Category Archives: CAR-T

Carvykti’s FDA Approval Anticipated Around February 28, 2022; JNJ Q4 2021 Earnings Call Summary

On Tuesday, January 25, JNJ held their Q4 and FY 2021 earnings call (press release / presentation) highlighting Carvykti’s (BCMA CAR-T; cilta-cel) anticipated FDA approval around February 28, 2022. Below, Celltelligence provides insights on how JNJ may leverage Carvykti’s best-in-class profile to quickly gain market share following launch.

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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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Could Breyanzi Receive a Positive CHMP Opinion This Week? Tecartus Continues to Experience Delays; January’s CHMP Agenda

On Monday, January 24, the CHMP agenda for January was released. Of note, Breyanzi (BMS’s CD19 CAR-T) is listed under the ‘Opinions’ section. No other key cell therapy-related updates were observed. Below, Celltelligence provides insights on the potential EU approval timeline for Breyanzi, while discussing regulatory timelines for Kymriah and Yescarta in r/r FL, Tecartus in r/r adult ALL, and Carvykti in r/r MM.

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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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Abecma Approved in Japan; Can BMS Meet the Increased Manufacturing Demand? Novartis and Pack Health Explore Digital Coaching to Improve Quality of Life Outcomes Following CAR-T Treatment

On Thursday, January 20, BMS announced (press release) that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Abecma (BCMA CAR-T) for the treatment of ≥4L r/r MM. Moreover, a new clinical study evaluating the feasibility of a Digital Health Coaching Program for individuals who have received CAR-T therapy was observed on CT.gov. Of note, Pack Health is the sponsor of the trial with Novartis and Ohio State University Comprehensive Cancer Center appearing as collaborators. Below, Celltelligence provides insights on Abecma’s potential market access in Japan, while commenting on how the current viral vector shortage could limit BMS’s ability to deliver Abecma in Japan.

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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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JPM 2022 Day 3 & 4: Precision and TCR2 Tx

On the third and fourth (final) day of JPM 2022, Celltelligence covered presentations by Precision BioSciences (presentation) and TCR2 Tx (press release / corporate presentation). 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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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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Gracell to Open an R&D Facility in the US; JPM 2022 Days 2 & 3: Legend, Allogene, and Autolus

A series of cell therapy-related news items have been observed:

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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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Mark Gergen Appointed as Poseida’s New CEO; Poseida and 2seventy Provide Business Updates for 2022; Allogene’s Collaboration with Antion Bio for miCAR Technology; JPM 2022 Day 2 Part 1: GSK and SpringWorks

A series of cell therapy-related news items have been observed:

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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Allogene’s FDA Clinical Hold Lifted; JPM 2022 Day 1: BMS, Novartis, JNJ, and Gilead

On Monday, January 10, Allogene (press release) announced that the FDA has lifted the clinical hold on their AlloCAR-T programs. Moreover, on the first day of JPM 2022, Celltelligence covered presentations by BMS (press release / presentation), Novartis (presentation), JNJ (press release), and Gilead (presentation). 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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Kymriah Absent From December’s CHMP Highlights

On Friday, December 17, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, no updates from Kymriah’s Type II variation in r/r FL were observed. Below, Celltelligence provides updated likely EU approval timelines for Kymriah, Yescarta, Tecartus, Breyanzi, and Carvykti (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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Daiichi Sankyo Authorizes Yescarta’s First Treatment Center in Japan 11 Months After Approval

On Thursday, December 16, Gilead (Kite) announced (press release) that Daiichi Sankyo has authorized Yescarta’s (Gilead’s CD19 CAR-T) first treatment center in Japan. Below, Celltelligence provides insights on how Yescarta’s footprint in Japan may potentially increase Gilead’s (Kite) WW market revenue, while discussing differences in ATC onboarding rates between the US and Japan.

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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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Novartis May Apply Learnings from BELINDA’s Failure to YTB323 in 2L DLBCL; How Could Novartis Position Their Novel T-Charge Manufacturing Platform in 2L DLBCL and MM Settings? Yescarta’s ZUMA-12 Demonstrates an 89% ORR in 1L DLBCL; ASH 2021 Day 3

On the last day of ASH 2021, 6 clinical updates were presented by Novartis and Gilead (Kite). 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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