Tag Archives: Adult ALL

Autolus Submits Obe-cel BLA in R/R B-ALL; GC012F Receives IND Clearance in rSLE

On Monday, November 27, Autolus announced (press release) the submission of a BLA to the FDA for the use of obe-cel (CD19 CAR-T) in adult r/r B-ALL, supported by data from the Ph1/2 FELIX trial.

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Obe-cel’s BLA Filing Anticipated by YE 2023; Multiple Clinical Updates Expected at ASH 2022; Autolus’s Q3 2022 Earnings Call Summary

On Thursday, November 3, Autolus held its Q3 2022 earnings call (press release / presentation) highlighting obe-cel’s (autologous CD19 CAR-T) anticipated BLA filing in r/r ALL by YE 2023. Additionally, initial results from obe-cel’s Ph2 FELIX trial are anticipated in Q4 2022, while other clinical updates from obe-cel, AUTO1/22 (autologous CD19 x CD22 CAR-T), and AUTO4 (autologous TRBC1 CAR-T) are expected at ASH 2022 (Dec 10 – 13). Below, Celltelligence provides insights on obe-cel’s potential approval timelines and competition in the r/r ALL setting, while discussing a delay in AUTO6NG’s (autologous GD2 CAR-T) Ph1 MCARGD2 trial initiation.

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The EC Grants Tecartus Marketing Authorization for R/R Adult ALL

On Tuesday, September 6, Gilead (Kite) announced (press release) that the European Commission (EC) granted Marketing Authorization for Tecartus (CD19 CAR-T) in r/r adult (≥26 years) B-ALL. Below, Celltelligence provides insights on Tecartus’s approval in the EU, while comparing it with ARI-0001 (academic CD19 CAR-T) and obe-cel (Autolus’s CD19 CAR-T).

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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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CHMP Adopts Positive Opinion for Tecartus; Yescarta Absent From July’s CHMP Highlights

On Friday, July 22, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, the CHMP adopted a positive opinion for Tecartus (Gilead / Kite’s CD19 CAR-T) in r/r adult B-ALL. Additionally, Yescarta (Gilead / Kite’s CD19 CAR-T) was absent from the CHMP highlights. Below, Celltelligence provides thoughts on Tecartus’s positive opinion, while discussing updated EU timelines for Yescarta.

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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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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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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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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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