FDA Granted Fast Track Designations to CB-010 in Refractory SLE and to CB-012 in R/R AML
“We are pleased to receive Fast Track designations from the FDA. This is a testament to the significant unmet need and the potential of CB-010 and CB-012 as readily available, off-the-shelf CAR-T cell therapies,” said Tina Albertson, MD, PhD, Caribou’s chief medical officer. “Based on previously reported data in our ongoing trial for patients with relapsed or refractory B cell non-Hodgkin lymphoma, CB-010 has shown encouraging safety, efficacy, and prolonged B cell aplasia following a single dose. Based on these data, we are eager to expand the clinical development program for CB-010 into LN and ERL, prevalent and severe autoimmune diseases.”
Share:
More News
“Fast Track designation in lung cancer represents an important milestone for TRE-515 and further validates our strategy of combining dCK inhibition with targeted cancer therapies,” said Dr. Ken Schultz, Trethera Chairman and CEO. “KRAS G12C inhibitors have transformed the NSCLC treatment landscape, but resistance and incomplete responses remain major challenges.
“AvenCell has built a differentiated cell therapy platform that brings together CRISPR-engineered allogeneic CAR-T technology with a unique switchable CAR approach designed to provide greater control over CAR-T activity,” said Todd Davis, CEO of Ligand. “We believe the combination of these technologies, together with the encouraging clinical data generated to
“Advanced gastric cancer is characterized by substantial biological and clinical heterogeneity. Previous studies have shown that the magnitude of benefit from PD-1 inhibitor therapy is closely associated with PD-L1 expression, and that there remains room to further improve outcomes, particularly in patients with low PD-L1 expression. How to broaden the
“The evERA results represent an important step forward for people with ER-positive advanced breast cancer and underscore the potential for giredestrant to help address the challenge of disease progression in this setting,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Together with the