Category Archives: Topics

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 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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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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Spotlight on Poseida’s CAR-T Strategy

Since the first US CAR-T approval in 2017, the cell therapy field has rapidly evolved with 5 additional CAR-Ts receiving FDA approval. Nevertheless, challenges surrounding TATs, cost, and patient access still remain for autologous CAR-Ts. As such, off-the-shelf assets could be the answer to the industry’s current pain points. The Celltelligence team recently discussed with Eric Ostertag, Poseida’s Executive Chairman, the changing cell therapy landscape and how Poseida’s differentiated allogeneic platform could bring these life-changing therapies to a greater number of patients. Below, the Celltelligence team provides an analysis on Poseida’s allogeneic technology and how they could challenge key allogeneic and autologous competitors.

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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 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:

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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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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PBCAR0191 Reports Improved Efficacy in CAR-T Relapse Patients; Precision to Evaluate PBCAR0191 with sLD; Updated Milestones for PBCAR19B and PBCAR269A; Precision Mid-Year 2022 Event

On Wednesday, June 8, Precision BioSciences held their mid-year 2022 pipeline update event (press release / presentation), highlighting updated clinical results from PBCAR0191’s (allogeneic CD19 CAR-T) Ph1/2a study in CAR-T relapse patients. Additionally, management provided updated milestones for PBCAR19B (stealth CD19 CAR-T) and PBCAR269A (allogeneic BCMA CAR-T). Below, Celltelligence provides insights on Precision’s lymphodepleting strategy for PBCAR0191 in CAR-T relapse patients, while discussing PBCAR0191’s potential regulatory pathway.

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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