Tag Archives: Gilead

Yescarta’s Sales Decline; Gilead’s (Kite) New Manufacturing Facility in Maryland to Be Operational By Mid-2022; Health Canada Approves Tecartus in MCL; Gilead’s Q3 2021 Earnings Call Summary

On Thursday, October 28, Gilead held their Q3 2021 earnings call (press release / presentation) highlighting Yescarta’s (CD19 CAR-T) sales decline and the anticipated opening of their new manufacturing facility in Frederick County, Maryland. On the same day, Gilead announced (press release) that Health Canada has approved Tecartus (CD19 CAR-T) in r/r mantle cell lymphoma (MCL), based on results from the Ph2 ZUMA-2 trial. Below, Celltelligence provides insights on the potential impact of increased ATC competition on Yescarta’s Q3 sales revenue, while outlining likely US and EU approval timelines for Yescarta in 2L r/r DLBCL and Tecartus in r/r adult ALL. Finally, Celltelligence discusses Tecartus’s approval and reimbursement in Canada.

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Takeda to Acquire GammaDelta Tx; Will Gilead (Kite) Pursue Gadeta?

On Wednesday, October 27, Takeda announced (press release) that they aim to fully acquire GammaDelta Therapeutics during Q1 2022 of Takeda’s fiscal year. Below, Celltelligence provides insights on why Takeda’s acquisition of GammaDelta Tx makes sense, while discussing whether Gilead (Kite) could prioritize acquiring Gadeta.

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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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JNJ Prepares for Cilta-cel’s Upcoming Approval; Could JNJ’s / Legend’s New Patient-Focused Digital Platform and Sales Force Strategy Position Cilta-cel for a Successful Launch?

On Thursday, October 21, FiercePharma published an article (publication) discussing cilta-cel’s launch strategy with Serge Messerlian, Janssen’s US Oncology President. Messerlian commented on JNJ’s / Legend’s plan to develop a digital platform for cilta-cel (BCMA CAR-T) while confirming that cilta-cel and Darzalex (JNJ’s CD38 antibody for r/r MM; daratumumab) will have separate sales teams. Below, Celltelligence provides insights on how JNJ / Legend could leverage Darzalex’s patient-focused digital platform and sales force team to increase patient referrals for cilta-cel upon approval.

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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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Tecartus Website Analysis

On Wednesday, October 6, an update on Tecartus’s patient website was observed, with Gilead (Kite) now including Tecartus’s approval in r/r adult ALL. Below, Celltelligence provides an analysis on the updates included within the Tecartus website and insights into Tecartus’s messaging within the MCL and ALL setting.

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Gilead’s (Kite) Tecartus Receives FDA Approval for R/R Adult ALL

On Friday, October 1, Gilead (Kite) announced (press release) that the FDA has granted approval for Tecartus (CD19 CAR-T) in r/r adult ALL. Of note, Tecartus is the first approved CAR-T in the US for the treatment of adult ALL. Below, Celltelligence provides insights on how Tecartus’s approval in adult ALL compares with Kymriah’s pediatric and young adult ALL indication.

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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 the Evolution of the Cell Therapy Landscape; Will Traditional αβ CAR-T Cells be Replaced by Novel Cell Types?

Although cell therapy companies have traditionally used alpha beta (αβ) T cells to manufacture CAR-T therapies, the cell therapy field is rapidly evolving with an increasing number of companies developing novel and highly differentiated platforms. Below, Celltelligence discusses how CAR-derived therapies from natural killer (NK) cells, gamma delta (γδ) T cells, macrophages, and iPSCs could treat liquid or solid tumors and whether these novel cell types may overcome the challenges and limitations faced by conventional CAR-Ts.

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Tecartus Receives FDA Approval for R/R Adult ALL

Late on Friday, October 1, Gilead (Kite) announced (press release) the US approval of Tecartus (CD19 CAR-T) in r/r adult ALL. Tecartus has become the first and only CAR-T therapy approved in r/r adult ALL. The Celltelligence team will be conducting a full analysis of Tecartus’s approval 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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GSK Explores Better Patient Selection Methods for Lete-cel; Could 2seventy bio Nominate Medigene’s PRAME TCR-T as Their Second Target? Adaptimmune Presents Preclinical Data from ADP-A2M4CD8; No Updated Preclinical Results from Carisma; Tecartus Absent from CHMP Highlights; ESMO 2021 Day 1&2

On the first two days of ESMO 2021, four key pre-clinical and clinical presentations from GSK, Medigene, Adaptimmune, and Carisma were presented. On Friday, September 17, the CHMP highlights for September were released. Of note, no updates from Tecartus’s Type II variation for r/r adult ALL were observed. Below, Celltelligence provides insights and context for each presentation, while providing likely EU approval timelines for Tecartus.

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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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FDA Accepts Gilead’s KITE-363 (CD19 x CD20 CAR-T) IND in LBCL

On Thursday, August 19, Gilead (Kite) announced (press release) that the FDA has accepted the IND for KITE-363 (CD19 x CD20 CAR-T) in LBCL. Below, Celltelligence provides details on KITE-363’s IND application while discussing potential competition KITE-363 may face upon 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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Breyanzi’s EU Approval Continues to Face Delays; Could Yescarta Receive an EC Approval for R/R FL by November 2021? No Mention of Cilta-cel in August’s CHMP Agenda

On Monday, August 16, the CHMP agenda for August was released. Of note, BMS has requested an additional clock-stop extension for Breyanzi (CD19 CAR-T), while Yescarta (Gilead’s CD19 CAR-T) has been listed under Type II variations to include ≥4L r/r FL as a new indication. Furthermore, no updates were observed for cilta-cel (JNJ’s / Legend’s BCMA CAR-T). Below, Celltelligence provides likely EU approval timelines for Breyanzi, Yescarta, and cilta-cel.

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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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