CTCL

Orphan designation: Synthetic hypericin Treatment of cutaneous T-cell lymphoma, 28/07/2015 Positive

Retrieved on: 
Thursday, April 18, 2024
Eurostat, Diagnosis, Civil service commission, X-ray, Growth, Medicine, Disease, Patient, Ageing, Committee, Knowledge, Tissue, Neoplasm, Light, Cutaneous T-cell lymphoma, Regulation, Cancer, EMA, IRIS, Quality of life, Reactive oxygen species, Lymph, CTCL, Clinical trial, European, Skin, COMP, Oxygen, European Commission, Immune system, Safety, Carmustine, Alfa, Marketing, Lymphatic system, Pharmaceutical industry

Orphan designation: Synthetic hypericin Treatment of cutaneous T-cell lymphoma, 28/07/2015 Positive

Key Points: 


Orphan designation: Synthetic hypericin Treatment of cutaneous T-cell lymphoma, 28/07/2015 Positive

Corvus Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, March 19, 2024
Atopic dermatitis, Head, T helper cell, HNSCC, Patient, PTCL, Lung cancer, Ipilimumab, Asthma, CTCL, ALCL, Fungal infection, Pulmonary fibrosis, Lymphocyte, RCC, Clinical trial, CRS, Marketing, B-cell lymphoma, Research, PR, PTCL-NOS, Psoriasis, T-cell lymphoma, ASH, Webcast, Immunomodulation, Pembrolizumab, PRS, Exposition, Cancer, Nivolumab, Safety, Scleroderma, Food, NSCLC, Teva Pharmaceuticals, Modified, Lymphoma, Knowledge, Allergy, Immunodeficiency, Time management, Peripheral, Poster, FDA, ITK, Conference call, Kidney cancer, T helper 17 cell, Society, Preprint, BioRxiv, Autoimmunity, Physician, Total, Pharmaceutical industry

BURLINGAME, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS) (GLOBAL NEWSWIRE), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the fourth quarter and year ended December 31, 2023.

Key Points: 
  • ET / 1:30 p.m. PT
    BURLINGAME, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS) (GLOBAL NEWSWIRE), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the fourth quarter and year ended December 31, 2023.
  • We have several exciting opportunities in immunology, including plans for a randomized, placebo controlled clinical trial of soquelitinib in atopic dermatitis.
  • Mr. Arcara previously served as senior vice president, head global marketing & portfolio and strategy for the innovative medicines and biosimilars business at Teva Pharmaceuticals.
  • ET (1:30 p.m. PT), during which time management will provide a business update and discuss the fourth quarter and full year 2023 financial results.

SIRPant Immunotherapeutics Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating SIRPant-M in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma

Retrieved on: 
Tuesday, March 12, 2024
XRT, ASH, Patient, PTCL, City, Tumor microenvironment, NHL, CTCL, Society, Safety, Bone marrow, Poster

“The culmination of years of development work, initially in Academia, and later taken forward by SIRPant, we are pleased to announce the dosing of the first patient in this Phase 1 study evaluating SIRPant-M™, last week at the City of Hope Cancer Center.”, said Jelle Kijlstra, M.D., Chief Medical Officer of SIRPant.

Key Points: 
  • “The culmination of years of development work, initially in Academia, and later taken forward by SIRPant, we are pleased to announce the dosing of the first patient in this Phase 1 study evaluating SIRPant-M™, last week at the City of Hope Cancer Center.”, said Jelle Kijlstra, M.D., Chief Medical Officer of SIRPant.
  • The interaction of immune cells in the tumor microenvironment influences progression of cutaneous T cell lymphoma,” said Christiane Querfeld, M.D., Ph.D., Director of the Multidisciplinary Cutaneous Lymphoma Program, and one of the principal investigators of the study.
  • Both B-cell and certain T-cell NHL (select PTCL; CTCL) are eligible.
  • The primary objective of the study is to assess the safety and tolerability of autologous SIRPant-M™.

Soligenix Announces Agreement on the Design of a Second Confirmatory Placebo-Controlled Trial for HyBryte™ With the European Medicines Agency

Retrieved on: 
Wednesday, April 3, 2024
Replicate, Fluorescent lamp, Patient, Cutaneous T-cell lymphoma, EMA, European Medicines Agency, CTCL, FLASH, Safety, Pharmaceutical industry

PRINCETON, N.J., April 3, 2024 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has received agreement from the European Medicines Agency (EMA) on the key design components of a confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) patients with early-stage disease. This confirmatory 18-week study is expected to enroll approximately 80 patients in the United States and Europe and is targeted to begin patient enrollment by the end of 2024 with top-line results anticipated in the second half of 2026.

Key Points: 
  • In this second study, all important clinical study design components remain the same as in the first FLASH study, including the primary endpoint and key inclusion-exclusion criteria.
  • While collaborative, the agency has expressed a preference for a longer duration comparative study over a placebo-controlled trial.
  • A sample size recalculation may be performed after examining the assumptions or the trial halted for either futility, safety concerns, or overwhelming efficacy.
  • Soligenix, participating clinical investigators, and any personnel involved in trial conduct will remain blinded to study treatment until completion of the trial.

Citius Pharmaceuticals Announces FDA Acceptance of the BLA Resubmission of LYMPHIR™ (Denileukin Diftitox) for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma

Retrieved on: 
Monday, March 18, 2024
T-cell lymphoma, PDUFA, Symantec Endpoint Protection, Letter, Disease, Patient, CRL, CTCL, Drug development, Safety, FDA, BLA, Food, Pharmaceutical industry

CRANFORD, N.J., March 18, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Company's Biologics License Application (BLA) for LYMPHIR™ (denileukin diftitox), an IL-2-based immunotherapy for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The FDA has assigned a PDUFA goal date of August 13, 2024.

Key Points: 
  • "The acceptance of the BLA resubmission reflects the completeness of our response to the enhanced product testing and additional controls highlighted by the FDA in their July 2023 CRL.
  • "We believe there remains a critical unmet need for an additional viable treatment option for patients with relapsed or refractory CTCL as current therapies are non-curative.
  • We look forward to the FDA's decision and the potential benefit LYMPHIR may provide patients with relapsed or refractory CTCL," added Mazur.
  • The resubmission follows dialog with the FDA resulting from a Complete Response Letter (CRL) received on July 28, 2023.

Domain Therapeutics and Chime Biologics announce manufacturing agreement to advance novel anti-CCR8 antibody for cancer immunotherapy

Retrieved on: 
Tuesday, March 12, 2024
GPCR, CLD, CDMO, Organization, Partnership, Patient, CGMP, Research, Cutaneous T-cell lymphoma, Cancer, G protein-coupled receptor, CTCL, Gq alpha subunit, Therapy, CCR8, Vaccine

Under the terms of the agreement, Chime Biologics will ensure stable cell line development (CLD) and DT-7012 candidate manufacturing to support clinical trials in strategic countries.

Key Points: 
  • Under the terms of the agreement, Chime Biologics will ensure stable cell line development (CLD) and DT-7012 candidate manufacturing to support clinical trials in strategic countries.
  • Chime Biologics' first global modular facility with single-use bioprocessing technology meets international cGMP standards with proven audit track records.
  • Stephan Schann, Chief Scientific Officer of Domain Therapeutics, said: "We're thrilled to collaborate with Chime Biologics, a great scientific and manufacturing expert, to advance DT-7012, our leading anti-CCR8 candidate, to the next development stage.
  • At Domain, we prioritize precision research and innovation and embrace new partnerships with organizations that share our vision and passion to advance immuno-oncology".

Withdrawn application: Adcetris, 23/02/2024

Retrieved on: 
Wednesday, April 3, 2024
PTCL-NOS, Lymphoma, B-cell lymphoma, CHOP, Patient, PTCL, Doxorubicin, Vincristine, CHP, Cancer, Vinblastine, European Medicines Agency, CTCL, Prednisone, Lymphocyte, Agency, Clinical trial, Skin, Dacarbazine, CD30, Cyclophosphamide, Medicine

Adcetris was designated an ‘orphan medicine’ (a medicine used in rare diseases) for peripheral T cell lymphoma 21 August 2019.

Key Points: 
  • Adcetris was designated an ‘orphan medicine’ (a medicine used in rare diseases) for peripheral T cell lymphoma 21 August 2019.
  • The cytotoxic molecule then enters the cancer cells and prevents them from dividing, causing the cancer cells to die.
  • The application was withdrawn after the European Medicines Agency had evaluated the initial information from the company and had prepared questions for the company.
  • If you are in a clinical trial and need more information about your treatment, speak with your clinical trial doctor.

STRATA Skin Sciences Announces Initiative to Expand Treatment Coverage

Retrieved on: 
Thursday, March 7, 2024
Lichen planus, Light therapy, Assistant, Vitiligo, Marketing, Cutaneous T-cell lymphoma, Quality of life, Senate, Atopic dermatitis, Skin, CTCL, Mycosis fungoides, CPT, Human, Light, Alopecia areata, Patient, STRATA, SSKN, Insurance, Pharmaceutical industry

The Company is leveraging its extensive patient database and engaging in targeted governmental relations efforts, this initiative focuses on broadening Current Procedural Terminology (“CPT”) code coverage to increase patient access to advanced treatments and enable higher provider reimbursement rates.

Key Points: 
  • The Company is leveraging its extensive patient database and engaging in targeted governmental relations efforts, this initiative focuses on broadening Current Procedural Terminology (“CPT”) code coverage to increase patient access to advanced treatments and enable higher provider reimbursement rates.
  • “Our focus extends beyond merely seeking expanded insurance coverage; we're advocating for the enhancement of patient quality of life and ensuring access to essential dermatologic treatments," stated Dr. Dolev Rafaeli, Vice Chairman and Chief Executive Officer of STRATA.
  • Over the past two months, as part of this advocacy initiative STRATA has sent over 1,000 legislative support letters to congressional and senate delegates on behalf of its patients.
  • Phototherapy has been the cornerstone of therapy for decades and remains an indispensable part of current therapy.

Kymera Therapeutics Announces Fourth Quarter and Full Year 2023 Financial Results and Provides a Business Update

Retrieved on: 
Thursday, February 22, 2024
Well, Janus, International, Neoplasm, Psoriasis, STAT6, Research, Toxicity, AML, Doctor of Philosophy, ASH, Investment, Blood, Atopic dermatitis, Cash, Growth, Janus kinase, Sale, Lupus, Skin, CTCL, PD-1, Inflammation, Society, JAK, Biomarker, Therapy, Immunology, Hidradenitis suppurativa, Administration, Webcast, Inflammatory bowel disease, Patient, Autoimmunity, Arm, Lymphoma, TYK2, Clinical trial, HS, TPD, G&A, Development, Dupilumab, Phase 1, Human, Pharmaceutical industry

Under the terms of the Sanofi/Kymera collaboration, the dosing of the first patients generated milestone payments totaling $55 million.

Key Points: 
  • Under the terms of the Sanofi/Kymera collaboration, the dosing of the first patients generated milestone payments totaling $55 million.
  • Enrollment in both trials is ongoing, with topline data expected to be reported in the first half of 2025.
  • Kymera unveiled its first-in-class oral STAT6 degrader, KT-621, at its Immunology R&D Day in January.
  • To access the conference call via phone, please dial +1 (833) 630-2127 or +1 (412) 317-1846 (International) and ask to join the Kymera Therapeutics call.

Citius Pharmaceuticals Resubmits the Biologics License Application of LYMPHIR™ (Denileukin Diftitox) for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma

Retrieved on: 
Wednesday, February 14, 2024
Symantec Endpoint Protection, FDA, Food, Safety, BLA, CRL, PDUFA, CTCL, Letter, Patient

CRANFORD, N.J., Feb. 13, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today announced the resubmission of the Company's Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for LYMPHIR™ (denileukin diftitox), an IL-2-based immunotherapy for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

Key Points: 
  • The resubmission follows ongoing engagement with the FDA resulting from a Complete Response Letter (CRL) received on July 28, 2023.
  • Citius believes it has addressed enhanced product testing and additional manufacturing controls noted in the letter.
  • There were no safety or efficacy issues cited and no additional trials required.
  • Based on Center for Drug Evaluation and Research timelines, FDA acceptance of the completed resubmission package and issuance of a Prescription Drug User Fee Act (PDUFA) date is expected within 30 days of resubmission.