Feb 27, 2025 | Press Releases
Regenerative Medicine Advanced Therapy (RMAT) designation follows clinical data of Absolute Lymphocyte Count (ALC) and significant Overall Survival (OS) correlations in QUILT trials across multiple tumor types including third line or greater metastatic pancreatic...
Feb 19, 2025 | Press Releases
Next-generation recombinant Bacillus Calmette-Guérin (rBCG) has undergone Phase 2 clinical trials in Europe in non-muscle invasive bladder cancer (NMIBC) Supplies of rBCG are now available, with shipments set to begin immediately via an FDA Expanded Access Program...
Feb 13, 2025 | Press Releases
CULVER CITY, Calif., February 13, 2025 – ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunity therapy company, today announced the Medicines and Healthcare products Regulatory Agency (MHRA) has validated and accepted the marketing authorization application for...
Jan 29, 2025 | Press Releases
Confirmatory trial builds on results of QUILT 3.055, a Phase 2 trial demonstrating ANKTIVA rescued T cells and activity of checkpoint inhibitors (CPIs) in patients with non-small cell lung cancer (NSCLC), who progressed on CPI therapies QUILT 3.055 showed prolonged...
Jan 27, 2025 | Press Releases
Application covers 30 countries in the European Union Submission is based on the ongoing QUILT 3.032 study in which 100 patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (NMIBC CIS) have been treated...
Jan 15, 2025 | Press Releases
BCG unresponsive non-muscle invasive bladder cancer (NMIBC) in the papillary indication: Anticipated supplemental biologics license application (BLA) submission in 2025 Alternative source of BCG in partnership with Serum Institute of India: Anticipated submission for...