Cutaneous T-cell lymphoma

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

Retrieved on: 
Freitag, Juni 14, 2024
Head, PD, Leukemia, Neoplasm, Patient, Fatigue, EHA, TPD, Brentuximab vedotin, Cutaneous T-cell lymphoma, Arthralgia, Bone marrow, Infrared spectroscopy correlation table, Mutation, Therapy, European Hematology Association, T-PLL, Safety, Biomarker, STAT3, DL2, CHL, T-cell prolymphocytic leukemia, Stomatitis, Lymphoma, DLS, Resource, Haematopoietic system, Tumor microenvironment, SOCS3, MD, Poster, NK, Carcinoma, Cholangiocarcinoma, DLT, Pharmacokinetics, Annual general meeting, PTCL, Peripheral T-cell lymphoma, Neck, CTCL, Plasma, Vaccine

WATERTOWN, Mass., June 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 shared new clinical data from its ongoing KT-333 Phase 1 trial. KT-333, a first-in-class, potent, highly selective, heterobifunctional small molecule degrader of STAT3, demonstrated antitumor responses in hematological malignancies with high unmet need, including relapsed/refractory classic Hodgkin’s lymphoma (cHL), cutaneous T-cell lymphoma (CTCL), and NK-cell lymphoma, at doses that were well-tolerated. The data were presented at the European Hematology Association (EHA) Annual Meeting, taking place from June 13-16, 2024, in Madrid, Spain. Results released in an EHA poster today include a data cut-off of June 3, 2024.

Key Points: 
  • The data were presented at the European Hematology Association (EHA) Annual Meeting, taking place from June 13-16, 2024, in Madrid, Spain.
  • Results released in an EHA poster today include a data cut-off of June 3, 2024.
  • The Company expects to complete the study and share additional clinical data to inform the program’s next development steps in 2024 at an upcoming medical meeting.
  • A copy of the EHA poster presentation is available in the Resource Library section of Kymera's website.

Setting the Stage for Success: PRISM MarketView Highlights Soligenix's Promising HyBryte™ Replication Trial

Retrieved on: 
Mittwoch, Juni 5, 2024
Patient, Cutaneous T-cell lymphoma, EMA, PRISM, European Medicines Agency, Probability, FLASH, Therapy, FDA, Food, News, CTCL, Pharmaceutical industry

Soligenix is targeting a CTCL therapeutics market that reached a value of $520 million in 2023.

Key Points: 
  • Soligenix is targeting a CTCL therapeutics market that reached a value of $520 million in 2023.
  • The company is working towards initiating a confirmatory Phase 3 placebo-controlled study, FLASH2, to replicate the results of Soligenix’s successful Phase 3 FLASH trial.
  • Dr. Christopher J. Schaber, President and Chief Executive Officer of Soligenix, told PRISM MarketView that FLASH2 is expected to have a higher probability of success, with a more robust response.
  • In conversation with PRISM MarketView, Dr. Schaber said that the corporate objectives for the continued studies were to reinforce and replicate the positive HyBryte™ data from the FLASH study.

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

ERS Genomics and IRBM Sign CRISPR/Cas9 License Agreement

Retrieved on: 
Montag, Mai 20, 2024
Stem Cells, Biotechnology, Health, Pharmaceutical, Oncology, Neurology, Medical Devices, Research, Infectious Diseases, Genetics, Science, IRBM, Yeast, Cas9, Infection, Doctor of Philosophy, Emmanuelle, Ovarian cancer, HIV, Bacteria, MD, Cutaneous T-cell lymphoma, CSO, Archaea, Drug discovery, HCV, Cell, Genomics, CRISPR, Therapy, Prokaryote, Gene editing, Vaccine

ERS Genomics Limited (‘ERS’), the CRISPR licensing Company, and IRBM, a leader in the field of drug discovery, today announced a non-exclusive CRISPR/Cas9 license agreement.

Key Points: 
  • ERS Genomics Limited (‘ERS’), the CRISPR licensing Company, and IRBM, a leader in the field of drug discovery, today announced a non-exclusive CRISPR/Cas9 license agreement.
  • The agreement grants IRBM access to ERS’ CRISPR/Cas9 patent portfolio.
  • IRBM is a drug discovery CRO with expertise ranging from target validation and hit finding to preclinical candidate nomination across various therapeutic areas, including oncology, infectious diseases, and neuroscience.
  • ERS Genomics licenses these patents via its direct license from Emmanuelle Charpentier and now has nearly 150 licenses in place worldwide.

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.

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

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.

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

Retrieved on: 
Dienstag, März 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".