Tag Archives: Orphan Drug Designation

TCR2 Tx Completes Gavo-Cel’s Ph1 Trial; Dosing Started in Gavo-cel’s Pivotal Ph2 Study; Gilead’s KITE-222 Receives Orphan Drug Designation

On Wednesday, September 28, 2022, TCR2 Tx held an investor event highlighting positive topline results from gavo-cel’s (TC-210; autologous mesothelin TRuC-T) Ph1 portion of the Ph1/2 trial (press release / presentation). On Tuesday, September 27, Gilead’s (Kite) KITE-222 (autologous CLL-1 CAR-T) was granted Orphan Drug Designation (ODD) by the FDA (FDA Designation). Below, Celltelligence provides insights on gavo-cel’s positive clinical results and future pivotal development as well as discusses KITE-222’s ODD in AML.

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Precision Partners With Tiziana for the Use of Foralumab as a Novel Lymphodepletion Agent; How Could an Anti-CD3 Antibody Improve CAR-T Efficacy? TCR2 Tx’s Gavo-cel Receives Orphan Drug Designation

On Thursday, September 2, Precision BioSciences announced (press release) an exclusive license agreement with Tiziana to evaluate foralumab (anti-CD3 monoclonal antibody) as a lymphodepletion (LD) agent for their allogeneic CAR-T therapies. On the same day, TCR2 Tx reported (press release) that the FDA has granted gavo-cel (mesothelin-targeted TRuC-T) Orphan Drug Designation (ODD) for the treatment of cholangiocarcinoma. Below, Celltelligence provides insights on how a foralumab LD regimen could enhance allogeneic CAR-T efficacy, while discussing gavo-cel’s ODD in cholangiocarcinoma.  

About The Author

The Celltelligence Team

|
Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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