Tag Archives: Gilead

JPM 2021 Day 2: Gilead and SpringWorks

On the second day of JPM 2021, Celltelligence covered presentations by Gilead (presentation) and SpringWorks (presentation). Below, Celltelligence provides a topline summary of key takeaways from each company followed by more in-depth coverage below.

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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 Tecartus Conditional Marketing Authorization for r/r MCL; UPDATED: US CAR-T Approvals Table

New content: The Celltelligence team has included and updated its CAR-T indications table for estimated approvals and submissions in the US (see below for download). 

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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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AUTO3 Outpatient Data in the Ph1/2 ALEXANDER Study; Updated Results for Liso-cel in the TRANSCEND CLL 004 Trial; ZUMA-5 Primary Analysis and Re-treatment; ASH Day 3

On the third day of ASH 2020, four key clinical updates were presented from Autolus, BMS and Gilead. Below, Celltelligence provides insights and context for each presentation.

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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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ZUMA-12 Reports an 85% ORR in 1L DLBCL; Liso-cel’s Safety Profile vs Kymriah and Yescarta; Comparison of OOS Use of CD19 Commercial CAR-Ts; ASH Day 2

On the second day of ASH 2020, four key clinical updates were presented from Novartis, Gilead, and BMS / bluebird bio. Below, Celltelligence provides insights and context for each presentation.

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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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CHMP Adopts Positive Opinion for Gilead’s Tecartus in r/r Mantle Cell Lymphoma

On Friday, October 16, Gilead announced (press release) that the CHMP has adopted a positive opinion for Tecartus (brexucabtagene autoleucel, formerly KTE-X19) in ≥3L r/r mantle cell lymphoma (MCL). If approved by the EC, Tecartus would become the first and only CAR-T treatment approved for r/r MCL in Europe. Below, Celltelligence provides thoughts on Tecartus’s positive CHMP opinion and the likelihood of Gilead onboarding EU centers within 30 days of EC approval.

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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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Gilead Highlights No Impact of COVID-19 on Yescarta Sales; Two New LCM Initiatives for Yescarta; Q2 2020 Earnings Call Summary

On Thursday, July 30, Gilead held their Q2 2020 earnings call (press release / financial report / presentation). The company highlighted resilient Yescarta sales despite the COVID-19 pandemic, growing 11% QoQ and 37% YoY WW. Of note, Gilead highlighted the recent approval of Tecartus and ongoing LCM efforts for both approved CAR-T’s. Below Celltelligence highlights key LCM initiatives for 2021 and the significance of a synergistic authorized treatment center (ATC) onboarding protocol for Gilead.

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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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Thoughts on Gilead’s Recent FDA Approval for Tecartus (KTE-X19) in R/R Mantle Cell Lymphoma

On Friday, July 24, Gilead announced (press release) FDA accelerated approval of Tecartus (brexucabtagene autoleucel, formerly KTE-X19), the first and only CAR-T treatment for r/r mantle cell lymphoma (MCL). Priority review for Tecartus was based on results from the Ph2 ZUMA-2 trial; a single-arm, open-label study in which 87% of patients responded, with a 62% CR rate. Below, Celltelligence provides manufacturing insights between Yescarta/Tecartus, and how Gilead’s onboarding policy may influence competitors’ future roll-out of additional CAR-T products.

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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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Gilead Announces EMA Approval for End-to-End Yescarta CAR-T Manufacturing at Amsterdam Facility

On Friday, June 12, Gilead announced (press release) that the European Medicine Agency (EMA) has approved the company’s Amsterdam facility for end-to-end manufacturing of Yescarta. Below, Celltelligence highlights the potential impact on Yescarta’s EU turn-around-time (TAT), and the effect this may have on Kymriah sales.

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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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