Citius Oncology Reports Positive Phase 1 Trial Results for LYMPHIR

Written by Emily J. Thompson, Senior Investment Analyst

Updated: 6 days ago

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Should l Buy CTOR?

Citius Oncology (CTOR), an oncology-focused biopharmaceutical company and majority-owned subsidiary of Citius Pharmaceuticals (CTXR) announced positive topline safety and efficacy results from an investigator-initiated Phase 1 trial evaluating LYMPHIR, or E7777, denileukin diftitox-cxdl, administered prior to commercial CD19-directed CAR-T therapy in patients with high-risk relapsed or refractory diffuse large B-cell lymphoma, or DLBCL. The trial was conducted by lead investigator, Dr. Veronika Bachanova, at the University of Minnesota and City of Hope. Full results were presented at the 2026 ASTCT & CIBMTR Tandem Meetings. The Phase 1 trial was designed to augment the lymphodepletion regimen prior to CAR-T infusion through the administration of LYMPHIR to potentially improve the anti-tumor activity of CAR-T therapies. LYMPHIR, an engineered fusion toxin that preferentially binds to the IL-2 receptor expressed on regulatory T-cells, or Tregs, is currently FDA-approved and commercially available for the treatment of relapsed or refractory cutaneous T-cell lymphoma, or CTCL, after one prior systemic therapy. All patients, n=14, completed treatment and proceeded to CAR-T infusion; LYMPHIR was well tolerated, with no dose-limiting toxicities observed; No Grade greater than or equal to3 LYMPHIR-related immune adverse events or infusion reactions were reported; and, Data demonstrated effective Treg depletion, and promising efficacy signals of enhanced standard lymphodepletion with the use of Treg-targeting LYMPHIR. The use of LYMPHIR in this study was investigational and outside of its FDA-approved indication. The Phase 1 study was not designed or powered to evaluate clinical efficacy, and no conclusions can be drawn regarding comparative effectiveness or long-term outcomes. Key Findings from the Phase 1 Trial include: Overall response rate was 86% at onemonth, including 57% complete responses and 29% partial responses; One-year progression-free survival was 77%.

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About CTOR

Citius Oncology, Inc. is a biopharmaceutical company. The Company is focused on developing and commercializing targeted oncology therapies. The Company’s lead product candidate is LYMPHIR, an engineered IL-2 diphtheria toxin fusion protein, for the treatment of patients with persistent or recurrent CTCL, a rare form of non-Hodgkin lymphoma. LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the diphtheria toxin (DT) fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death.

About the author

Emily J. Thompson

Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.

LYMPHIR Shows Promise in Gynecologic Cancer Treatment

19 hours agoPRnewswire

Clinical Trial Results: The Phase 1 trial led by the University of Pittsburgh demonstrated that LYMPHIR combined with KEYTRUDA showed no unexpected safety signals in 25 patients, indicating a favorable safety profile that could offer new treatment options for difficult-to-treat gynecologic cancers.
Efficacy Assessment: Among 21 evaluable patients, the combination therapy achieved a 24% objective response rate (ORR) and a 48% clinical benefit rate (CBR), highlighting the potential of this combination to enhance anti-tumor activity and warranting further investigation.
Market Potential: LYMPHIR is estimated to have a market potential exceeding $400 million, and as demand for novel therapies increases, Citius Oncology's competitive positioning in oncology will be further strengthened, particularly in the ovarian cancer sector where immunotherapy has had limited impact.
Future Research Plans: Citius Oncology intends to explore the efficacy of LYMPHIR in subsequent Phase 2 studies, and if results are confirmed, it could provide a transformative treatment option for gynecologic cancer patients, significantly improving patient outcomes.