Category Archives: CD19

We’re Back! Holiday Recap Ahead of JPM 2024 (Blast 2/2): Risk of Secondary Hematological Malignancies Included in the Black Box of Carvykti’s US Prescribing Information; FDA Approved Yescarta’s Label Update to Incorporate OS Data; Galapagos Initiates Recruitment of GLPG5301 Trial in ≥3L MM

Ahead of JPM Week, Celltelligence is publishing a series of 2 blasts with the most important cell therapy-related news items that occurred during the holidays. In this second blast, the following news are covered:

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We’re Back! Holiday Recap Ahead of JPM 2024 (Blast 1/2): Thoughts on AstraZeneca’s Acquisition of Gracell

Happy New Year! It’s great to be back in 2024 serving our growing audience!

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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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Could Abecma and Carvykti Be Approved in January 2024? Obe-cel MAA Could Happen in Q1 2024; December CHMP Highlights

On Friday, December 15, the CHMP meeting highlights were released. Of note, Carvykti (JNJ / Legend’s BCMA CAR-T) was absent from the CHMP highlights, implying that the Type II Variation (T2V) for its approval in ≥2L MM has received a second Request for Supplementary Information (RSI). Moreover, recall that the Abecma (BMS / 2seventy’s BCMA CAR-T) T2V in ≥3L MM was not included on Monday’s CHMP agenda. Below, Celltelligence provides insights on the December CHMP meeting with updated EU timelines for both cell therapies, while discussing the possible timeline for obe-cel accelerated assessment. 

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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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Anito-cel Elicits Improved Responses Across HR Subgroups; Gracell’s GC012F Shows Best-In-Class Safety and Efficacy Profiles; Increased Lymphodepleting Dose Enhances P-BCMA-ALLO1’s Responses Significantly; ASH 2023 Analysis 6

ASH 2023 Analysis 6: Arcellx, Gracell, and Poseida presented updated clinical data about their cell therapies in multiple myeloma. 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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A New Pivotal Trial for Caribou’s CB-010 in ≥2L LBCL to Start in 2024; Is the FDA Changing Perspective on the Clinical Development of Allogeneic CAR-Ts in Earlier Lines?

On Tuesday, December 12, Caribou announced (press release) positive FDA feedback for the initiation of a Ph3 trial evaluating CB-010 (allogeneic CD19 CAR-T; PD-1 KO + TCR KO) in patients with ≥2L LBCL, set to start by YE 2024. Below, Celltelligence provides insights on the significance of the FDA’s decision, discussing the possible outcomes of CB-010 in ≥2L LBCL and the hurdles that Caribou could encounter along the clinical development of its lead asset.

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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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JNJ / AbelZeta and Mustang Bio Present Clinical Updates from their Assets Targeting CD20 in NHL; ASH 2023 Analysis 5

ASH 2023 Analysis 5: JNJ / AbelZeta and Mustang Bio presented clinical updates from assets targeting CD20 in NHL. 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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Breyanzi Demonstrates Excellent Efficacy in 2L HR FL; Galapagos’s Point-of-Care Manufactured GLPG5101 Shows a Promising Efficacy and Safety Profile; ASH 2023 Analysis 4

ASH 2023 Analysis 4: BMS and Galapagos presented updated clinical data about their cell therapies in lymphoma. 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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Breyanzi Demonstrates Long Duration of Response in 2L Transplant Ineligible LBCL and Consistent RW Results Regardless of Comorbidities in R/R LBCL; Prior Bridging Therapy Does Not Impact Yescarta Efficacy or Safety in R/R LBCL; ASH 2023 Analysis 3

ASH 2023 Analysis 3: Gilead (Kite) and BMS presented real-world (RW) and clinical data updates in r/r LBCL. 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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Obe-cel Demonstrates Promising Efficacy in Patients with Low Leukemia Burden; Pooled Analysis from ALLCAR19 and FELIX Trials Suggests Long Durability of Response; ASH 2023 Analysis 2

ASH 2023 Analysis 2: Autolus presented updated clinical data from its lead asset obe-cel (CD19 CAR-T). 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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Could Carvykti Receive a Positive Opinion this Week? The Obe-cel Accelerate Assessment to Be Discussed for Adoption; December’s CHMP Agenda

On Monday, December 11, the CHMP Agenda for December was released. Of note, Carvykti (JNJ / Legend’s BCMA CAR-T) was included in the ‘Type II Variations – Opinions or Requests for Supplementary Information’ section for ≥2L MM, while Abecma (BMS / 2seventy bio’s BCMA CAR-T) Type II Variation for ≥3L MM was absent from the agenda.

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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