and has been expanded to include City of Hope. Enrollment is underway for patients diagnosed with relapsed or refractory BCL, for which treatment with CAR-Ts is planned, and who are considered at high risk for progression after CAR-T therapy.