Peripheral T-cell lymphoma

Innate Pharma Presents Data From Ongoing Phase 2 TELLOMAK Trial Demonstrating Clinical Activity of Lacutamab in Advanced Sézary Syndrome at ASH 2022

Retrieved on: 
Saturday, December 10, 2022
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In line with previous observations, lacutamab demonstrated a favorable safety profile for patients with advanced Szary syndrome in the TELLOMAK Phase 2 preliminary analysis.

Key Points: 
  • In line with previous observations, lacutamab demonstrated a favorable safety profile for patients with advanced Szary syndrome in the TELLOMAK Phase 2 preliminary analysis.
  • The data continues to support our fast to market strategy for lacutamab in the niche setting of Szary syndrome where lacutamab was granted U.S. Fast Track designation and EU Prime designation.
  • We thank the investigators, clinical research coordinators, patients and caregivers involved in the ongoing TELLOMAK program.
  • Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

Citius Pharmaceuticals, Inc. Announces U.S. Food and Drug Administration Acceptance of Biologics License Application of Denileukin Diftitox for the Treatment of Patients with Persistent or Recurrent Cutaneous T-Cell Lymphoma

Retrieved on: 
Thursday, December 1, 2022
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CRANFORD, N.J., Dec. 1, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's Biologics License Application (BLA) for denileukin diftitox ("I/ONTAK" or "E7777"), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). I/ONTAK is a purified and more bioactive formulation of previously FDA-approved ONTAK®. The PDUFA target action date is September 28, 2023. The BLA is supported by a pivotal Phase 3 study (NCT01871727). 

Key Points: 
  • "The acceptance of the previously announced BLA submission for I/ONTAK is another important regulatory milestone for our oncology program.
  • I/ONTAK, a purified version of denileukin diftitox, is a reformulation of previously FDA-approved oncology treatment ONTAK.
  • The new formulation received regulatory approval in Japan in 2021 for the treatment of CTCL and peripheral T-cell lymphoma (PTCL).
  • 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.

Citius Pharmaceuticals, Inc. Secures $3.6 million through New Jersey Economic Development Program

Retrieved on: 
Monday, November 21, 2022
Transfer, Quality of life, Drug Quality and Security Act, IL-2R, CTCL, Tax, New Jersey Department of Health, PTCL, Fast Track, New Jersey Economic Development Authority, Immunotherapy, BLA, Net, Economic development, FDA, NOL, Treasury, Research, Patent, Annual report, Hemorrhoid, Pivotal, Patient, COVID-19, Risk, File, Regulation of tobacco by the U.S. Food and Drug Administration, Regulation, CGMP, State, Food, T-cell lymphoma, Peripheral T-cell lymphoma, Health insurance, Pharmaceutical industry, Citius, Altius, Fortius

CRANFORD, N.J., Nov. 21, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the Company has been selected to participate in New Jersey's Technology Business Tax Certificate Transfer (NOL) Program, more commonly known as the Net Operating Loss (NOL) Program, and will receive $3.6 million in non-dilutive capital through the New Jersey Economic Development Authority (NJEDA). Citius expects to receive the funds by late 2022 or early 2023.

Key Points: 
  • "This was the first year that Citius qualified for the program, and we are delighted to have been selected to participate in New Jersey's NOL Program.
  • We are thankful to the NJ Economic Development Authority for aiding our efforts in our initial year of participation.
  • The average award for companies approved to sell their net operating losses through the program in 2022 was over $3.1 million.
  • The New Jersey Economic Development Authority (NJEDA) serves as the State's principal agency for driving economic growth.

Citius Pharmaceuticals Announces Efficacy and Safety Data for its I/ONTAK (E7777) Phase 3 Study for Treatment of Cutaneous T-Cell Lymphoma to be Presented at the 64th American Society of Hematology (ASH) Annual Meeting

Retrieved on: 
Wednesday, November 9, 2022
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CRANFORD, N.J., Nov. 9, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today announced that abstracts for I/ONTAK (E7777) for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL) have been accepted for presentations at the prestigious 64th American Society of Hematology (ASH) Annual Meeting, to be held in New Orleans, December 10-13, 2022.

Key Points: 
  • I/ONTAK is a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments.
  • ONTAK was marketed in the U.S. from 1999 to 2014, when it was voluntarily withdrawn from the market.
  • The new formulation received regulatory approval in Japan in 2021 for the treatment of CTCL and peripheral T-cell lymphoma (PTCL).
  • 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.

Preliminary Results from Two Clinical Studies of Selinexor to be Presented at 2022 ASH Annual Meeting

Retrieved on: 
Monday, November 7, 2022
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SHANGHAI and HONG KONG, Nov. 6, 2022 /PRNewswire/ -- Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, today announced that it will present updated results from the Phase Ib TOUCH study of selinexor for treatment of R/R T and NK-cell lymphoma in a poster at the upcoming 2022 American Society of Hematology (ASH) Annual Meeting. In addition, preliminary results from the investigator-initiated LAUNCH trial will be published in an on-line abstract. The 2022 ASH Annual Meeting will be held virtually and in person in New Orleans, Louisiana, the United States, from December 10-13, 2022.

Key Points: 
  • In addition, preliminary results from the investigator-initiated LAUNCH trial will be published in an on-line abstract.
  • The 2022 ASH Annual Meeting will be held virtually and in person in New Orleans, Louisiana, the United States, from December 10-13, 2022.
  • "The data to be presented at ASH 2022 highlights the broad clinical potential and manageable side effect profile of selinexor in patients with well-defined T-cell lymphomas and R/R MM," said Dr. Jay Mei, Antengene's Founder, Chairman and CEO.
  • "It is our great pleasureto share these updates with the hematology/oncology community at ASH 2022."

Autolus Therapeutics to Present Three Clinical Data Updates at the American Society of Hematology (ASH) Annual Meeting 2022

Retrieved on: 
Thursday, November 3, 2022
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Were looking forward to presenting follow up data from three of our clinical trials at ASH this year.

Key Points: 
  • Were looking forward to presenting follow up data from three of our clinical trials at ASH this year.
  • For both AUTO1/22 in pediatric ALL patients and for AUTO4 in peripheral T Cell Lymphoma we will present longer follow up data.
  • Overall, obe-cel has a tolerable safety profile in patients with r/r B-cell cancers despite high disease burden.
  • In collaboration with Autolus academic partner, UCL, obe-cel is currently being evaluated in a Phase 1 clinical trials for B-NHL.

Innate Pharma to Present Results From a Preliminary Analysis of the TELLOMAK Phase 2 Trial in Patients With Advanced Sezary Syndrome and ANKET™ Platform at ASH 2022

Retrieved on: 
Friday, November 4, 2022
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Lacutamab in patients with advanced Sezary syndrome: results from an interim analysis of the TELLOMAK phase 2 trial

Key Points: 
  • Lacutamab in patients with advanced Sezary syndrome: results from an interim analysis of the TELLOMAK phase 2 trial
    Presenter: Dr Pierluigi Porcu, Director, Division of Medical Oncology and Hematopoietic Stem Cell Transplantation, Thomas Jefferson University Hospitals, Philadelphia
    Session Name: 704.
  • Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational: Poster III
    The posters and presentation will be available on the Publications section of innate-pharma.com following the meeting.
  • Rare cutaneous lymphomas of T lymphocytes has a poor prognosis with few efficacious and safe therapeutic options at advanced stages.
  • Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

EQS-News: MorphoSys Presents Preliminary Results from Phase 1/2 Study of Tulmimetostat (CPI-0209) Supporting Its Potential Application in a Broad Array of Advanced Tumors

Retrieved on: 
Friday, October 28, 2022
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Advanced cancer patients who have progressed following prior therapies have significant treatment needs that might benefit from a targeted approach with an EZH2 inhibitor.

Key Points: 
  • Advanced cancer patients who have progressed following prior therapies have significant treatment needs that might benefit from a targeted approach with an EZH2 inhibitor.
  • At trial entry, 68% of patients had been treated with at least three prior lines of therapy.
  • Of the 10 evaluable patients with ovarian clear cell carcinoma, four had a partial response and three had stable disease.
  • These initial results support patient selection based on ARID1A and BAP1 in the ongoing Phase 2 expansion study.

Citius Pharmaceuticals to Present at Dawson James Securities Small Cap Growth Conference on October 12, 2022

Retrieved on: 
Thursday, October 6, 2022
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Wyndham Grand Hotel in Jupiter, Florida

Key Points: 
  • Wyndham Grand Hotel in Jupiter, Florida
    To request a meeting, please contact your Dawson James representative.
  • I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and peripheral T-cell lymphoma (PTCL).
  • In the first half of 2022, Citius initiated a Phase 2b trial for Halo-Lido, a topical formulation for the relief of hemorrhoids.
  • The Company anticipates completing enrollment in the Halo-Lido trial by the end of 2022.

Citius Pharmaceuticals, Inc. Submits Biologics License Application to the U.S. Food and Drug Administration for Denileukin Diftitox for the Treatment of Patients with Persistent or Recurrent Cutaneous T-Cell Lymphoma

Retrieved on: 
Wednesday, September 28, 2022
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"The treatment of advanced cutaneous T-cell lymphoma remains a complex and challenging unmet medical need.

Key Points: 
  • "The treatment of advanced cutaneous T-cell lymphoma remains a complex and challenging unmet medical need.
  • Each year, thousands of patients are diagnosed with CTCL, a debilitating orphan disease with no single standard of care.
  • "The BLA filing for denileukin diftitox marks the first of our pipeline candidates to be submitted for FDA approval."
  • I/ONTAK, a purified version of denileukin diftitox, is a reformulation of previously FDA-approved oncology treatment ONTAK.