Tag Archives: CD19 CAR-T

Thoughts on Breyanzi’s Continuing EU Regulatory Delays; Will Kymriah Receive a Positive CHMP Opinion for R/R FL in December 2021? No Updates for Tecartus, Cilta-cel, and Yescarta in October’s CHMP Agenda

On Monday, October 11, the CHMP agenda for October was released. Of note, Breyanzi (BMS’s CD19 CAR-T) is listed under the ‘List of outstanding issues (LoOI)’ section, while Kymriah (Novartis’s CD19 CAR-T) has been listed under ‘Type II variations’ to include ≥3L r/r FL as a new indication. No updates were observed for Tecartus (Gilead’s CD19 CAR-T), cilta-cel (JNJ / Legend’s BCMA CAR-T), or Yescarta (Gilead’s CD19 CAR-T). Below, Celltelligence provides likely EU approval timelines for Breyanzi and Kymriah.

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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 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

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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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Thoughts on Novartis’s Ph3 BELINDA Trial Failure; Will Novartis Continue Pursuing Kymriah in the 2L DLBCL Setting?

Recently, Novartis reported (press release) that their Ph3 BELINDA study evaluating Kymriah (CD19 CAR-T) in 2L NHL did not meet its primary endpoint (EFS) compared to the standard of care (SoC). Below, Celltelligence provides insights on how Novartis’s trial design could have potentially contributed to BELINDA’s failure, while discussing alternative approaches that Novartis may take to stay in the 2L DLBCL setting.

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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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JW Tx’s Relma-cel (JWCAR029; CD19 CAR-T) Approved in China as Benoda for ≥3L R/R LBCL

On Friday, September 3, the Chinese NMPA announced (press release) the approval of JW Therapeutic’s relma-cel (relmacabtagene autoleucel / JWCAR029; CD19 CAR-T) in ≥3L r/r LBCL. Of note, relma-cel will be commercialized under the brand name Benoda. Below, Celltelligence provides insights on potential reimbursement hurdles JW Tx may face in China, while discussing Kymriah’s (Novartis’s CD19 CAR-T) delayed Chinese 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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UPDATED: Indications Table for CD19 CAR-T US Approvals and Submissions

New content: The Celltelligence team has updated their CD19 CAR-T indications table for estimated US approvals and submissions following key Q2 2021 earnings presentations and recent press releases (see below for download).

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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 Consolidates Their Position as Market Leader; Could Tecartus in R/R Adult ALL Receive A Positive CHMP Opinion By YE 2021? Gilead’s Q2 2021 Earnings Call Summary

On Thursday, July 29, Gilead held their Q2 2021 earnings call (press release / presentation) highlighting an increase in overall revenue for their cell therapy franchise, while discussing the benefits of a potential FDA approval for Yescarta (CD19 CAR-T) in 2L r/r DLBCL. Furthermore, management highlighted the submission of a Type II variation to the EMA for Tecartus (CD19 CAR-T) in r/r adult ALL. Below, Celltelligence provides insights on how Gilead may leverage Yescarta’s and Tecartus’s expansion into new indications to consolidate their position as a cell therapy market leader, while discussing likely EU approval timelines for Tecartus.

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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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First Patient Dosed With Precision’s Stealth Cell PBCAR19B

On Thursday, July 1, Precision BioSciences announced (press release) that the first patient has been dosed with PBCAR19B (stealth allogeneic CD19 CAR-T) in the Ph1 trial for r/r NHL. Below, Celltelligence discusses Precision’s stealth cell program while providing insights on how Precision could apply learnings from PBCAR19B’s dosing strategy to other programs.

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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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New Gilead-Sponsored Post-Marketing Trial for Tecartus (ZUMA-2 Cohort 3) in R/R MCL

On Monday, May 10, a new post-marketing Tecartus Ph2 ZUMA-2 Cohort 3 trial in r/r MCL was observed on CT.gov. Below, Celltelligence provides insights on the study’s design and how Gilead could leverage this trial to gain a full FDA approval for Tecartus.

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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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Kymriah’s Sales Continue to Grow; Novartis Q1 2021 Earnings Call Summary

On Tuesday, April 27, Novartis held their Q1 2021 earnings presentation (press release / presentation) highlighting Kymriah’s continued growth. Of note, no major clinical or regulatory updates were reported. Below, Celltelligence provides its latest US ATC count and insights on how Novartis’s expanding ATC footprint could have facilitated Kymriah’s continued sales growth compared to key competitor Gilead (Kite).

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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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