Cutaneous T-cell lymphoma

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

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.

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".

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.

Alys Pharmaceuticals launches with $100M financing from Medicxi to advance Immuno-Dermatology focused pipeline

Retrieved on: 
Monday, February 12, 2024
Cancer, Cutaneous T-cell lymphoma, Research, Skin, POC, University of Massachusetts, Atopic dermatitis, Inflammation, Gustave Roussy, Vitiligo, Mastocytosis, Partner, Peptide, Alopecia areata, Therapy, Patient, Small RNA, LMU, Georgia Tech, Nobel Prize, Pharmaceutical industry

BOSTON and GENEVA, Switzerland, Feb. 12, 2024 /PRNewswire/ -- Alys Pharmaceuticals, Inc. ("Alys"), an immuno-dermatology focused company, launches today with an R&D pipeline enabled by multiple platform technologies and a $100 million financing by Medicxi.

Key Points: 
  • BOSTON and GENEVA, Switzerland, Feb. 12, 2024 /PRNewswire/ -- Alys Pharmaceuticals, Inc. ("Alys"), an immuno-dermatology focused company, launches today with an R&D pipeline enabled by multiple platform technologies and a $100 million financing by Medicxi.
  • Originating from the aggregation of six asset-centric Medicxi companies, Alys boasts a robust pipeline of innovative programs and platforms targeting multiple dermatological indications.
  • The pipeline also includes programs focused on underserved indications such as mastocytosis, cutaneous T-cell lymphoma or prevention of skin side effects of oncology therapies.
  • Alys combines the assets and platforms of Aldena Therapeutics, Graegis Pharmaceuticals, Granular Therapeutics, Klirna Biotech, Nira Biosciences and Vimela Therapeutics.

Alys Pharmaceuticals launches with $100M financing from Medicxi to advance Immuno-Dermatology focused pipeline

Retrieved on: 
Monday, February 12, 2024
Cancer, Cutaneous T-cell lymphoma, Research, Skin, POC, University of Massachusetts, Atopic dermatitis, Inflammation, Gustave Roussy, Vitiligo, Mastocytosis, Partner, Peptide, Alopecia areata, Therapy, Patient, Small RNA, LMU, Georgia Tech, Nobel Prize, Pharmaceutical industry

BOSTON and GENEVA, Switzerland, Feb. 12, 2024 /PRNewswire/ -- Alys Pharmaceuticals, Inc. ("Alys"), an immuno-dermatology focused company, launches today with an R&D pipeline enabled by multiple platform technologies and a $100 million financing by Medicxi.

Key Points: 
  • BOSTON and GENEVA, Switzerland, Feb. 12, 2024 /PRNewswire/ -- Alys Pharmaceuticals, Inc. ("Alys"), an immuno-dermatology focused company, launches today with an R&D pipeline enabled by multiple platform technologies and a $100 million financing by Medicxi.
  • Originating from the aggregation of six asset-centric Medicxi companies, Alys boasts a robust pipeline of innovative programs and platforms targeting multiple dermatological indications.
  • The pipeline also includes programs focused on underserved indications such as mastocytosis, cutaneous T-cell lymphoma or prevention of skin side effects of oncology therapies.
  • Alys combines the assets and platforms of Aldena Therapeutics, Graegis Pharmaceuticals, Granular Therapeutics, Klirna Biotech, Nira Biosciences and Vimela Therapeutics.

Orphan designation: Resminostat Treatment of cutaneous T-cell lymphoma, 13/10/2024 Positive

Retrieved on: 
Sunday, February 4, 2024
COMP, IRIS, AG, European Commission, Resminostat, Cutaneous T-cell lymphoma, Committee, EMA, Pharmaceutical industry

EU/3/23/2835 - orphan designation for treatment of cutaneous T-cell lymphoma

Key Points: 
  • EU/3/23/2835 - orphan designation for treatment of cutaneous T-cell lymphoma
    Resminostat
    OrphanHuman
    4SC AG
    For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
    European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
  • The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:
    EMA list of opinions on orphan medicinal product designation
    EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform:

Domain Therapeutics Awarded Hospital-University Research in Health (RHU) SPRINT Consortium Grant to Progress Its Proprietary CCR8 Antibody Candidate to the Clinic

Retrieved on: 
Thursday, January 25, 2024
Technology, Biotechnology, Health, Biometrics, Other Health, Pharmaceutical, Artificial Intelligence, Oncology, Other Science, Research, Hospitals, Health Technology, Science, Clinical Trials, Patient, Therapy, G protein-coupled receptor, AP-HP, Multimedia, Fatigue, Intelligence, Medicen, Government, Cancer, Cutaneous T-cell lymphoma, Drug discovery, Quality of life, SPRINT, Survival rate, Regulatory T cell, National Cancer Institute, Disease, Study Group, Sarcoma, Hospital, GPCR, Pain, Gq alpha subunit, ANR, TME, RHU, Physician, Pharmaceutical industry

Domain Therapeutics (“Domain” or “the Company”), a clinical-stage global biopharmaceutical company developing innovative drug candidates in immuno-oncology targeting G Protein-Coupled Receptors (GPCRs), today announces it has been awarded a grant as part of the Hospital-University Research in Health (RHU) SPRINT consortium.

Key Points: 
  • Domain Therapeutics (“Domain” or “the Company”), a clinical-stage global biopharmaceutical company developing innovative drug candidates in immuno-oncology targeting G Protein-Coupled Receptors (GPCRs), today announces it has been awarded a grant as part of the Hospital-University Research in Health (RHU) SPRINT consortium.
  • View the full release here: https://www.businesswire.com/news/home/20240125583037/en/
    The SPRINT project aims to revolutionize the management of patients with CTCL and deliver a new cure paradigm as a standard-of-care.
  • The grant that we have been awarded by the RHU SPRINT consortium will support the progress of DT-7012, an anti-CCR8 monoclonal antibody which has incredible potential as a best-in-class therapeutic, into the clinic.
  • Domain was already awarded a first RHU grant, RHU CONDOR for Sarcoma, in the previous campaign, leveraging another proprietary asset.

Kymera Therapeutics Presents Interim Results from STAT3 Degrader Phase 1 Clinical Trial at American Society of Hematology Annual Meeting

Retrieved on: 
Monday, December 11, 2023
Patient, STAT3, Montefiore Medical Center, Cholangiocarcinoma, Stomatitis, Neoplasm, Constipation, Tumor microenvironment, PRS, SOCS3, Relapse, Leukemia, Anemia, Fatigue, Nausea, Blood, Carcinoma, Society, Therapy, CTCL, Infrared spectroscopy correlation table, PD, Head, ASH, T-PLL, Cancer, Biomarker, Poster, Peripheral T-cell lymphoma, TPD, Safety, Arthralgia, Cutaneous T-cell lymphoma, PTCL, T-cell prolymphocytic leukemia, Lymphoma, Bone marrow, Pharmaceutical industry

WATERTOWN, Mass., Dec. 10, 2023 (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 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 early signs of antitumor activity at doses that were generally well-tolerated and associated with substantial STAT3 knockdown in blood and tumor. The data were presented at the American Society of Hematology (ASH) 65th Annual Meeting and Exposition taking place from December 9-12, 2023, in San Diego, California.

Key Points: 
  • The data were presented at the American Society of Hematology (ASH) 65th Annual Meeting and Exposition taking place from December 9-12, 2023, in San Diego, California.
  • The poster provides an interim update with a data cut-off as of October 18, 2023.
  • Dr. Aditi Shastri from Montefiore Medical Center and Albert Einstein College of Medicine, a lead investigator in the study, presented the interim Phase 1 findings.
  • Preclinical data demonstrating the potential of STAT3 protein degraders as a therapeutic approach in venetoclax-resistant Acute Myeloid Leukemia was also presented at the meeting.

Shorla Oncology & EVERSANA Announce U.S. Commercial Launch of FDA-Approved JYLAMVO, the First and Only Oral Methotrexate Solution Approved in the U.S. for Adults

Retrieved on: 
Tuesday, December 19, 2023
Partnership, Acute lymphoblastic leukemia, FDA, Rheumatoid arthritis, Refrigeration, Pharmacovigilance, Knowledge, Cancer, Mycosis fungoides, Patient, Psoriasis, ALL, Cutaneous T-cell lymphoma, Methotrexate, Pharmaceutical industry

and CHICAGO, Dec. 19, 2023 /PRNewswire/ -- Shorla Oncology ('Shorla') , a U.S.-Ireland specialty pharmaceutical company, and EVERSANA®, a leading provider of commercialization services to the life science industry, today announced the commercial launch of JYLAMVO (methotrexate) oral solution, the first and only oral methotrexate solution approved in the United States for use in adults.

Key Points: 
  • and CHICAGO, Dec. 19, 2023 /PRNewswire/ -- Shorla Oncology ('Shorla') , a U.S.-Ireland specialty pharmaceutical company, and EVERSANA®, a leading provider of commercialization services to the life science industry, today announced the commercial launch of JYLAMVO (methotrexate) oral solution, the first and only oral methotrexate solution approved in the United States for use in adults.
  • "We are delighted to introduce JYLAMVO as an alternative treatment option for patients who may have difficulty swallowing pills," said Sharon Cunningham, Chief Executive Officer of Shorla Oncology.
  • JYLAMVO received FDA approval in November 2022 and was acquired by Shorla Oncology in October 2023 .
  • Founded in Ireland, Shorla specializes in developing innovative oncology drugs, with a focus on orphan and pediatric cancers.