CTCL

Cellectar Biosciences and City of Hope Cancer Center Enter Collaboration to Evaluate Iopofosine I 131 in Mycosis Fungoides

Retrieved on: 
Mittwoch, Mai 29, 2024
Partnership, Patient, B-cell lymphoma, WAM, Bone marrow, Risk, Food, NDA, Prevalence, MF, CTCL, FDA, Skin, Waldenström, WM, Mycosis fungoides, Malignancy, Death, Blood, Neoplasm, Cancer, Multiple myeloma, PDC, Research, NHL, DLBCL, NCI-designated Cancer Center, City, Pharmaceutical industry

FLORHAM PARK, N.J., May 29, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, announced today a strategic partnership with City of Hope Cancer Center, one of the largest cancer research and treatment organizations in the United States. The collaboration will focus on the clinical development of Cellectar’s lead radioconjugate asset, iopofosine I 131, in mycosis fungoides (MF), a rare form of non-Hodgkin’s lymphoma (NHL) that affects the skin and, in some patients, internal organs and blood. Iopofosine is the first systemic targeted radiotherapeutic to be assessed for cutaneous T-cell lymphomas (CTCL). The investigator sponsored trial will evaluate approximately 10 patients; initiation is planned for late 2024 or early 2025.

Key Points: 
  • The collaboration will focus on the clinical development of Cellectar’s lead radioconjugate asset, iopofosine I 131, in mycosis fungoides (MF), a rare form of non-Hodgkin’s lymphoma (NHL) that affects the skin and, in some patients, internal organs and blood.
  • Iopofosine is the first systemic targeted radiotherapeutic to be assessed for cutaneous T-cell lymphomas (CTCL).
  • The investigator sponsored trial will evaluate approximately 10 patients; initiation is planned for late 2024 or early 2025.
  • “We are excited to partner with Cellectar Biosciences to evaluate iopofosine in patients with mycosis fungoides,” said Dr. Steven T. Rosen, executive vice president and director emeritus, Comprehensive Cancer Center and Beckman Research Institute of City of Hope.

PRISM MarketView Highlights Soligenix, Inc. as it Builds on Compelling Phase 3 Data with Key Catalysts on the Horizon

Retrieved on: 
Dienstag, Mai 21, 2024
Disease, Patient, COVID-19, Food, European Medicines Agency, Interview, CTCL, FDA, Drug development, Psoriasis, Dermatology, Cutaneous T-cell lymphoma, EMA, Journal, FLASH, PRISM, Therapy, Ricin, NIH, Pharmaceutical industry

Soligenix has recently achieved success in its first Phase 3 clinical trial of HyBryte™ (synthetic hypericin) for cutaneous T-cell lymphoma (CTCL), a rare and chronic cancer.

Key Points: 
  • Soligenix has recently achieved success in its first Phase 3 clinical trial of HyBryte™ (synthetic hypericin) for cutaneous T-cell lymphoma (CTCL), a rare and chronic cancer.
  • The trial showed statistical significance in its primary endpoint, and a second confirmatory Phase 3 study is set to commence in 2024.
  • The open-label study, involving nine patients, showed significant improvements in CTCL lesions, confirming the efficacy seen in the Phase 3 FLASH trial.
  • "We will be enrolling the first patients in our 18-week Phase 3 placebo-controlled study evaluating HyBryte™ in CTCL across the US and Europe.

Kymera Therapeutics to Present New Clinical Data from the Ongoing Phase 1 Trial of STAT3 Degrader KT-333 at EHA Annual Meeting

Retrieved on: 
Dienstag, Mai 14, 2024
Patient, Stomatitis, DL2, Plasma, PD, T-cell prolymphocytic leukemia, Relapse, ALT, Nausea, Tumor microenvironment, CTCL, Therapy, Neoplasm, Arthralgia, Safety, Constipation, Lymphoma, MD, T-PLL, EHA, PTCL, STAT3, Cutaneous T-cell lymphoma, Biomarker, CHL, Fatigue, Infrared spectroscopy correlation table, Peripheral T-cell lymphoma, TPD, European Hematology Association, SOCS3, Annual general meeting

WATERTOWN, Mass., May 14, 2024 (GLOBE NEWSWIRE) --  Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today announced that new Phase 1 data for KT-333, a first-in-class degrader of STAT3, highlighting safety, pharmacokinetics (PK), pharmacodynamics (PD) and clinical responses will be presented at the European Hematology Association (EHA) Annual Meeting, taking place from June 13-16, 2024, in Madrid, Spain. Results released in an EHA abstract today, which include a data cut-off as of February 6, 2024, demonstrate that KT-333 is a potent and selective STAT3 degrader that has demonstrated clinically significant responses in specific patient populations. The poster presentation is expected to include additional data, including PK/PD, safety and results of disease response assessments from additional patients subsequent to the abstract cut-off date.

Key Points: 
  • The poster presentation is expected to include additional data, including PK/PD, safety and results of disease response assessments from additional patients subsequent to the abstract cut-off date.
  • “We’re encouraged by the Phase 1 data generated to date.
  • We have also achieved substantial target knockdown and pathway activation,” said Jared Gollob, MD, Chief Medical Officer, Kymera Therapeutics.
  • Title: Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of KT-333, a Targeted Protein Degrader of STAT3, in Patients with Relapsed or Refractory Hematologic and Solid Tumor Cancers

Soligenix Announces Recent Accomplishments And First Quarter 2024 Financial Results

Retrieved on: 
Freitag, Mai 10, 2024
Partnership, Disease, Patient, Infection, SUDV, Doctor of Philosophy, Vaccine, COVID-19, Patent, Food, European Medicines Agency, Income tax, CTCL, FDA, Government, Safety, Cutaneous T-cell lymphoma, EMA, Acquisition, Research, Food and Drug Administration, MARV, Post-exposure prophylaxis, Pharmaceutical industry

PRINCETON, N.J., May 10, 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 its recent accomplishments and financial results for the quarter ended March 31, 2024.

Key Points: 
  • PRINCETON, N.J., May 10, 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 its recent accomplishments and financial results for the quarter ended March 31, 2024.
  • This study will enroll approximately 80 patients across the U.S. and Europe, starting before the end of 2024, with top-line results expected in the second half of 2026.
  • Financial Results – Quarter Ended March 31, 2024
    Soligenix's revenues for the quarter ended March 31, 2024 were $0.1 million as compared to $0.3 million for the quarter ended March 31, 2023.
  • As of March 31, 2024, the Company's cash position, exclusive of the approximate $4.3 million in net proceeds from our recent financing, was approximately $7.1 million.

Corvus Pharmaceuticals Provides Business Update and Reports First Quarter 2024 Financial Results

Retrieved on: 
Montag, Mai 6, 2024
FDA, Total, ITK, Research, PTCL, PR, Doctor of Philosophy, Webcast, Fungal infection, Atopic dermatitis, RCC, Lymphoma, Vanderbilt University Medical Center, Lung cancer, Conference call, Kidney cancer, Conference, CRS, Peripheral, Assistant, PRS, NSCLC, Patient, Safety, Pembrolizumab, Modified, CTCL, Time management, Clinical trial, Division, Sale, A2A, Adenosine, HNSCC, T-cell lymphoma, Nivolumab, Ipilimumab, B-cell lymphoma, Disease, ALCL, Physician, Head, PTCL-NOS, Pharmaceutical industry

BURLINGAME, Calif., May 06, 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 first quarter ended March 31, 2024.

Key Points: 
  • ET / 1:30 p.m. PT
    BURLINGAME, Calif., May 06, 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 first quarter ended March 31, 2024.
  • Corvus anticipates initiating a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed PTCL in the third quarter of 2024.
  • Corvus will host a conference call and webcast today, Monday, May 6, 2024, at 4:30 p.m.
  • ET (1:30 p.m. PT), during which time management will provide a business update and discuss the first quarter 2024 financial results.

First Interim Analysis of PROSPER Study Details Patient-Reported Symptom Burden of Mycosis Fungoides and Sézary Syndrome

Retrieved on: 
Montag, April 15, 2024
Oncology, Health, General Health, Research, Pharmaceutical, Science, TSA, University, Patient, MF, Cutaneous T-cell lymphoma, Skin, Blood, Kyowa Kirin, Thermoregulation, CTCL, Disease, Lymphoma, Quality of life (healthcare), Lymph, Mycosis fungoides, University of Birmingham, Neoplasm

In a proportion of cases, the disease may spread to the lymph nodes, blood, and/or other organs.

Key Points: 
  • In a proportion of cases, the disease may spread to the lymph nodes, blood, and/or other organs.
  • In the current interim analysis, symptom scores (mean) were reported for 20 adult patients with relapsed or refractory disease (8 MF; 12 SS) over their first 16 weeks of mogamulizumab treatment.
  • Prior to treatment initiation, patients reported their symptom burden using a 1 – 10 numeric scale.
  • At baseline, skin itch scored highest (6.6) followed by skin redness (6.2), flaking skin (5.9) and skin pain (4.0).

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

Retrieved on: 
Donnerstag, 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: 
Dienstag, März 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: 
Dienstag, März 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: 
Mittwoch, 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.