Tag Archives: Gilead

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 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:

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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 (Kite) and 2seventy Bio Present Study Designs for their Next-Generation Assets Targeting Hematologic Malignancies; ASCO 2022 Analysis 3

ASCO 2022 Analysis 3: Gilead (Kite) and 2seventy bio reported study designs for their novel assets treating B cell malignancies. 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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Gilead’s Cell Therapy Sales Continue to Grow; Gilead’s New Manufacturing Facility Could Accelerate Yescarta’s Launch in 2L LBCL; Gilead’s Q1 2022 Earnings Call Summary

On Thursday, April 28, Gilead (Kite) held their Q1 2022 earnings call (press release / presentation) highlighting an increase in revenue for their cell therapy franchise, while discussing new clinical developments for Yescarta (CD19 CAR-T). Additionally, management noted the FDA approval of their state-of-the-art manufacturing site in Frederick, MD. Below, Celltelligence provides insights on how Gilead’s new cell therapy facility could assist Yescarta’s expected increase in demand, while discussing Yescarta’s expansion into 2L LBCL.

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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’s Oncology Deep Dive 2022: Celltelligence Analysis – Part 2

On Thursday, April 14, Gilead / Kite held their Oncology Deep Dive event (presentation) highlighting a rapid manufacturing process, while discussing strategies to remain innovative in the cell therapy space via robust collaborations and novel technologies. Below, Celltelligence provides a second round of insights on Gilead / Kite’s rapid manufacturing and off-the-shelf cell therapy candidates.

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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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CHMP Adopts Positive Opinion for Yescarta in ≥4L FL; Yescarta in 2L DLBCL Absent from April’s CHMP Meeting

On Friday, April 22, the CHMP meeting highlights were released following Tuesday’s CHMP agenda. Of note, the CHMP adopted a positive opinion for Yescarta (Gilead / Kite’s CD19 CAR-T) in ≥4L r/r FL. Additionally, Yescarta’s Type II variation for 2L DLBCL was absent from April’s CHMP meeting. Below, the Celltelligence team provides thoughts on Yescarta’s positive opinion in r/r FL, while providing updated EU timelines for Yescarta in 2L DLBCL.

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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’s Oncology Deep Dive 2022: Celltelligence Analysis – Part 1

On Thursday, April 14, Gilead / Kite held their Oncology Deep Dive event, highlighting their differentiated pipeline, with key updates to their cell therapy platforms, including several new clinical trials (Presentation). Below, Celltelligence provides insights on Gilead / Kite’s expansion of Yescarta and Tecartus (CD19 CAR-Ts) into earlier lines of therapy / additional indications.

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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 and Kymriah Product Attributes; Early Results from Gracell’s GC502 Ph1 Study in r/r B-ALL; Legend’s LB1901 Ph1 Study Design in r/r TCL; AACR 2022 Analysis 3

AACR 2022 Analysis 3: Several clinical updates were presented by Gilead, Novartis, Gracell, and Legend. Below, Celltelligence provides insights and context for each presentation. 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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Thoughts on Yescarta’s FDA Approval in 2L LBCL

On Friday, April 1, Gilead (Kite) announced (press release) that the FDA has approved Yescarta (CD19 CAR-T) in 2L LBCL. Of note, Yescarta is now approved for adult patients with LBCL that are refractory or have relapsed within 12 months of 1L chemoimmunotherapy, independent of their eligibility for ASCT. Below, Celltelligence provides insights on how Yescarta could become the CAR-T of choice for 2L LBCL while discussing Gilead’s (Kite) potential strategy to increase patient referrals for Yescarta over ASCT.

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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 Becomes the First Approved CAR-T for 2L LBCL in the US

On Friday, April 1, Gilead (Kite) announced (press release) that the FDA approved Yescarta (CD19 CAR-T) in 2L LBCL based on results from the Ph3 ZUMA-7 trial. Of note, Yescarta has become the first 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.   

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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