Latest news with #CTCL
Globe and Mail
03-07-2025
- Business
- Globe and Mail
Mycosis Fungoides Pipeline Appears Robust With 4+ Key Pharma Companies Actively Working in the Therapeutics Segment
DelveInsight's, ' Mycosis Fungoides Pipeline Insight, 2025 ' report provides comprehensive insights about 4+ companies and 6+ pipeline drugs in Mycosis Fungoides pipeline landscape. It covers the Mycosis Fungoides pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Mycosis Fungoides pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Discover the latest drugs and treatment options in the Mycosis Fungoides Pipeline. Dive into DelveInsight's comprehensive report today! @ Mycosis Fungoides Pipeline Outlook Key Takeaways from the Mycosis Fungoides Pipeline Report In June 2025, M.D. Anderson Cancer Center announced a study of ultra-low-dose-total-skin electron beam therapy with brentuximab vedotin (ULD-TSEBT+BV) among patients with stage I-IV mycosis fungoides/Sezary syndrome. In June 2025, Soligenix conducted a Phase 3 study is to evaluate the ability of an 18-week course of HyBryte and visible light to induce a Treatment Response in patients with patch/plaque phase CTCL compared to patients receiving placebo and visible study will evaluate the efficacy and safety of HyBryte (0.25% hypericin) gel or placebo gel applied twice weekly for 18 weeks. Treated lesions will be covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light. All of the participant's lesions that are readily available for exposure to the visible light source will be treated and 3 to 5 index lesions in each patient will be prospectively identified and documented for modified Composite Assessment of Index Lesion Severity (mCAILS) evaluation. Participants will be followed every 4 weeks for a total of 12 weeks following their last light session. DelveInsight's Mycosis Fungoides Pipeline report depicts a robust space with 3+ active players working to develop 3+ pipeline therapies for Mycosis Fungoides treatment. The leading Mycosis Fungoides Companies such as Innate Pharma, Soligenix, Bristol-Myers Squibb and others. Promising Mycosis Fungoides Pipeline Therapies such as Brentuximab vedotin, mechlorethamine-MCH (nitrogen mustard), Hypericin, Ritlecitinib, Methoxsalen+ECP, AFM13 and others. Stay ahead with the most recent pipeline outlook for Mycosis Fungoides. Get insights into clinical trials, emerging therapies, and leading companies with Mycosis Fungoides @ Mycosis Fungoides Treatment Drugs Mycosis Fungoides Emerging Drugs Profile Hypericin: Soligenix HyBryte™ (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte™ is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by safe, visible light approximately 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. Currently, the drug is in Phase III stage of its development for the treatment of Mycosis Fungoides. IPH4102: Innate Pharma Lacutamab (IPH4102) is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody, which is currently in clinical trials for treatment of cutaneous T-cell lymphoma (CTCL), an orphan disease, and peripheral T cell lymphoma (PTCL). Lacutamab has been granted U.S. FDA Breakthrough Therapy Designation for relapsed or refractory Sézary syndrome. Innate Pharma SA announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to lacutamab, an anti-KIR3DL2 cytotoxicity-inducing antibody, for the treatment of adult patients with relapsed or refractory (r/r) Sézary syndrome (SS) after at least 2 prior systemic therapies including mogamulizumab. Currently, the drug is in Phase II stage of its development for the treatment of Mycosis Fungoides. The Mycosis Fungoides Pipeline Report Provides Insights into- The report provides detailed insights about companies that are developing therapies for the treatment of Mycosis Fungoides with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Mycosis Fungoides Treatment. Mycosis Fungoides Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Mycosis Fungoides Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Mycosis Fungoides market Explore groundbreaking therapies and clinical trials in the Mycosis Fungoides Pipeline. Access DelveInsight's detailed report now! @ New Mycosis Fungoides Drugs Mycosis Fungoides Companies Innate Pharma, Soligenix, Bristol-Myers Squibb and others. Mycosis Fungoides pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Mycosis Fungoides Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Unveil the future of Mycosis Fungoides Treatment. Learn about new drugs, Mycosis Fungoides Pipeline developments, and key companies with DelveInsight's expert analysis @ Mycosis Fungoides Market Drivers and Barriers Scope of the Mycosis Fungoides Pipeline Report Coverage- Global Mycosis Fungoides Companies- Innate Pharma, Soligenix, Bristol-Myers Squibb and others. Mycosis Fungoides Pipeline Therapies- Brentuximab vedotin, mechlorethamine-MCH (nitrogen mustard), Hypericin, Ritlecitinib, Methoxsalen+ECP, AFM13 and others. Mycosis Fungoides Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Mycosis Fungoides Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Get the latest on Mycosis Fungoides Pipeline Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ Mycosis Fungoides Companies, Key Products and Unmet Needs Table of Contents Introduction Executive Summary Mycosis Fungoides: Overview Pipeline Therapeutics Therapeutic Assessment Mycosis Fungoides– DelveInsight's Analytical Perspective Late Stage Products (Phase III) Hypericin: Soligenix Drug profiles in the detailed report….. Mid Stage Products (Phase II) IPH4102: Innate Pharma Drug profiles in the detailed report….. Early Stage Products (Phase I) Drug Name: Company Name Drug profiles in the detailed report….. Preclinical and Discovery Stage Products Drug Name: Company Name Inactive Products Mycosis Fungoides Key Companies Mycosis Fungoides Key Products Mycosis Fungoides- Unmet Needs Mycosis Fungoides- Market Drivers and Barriers Mycosis Fungoides- Future Perspectives and Conclusion Mycosis Fungoides Analyst Views Mycosis Fungoides Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:
Health Line
01-07-2025
- Health
- Health Line
Does Medicare Cover Methoxsalen?
Medicare may cover methoxsalen capsules (Oxsoralen-Ultra) when used with UV light therapy for treating psoriasis. Plus, Medicare may cover the injection form of methoxsalen (Uvadex) when prescribed for treating cutaneous T-cell lymphoma (CTCL) that hasn't responded to other treatments as part of a special kind of light therapy called photopheresis. Medicare coverage for methoxsalen capsule Medicare Part D and Medicare Advantage Prescription Drug (MAPD) plans may cover methoxsalen as part of light therapy for psoriasis if other treatments haven't worked for the condition and your doctor has clearly documented this for Medicare. That said, whether your plan covers the brand name or the generic drug depends on your specific plan. In addition, while methoxsalen with light therapy may be effective for treating other skin issues like vitiligo, Medicare usually covers medications based on the conditions approved by the Food and Drug Administration (FDA). Medicare coverage for methoxsalen injection Medicare may also cover the injection form of this medication when combined with photopheresis to help treat CTCL if other treatments haven't worked and a doctor has also documented this for Medicare. But in this case, doctors don't inject the drug directly into your body. Instead, they inject it into the instrument during the photopheresis process. Because of this, if your treatment is covered, the injection drug will likely fall under the coverage of Medicare Part B. The procedure itself is usually covered by Part B as long as it's done in a clinic and doesn't require a hospital stay. If you need to receive it while you're in the hospital, though, it might then be covered under Part A.
Yahoo
17-06-2025
- Business
- Yahoo
Citius Oncology Anticipates Commercial Launch of LYMPHIR™ in 2025
CRANFORD, N.J., June 17, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today 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. "We've made steady and meaningful progress toward commercialization over the past several months," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharma. "With our supply chain secured, market access supported, and no anticipated impediments to reimbursement, we are encouraged by the momentum we've built. These efforts are pivotal as we transition into a commercial-stage company and believe the planned 2025 launch of LYMPHIR has the potential to be an important inflection point for both the company and the CTCL community," added Mazur. Manufacturing and Supply Chain Readiness Citius Oncology has completed commercial-scale manufacturing of LYMPHIR, with packaged and labeled inventory now held at a leading global Contract Development and Manufacturing Organization (CDMO). Sufficient inventory has been manufactured, with a product shelf life of 60 months, to meet projected demand for 12 to 18 months post-launch. Citius Oncology has executed one and is finalizing other distribution services agreements with multiple top-tier global pharmaceutical logistics partners to support broad access and timely delivery across the United States. These agreements are intended to provide access for CTCL patients so that they may be treated at both major cancer centers and within the community setting. KOL Engagement As part of its extensive market research efforts, our team has engaged U.S. Key Opinion Leaders (KOLs) in CTCL and participated in a series of medical congresses and community forums to build awareness and gather insight. Our engagement with the Cutaneous Lymphoma Foundation and similar organizations continues to shape LYMPHIR's patient-centered commercial approach. A recent Advisory Board convened at the 2024 American Society of Hematology Annual Meeting, composed of leading CTCL experts, provided us with information that informed both launch strategy and refinement of target patient profiles. Early interest from the clinical community is evident, with 70 institutional oncology centers already signed up via the LYMPHIR™ website ( Commercial & Marketing Activities The commercial team has developed a targeted launch strategy that leverages a proprietary generative AI model to efficiently and effectively target key accounts. These efforts are designed to amplify the expertise of the commercial organization so that they may have more meaningful interactions with providers, ultimately reaching CTCL patients who would benefit from LYMPHIR more expeditiously. A comprehensive suite of marketing and educational materials has been developed to support LYMPHIR's introduction. These tools are tailored to providers, patients, and caregivers and include clinical guides, dosing protocols, and disease awareness content. Market Access Update LYMPHIR's inclusion in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines, assignment of a permanent J-code under HCPCS, and Citius Oncology's continued engagement with payors, positions the product for efficient reimbursement and coverage at launch. Financing and Strategic Partnerships The successful capital raise recently completed by Citius Pharma assists with final preparations for LYMPHIR's commercialization, supporting the planned launch of LYMPHIR in the second half of 2025. Concurrently, the Company is actively engaged in strategic partnership discussions, guided by its financial advisor, to expand LYMPHIR's market reach and evaluate potential future development opportunities. About LYMPHIR™ (denileukin diftitox-cxdl) 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 (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface of tumor cells and immunosuppressive regulatory T-cells (T-regs) and is internalized. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. This action leads to direct tumoricidal effects as well as a transient depletion of T-regs to enhance overall antitumor activity. In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize denileukin diftitox in all markets except for Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA in August 2024. About Cutaneous T-cell Lymphoma Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions, leading to a decrease in the quality of life of patients with this disease due to severe pain and pruritus. Mycosis Fungoides (MF) and Sézary Syndrome (SS) comprise the majority of CTCL cases. Depending on the type of CTCL, the disease may progress slowly and can take anywhere from several years to upwards of ten to potentially reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant and can spread to the lymph nodes and internal organs, resulting in a poor prognosis. Given the duration of the disease, patients typically cycle through multiple agents to control disease progression. CTCL affects men twice as often as women and is typically first diagnosed in patients between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation, for which only a small fraction of patients qualify, there is currently no curative therapy for advanced CTCL. INDICATION LYMPHIR is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with r/r Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. IMPORTANT SAFETY INFORMATION BOXED WARNING: CAPILLARY LEAK SYNDROME Capillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves, or permanently discontinue based on severity. WARNINGS AND PRECAUTIONS Capillary Leak Syndrome LYMPHIR can cause capillary leak syndrome (CLS), including life-threatening or fatal reactions. CLS was defined in the clinical trials as the occurrence of at least 2 of the following symptoms at any time during LYMPHIR therapy: hypotension, edema, and serum albumin <3 g/dL. These symptoms were not required to occur simultaneously to be characterized as capillary leak syndrome. As defined, CLS occurred in 27% of patients in the pooled population across 3 clinical trials, including 8% with Grade 3. There was one (0.8%) fatal occurrence of CLS. Of the patients with CLS, 22% had recurrence. The majority of CLS events (81%) occurred within the first 2 cycles of treatment. The median time to onset from Cycle 1, Day 1 was 6.5 days (range: 1 to 77), the median duration of CLS was 14 days (range: 2 to 40), and 75% of patients had resolution. The most common symptoms included edema, hypoalbuminemia, and hypotension. Pleural effusion, pericardial effusion, and dehydration also occurred. Regularly assess patients for weight gain, new onset or worsening of edema, dyspnea, and hypotension (including orthostatic changes). Monitor serum albumin levels prior to the initiation of each cycle of therapy and more often as clinically indicated. Withhold, reduce dose, or permanently discontinue based on severity. If LYMPHIR is withheld, resume LYMPHIR following resolution of CLS and when serum albumin is greater than or equal to 3 g/dL. Visual Impairment LYMPHIR can cause serious visual impairment, including changes in visual acuity and color vision. In the pooled population across 3 clinical trials, visual impairment occurred in 9%, with Grade 1 in 8% and Grade 2 in 1%. The most commonly reported symptom was blurred vision. Of the patients with visual impairment, 67% had resolution of their visual impairment. Perform baseline ophthalmic examination and monitor as clinically indicated. If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision, or blurred vision, refer for ophthalmologic evaluation. Withhold LYMPHIR until visual impairment resolves or permanently discontinue based on severity. Infusion-Related Reactions LYMPHIR can cause serious infusion-related reactions. Infusion-related reactions were reported in 69% of patients in the pooled population across 3 clinical trials of patients who received LYMPHIR, with Grade 3 infusion-related reactions in 3.4% [see Adverse Reactions (6.1)]. Eighty-three percent of infusion-related reactions occurred in Cycles 1 and 2. The most common symptoms included nausea, fatigue, chills, musculoskeletal pain, vomiting, fever, and arthralgia. Premedicate patients for the first three cycles prior to starting a LYMPHIR infusion [see Dosage and Administration (2.3)]. Monitor patients frequently during infusion. For Grade 2 or higher infusion reactions, premedicate at least 30 minutes prior to each subsequent infusion with a systemic steroid for at least 3 cycles. Interrupt or discontinue LYMPHIR based on severity [see Dosage and Administration (2.4)]. Institute appropriate medical management. Hepatotoxicity LYMPHIR can cause hepatotoxicity. In the pooled safety population, elevated ALT occurred in 70% of patients, with Grade 3 ALT occurring in 22%; elevated AST occurred in 64% of patients, with Grade 3 AST elevation occurring in 9%. For Grade 3 events, median time to onset was 8 days (range: 1 to 15 days); median time to resolution was 15 days (range: 7 to 50 days); all cases of Grade 3 ALT or AST elevations resolved [see Adverse Reactions (6.1)]. Elevated total bilirubin occurred in 5% of patients, with Grade 3 occurring in 0.9%. Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold, reduce dose, or permanently discontinue LYMPHIR based on severity. Embryo-Fetal Toxicity Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to the initiation of LYMPHIR. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for 7 days following the last dose of LYMPHIR. ADVERSE REACTIONS The most common adverse reactions (≥20%), including laboratory abnormalities, are increased transaminases, albumin decreased, nausea, edema, hemoglobin decreased, fatigue, musculoskeletal pain, rash, chills, constipation, pyrexia, and capillary leak syndrome USE IN SPECIFIC POPULATIONS Pregnancy Risk SummaryBased on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. There are no available data on the use of LYMPHIR in pregnant women to evaluate for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with denileukin diftitox. Denileukin diftitox-cxdl causes depletion of regulatory T lymphocytes (Treg), immune activation, and capillary leak syndrome, compromising pregnancy maintenance. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. Lactation Risk SummaryNo data are available regarding the presence of denileukin diftitox-cxdl in human milk, the effects on the breastfed child, or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with LYMPHIR and for 7 days after the last dose. Females and Males of Reproductive Potential Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. Pregnancy TestingVerify the pregnancy status of females of reproductive potential prior to initiating LYMPHIR. Contraception FemalesAdvise females of reproductive potential to use effective contraception during treatment with LYMPHIR and for 7 days after the last dose. Infertility MalesBased on findings in rats, male fertility may be compromised by treatment with LYMPHIR. The reversibility of the effect on fertility is unknown. Pediatric UseSafety and effectiveness of LYMPHIR in pediatric patients have not been established. Geriatric UseOf the 69 patients with Stage I-III r/r CTCL who received LYMPHIR, 34 patients (49%) were 65 years of age and older and 10 patients (14%) were 75 years of age and older. Clinical studies of LYMPHIR did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. You may report side effects to the FDA at 1-800-FDA-1088 or You may also report side effects to Citius Oncology, Inc. 1-844-459-6744. Please read Important Safety Information and full Prescribing Information, including Boxed WARNING, for LYMPHIR. About Citius Oncology, Inc. Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In August 2024, its primary asset, LYMPHIR, was approved by the FDA for the treatment of adults with relapsed or refractory CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more information, please visit About Citius Pharmaceuticals, Inc. Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) 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 Pharma or Citius Oncology. 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: our ability to commercialize LYMPHIR and any of our other product candidates that may be approved by the FDA; our ability to use the latest technology to support our commercialization efforts; our need for substantial additional funds; our ability to regain compliance with Nasdaq's continued listing standards; our ability to successfully implement and maintain distribution agreements with current or other future distribution partners; potential disruptions or performance issues involving third-party logistics providers; 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; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; 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 Oncology's and Citius Pharma's Annual Reports on Forms 10-K for the year ended September 30, 2024, filed with the SEC on December 27, 2024, 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 Allenir@ 908-967-6677 x113 Media Contact: STiR-communicationsGreg SalsburgGreg@ View original content to download multimedia: SOURCE Citius Oncology, Inc. Erreur lors de la récupération des données Connectez-vous pour accéder à votre portefeuille Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données
Yahoo
12-06-2025
- Business
- Yahoo
BioInvent Presents Promising Phase 2a Monotherapy Data for BI-1808 in CTCL at EHA 2025
Data from the ongoing Phase 2a study shows a 100% disease control rate with 45% of patients with advanced cutaneous T-cell lymphoma achieving an objective response: One complete response, three partial responses, and five stable diseases in nine evaluable patients so far Robust immune activation supporting clinical activity observed Study continues to enroll patients; dose optimization phase to follow. LUND, SE / / June 12, 2025 / BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announced updated positive data from the ongoing Phase 2a dose expansion study of BI-1808 monotherapy in cutaneous T-cell lymphoma (CTCL). The data will be presented in a poster at the European Hematology Association (EHA) 2025 congress, June 12-15 in Milan, Italy. As of the cut-off date May 15, 2025, data showed a 100% disease control rate in nine evaluable patients with CTCL. Forty-five percent of these patients achieved an objective response, with one patient achieving a complete response (CR), three achieving a partial response (PR), and five exhibiting stable disease (SD). Additionally, two patients with peripheral T-cell lymphoma (PTCL) were evaluable, of which one showed a PR, while the other showed SD. Overall, BI-1808 monotherapy demonstrates promising clinical activity and robust immune BI-1808 was well tolerated, with all treatment-related adverse events reported as mild or moderate (Grade 1-2). Notably, no Grade 3 or higher adverse events were observed. Transient disease flares, including skin peeling, erythema, and pruritus during the first weeks of treatment, were observed and shown to be associated with the BI-1808 immunologic mechanism. These flares coincide with regulatory T cell depletion and influx of CD8+ T cells into the skin, indicating on-target immune activation. Immunofluorescence multiplexing, starting at week 5, further confirmed increased CD8+ T cell infiltration and elevated granzyme B, supporting the drug candidate's mechanism of action. "These results reinforce the potential of BI-1808 as a novel immune-modulating therapy for CTCL," said Martin Welschof, Chief Executive Officer of BioInvent. "The early and sustained immune activation observed, combined with a favorable safety profile and 100% disease control rate, support the value of our anti-Tumor Necrosis Factor Receptor 2 (TNFR2) approach. We believe that these early Phase 2a data represent a meaningful milestone in our mission to deliver transformative therapies for difficult-to-treat patients, and we look forward to advancing BI-1808 into later-stage studies." Details of the poster:Title: Robust Single Agent Activity of BI-1808, a Tumor Necrosis Factor Receptor 2 (TNFR2) Blocker/Depleter, in Cutaneous T Cell Lymphoma (CTCL) PatientsSession Date and Time: June 13, 2025, 6:30-7:30 pm CESTSession Title: Poster Session 1Lead Author: Stefan K. Barta, University of Pennsylvania Hospital, Philadelphia, PA, USAAbstract Number: PF961 The poster will be posted to the Scientific Publications section of the company website ( ). The safety and preliminary efficacy of BI-1808 monotherapy are currently being evaluated in a sub-cohort (Part A) of the ongoing Phase 2a ( NCT04752826 ) study in patients with T-cell lymphomas, including CTCL. The study is expected to enroll 20 patients at a signal-seeking dose, after which a dose optimization phase is planned to be initiated. In April 2025, BioInvent received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for BI-1808 for the treatment of CTCL and in March 2025, Orphan Drug Designation was received from the same agency for BI-1808 in T-cell lymphoma (TCL). About BI-1808The anti-TNFR2 antibody BI-1808 is part of BioInvent's tumor-associated regulatory T cells (Treg)-targeting program. TNFR2 is particularly upregulated on Tregs of the tumor microenvironment and has been shown to be important for tumor expansion and survival, representing a new and promising target for cancer immunotherapy. BI-1808 is a first-in-class drug candidate in clinical development for the treatment of solid tumors and blood cancer. BI-1808 has shown single agent activity and excellent tolerability in an ongoing Phase 2a study and signs of efficacy and favorable safety profile in combination with pembrolizumab in the ongoing Phase 1/2a study. About BioInventBioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently five drug candidates in six ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at . For further information, please contact:Cecilia Hofvander, VP Investor RelationsPhone: +46 (0)46 286 85 50Email: International AB (publ)Co. Reg. No.: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release. This information is information that BioInvent International is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-06-12 09:00 CEST. Attachments BioInvent Presents Promising Phase 2a Monotherapy Data for BI-1808 in CTCL at EHA 2025 SOURCE: BioInvent International View the original press release on ACCESS Newswire Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
09-06-2025
- Business
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Citius Oncology Enters into Distribution Services Agreement with Cardinal Health
Agreement supports the upcoming launch of LYMPHIR for the treatment of cutaneous T-cell lymphoma CRANFORD, N.J., June 9, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that it has entered into a distribution services agreement with Cardinal Health (NYSE: CAH), a leading provider of pharmaceutical and specialty pharmaceutical distribution services in the United States. This agreement is designed to help provide access to LYMPHIR™ (denileukin diftitox-cxdl), an innovative immunotherapy FDA-approved for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL), in support of its anticipated U.S. commercial launch. "This agreement marks a key step forward in our launch readiness efforts," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharmaceuticals. "Cardinal Health's proven distribution capabilities will help ensure LYMPHIR reaches healthcare providers and patients efficiently and reliably, as we work to build a robust commercial distribution network." Under the agreement, Cardinal Health will serve as an authorized distributor of record for Citius Oncology providing specialty pharmaceutical distribution services. About LYMPHIR™ (denileukin diftitox-cxdl) 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 DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors. In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of CTCL and PTCL. Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize LYMPHIR in all markets except for Japan and certain parts of Asia. LYMPHIR was approved by the FDA in August 2024. About Cutaneous T-cell Lymphoma Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions, leading to a decrease in the quality of life of patients with this disease due to severe pain and pruritus. Mycosis Fungoides (MF) and Sézary Syndrome (SS) comprise the majority of CTCL cases. Depending on the type of CTCL, the disease may progress slowly and can take anywhere from several years to upwards of ten to potentially reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant and can spread to the lymph nodes and internal organs, resulting in a poor prognosis. Given the duration of the disease, patients typically cycle through multiple agents to control disease progression. CTCL affects men twice as often as women and is typically first diagnosed in patients between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation, for which only a small fraction of patients qualify, there is currently no curative therapy for advanced CTCL. INDICATION LYMPHIR is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with r/r Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. IMPORTANT SAFETY INFORMATION BOXED WARNING: CAPILLARY LEAK SYNDROME Capillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves, or permanently discontinue based on severity. WARNINGS AND PRECAUTIONS Capillary Leak Syndrome LYMPHIR can cause capillary leak syndrome (CLS), including life-threatening or fatal reactions. CLS was defined in the clinical trials as the occurrence of at least 2 of the following symptoms at any time during LYMPHIR therapy: hypotension, edema, and serum albumin <3 g/dL. These symptoms were not required to occur simultaneously to be characterized as capillary leak syndrome. As defined, CLS occurred in 27% of patients in the pooled population across 3 clinical trials, including 8% with Grade 3. There was one (0.8%) fatal occurrence of CLS. Of the patients with CLS, 22% had recurrence. The majority of CLS events (81%) occurred within the first 2 cycles of treatment. The median time to onset from Cycle 1, Day 1 was 6.5 days (range: 1 to 77), the median duration of CLS was 14 days (range: 2 to 40), and 75% of patients had resolution. The most common symptoms included edema, hypoalbuminemia, and hypotension. Pleural effusion, pericardial effusion, and dehydration also occurred. Regularly assess patients for weight gain, new onset or worsening of edema, dyspnea, and hypotension (including orthostatic changes). Monitor serum albumin levels prior to the initiation of each cycle of therapy and more often as clinically indicated. Withhold, reduce dose, or permanently discontinue based on severity. If LYMPHIR is withheld, resume LYMPHIR following resolution of CLS and when serum albumin is greater than or equal to 3 g/dL. Visual Impairment LYMPHIR can cause serious visual impairment, including changes in visual acuity and color vision. In the pooled population across 3 clinical trials, visual impairment occurred in 9%, with Grade 1 in 8% and Grade 2 in 1%. The most commonly reported symptom was blurred vision. Of the patients with visual impairment, 67% had resolution of their visual impairment. Perform baseline ophthalmic examination and monitor as clinically indicated. If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision, or blurred vision, refer for ophthalmologic evaluation. Withhold LYMPHIR until visual impairment resolves or permanently discontinue based on severity. Infusion-Related Reactions LYMPHIR can cause serious infusion-related reactions. Infusion-related reactions were reported in 69% of patients in the pooled population across 3 clinical trials of patients who received LYMPHIR, with Grade 3 infusion-related reactions in 3.4% [see Adverse Reactions (6.1)]. Eighty-three percent of infusion-related reactions occurred in Cycles 1 and 2. The most common symptoms included nausea, fatigue, chills, musculoskeletal pain, vomiting, fever, and arthralgia. Premedicate patients for the first three cycles prior to starting a LYMPHIR infusion [see Dosage and Administration (2.3)]. Monitor patients frequently during infusion. For Grade 2 or higher infusion reactions, premedicate at least 30 minutes prior to each subsequent infusion with a systemic steroid for at least 3 cycles. Interrupt or discontinue LYMPHIR based on severity [see Dosage and Administration (2.4)]. Institute appropriate medical management. Hepatotoxicity LYMPHIR can cause hepatotoxicity. In the pooled safety population, elevated ALT occurred in 70% of patients, with Grade 3 ALT occurring in 22%; elevated AST occurred in 64% of patients, with Grade 3 AST elevation occurring in 9%. For Grade 3 events, median time to onset was 8 days (range: 1 to 15 days); median time to resolution was 15 days (range: 7 to 50 days); all cases of Grade 3 ALT or AST elevations resolved [see Adverse Reactions (6.1)]. Elevated total bilirubin occurred in 5% of patients, with Grade 3 occurring in 0.9%. Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold, reduce dose, or permanently discontinue LYMPHIR based on severity. Embryo-Fetal Toxicity Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to the initiation of LYMPHIR. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for 7 days following the last dose of LYMPHIR. ADVERSE REACTIONS The most common adverse reactions (≥20%), including laboratory abnormalities, are increased transaminases, albumin decreased, nausea, edema, hemoglobin decreased, fatigue, musculoskeletal pain, rash, chills, constipation, pyrexia, and capillary leak syndrome USE IN SPECIFIC POPULATIONS Pregnancy Risk SummaryBased on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. There are no available data on the use of LYMPHIR in pregnant women to evaluate for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with denileukin diftitox. Denileukin diftitox-cxdl causes depletion of regulatory T lymphocytes (Treg), immune activation, and capillary leak syndrome, compromising pregnancy maintenance. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. Lactation Risk SummaryNo data are available regarding the presence of denileukin diftitox-cxdl in human milk, the effects on the breastfed child, or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with LYMPHIR and for 7 days after the last dose. Females and Males of Reproductive Potential Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. Pregnancy TestingVerify the pregnancy status of females of reproductive potential prior to initiating LYMPHIR. Contraception FemalesAdvise females of reproductive potential to use effective contraception during treatment with LYMPHIR and for 7 days after the last dose. Infertility MalesBased on findings in rats, male fertility may be compromised by treatment with LYMPHIR. The reversibility of the effect on fertility is unknown. Pediatric UseSafety and effectiveness of LYMPHIR in pediatric patients have not been established. Geriatric UseOf the 69 patients with Stage I-III r/r CTCL who received LYMPHIR, 34 patients (49%) were 65 years of age and older and 10 patients (14%) were 75 years of age and older. Clinical studies of LYMPHIR did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. You may report side effects to the FDA at 1-800-FDA-1088 or You may also report side effects to Citius Pharmaceuticals at 1-844-459-6744. Please read Important Safety Information and full Prescribing Information, including Boxed WARNING, for LYMPHIR. About Citius Oncology, Inc. Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In August 2024, its primary asset, LYMPHIR, was approved by the FDA for the treatment of adults with relapsed or refractory CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more information, please visit About Citius Pharmaceuticals, Inc. Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) 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 Pharma or Citius Oncology. 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: our ability to commercialize LYMPHIR and any of our other product candidates that may be approved by the FDA; our need for substantial additional funds; our ability to successfully implement and maintain distribution agreements with current or other future distribution partners; potential disruptions or performance issues involving third-party logistics providers; 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; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; 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 Oncology's and Citius Pharma's Annual Reports on Forms 10-K for the year ended September 30, 2024, filed with the SEC on December 27, 2024, 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 Allenir@ 908-967-6677 x113 Media Contact: STiR-communicationsGreg SalsburgGreg@ View original content to download multimedia: SOURCE Citius Pharmaceuticals, Inc.
