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Last update 26 Dec 2024

Denileukin Diftitox

Last update 26 Dec 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Fusion protein

Synonyms

DAB389 interleukin-2, Denileukin, Denileukin difitox (genetical recombination) (JAN)

+ [19]

Target

IL2RA

Mechanism

IL2RA agonists(Interleukin-2 receptor alpha chain agonists)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [2]

Active Indication

Cutaneous T-cell lymphoma refractoryRecurrent cutaneous T-cell lymphomaPeripheral T-Cell Lymphoma+ [3]

Inactive Indication

AlopeciaB-cell lymphoma refractoryChronic Lymphocytic Leukemia+ [13]

Originator Organization

Ligand Pharmaceuticals, Inc.

Active Organization

Eisai Co., Ltd.

Eisai, Inc.

Northwestern University

+ [3]

Inactive Organization

Ligand Pharmaceuticals, Inc.

Ajinomoto Co., Inc.

Drug Highest PhaseApproved

First Approval Date

US (05 Feb 1999),

Cutaneous T-Cell Lymphoma

RegulationAccelerated Approval (US), Orphan Drug (EU), Orphan Drug (US)

Structure/Sequence

Sequence Code 17073438

Source: *****

Clinical Trials associated with Denileukin Diftitox

NCT05200559

/ RecruitingPhase 1/2IIT

The Efficacy of T-regulatory Cell Depletion with E7777 Combined with Immune Checkpoint Inhibitor, Pembrolizumab, in Recurrent or Metastatic Solid Tumors: Phase I/II Study

Epithelial ovarian cancer (OC) is the most lethal gynecologic cancer: nearly 22,000 women are diagnosed with OC in the US annually and 63% are expected to die from their disease. The 5-year overall survival rate is unacceptably low at 20-30%, with > 50% of patients experiencing recurrence of their disease. Recurrent, platinum-resistant OC is characterized by a low response to chemotherapy (<10-15%) and poor prognosis, with overall survival estimated to be <12 months. Thus, there is an urgent need to identify novel therapies to improve outcomes for patients with recurrent, platinum resistant OC. The primary focus in this trial is targeting tumor associated immunosuppressive T-regs with E7777 combined with PD-1 inhibitor, pembrolizumab. This trial will enroll patients with solid tumors in the dose escalation portion and specified cohorts in the dose expansion portion. In the Phase I portion, 18-30 patients will be enrolled. In the dose expansion portion, approximately 40 patients (20 in each cohort) will be enrolled. Given the relatively poor prognosis and limited treatment options for these patients, this population is considered appropriate for trials of novel therapeutic candidates.

Start Date30 Sep 2022

Sponsor / Collaborator

University of Pittsburgh

[+1]

NCT04855253

/ RecruitingPhase 1/2IIT

Phase I/II Trial Using E7777 to Enhance Regulatory T-Cell Depletion Prior to Tisagenlecleucel (Kymriah) Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

This is a single institution Phase I study to determine the maximum tolerated dose (MTD) of E7777 when given prior to cyclophosphamide/fludarabine (CY/Flu) lymphodepletion (LD) chemotherapy and Kymriah, a commercial tisagenlecleucel product, for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are at a higher risk for failure of CAR-T therapy.

Start Date09 Jun 2021

Sponsor / Collaborator

University of Minnesota Masonic Cancer Center

NCT05137847

/ CompletedNot Applicable

Post-marketing Observational Study of Remitoro® Intravenous Injection 300 μg - Safety of Remitoro in Patients With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study)

The primary purpose of the study is to investigate the incidence of adverse drug reactions (ADRs) (ADR of special interest: capillary leak syndrome, infusion reaction, rhabdomyolysis, myelosuppression, infection, hepatic dysfunction, visual impairment/color blindness, ischemic heart disease/arrhythmia/cardiac failure, and severe skin disorders).

Start Date24 May 2021

Sponsor / Collaborator

Eisai, Inc.

100 Clinical Results associated with Denileukin Diftitox

100 Translational Medicine associated with Denileukin Diftitox

100 Patents (Medical) associated with Denileukin Diftitox

309

Literatures (Medical) associated with Denileukin Diftitox

01 Feb 2025·JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

Compromising the immunogenicity of diphtheria toxin-based immunotoxins through epitope engineering: An in silico approach

Article

Author: Ramshini, Amirreza ; Golichenari, Behrouz ; Gholipour, Nazila ; Rezaei, Ehsan ; Heiat, Mohammad ; Sahebkar, Amirhossein

Immunotoxins are genetically engineered recombinant proteins consisting of a targeting moiety, such as an antibody, and a cytotoxic toxin moiety of microbial origin. Pseudomonas exotoxin A and diphtheria toxin (DT) have been abundantly used in immunotoxins, with the latter applied as the toxin moiety of the FDA-approved drug Denileukin diftitox (ONTAK®). However, the use of immunotoxins provokes an adverse immune response in the host body against the toxin moiety, limiting their efficacy. In silico approaches have received increasing attention in protein engineering. In this study, the epitopes responsible for immunogenicity were identified through multiple platforms. By subtracting conserved and ligand-binding residues, K33, T111, and E112 were identified as common epitopes across all platforms. Substitution analysis evaluated alternative residues regarding their impact on protein stability, considering 19 different amino acid substitutions. Among the mutants explored, the T111A-E112G mutant exhibited the most destabilizing substitution for DT, thereby reducing immunogenicity. Finally, a 3D model of the mutant was generated and verified. The model was then docked with its native ligand NADH, and the complex's molecular behavior was simulated using molecular dynamics.

01 Dec 2024·GYNECOLOGIC ONCOLOGY

Intraperitoneal immunotherapy with denileukin diftitox (ONTAK) in recurrent refractory ovarian cancer

Article

Author: Childs, Jennifer S. ; Swensen, Ron E. ; Dang, Yushe ; Reichow, Jessica L. ; Goff, Barbara A. ; Goff, Barbara A ; Disis, Mary L ; Salazar, Lupe G ; Liao, John B ; Coveler, Andrew L. ; Disis, Mary L. ; Swensen, Ron E ; Coveler, Andrew L ; Reichow, Jessica L ; Liao, John B. ; Childs, Jennifer S ; Salazar, Lupe G. ; Hitchcock-Bernhardt, Katie M. ; Hitchcock-Bernhardt, Katie M ; Gwin, William R ; Gwin, William R. ; Jejurikar, Nikita S ; Jejurikar, Nikita S.

BACKGROUND:

Denileukin diftitox (ONTAK) is a diphtheria/IL-2R fusion protein able to deplete regulatory T cells in peripheral blood. Regulatory T cells in the local immune microenvironment have been shown to be associated with poor prognosis in ovarian cancer. This study examined whether denileukin diftitox (ONTAK) could be safely administered intraperitoneal in patients with advanced refractory ovarian cancer and assessed its effects on regulatory T cells and tumor associated cytokines in ascites and peripheral blood.

PATIENTS AND METHODS:

A phase I dose escalation study of intraperitoneal denileukin diftitox (ONTAK) enrolled 10 patients with advanced, refractory ovarian carcinoma at 3 doses (5 μg/kg, 15 μg/kg, and 25 μg/kg). Serial CA-125 measurements assessed clinical response. Regulatory T cells were quantified using RT-PCR and cytokine levels measured by Luminex.

RESULTS:

The maximum tolerated dose was 15 μg/kg with a dose limiting toxicity observed in 1 out of 6 patients in the expansion group. The majority of adverse events were transient grades 1-2. One patient treated at the 25 μg/kg dose experienced cytokine storm with prolonged hospitalization. 3 patients had decreases in CA-125 after treatment but none met criteria for partial response. Treatment with denileukin diftitox (ONTAK) decreased regulatory T cells in peripheral blood and ascites. Treated patients did not show any significant changes in IL-8, TGF-β, sIL2Ra in ascites or peripheral blood.

CONCLUSIONS:

Denileukin diftitox (ONTAK) can be safely administered intraperitoneally to recurrent refractory ovarian cancer patients. Regulatory T cells were reduced in ascites and peripheral blood, but there were no significant changes in cytokine levels.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov # NCT00357448.

06 Dec 2023·Advances in hematology

Novel Pharmacological Treatment Options of Steroid-Refractory Graft-versus-Host Disease

Review

Author: Chattaraj, Asmi ; Laek, Babray ; Khan, Rafiullah ; Wahab, Ahsan ; Proskuriakova, Ekaterina ; Ali, Rimsha ; Shah, Mitali ; Garg, Chandi ; Kovalenko, Iuliia ; Saleem, Tabinda ; Seyedroudbari, Sara ; Golubykh, Konstantin ; Mirza, Taaha

Background. Graft-versus-host disease (GVHD) is a potentially fatal complication of allogeneic hematopoietic stem cell transplant. The mainstay of treatment is corticosteroids, which are ineffective in 30–50% of cases. Steroid-refractory GVHD (SR-GVHD) confers a poor prognosis, with high mortality rates despite appropriate therapy. While there is no reliable treatment for SR-GVHD, a variety of novel therapeutic options are slowly emerging and have yet to be examined simultaneously. Objectives. This review evaluates the potential of novel therapeutic options, as well as their efficacy and safety, for the treatment of SR-GVHD. Study Design. The literature search was conducted in PubMed, Cochrane, and Embase, employing MeSH terms and keywords. The studies had to be prospective phases 1, 2, or 3. We excluded retrospective and nonoriginal studies. Results. While the only approved drug for acute GVHD is ruxolitinib with an impressive overall response rate of 73.2% and a complete response of 56.3%, several monoclonal antibodies and other agents are currently under investigation, offering promising results. These include anti-CD2, anti-CD147, IL-2 antagonist, a mixture of anti-CD3 and anti-CD7 antibodies, anti-CD25, monoclonal antibody to a4b7 on T-cells, anti-CD26, pentostatin, sirolimus, denileukin diftitox, infliximab, itacitinib, and alpha-1 antitripsin. However, the toxicities associated with these novel drugs need further investigation. For chronic GVHD, approved options include ruxolitinib with an ORR of up to 62%, ibrutinib with an ORR of up to 77%, and belumosudil with an ORR of up to 77%. Meanwhile, emerging treatments include tyrosine kinase inhibitors such as nilotinib, rituximab, and low-dose IL-2, as well as axatilimab and pomalidomide. Conclusion. While their efficacy needs to be better evaluated through large-scale, multicenter, randomized clinical trials, these novel agents show potential and could provide a better alternative for SR-GVHD treatment in the future.

News (Medical) associated with Denileukin Diftitox

22 Nov 2024

·www.prnewswire.com

Citius Pharmaceuticals, Inc. Announces 1-for-25 Reverse Stock Split

CRANFORD, N.J., Nov. 22, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR) announced today that it will be executing a reverse stock split of its common stock, par value $0.001 per share, at a ratio of 1-for-25 ("Reverse Stock Split"). Pursuant to the laws of the State of Nevada and subject to prior approval by the Company's Board of Directors, Citius Pharma was not required to obtain shareholder approval to effectuate the Reverse Stock Split. The Reverse Stock Split will become effective at 5:00 pm Eastern Time on November 25, 2024. The Company's common stock will begin trading on the Nasdaq Capital Market on a split-adjusted basis beginning upon market open on November 26, 2024, under the Company's existing trading symbol "CTXR" with the new CUSIP number 17322U306. The Reverse Stock Split is intended to increase the per share trading price of Citius Pharma's common stock to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on the Nasdaq Capital Market. Under Section 78.207 of the Nevada Revised Statutes, the Company may decrease its authorized shares of Common Stock and correspondingly decrease the number of issued and outstanding shares of Common Stock by resolution adopted by the Board of Directors, without obtaining the approval of the stockholders. The Reverse Stock Split was approved by the Company's Board of Directors pursuant to the Nevada Revised Statutes and was effectuated by the filing of a Certificate of Change with office of the Nevada Secretary of State. At the effective time of the Reverse Stock Split, every twenty-five (25) issued and outstanding shares of the Company's common stock will be combined automatically into one (1) share of the Company's common stock without any change in the par value per share. No fractional shares will be issued in connection with the reverse stock split, and any fractional shares resulting from the Reverse Stock Split will be rounded up to the nearest whole share at the participant level. The reverse stock split will reduce the number of authorized shares of the Company's common stock from 400 million shares to 16 million shares and the ownership percentage of each stockholder will remain unchanged other than as a result of the rounding of fractional shares. The Reverse Stock Split will reduce the number of issued and outstanding shares of the Company's common stock from approximately 193 million to approximately 7.7 million. In addition, the Reverse Stock Split will apply to the Company's common stock issuable upon the exercise of the Company's outstanding warrants and stock options, with proportionate adjustments to be made to the exercise prices thereof and under the Company's equity incentive plans, as applicable. The Company's transfer agent, VStock Transfer LLC, will act as the exchange agent for the reverse stock split. Stockholders holding their shares in book-entry form or in "street name" through a bank, broker, or other nominee will not need to take any action in connection with the reverse stock split. About Citius Pharmaceuticals, Inc. Citius Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. In August 2024, the FDA approved LYMPHIR™, a targeted immunotherapy for an initial indication in the treatment of cutaneous T-cell lymphoma. Citius Pharma's late-stage pipeline also includes Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A Pivotal Phase 3 Trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 Trial. Citius is actively engaged with the FDA to outline next steps for both programs. Citius Pharmaceuticals owns 92% of Citius Oncology. For more information, please visit . Forward-Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated, and, unless noted otherwise, that apply to Citius Pharma and Citius Oncology, are: the potential impact of the reverse split on the bid price of the Company's common stock; Citius Pharma's ability to regain compliance with and continue to meet Nasdaq's continued listing standards; our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; risks related to research using our assets but conducted by third parties; our ability to commercialize LYMPHIR and any of our other product candidates that may be approved by the FDA; the estimated markets for our product candidates and the acceptance thereof by any market; the ability of our product candidates to impact the quality of life of our target patient populations; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; the early stage of products under development; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; competition; as well as other risks described in our SEC filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission ("SEC") filings which are available on the SEC's website at , including in Citius Pharma's Annual Report on Form 10-K for the year ended September 30, 2023, filed with the SEC on December 29, 2023, as updated by our subsequent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. Investor Relations for Citius Pharmaceuticals: Investor Contact: Ilanit Allen [email protected] 908-967-6677 x113 Media Contact: STiR-communications Greg Salsburg [email protected] SOURCE Citius Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Drug Approval

18 Nov 2024

·www.prnewswire.com

Citius Pharmaceuticals Announces Closing of $3 Million Registered Direct Offering

CRANFORD, N.J., Nov. 18, 2024 /PRNewswire/ -- Citius Pharmaceuticals Inc. (Nasdaq: CTXR) ("Citius Pharma" or the "Company"), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today closed its previously announced registered direct offering for the purchase of an aggregate of 12,000,000 shares of its common stock and accompanying warrants to purchase up to an aggregate of 12,000,000 shares of its common stock, at a purchase price of $0.25 per share and accompanying warrant. The warrants have an exercise price of $0.25 per share, are exercisable immediately upon issuance, and expire five years from the initial exercise date. H.C. Wainwright & Co. acted as the exclusive placement agent for the offering. The aggregate gross proceeds to the Company from the offering were $3 million, before deducting the placement agent fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering for general corporate purposes, including pre-clinical and clinical development of our product candidates and working capital and capital expenditures. The securities described above are being offered pursuant to a "shelf" registration statement (File No. 333-277319) filed with the Securities and Exchange Commission ("SEC") on February 23, 2024 and declared effective on March 1, 2024. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the securities being offered was filed with the SEC on November 18, 2024, and is available at the SEC's website at . Electronic copies of the prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at [email protected]. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. About Citius Pharmaceuticals, Inc. Citius Pharma is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. In August 2024, the FDA approved LYMPHIR™, a targeted immunotherapy for an initial indication in the treatment of cutaneous T-cell lymphoma. Citius Pharma's late-stage pipeline also includes Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A Pivotal Phase 3 Trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 Trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. Citius Pharma owns 92% of Citius Oncology, Inc. ("Citius Oncology"). For more information, please visit . Forward Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Pharma. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price, and includes statements related to the intended use of net proceeds from the offering. Factors that could cause actual results to differ materially from those currently anticipated, and, unless noted otherwise, that apply to Citius Pharma and Citius Oncology, are: related to the closing of the offering; our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; Citius Pharma's ability to regain compliance with and continue to meet Nasdaq's continued listing standards; our ability to commercialize LYMPHIR and any of our other product candidates that may be approved by the FDA; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; risks related to research using our assets but conducted by third parties; our need for substantial additional funds; the estimated markets for our product candidates and the acceptance thereof by any market; the ability of our product candidates to impact the quality of life of our target patient populations; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; the early stage of products under development; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; competition; as well as other risks described in our SEC filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at , including in Citius Pharma's Annual Report on Form 10-K for the year ended September 30, 2023, filed with the SEC on December 29, 2023, as updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. Investor Contact: Ilanit Allen [email protected] 908-967-6677 x113 Media Contact: STiR-communications Greg Salsburg [email protected] SOURCE Citius Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3ImmunotherapyDrug Approval

15 Nov 2024

·www.prnewswire.com

Citius Pharmaceuticals Announces $3 Million Registered Direct Offering

CRANFORD, N.J., Nov. 15, 2024 /PRNewswire/ -- Citius Pharmaceuticals Inc. (Nasdaq: CTXR) ("Citius Pharma" or the "Company"), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced that it has entered into definitive agreements for the purchase of an aggregate of 12,000,000 shares of its common stock and accompanying warrants to purchase up to an aggregate of 12,000,000 shares of its common stock, at a purchase price of $0.25 per share and accompanying warrant in a registered direct offering. The warrants will have an exercise price of $0.25 per share, will be exercisable immediately upon issuance, and will expire five years from the initial exercise date. The closing of the offering is expected to occur on or about November 18, 2024, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The aggregate gross proceeds to the Company from the offering are expected to be $3 million, before deducting the placement agent fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering for general corporate purposes, including pre-clinical and clinical development of our product candidates and working capital and capital expenditures. The securities described above are being offered pursuant to a "shelf" registration statement (File No. 333-277319) filed with the Securities and Exchange Commission ("SEC") on February 23, 2024 and declared effective on March 1, 2024. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the securities being offered will be filed with the SEC and be available at the SEC's website at . Electronic copies of the prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at [email protected]. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. About Citius Pharmaceuticals, Inc. Citius Pharma is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. In August 2024, the FDA approved LYMPHIR, a targeted immunotherapy for an initial indication in the treatment of cutaneous T-cell lymphoma. Citius Pharma's late-stage pipeline also includes Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A Pivotal Phase 3 Trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 Trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. Citius Pharma owns 92% of Citius Oncology, Inc. ("Citius Oncology"). For more information, please visit . Forward Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Pharma. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price, and includes all statements related to the completion of the offering, the satisfaction of customary closing conditions related to the offering and the intended use of net proceeds from the offering. Factors that could cause actual results to differ materially from those currently anticipated, and, unless noted otherwise, that apply to Citius Pharma and Citius Oncology, are: related to the closing of the offering; our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; Citius Pharma's ability to regain compliance with and continue to meet Nasdaq's continued listing standards; our ability to commercialize LYMPHIR and any of our other product candidates that may be approved by the FDA; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; risks related to research using our assets but conducted by third parties; our need for substantial additional funds; the estimated markets for our product candidates and the acceptance thereof by any market; the ability of our product candidates to impact the quality of life of our target patient populations; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; the early stage of products under development; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; competition; as well as other risks described in our SEC filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at , including in Citius Pharma's Annual Report on Form 10-K for the year ended September 30, 2023, filed with the SEC on December 29, 2023, as updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. Investor Contact: Ilanit Allen [email protected] 908-967-6677 x113 Media Contact: STiR-communications Greg Salsburg [email protected] SOURCE Citius Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Phase 2Drug ApprovalImmunotherapy

100 Deals associated with Denileukin Diftitox

External Link

KEGG	Wiki	ATC	Drug Bank
D03682	Denileukin Diftitox	L01XX29	DB00004

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Cutaneous T-cell lymphoma refractory	US	Citius Pharmaceuticals, Inc.	07 Aug 2024
Recurrent cutaneous T-cell lymphoma	US	Citius Pharmaceuticals, Inc.	07 Aug 2024
Peripheral T-Cell Lymphoma	JP	Eisai Co., Ltd.	23 Mar 2021
Cutaneous T-Cell Lymphoma	US	Eisai, Inc.	05 Feb 1999

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Malignant melanoma stage IV	Phase 2	US	Eisai, Inc.	22 Jun 2010
Secondary malignant neoplasm of pancreas	Phase 2	US	Eisai, Inc.	01 Oct 2008
Metastatic melanoma	Phase 2	US	Eisai, Inc.	23 Apr 2007
B-cell lymphoma refractory	Phase 2	US	Eisai, Inc.	01 Mar 2005
Chronic Lymphocytic Leukemia	Phase 2	US	Eisai, Inc.	01 Mar 2003
Chronic Lymphocytic Leukemia	Phase 2	AR	Eisai, Inc.	01 Mar 2003
Chronic Lymphocytic Leukemia	Phase 2	AU	Eisai, Inc.	01 Mar 2003
Chronic Lymphocytic Leukemia	Phase 2	BR	Eisai, Inc.	01 Mar 2003
Chronic Lymphocytic Leukemia	Phase 2	CA	Eisai, Inc.	01 Mar 2003
Indolent B-Cell Non-Hodgkin Lymphoma	Phase 2	US	Eisai, Inc.	01 May 2000

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01871727 (Lead-In \| Pivotal Study 302, CTgov)	Phase 3	Cutaneous T-Cell Lymphoma	112	E7777 (Lead-In Part: E7777 6 mcg/kg)	epsluswckr(jbbtolotoa) = eorwaedgov otklycugoo (hqurcmkzzz, eavpuswhbs - oyfazeepfs) View more	-	13 Nov 2024
				E7777 (Lead-In Part: E7777 9 mcg/kg)	epsluswckr(jbbtolotoa) = qgzhhjxqfj otklycugoo (hqurcmkzzz, ipotssdzva - gjocoxitvd) View more
NCT05200559 (SITC2024) Manual	Phase 1	Solid tumor	16	E7777 + pembrolizumab	weuymyjigi(sczenkwuwd) = no DLTs were noted in DL 1 (3 mcg/kg) n=3, DL2 (6 mcg/kg) n=2, and DL3 (9 mcg/kg) n=2. One patient experienced a DLT at in DL4 (12 mcg/kg) n=9 and she was able to safely continue treatment. hvqvpaxbri (zmogpqezhu ) View more	Positive	05 Nov 2024
NCT01871727 (FDA_CDER) Manual	Phase 2	Recurrent cutaneous T-cell lymphoma \| Cutaneous T-cell lymphoma refractory	69	LYMPHIR 9 mcg/kg/day	mzgibgnneo(pwdsypveyd) = atlladzoik bgamzdiwts (wimldymilq, 25 - 49) View more	Positive	07 Aug 2024
NCT01871727 (Pivotal Study 302, ASH 12022 \| ASH 22022) Manual	Phase 3	Cutaneous T-cell lymphoma refractory	112	E7777	yndtvuukvi(rtjevbehwk) = kxqzmkseto mtxuthkfij (ovvuniorqy, 25.0 - 48.7) View more	Positive	15 Nov 2022
NCT01127451 (CTgov)	Phase 2	Malignant melanoma stage IV	75	Denileukin diftitox (Denileukin Diftitox on Days 1 to 4)	fbiubibxfw(vfpfdmcumy) = esddtnwxic xborqssnua (xczuwfdyqf, cpqzgspnig - llwwmnmfqc) View more	-	13 Apr 2022
				Denileukin diftitox (Denileukin Diftitox on Days 1, 8, and 15)	fbiubibxfw(vfpfdmcumy) = zyjyglxsbu xborqssnua (xczuwfdyqf, bkofzvmidr - axgqkyzlng) View more
NCT01871727 (Lead-In, Biospace) Manual	Phase 3	Cutaneous T-Cell Lymphoma	71	E7777 (Independent (IRC) Stage I-III)	fylathdqnx(qstqwwgzad) = gixaxugupz mucwyqdyer (bxevntfbws, 25.0 - 48.7) View more	Positive	06 Apr 2022
				E7777 (Investigator Stage I-III)	fylathdqnx(qstqwwgzad) = dcubjkobrc mucwyqdyer (bxevntfbws, 30.6 - 54.6) View more
NCT02676778 (CTgov)	Phase 2	Peripheral T-Cell Lymphoma \| Cutaneous T-Cell Lymphoma	45	E7777+PTCL (PTCL: E7777 9 mcg/kg/Day)	idcpjswvus(vehpummbui) = odcszqecib xlyrswozxm (bytmvoptzr, llxhxjvilq - bxwsaxfjev) View more	-	15 Jul 2021
				E7777 (CTCL: E7777 9 mcg/kg/Day)	idcpjswvus(vehpummbui) = dimhokhxnl xlyrswozxm (bytmvoptzr, yjctrwacdp - zksjpmjpuv) View more
NCT00515528 (CTgov)	Phase 2	Metastatic melanoma	17	4-peptide melanoma vaccine (Vaccine Alone)	vfernrwron(gaqebqisdd) = majeulyxxu ohgudbcnkp (djqxifnjza, gdiojwbayi - szpzloytwq) View more	-	29 Oct 2020
				Ontak+4-peptide melanoma vaccine (Vaccine Plus Ontak)	vfernrwron(gaqebqisdd) = ppysnpsjkz ohgudbcnkp (djqxifnjza, vnucxraxqr - eoohotouqf) View more
NCT00632827 (CTgov)	Phase 2	Peripheral T-Cell Lymphoma	21	Granulocyte-colony stimulating factor (G-CSF)+Denileukin diftitox+etoposide+cyclophosphamide+Carmustine+Leucovorin+doxorubicin hydrochloride+Gemcitabine+Navelbine+Vincristine+Methotrexate+Cytarabine	wvddcbipsm(hxqfjvxomq) = okgxmwandi fblwkwvrio (loqbxzmizf, wxrnohhuee - drevojnaek) View more	-	27 Apr 2020
NCT00211185 (CONCEPT, CTgov)	Phase 2	Peripheral T-Cell Lymphoma	49	Denileukin diftitox+Pegfilgrastim+Cyclophosphamide+Prednisone+Doxorubicin+Vincristine	dqplsvkhvu(icefctpoaf) = urraawvxxj bbwjwrsgbo (rumdezsmux, jlyhbetuwu - xnjmcgpjrj) View more	-	18 Mar 2020

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