Category Archives: Topics

Allogene’s AlloCAR-T Programs Placed on Clinical Hold by the FDA

On Thursday, October 7, Allogene announced (press release) that the FDA has placed a clinical hold on all of Allogene’s AlloCAR-T trials, with the company providing additional insights via a webcast. Of note, the FDA ordered the clinical hold following a reported chromosomal abnormality event from a patient treated with ALLO-501A (allogeneic CD19 CAR-T) in the Ph1/2 ALPHA-2 study for r/r LBCL. Additionally, on Friday, October 8, Precision BioSciences released a statement (press release) highlighting the safety of their allogeneic CAR-T approach. Below, Celltelligence provides insights on the potential impact of the clinical hold, while discussing how other companies developing gene-edited allogeneic therapies could be affected.

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Tecartus Website Analysis

On Wednesday, October 6, an update on Tecartus’s patient website was observed, with Gilead (Kite) now including Tecartus’s approval in r/r adult ALL. Below, Celltelligence provides an analysis on the updates included within the Tecartus website and insights into Tecartus’s messaging within the MCL and ALL setting.

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The Celltelligence Team

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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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T-Cure Partners With Atlas to Develop a KK-LC-1 Diagnostic Test

On Tuesday, October 5, T-Cure announced (press release) a collaborative agreement with Atlas Antibodies for the development, manufacture, and supply of CT83 (KK-LC-1-directed monoclonal antibody). Of note, CT83 will be used for the development of a diagnostic test to identify KK-LC-1-expressing tumors. Below, Celltelligence provides insights on how the use of a companion diagnostic test could improve clinical outcomes, while discussing T-Cure’s novel TCR-T pipeline.

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The Celltelligence Team

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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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BMS Bets on Digital Health Coaching Following CAR-T Treatment to Improve Quality of Life Outcomes

On Friday, October 1, a new clinical study evaluating the feasibility of a Digital Health Coaching Program for individuals who have received CAR-T therapy was observed on CT.gov. Of note, Pack Health is the sponsor of the trial with BMS and the MD Anderson Cancer Center appearing as collaborators. Below, Celltelligence provides insights on BMS’s use of digital tools as a potential strategy to facilitate CAR-T reimbursement, while discussing BMS’s recently launched marketing campaign.

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The Celltelligence Team

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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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Gilead’s (Kite) Tecartus Receives FDA Approval for R/R Adult ALL

On Friday, October 1, Gilead (Kite) announced (press release) that the FDA has granted approval for Tecartus (CD19 CAR-T) in r/r adult ALL. Of note, Tecartus is the first approved CAR-T in the US for the treatment of adult ALL. Below, Celltelligence provides insights on how Tecartus’s approval in adult ALL compares with Kymriah’s pediatric and young adult ALL indication.

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The Celltelligence Team

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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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Thoughts On the Evolution of the Cell Therapy Landscape; Will Traditional αβ CAR-T Cells be Replaced by Novel Cell Types?

Although cell therapy companies have traditionally used alpha beta (αβ) T cells to manufacture CAR-T therapies, the cell therapy field is rapidly evolving with an increasing number of companies developing novel and highly differentiated platforms. Below, Celltelligence discusses how CAR-derived therapies from natural killer (NK) cells, gamma delta (γδ) T cells, macrophages, and iPSCs could treat liquid or solid tumors and whether these novel cell types may overcome the challenges and limitations faced by conventional CAR-Ts.

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The Celltelligence Team

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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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Tecartus Receives FDA Approval for R/R Adult ALL

Late on Friday, October 1, Gilead (Kite) announced (press release) the US approval of Tecartus (CD19 CAR-T) in r/r adult ALL. Tecartus has become the first and only CAR-T therapy approved in r/r adult ALL. The Celltelligence team will be conducting a full analysis of Tecartus’s approval in the coming days.

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The Celltelligence Team

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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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Gilead Files an sBLA for Yescarta in 2L R/R DLBCL

On Thursday, September 30, Gilead (Kite) announced (press release) that they have submitted an sBLA to the FDA for Yescarta (CD19 CAR-T) in 2L r/r DLBCL. Of note, Yescarta’s sBLA application is supported by data from the Ph3 ZUMA-7 trial in 2L r/r DLBCL. Below, Celltelligence provides insights on Yescarta’s estimated FDA approval timeline for 2L r/r DLBCL, while discussing how Breyanzi (BMS) and Kymriah (Novartis) compare in the 2L setting.

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The Celltelligence Team

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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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Ziopharm’s TCR-T Program Pushed Back to H1 2022; Ziopharm Sheds Over 50% of Its Workforce

On Monday, September 27, Ziopharm announced (press release) that they have reduced their staffing levels by over 50% (eliminating 60 positions) while extending their cash runway into H1 2023. Additionally, management confirmed that the first patient from the Ph1/2 TCR-T Library trial is expected to be dosed in H1 2022. Below, Celltelligence provides insights on Ziopharm’s TCR-T program delay, in-house manufacturing strategy, and if the company’s latest measures will regain shareholders’ confidence.

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The Celltelligence Team

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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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Precision Appoints Michael Amoroso as Their New CEO

On Monday, September 27, Precision BioSciences announced (press release) the appointment of Michael Amoroso as the company’s President, Chief Executive Officer (CEO), and member of the Board of Directors, all effective October 15, 2021. Below, Celltelligence provides insights on how Amoroso could lead Precision through their next phase of growth.

About The Author

The Celltelligence Team

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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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