NAARDEN, The Netherlands — Kynexis, a biotechnology company focused on precision therapeutics by leveraging biomarkers and human genetics for brain diseases, announced today that the first healthy volunteers have been dosed in its first-in-human phase 1 study of KYN-5356. KYN-5356, a clinical-stage small molecule targeting a key enzyme in the...
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TOKYO, LONDON and BOSTON — Kyowa Kirin Co., Ltd., (TSE: 4151, President and COO: Abdul Mullick, “Kyowa Kirin”) and Orchard Therapeutics announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted Orphan Regenerative Medicine Product Designation to OTL-200, also known as atidarsagene autotemcel, an investigational ex vivo autologous...
LONDON – The National Institute for Health and Care Excellence (NICE) today published its final appraisal document (FAD) for POTELIGEO® (mogamulizumab) announcing that POTELIGEO will not be made available on the NHS[1] in England and Wales. Mogamulizumab is a treatment for adults living with rare blood cancers, mycosis fungoides (MF) and...
LONDON – The National Institute for Health and Care Excellence (NICE) has upheld an appeal lodged by Kyowa Kirin, Lymphoma Action and Leukaemia Care, and the UK Cutaneous Lymphoma Group (UKCLG) as part of the Single Technology Appraisal for POTELIGEO® (mogamulizumab) for the treatment of adults with the ultra-rare blood cancers...
Fukuoka, Japan – Researchers from Kyushu University have identified a potential therapeutic target for the treatment of advanced multiple sclerosis (MS), a potentially disabling condition associated with the central nervous system. In their latest study, conducted using an experimental mouse model of MS, they explored the role of connexin 43...
EMERYVILLE, Calif. — Kyverna Therapeutics, Inc. (Kyverna), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, today announced the signature of a collaboration agreement with Stanford University to allow the use of KYV-101, an investigational, anti-CD19 CAR T-cell therapy in an open label,...
EMERYVILLE, Calif. — Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today announced positive interim data from the Phase 2 portion of the registrational KYSA-6 clinical trial of KYV-101 in generalized myasthenia gravis (gMG). The data will be shared...
EMERYVILLE, Calif. — Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today announced positive topline data from KYSA-8, its registrational Phase 2 trial of mivocabtagene autoleucel (‘miv-cel’, formerly KYV-101), a fully human, autologous CD19-targeting CAR T-cell therapy with CD28...
EMERYVILLE, Calif. — Kyverna Therapeutics, Inc., a patient-centered clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, today announced it received fast track designation by the U.S. Food and Drug Administration (FDA) for its autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate,...
LA JOLLA, CA — La Jolla Institute for Immunology (LJI) is working to guide the development of new tuberculosis vaccines and drug therapies. Now a team of LJI scientists has uncovered important clues to how human T cells combat Mycobacterium tuberculosis, the bacterium that causes TB. Their findings were published...