Aspen Neuroscience Nabs FDA RMAT Designation for its Parkinson’s Cell Therapy
The designation gives Aspen added FDA support as it advances sasineprocel, a personalized autologous cell therapy for Parkinson’s disease, through clinical development.
News
Life Biosciences Doses First Patient in Phase 1 of ER‑100 for Optic Neuropathies, Aiming to Rejuvenate Aging Cells
The trial will assess the safety and tolerability of ER‑100, an epigenetic restoration therapy designed to restore retinal ganglion cell function, while also measuring visual outcomes.
CREATE Medicines to Launch First Phase 1/2 In Vivo Trial of CAR-T Candidate CRT-402 for Autoimmune Diseases in Australia
The approval enables CREATE to start enrolling Australian patients with lupus, systemic sclerosis, and inflammatory myopathies in a first-in-human study of its in vivo CD19-targeted CAR-T therapy, designed to deplete harmful B...
Novo Nordisk Publishes Results from Embryonic Stem Cell-Derived Dopaminergic Cells for Parkinson’s Phase 1/2
The early trial, published in Nature, found that transplanting stem cell-derived dopaminergic progenitor cells into the brains of people with moderate Parkinson’s disease appeared feasible and showed a favorable 12-month safety profile,...
Sonoma Biotherapeutics to Automate its Treg Cell Manufacturing Using Cellares’ Cell Shuttle Platform
The partnership will move Sonoma Biotherapeutics’ Phase 1 autologous CAR-Treg therapy for treatment-resistant rheumatoid arthritis onto Cellares’ automated manufacturing and quality control systems to improve scalability, consistency, and readiness for later-stage development.
Kolon’s Cell-Based Gene Therapy Fails Phase 3 Osteoarthritis Trial
Kolon TissueGene’s phase 3 trial found its osteoarthritis therapy did not improve knee pain or function versus placebo, leaving the biotech to await results from a second late-stage study before deciding the...
Kenai Therapeutics Completes Enrollment of Phase 1b/2a Parkinson’s iPSC Trial
The iPSC-derived neural cell therapy takes its next step in potentially restoring dopaminergic neurons lost to the condition.
MEDIPOST Doses First US Patient in Umbilical Cord Stem Cell Therapy for Knee Osteoarthritis Phase 3
And it begins... the Korean biotech company whose product, Cartistem, has been approved in Korea since 2012, passed Phase 3 in Japan, and is now entering the West.
Cell Therapies to Manufacture CAR-T Therapy for Phase 1/2b Solid Tumor Trial in Australia
The Australian CDMO will manufacture A-SEEDS' therapy for the upcoming trial down under.
Aspen Neuroscience Completes Cohort 3 and 4 Dosing in iPSC-Derived Phase 1/2a for Parkinson’s
The ASPIRO trial of sasineprocel is progressing; fifteen patients have been dosed with the commercial-ready formulation of the autologous cell therapy.
