Lymphir (denileukin diftitox-cxdl) / Eisai, Citius Oncology, Cardinal Health, Cencora, Integris Pharma, Er-Kim Pharma - LARVOL DELTA

Citius Oncology Announces $18 Million Concurrent Registered Direct Offering and Private Placement Priced At-The-Market Under Nasdaq Rules (Businesswire) - "In addition, the Company has agreed to issue to the investor unregistered warrants to purchase up to 1,284,404 shares of common stock at an exercise price of $1.09 per share....The gross proceeds from the offerings, before deducting the placement agent's fees and other offering expenses payable by the Company, are expected to be approximately $18 million. The Company intends to use the net proceeds from the offerings to support the commercial launch of LYMPHIR and for working capital and general corporate purposes."

Financing • Cutaneous T-cell Lymphoma

Citius Oncology Expands LYMPHIR Distribution to Turkey and Middle East Countries Through Exclusive Agreement with Er-Kim (PRNewswire) - "Under the terms of the agreement, Er-Kim will be the exclusive distributor of LYMPHIR in Turkey and key Gulf Cooperation Council (GCC) countries, including Bahrain, Qatar, Oman, Kuwait, Saudi Arabia, and the United Arab Emirates....Er-Kim will be responsible for sales, marketing and reimbursement activities, under applicable laws, in each territory. Citius Oncology will supply finished product and support Er-Kim's efforts as part of the agreement."

Licensing / partnership • Cutaneous T-cell Lymphoma

Citius Oncology Announces U.S. Commercial Launch of LYMPHIR, a Novel Cancer Immunotherapy for Cutaneous T-Cell Lymphoma (CTCL) (PRNewswire) - "The FDA approval of LYMPHIR was based on data from Pivotal Study 302 (NCT01871727), which evaluated the efficacy and safety of LYMPHIR in patients with Stage I–III CTCL who had received at least one prior systemic treatment."

Launch US • Cutaneous T-cell Lymphoma

Citius Oncology to Exhibit at the 67th American Society of Hematology (ASH) Annual Meeting (Citius Pharma Press Release) - "This event offers a great platform to meet with CTCL stakeholders to discuss how LYMPHIR's clinical profile may offer an important treatment option for patients with cutaneous T-cell lymphoma."

Clinical • Cutaneous T-cell Lymphoma

Citius Oncology to Advance Commercial Launch of LYMPHIR with Verix AI Integration (Citius Pharma Press Release) - "Citius Oncology's commercial team intends to further leverage Verix's innovative Tovana platform to support the anticipated fourth quarter 2025 U.S. commercialization of LYMPHIR (denileukin diftitox-cxdl), a novel immunotherapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy."

Commercial • Launch US • Cutaneous T-cell Lymphoma

Clinically approved immunotoxins targeting hematological cancers: "the best of both worlds". (PubMed, Front Pharmacol) - "In this review, we analyze three FDA-approved RITs, namely, moxetumomab pasudotox, tagraxofusp, and denileukin diftitox, that utilize bacterial toxins from Pseudomonas and Corynebacterium diphtheriae to treat refractory/relapsed (R/R) HCL, BPDCN, and adult R/R cutaneous T-cell lymphoma (CTCL), respectively. We reviewed their comprehensive safety profiles, describe complications associated with these fusion proteins, and, finally, discuss potential risk management strategies that may enhance their clinical outcomes. Overall, RITs have demonstrated efficacy, and researchers continue to extend these findings to other indications."

Journal • Review • Cutaneous T-cell Lymphoma • Hairy Cell Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Citius Oncology Signs U.S. Distribution Agreement with McKesson to Support LYMPHIR Commercial Launch (PRNewswire) - "Under the agreement, McKesson will serve as an authorized distributor of record for LYMPHIR (denileukin diftitox-cxdl)....The agreement with McKesson completes Citius Oncology's core U.S. distribution network for LYMPHIR....This strategic milestone ensures broad and reliable access to the therapy in preparation for its planned commercial launch in the fourth quarter of 2025."

Launch US • Licensing / partnership • Cutaneous T-cell Lymphoma

Citius Pharmaceuticals Announces a Registered Direct Offering of $6.0 Million Priced At-The-Market Under Nasdaq Rules (PRNewswire) - " The closing of the offering is expected to occur on or about October 21, 2025, subject to the satisfaction of customary closing conditions.... The Company currently intends to use the net proceeds from the offering to support the commercial launch of LYMPHIR, including milestone, regulatory and other payments, development initiatives for all of our product candidates, as well as for general corporate purposes."

Financing • Cutaneous T-cell Lymphoma

Citius Oncology Signs Exclusive Commercialization Agreement with EVERSANA to Support Planned Q4 2025 Launch of LYMPHIR (Citius Pharma Press Release) - "Under the Master Service Agreement, EVERSANA will serve as Citius Oncology's exclusive commercialization partner, providing an integrated suite of pre- and post-launch operations services. These services include medical information, pharmacovigilance, revenue cycle management, program management, data and analytics, and channel management. As launch preparations advance, additional commercialization services are expected to be integrated...This agreement marks an expansion of EVERSANA's vital role in advancing Citius Oncology's pre-commercial strategy, building on the foundational work already completed in preparation for the U.S. launch of LYMPHIR."

Commercial • Launch US • Cutaneous T-cell Lymphoma

Citius Oncology Establishes International Access to LYMPHIR via Named Patient Programs in Southern Europe (Citius Pharma Press Release) - "As part of its NPP strategy, Citius has entered into an exclusive distribution agreement with Integris Pharma S.A., headquartered in Athens, Greece. The partnership covers Greece, Cyprus, Malta, Bulgaria, Romania, Croatia, Serbia, Albania, Bosnia Herzegovina, Kosovo, Montenegro and North Macedonia."

Commercial • Cutaneous T-cell Lymphoma

Citius Oncology Deploys AI Platform to Amplify the Performance of its Commercial Team Ahead of LYMPHIR Launch (Businesswire) - "The proprietary system uses company-defined criteria to identify patterns in treatment and diagnosis, enabling our commercial team to immediately target prescribers whose patients may benefit from LYMPHIR. The platform uses machine learning to continuously refine its ability to identify potential LYMPHIR candidates and allow the commercial team to support more informed patient care."

Commercial • Cutaneous T-cell Lymphoma

Citius Pharmaceuticals, Inc. Reports Fiscal Third Quarter 2025 Financial Results and Provides Business Update (Citius Pharma Press Release) - "Final preparations are underway by our oncology subsidiary for the planned U.S. launch of LYMPHIR in the fourth quarter of 2025."

Launch US • Cutaneous T-cell Lymphoma

Citius Oncology Expands Distribution Network for LYMPHIR with Execution of Distribution Services Agreement with Cencora (Citius Pharma Press Release) - "Citius Oncology...announced the execution of a distribution services agreement with Cencora (formerly AmerisourceBergen), a global pharmaceutical services company. This agreement marks another significant step forward in the Company's commercial launch strategy for LYMPHIR (denileukin diftitox-cxdl), its FDA-approved immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL)...This new agreement expands Citius Oncology's commercial distribution network, providing additional access and product availability upon launch. The agreement with Cencora, a leader in specialty pharmaceutical distribution and services, builds on a previously announced distribution services agreement to support long-term scalability and market reach of LYMPHIR....Under the terms of the agreement, Cencora will serve as a wholesale distributor for LYMPHIR, providing specialty distribution services to facilitate product availability across its distribution network."

Commercial • Cutaneous T-cell Lymphoma

Citius Oncology Announces Closing of $9.0 Million Public Offering (PRNewswire) - "Citius Oncology...announced the closing of its 'reasonable best-efforts' public offering of 6,818,182 shares of common stock of the Company and warrants to purchase shares of common stock at a public offering price of $1.32 per share. The warrants have an exercise price of $1.32 per share, are immediately exercisable upon issuance, and expire five years from the date of issuance. Gross proceeds from the offering, before deducting placement agent fees and other estimated offering expenses, are approximately $9.0 million....The Company intends to use the net proceeds from the offering primarily to support the commercialization of LYMPHIR, including milestone, royalty, or other payments pursuant to existing license agreements, as well as for working capital and general corporate purposes."

Commercial • Cutaneous T-cell Lymphoma

Citius Oncology Anticipates Commercial Launch of LYMPHIR in 2025 (Citius Pharma Press Release) - "Citius Oncology, Inc... announced that preparations for the commercial launch of LYMPHIR, an FDA-approved immunotherapy for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL), are nearing completion. The Company believes it is now operationally positioned to transition from a development-stage enterprise to a fully integrated commercial organization, with all major launch-enabling activities underway. Final preparations are in process for a U.S. launch of LYMPHIR in the second half of 2025."

Launch US • Cutaneous T-cell Lymphoma

Citius Pharmaceuticals Announces a Registered Direct Offering of Up To $15.8 Million Priced At-The-Market Under Nasdaq Rules (Citius Pharma Press Release) - "Citius Pharmaceuticals Inc...announced that it has entered into definitive agreements for the purchase of an aggregate of 4,920,000 shares of its common stock (or pre-funded warrant in lieu thereof) and accompanying short-term warrants to purchase up to an aggregate of 9,840,000 shares of its common stock, at a purchase price of $1.22 per share (or pre-funded warrant in lieu thereof) and accompanying short-term warrant in a registered direct offering priced at-the-market under Nasdaq rules....The Company currently intends to use the net proceeds from the offering to support the commercial launch of LYMPHIR, including milestone, regulatory and other payments, as well as for general corporate purposes."

Financing • T Cell Non-Hodgkin Lymphoma

Eisai Satisfies All-Case Surveillance Requirement for Anticancer Agent Remitoro (Eisai Press Release) - "Eisai...announced today that it has received notification from Japan’s Ministry of Health, Labour, and Welfare (MHLW) that the 'all-case surveillance' post-marketing observational study condition required at the time of approval of anticancer agent 'Remitoro for Intravenous Drip Infusion 300μg' (Denileukin Diftitox (Genetical Recombination)) for the indications of T-cell Lymphoma has been cleared....Based on the safety data in 111 patients and efficacy data in 85 patients submitted to the MHLW as the results of analyses of this all-case surveillance, the MHLW has concluded that the all-case surveillance was conducted properly and the necessary measures to ensure proper use of the product were sufficient to lift the condition."

Japanese regulatory • T Cell Non-Hodgkin Lymphoma

Selecting appropriate therapy for cutaneous T-cell lymphomas (CTCLs): recent advances and the unmet need. (PubMed, Expert Opin Pharmacother) - No abstract available

Journal • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Effect of E7777 Immunogenicity on Pharmacokinetics, Efficacy, and Safety in Adult Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma. (PubMed, Clin Transl Sci) - "Serious TE adverse events were reported by 32.1% of TE E-ADA-positive patients, 29.0% of TE I-ADA-positive patients, 100% of E-ADA-negative patients, and 73.3% of I-ADA-negative patients. These results indicate that the presence of ADAs decreased E7777 exposure over time but did not adversely impact efficacy and safety in patients with CTCL."

Journal • PK/PD data • Cutaneous T-cell Lymphoma • Hematological Malignancies • Infectious Disease • Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • IL2

Citius Pharmaceuticals and Citius Oncology Announce Unique Permanent J-Code Issued for LYMPHIR by Centers for Medicare and Medicaid Services (PRNewswire) - "Citius Pharmaceuticals, Inc...today announced that LYMPHIR (denileukin diftitox-cxdl) has been assigned a unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code (J9161) by the Centers for Medicare & Medicaid Services (CMS)...Effective April 1, 2025, healthcare providers may use the permanent J-code, J9161 (Injection, denileukin diftitox-cxdl, for intravenous use, 1 microgram), when submitting claims for LYMPHIR."

Medicaid • Medicare • Cutaneous T-cell Lymphoma

Study of E7777 Prior to Kymriah for R/R DLBCL (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Masonic Cancer Center, University of Minnesota | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • MYC

Citius Pharmaceuticals and Citius Oncology Highlight LYMPHIR Commercial Launch Planned for the First Half of 2025 (PRNewswire) - "Management is focused on making LYMPHIR available to patients as quickly as possible, with preparations underway for launch in the first half of 2025...Key Launch Preparations and Activities...Secured commercial supply agreements with leading contract manufacturing organizations (CMOs); First Year Launch Supply has been produced...Rolled out targeted education programs aimed at oncologists, hematologists, and other key medical professionals...Working closely with payers and healthcare providers to secure reimbursement pathways that facilitate patient access; Submitted an application for a unique J-code under the Healthcare Common Procedure Coding System (HCPCS) to streamline reimbursement processes; Secured LYMPHIR's inclusion in the National Comprehensive Cancer Network (NCCN) guidelines, a key factor in influencing clinical decision-making and payer coverage in the U.S....patient assistance program to help with financial support and access to LYMPHIR."

Commercial • Launch US • NCCN guideline • Cutaneous T-cell Lymphoma

Efficacy and Safety of Denileukin Diftitox-Cxdl, an Improved Purity Formulation of Denileukin Diftitox, in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (J Clin Oncol) - P3 | N=112 | NCT01871727 | Sponsor: Eisai Inc. | "The PEAS included 69 patients (median age, 64.0 years). The ORR was 36.2% (95% CI, 25.0 to 48.7), including 8.7% with complete response. The median DOR was 8.9 months (95% CI, 5.0 to not estimable), and the median (Q1-Q3) TTR was 1.4 (0.7-2.1) months. A total of 84.4% of patients showed decreased skin tumor burden, with 48.4% showing a ≥50% decrease. Treatment-emergent adverse events (TEAEs) of special interest, most of which were grade 1 or 2, included infusion reaction (73.9%), hypersensitivity (68.1%), hepatotoxicity (36.2%), and capillary leak syndrome (20.3% [grade ≥3, 5.8%])."

P3 data • Cutaneous T-cell Lymphoma

Efficacy and Safety of Denileukin Diftitox-Cxdl, an Improved Purity Formulation of Denileukin Diftitox, in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma. (PubMed, J Clin Oncol) - "Efficacy and safety results show that DD-cxdl would potentially fulfill a serious, unmet medical need for patients with R/R CTCL."

Journal • Cutaneous T-cell Lymphoma • Dermatology • Fatigue • Hematological Malignancies • Hepatology • Immunology • Infectious Disease • Lymphoma • Mycosis Fungoides • Oncology • Sezary Syndrome • Skin Cancer • T Cell Non-Hodgkin Lymphoma • IL2

T-regulatory cell depletion with E7777 combined with pembrolizumab in patients with recurrent solid tumors: phase I trial (SITC 2024) - "Another patient had progressed on prior therapy including pembrolizumab combined with Lenvatinib. Initial efficacy data are encouraging including patients who progressed on prior anti-PD1 therapy. Ongoing translational work is ongoing to explore the impact on level of T-regulatory cells and CD8 T-cells and if it correlates with clinical benefit."

Clinical • P1 data • Oncology • Solid Tumor • CD8