Tag Archives: ALL

UPDATED: Indications Table for CD19 CAR-T US Approvals and Submissions

New content: The Celltelligence team has updated its CD19 CAR-T indications table for estimated US approvals and submissions following key Q1 2022 earnings presentations and recent press releases (see below for download).

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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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Autolus Presents Updated Results for Obe-cel, AUTO1/22, and AUTO4; Autolus’s EHA 2022 Investor Event; Academic BCMA CAR-T ARI0002h Reports Encouraging Efficacy in R/R MM; EHA 2022 Final Analysis

EHA 2022 Final Analysis: Autolus presented clinical results for obe-cel, AUTO1/22, and AUTO4, while Hospital Clinic Barcelona reported data from ARI0002h. Moreover, Autolus held an investor call following updated clinical data presented at EHA 2022. Below, Celltelligence provides insights and context for key selected presentations and highlights from the call. The following topics are covered below:

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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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Initial Data from Yescarta’s Ph2 ZUMA-14 Study for R/R LBCL in Combination with Rituximab; Updated Results for Tecartus in ALL and MCL; ASCO 2022 Analysis 2

ASCO 2022 Analysis 2: Gilead (Kite) reported updated clinical data in LBCL, MCL, and adult B-ALL. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:

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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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Yescarta in 2L LBCL and Tecartus in R/R ALL Absent from May’s CHMP Highlights

On Friday, May 20, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, Yescarta (Gilead / Kite’s CD19 CAR-T) in 2L LBCL and Tecartus (Gilead / Kite’s CD19 CAR-T) for r/r ALL were absent from May’s CHMP highlights. Below, the Celltelligence team provides updated EU timelines for Yescarta in 2L LBCL and Tecartus in r/r ALL.

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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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Will Kymriah Receive a CHMP Positive Opinion in R/R FL This Week? Carvykti’s CHMP Opinion Likely to Occur by February 2022; Tecartus and Breyanzi Continue to Experience Delays; December’s CHMP Agenda

On Monday, December 13, the CHMP agenda for December was released. Of note, Kymriah’s (Novartis’s CD19 CAR-T) Type II variation for r/r FL is listed as ‘For Adoption’, while Carvykti (JNJ / Legend’s BCMA CAR-T; cilta-cel) is displayed under the ‘List of outstanding issues (LoOI)’ section. Moreover, Tecartus (Gilead’s / Kite’s CD19 CAR-T) and Breyanzi (BMS’s CD19 CAR-T) were absent from December’s CHMP agenda. Below, Celltelligence provides insights on potential EU approval timelines for Kymriah and Carvykti, while discussing possible causes for Tecartus’s and Breyanzi’s regulatory delays.

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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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Comparison of Kymriah’s and Breyanzi’s Efficacy Profile; Gilead Presents Updated Results from Tecartus’s Ph1/2 ZUMA-3 (ALL) and Ph2 ZUMA-2 (MCL) Trials; ASCO 2021 Day 1

On the first day of ASCO 2021, four key clinical updates were presented from Novartis and Gilead. Below, Celltelligence provides insights and context for each presentation.

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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 Files Tecartus’s sBLA in Adult R/R ALL; AUTO1 Receives PRIME Designation by the EMA; JNJ / Legend Complete Cilta-cel’s Rolling BLA in the US; BMS Files Abecma in Japan for R/R MM; Precision’s New CEO Transition Plan

Ahead of AACR, a series of cell therapy-related news items have been observed:

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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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New Autolus AUTO1 Pivotal Trial in Adult ALL Posted

A new Autolus-sponsored AUTO1 Ph1b/2 AUTO1-AL1 trial in r/r adult ALL has been observed on CT.gov. Of note, the trial uses a split dosing regimen. Below, Celltelligence provides insights on this new pivotal trial and how a split dose could differentiate Autolus’s position compared to CAR-T leaders Novartis and Gilead in r/r adult ALL.

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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