Category Archives: Autologous

Thoughts on Breyanzi’s FDA Approval in 2L LBCL

On Friday, June 24, BMS announced (press release) that the FDA approved Breyanzi (CD19 CAR-T) in 2L LBCL. Of note, Breyanzi’s approval in 2L LBCL is based on results from the Ph3 TRANSFORM study and Ph2 PILOT trial. Below, Celltelligence provides insights on how Breyanzi’s broad label in 2L LBCL compares with key competitor Yescarta (Gilead / Kite’s CD19 CAR-T), while discussing how BMS may position Breyanzi in the 2L setting.

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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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The EC Grants Yescarta Marketing Authorization for ≥4L R/R FL

On Tuesday, June 28, Gilead (Kite) announced (press release) that the European Commission (EC) granted Marketing Authorization for Yescarta (CD19 CAR-T) in ≥4L r/r FL. Below, Celltelligence provides insights on Yescarta’s approval in the EU, while comparing it with key competitor Kymriah (Novartis’s CD19 CAR-T).

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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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Breyanzi Receives FDA Approval for 2L LBCL

Late on Friday, June 24, BMS announced (press release) that the FDA approved Breyanzi (CD19 CAR-T) in 2L LBCL based on results from the Ph3 TRANSFORM trial and Ph2 PILOT study. Of note, Breyanzi is the second CD19 CAR-T to move into an earlier line of therapy for LBCL. The Celltelligence team will be conducting a full thoughts-on analysis and label review 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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Breyanzi Could Receive a CHMP Opinion for 2L LBCL (TI) as Early as September 2022; Yescarta in 2L LBCL and Tecartus in R/R ALL Absent from June’s CHMP Highlights

On Friday, June 24, the CHMP meeting highlights were released following Monday’s CHMP agenda. As previously anticipated by the Celltelligence team, no cell therapy-related updates were observed in June’s CHMP Highlights. Below, the Celltelligence team provides a full analysis of June’s CHMP meeting with updated EU timelines for Breyanzi in 2L LBCL (TI) and Tecartus in r/r ALL.

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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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Breyanzi Starts EMA Assessment in 2L LBCL (TI); Tecartus and Yescarta Absent from June’s CHMP Agenda

On Monday, June 20, the CHMP agenda for June was released. Of note, Breyanzi (BMS’s CD19 CAR-T) was listed as ‘Start of Procedure’ under ‘Type II Variations: Extension of Indications’ for 2L LBCL transplant-intended (TI) patients. Additionally, Tecartus (Gilead / Kite’s CD19 CAR-T) in r/r adult B-ALL and Yescarta (Gilead / Kite’s CD19 CAR-T) for 2L LBCL were absent from the CHMP agenda.

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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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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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Gracell Presents Updated Results for GC012F and GC502; Gracell’s EHA 2022 Investor Event; EHA 2022 Analysis 2

EHA 2022 Analysis 2: Gracell presented clinical results for GC012F’s dual FasTCAR-T in r/r B-NHL + r/r MM, and GC502’s TruUCAR in r/r B-ALL. Additionally, Gracell 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:

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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Novartis Presents Updated Results for T-Charge Assets PHE885 and YTB323; A Comparative Analysis Demonstrates Kymriah’s Safety Superiority Over Yescarta in R/R FL; EHA 2022 Analysis 1

EHA 2022 Analysis 1: Novartis presented clinical updates for two T-Charge assets and a comparative study of Kymriah and Yescarta in r/r FL was reported. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:

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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Adaptimmune and GSK Present Updated Results from Afami-cel and Lete-cel ; CARsgen’s CT041 Demonstrates Clinical Efficacy in Gastric Cancer; First Clinical Data from Carisma’s CT-0508; ASCO 2022 Final Analysis

ASCO 2022 Final Analysis: Adaptimmune, GSK, CARsgen, and Carisma presented clinical updates from their novel cell therapies in solid tumors. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:

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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Novel CAR-T Assets in MM; Arcellx, Gracell, and OriCell Present Updated Clinical Results in R/R MM; ASCO 2022 Analysis 4

ASCO 2022 Analysis 4: Arcellx, Gracell, and OriCell presented clinical updates from their novel CAR-Ts in r/r MM. Additionally, Arcellx held an ASCO 2022 Investor Event. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:

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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