Cell and Gene Therapy
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Bristol Myers Squibb will be using Cellares’ Cell Shuttles, an automated production system capable of producing multiple cell therapies simultaneously, to potentially improve turnaround time to support the pharma’s CAR T cell therapies.
Following a months-long safety review, the regulator on Thursday said it is now requiring updated black box warnings for all commercially available CAR-T therapies to reflect the risk of secondary malignancies.
A one-time treatment for Parkinson’s disease could be a ‘market changer,’ experts told BioSpace, adding that cell therapies could limit the adverse effects seen with current drugs.
From gene-corrected cell therapies to a new CAR-T, the cell and gene therapy space looks to expand its reach into the market.
Cullinan Oncology, now renamed Cullinan Therapeutics, is riding the growing wave of interest in autoimmune disorders by refocusing its bispecific T cell-engager CLN-978 for systemic lupus erythematosus.
Roche’s Genentech subsidiary is terminating for undisclosed reasons its 2021 contract with Adaptimmune for the development of allogeneic T-cell therapeutics.
Investors were disappointed in data from a mid-stage study of Enlivex Therapeutics’ Allocetra cell therapy for the treatment of sepsis. The Israeli company is considering a follow-on trial in sepsis caused by urinary tract infection.
The approvals, third line for BMS and 2seventy Bio’s Abecma and second line for J&J and Legend Biotech’s Carvykti, represent a new class of therapy for these blood cancer patients.
Gamida Cell, whose cell therapy for blood cancer was approved last year by the FDA, is being taken private and restructuring due to liquidity constraints.
Nanoscope Therapeutics nabbed a victory on the changed primary endpoint of its Phase IIb vision loss gene therapy trial Tuesday, teeing the biotech up to file for FDA approval of the candidate this year.