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FDA clears IND application for CAR T-cell therapy for advanced mesothelioma

The U.S. Food and Drug Administration recently approved an investigational new drug application for ATA2271, a chimeric antigen receptor T-cell therapy for the treatment of advanced mesothelioma developed by Atara Biotherapeutics.

ATA2271 is an autologous CAR T-cell therapy that targets mesothelin antigens expressed on the surface of certain solid tumors.

The therapy was developed using two novel proprietary technologies, 1XX costimulatory domain technology to simultaneously extend T-cell effector function while limiting cell exhaustion and genetic modification to the CAR T cells to achieve checkpoint blockade by PD-1 DNR that overcomes the immune suppression of PD-L1.

The study’s results showed that ATA2271 was associated with less cell exhaustion, improved functional persistence, serial cell killing, and enhanced in vivo efficacy compared with previous-generation, mesothelin-directed CAR T-cell therapy.

The recently obtained IND approval allows Atara Biotherapeutics to initiate an open-label, single-arm, phase 1 clinical trial of ATA2271 for patients with advanced mesothelioma.

(Source: Healio, 2020)

AgeX Therapeutics and Lineage Cell Therapeutics Expands Agreement In Regards To ESI Stem Cell Lines. 

AgeX Therapeutics, Lineage Cell Therapeutics, and ES Cell International recently announced the expansion of their collaboration in regards to ESI stem cell lines. No other information in the agreement was disclosed. 

ESI cell lines are Good Manufacturing Practice (cGMP) approved, has been registered with the National Institutes of Health (NIH), and has been widely studied as a potential source for the industrial-scale manufacture of any cell type in the human body.

The ESI cell lines are known for being the first clinical-grade human pluripotent stem cell lines created and may potentially generate limitless quantities of all the cell types of the human body from many master cell banks with a wide array of potential therapeutic applications.

ESI cells are also among the few pluripotent stem cell lines from which a derived cell therapy product candidate has been granted FDA investigational new drug (IND) clearance to begin human clinical studies.

(Source: Business Wire, 2020)

Catalent invests $130 million into its cell and gene therapy site in Maryland. 

Catalent to invest $130 million into its cell and gene therapy manufacturing facility in Harmans, Maryland, to expand its late-stage production capacity. 

The newest investment will add five late-stage clinical and commercial manufacturing suites to the site and is expected to be operational in the first half of 2022. 

The investment will bring the total number of manufacturing suites to 15 at the planned 350,000-square-foot site near the Washington International airport. 

The Harmans facility in Maryland recently received FDA approval for commercial production, and its initial 10 manufacturing suites are set to be fully operational by the first quarter of 2021. 

(Source: Fierce Pharma, 2020)