AstraZeneca’s Saphnelo (anifrolumab) has demonstrated strong results for the treatment of systemic lupus erythematosus (SLE). In the Phase III TULIP-SC trial, 56.2% of patients who received Saphnelo via subcutaneous (SC) self-administration achieved a reduction in disease activity at Week 52 versus 37.1% receiving placebo, as measured by the British Isles Lupus Assessment Group-based Composite Lupus… Read More
The latest episode of the DDW Highlights Podcast is now available to listen to below. DDW’s Bruno Quinney narrates five key stories of the previous week to keep DDW subscribers up-to-date on the latest industry news. Last week’s top story came from women’s health, as Bayer paved the way for… Read More
News round-up for 27 – 31 October by Bruno Quinney, Content Team at DDW. Women’s health is top of this week’s agenda, as Bayer paves the way for a new approach to treat hot flashes due to menopause. Elsewhere, an anti-obesity medication has health benefits beyond weight… Read More
Bristol Myers Squibb has shared its first results in chronic, refractory autoimmune diseases from the Phase I Breakfree-1 study of its investigational, autologous CD19-targeted NEX-T CAR T cell therapy BMS-986353 (CC-97540). The data evaluates a total of 71 treated patients across the systemic sclerosis (SSc), systemic lupus… Read More
Charles River Laboratories and Valo Health have announced the identification of an advanceable product candidate for the treatment of different forms of lupus and other autoimmune indications. The discovery was the first using Logica, an artificial intelligence (AI)-powered drug development solution that translates biological insights into optimised… Read More
Positive preclinical data for novel CD19xCD3 T cell engager CLN-978 have supported its potential as a new therapeutic option for autoimmune diseases. Cullinan Therapeutics presented the preclinical results and a study schema for a planned Phase Ib study in patients with moderate to severe systemic lupus… Read More
Kyverna Therapeutics has revealed plans to present updated clinical data from lupus nephritis (LN) patients treated with KYV-101 at the American College of Rheumatology (ACR) Covergence 2024. The data are from the ongoing Kyverna-sponsored KYSA-1 and KYSA-3 Phase I/II studies and named patient treatments. Read More
The US Food and Drug Administration (FDA) has granted fast track designation to SYNCAR-001 + STK-009. The treatment is indicated for patients with severe, refractory systemic lupus erythematosus (SLE), without the use of lymphodepletion. The fast-track designation follows investigational new drug (IND) clearance for… Read More
In June 2023, a patient at Universitätsklinikum Erlangen in Germany became the first child with lupus to receive CAR-T therapy. The treatment was the last resort to slow down systemic lupus erythematosus (SLE), which is a serious autoimmune disease that was attacking the patient’s body and… Read More
Otsuka Pharmaceutical’s Lupkynis (voclosporin) is the first oral treatment to be approved in Europe for the treatment of active lupus nephritis (LN) in adult patients. The drug has received approval from the European Commission (EC) in combination with mycophenolate mofetil (MMF) for the treatment of adult patients with active class… Read More
Domainex has revealed human ex vivo data indicating that DMXD-011 could be effective in treating interferonopathies such as lupus, Sjögren’s syndrome, and scleroderma. The drug candidate is an inhibitor of protein kinases TBK1 and IKK-epsilon, which previous studies suggest should be highly-effective in the treatment of inflammatory diseases. The efficacy of DMXD-011… Read More
