The planned trial is designed for patients whose multiple myeloma has returned or resisted treatment after at least three prior lines of therapy.
The company hopes to nab the first approval in the world for this indication.
The retrospective analysis compared 76 phase 1b participants with 360 historical registry patients selected using similar age, diagnosis, conditioning and donor-match criteria.
The operational site and its team have completed 145 batches under good manufacturing practice standards, enabling immediate client onboarding.
This Phase I, single-arm study plans to enroll 20 adults with steroid-refractory moderate or severe disease to receive up to three intravenous infusions alongside standard therapy.
The combined company operates 16 qualified manufacturing suites across three U.S. sites, supporting cell therapy programs from early development through commercial supply.
The project will test whether GenomeFrontier’s virus-free process, including electroporation-based transfection, can be adapted to Cellares’ automated system to support U.S. clinical manufacturing.
Up to 40 patients with relapsed or refractory multiple myeloma may enroll to test an approach designed to generate engineered T cells inside the body.
The multicenter study will begin with 6 to 24 participants to select a dose, followed by about 95 participants divided into two disease-pattern cohorts.
Longeveron received a $1 million milestone award to test laromestrocel’s potential to reduce aging frailty and improve muscle, cognitive and immune function in older adults.
The investigators will evaluate a dual-target CAR T-cell therapy designed to attack B7-H3 and IL-8 in adults and children with advanced solid tumors.
The Phase 2 study will enroll about 53 patients to evaluate a single off-the-shelf CAR T-cell dose, with complete renal response at Week 26 as the primary endpoint.
Terumo BCT will present new data from an integrated isolation, activation, transduction and serum-free expansion workflow using Quantum Flex™
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 cells without the complex manufacturing of traditional cell therapies.
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.
The Australian CDMO will manufacture A-SEEDS' therapy for the upcoming trial down under.
Sad day for the industry, here's a summary of the CEO/Executive Chairman's readouts of the trials.
Could a gentler, more scalable method improve how cells are isolated for advanced therapies? We spoke with Bracco’s Sophie He about the early data, manufacturing potential, and challenges ahead.
Following Phase 3, TREGZI, known as Orca-T, had higher graft-versus-host disease-free survival at one year in patients receiving conventional blood stem cell transplants.
Verismo is ramping up its 2 Phase 1s targeting solid tumors and B-Cell non-Hodgkin lymphomas, selecting Cryoport for its cold chain.
Based on the RCT results published in The Lancet, the Chinese biotech company has received approval for the world's first CAR-T for solid tumors.
Cell and gene therapies are advancing quickly, but the systems needed to deliver them at scale are still lagging behind. Terumo’s new Ecosystem Blueprint aims to bridge that gap in Asia-Pacific by integrating workflows, equipment, and training into a coordinated model to move from isolated…
Building on work at the University of Wisconsin-Madison, the Australian biotech company expects to release data from its Phase 3 iPSC-derived MSC KOA & Phase 2 Graft-vs-Host-Disease trials in the coming months.
The company is expanding its preclinical work on acute respiratory syndrome to investigate whether its fibroblasts may help with deadly lung inflammation, vascular leakage, and tissue damage.
The therapy has been approved in the USA since 2024, and it'll soon be available down under as well, potentially reimbursed by Australia's pharma subsidy program.